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Evidenze cliniche per l'uso di fasce addominali e un nuovo design radicale per renderle più efficaci

A literature review of complications after major abdominal surgeries, the use of ordinary abdominal binders, and presentation of a new generation of binders.

The purpose of this document is to review the available data of the status of major abdominal surgery (MAS), including the incidence of postoperative complications, costs, and readmission rates. The goal is to summarize the common principles of prevention of complications, and the role common abdominal binders are playing today as an adjunctive method to prevent complications.

A new abdominal binder design is described, how and why its features differ from ordinary binders, and a discussion follows on how the new design offers a significant upgrade in the way health care staff perform wound care and assists patients with mobilization. The conclusion summarizes key issues for a successful recovery of patients after major abdominal surgeries.

World Population and the Incidence of Major Abdominal Surgery (MAS)

Every year more than 300 million people worldwide have major abdominal surgery (MAS) This translates into about one operation for every 25 persons. Almost 75% of these surgeries are performed in less than a third of the world’s population and in countries that spend from $400 to $1000 per capita on healthcare. When more than $1000 is spent per person, roughly one of every eleven people will undergo a major surgery, while only 1out of every 339 people will have major surgery if US$100 or less per head is spent on health care. The latter group accounts for more than a third (34.8%) of the global population and only 3.5% (8.1 million) of all surgical procedures. In a period of just eight years (2004-2012), surgical interventions increased 33.6% with the largest proportional increase in countries who spent less than US$400 per capita on health care [1 -2]. This data shows that we can expect a continued significant increase in MAS in developing countries as they grow and increase health care spending per person.

Incidence, Type, Costs of Complications and Readmission Rates

…more than 40% of all postoperative complications occurred after discharge, and 75% of those happened 14 days after leaving the hospital.

Complication rates and mortality after abdominal surgery are difficult to compare due to the variety of interventions. One large study reported data from 250 US hospitals in a five year period (2005 through 2010) from more than 550,000 patients and found the overall complication rate was 16.7 % within 30 postoperative days. They also found more than 40% of all postoperative complications occurred after discharge, and 75% of those happened 14 days after leaving the hospital [3]. The 10 most common complications were superficial site infection (31.1%), organ space infection (13.9%), severe sepsis (11.4%), urinary tract infection (9.7%), deep surgical site infection (7.3%), wound dehiscence (4.7%), deep venous thrombosis (4.0%), pneumonia (3.7%), septic shock (2.7%), and pulmonary embolism (2.4%) [3].

Complications after major surgeries can be life threatening and require readmission which has huge economic implications. One study reported average costs for major abdominal surgery (MAS) to be US$ 9,785 per patient without complications. This amount almost doubled to US$ 17,570 after minor complications, and more than tripled to US$ 33,280 after major complications, which occurred in 20% of patients undergoing MAS and
accounted for 50% of the total costs of care[4].

 

…30-day readmission occurred in 11.4% of patients. Between 31 and 90 days readmission occurred an additional 11.9%, for a total 90-day readmission rate of 23.3% of patients.

A review of the commercial health insurance records over a 7-year period (2002-2008) of 10,882 patients who underwent colorectal surgery, showed that 30-day readmission occurred in 11.4% of patients. Between 31 and 90 days readmission occurred an additional 11.9%, for a total 90-day readmission rate of 23.3% of patients. The mean length of stay for readmission was 8 days, and the median cost was approximately $9000 per readmission, which adds up to $300 million in additional costs in the US per year for colorectal surgery alone [5].

Another study confirmed the readmission rate of 44,822 patients who underwent colorectal resection for cancer at 1401 US hospitals in a 5-year period (1997- 2002) who had an overall 30-day readmission rate of 12.3% [6].

Major abdominal surgery procedures represent an enormous challenge to the health care system. The incidence of complications is unacceptably high, and almost half occur after patients leave the hospital with most of them occurring within just weeks. The consequences are a significant number of readmissions and huge additional costs for health care providers.

Surgical Site Infections (SSI)

Surgical site infections have been reported in more than a third of all complications after major abdominal surgery (MAS), and the incidence is most likely underestimated since a significant proportion of cases are diagnosed after discharge [3].

Surgical site infections has been reported in more than a third of all complications after major abdominal surgery (MAS), and the incidence is most likely underestimated…

SSI contributes to prolonged stay in the hospital with a significant extra financial burden to the health care system. In a group of 2,250 patients, the total excess cost for SSIs was found to be $10,497 per case and led to an additional 4.3 days in the hospital [7]. Another group evaluated SSI in 7 categories of surgical procedures including gastrointestinal and colorectal interventions and found the length of stay extended by an average of 9.7 days in 6891 cases of 723,490 hospitalizations. This increased cost by $20,842 per admission, which from a US national perspective associated SSI with an additional 406,730 hospital-days and hospital costs exceeding $900 million. In addition, there would be 91,613 readmissions for treatment of SSI accounting for a further 521,933 days of care at a cost of nearly $700 million [8].

The incidence of SSI after MAS has been reported to be 15%–25% [9 - 10], and is the most common reason for unplanned readmission with a rate of 19.5% [11]. It is thought that up to half of SSIs can be prevented, and preventive measures, such as better optimization of patients prior to surgery, improved surgical and sterile techniques and management of patients during the recovery period has been advocated in order to prevent SSIs [12].

A model to predict patients at high risk for surgical site infection was developed in order to implement appropriate preventive strategies with fourteen variables identified to be independently associated with increased risk of SSI: age over 40 years, diabetes, dyspnea, use of steroids, alcoholism, smoking, recent radiotherapy, American Society of Anesthesiologists (ASA) class 2 or higher, preoperative laboratory values (albumin<3.5 mg="" dl="" total="" bilirubin="">1.0 mg/dL), and operative characteristics (emergency, complexity, type of procedure, and wound classification) [13].

SSI rates remain high even with implementation of preventive measures which is concerning since SSI is associated with more than doubling the risk of mortality [14].

The incidence of SSI after MAS has been reported to be 15%–25%, and is the most common reason for unplanned readmission…

Abdominal Wound Dehiscence (AWD)

The incidence of abdominal wound dehiscence, one of the most serious postoperative complications, ranges between 0.3-3.5% and as high as 10% among the elderly, with a mortality rate as high as 45%.

The incidence of abdominal wound dehiscence, one of the most serious postoperative complications, ranges between 0.3-3.5% and as high as 10% among the elderly, with a mortality rate as high as 45% [15-16]. An incidence of 2.9% of AWD was reported in a group of 1,879 patients undergoing intra-abdominal procedures. Patients developed wound dehiscence on average at the eight postoperative day and about 80% of these patients were operated on as an emergency procedure with a mortality rate of 25%. Patients who developed abdominal wound dehiscence had a higher rate of wound infection, circulatory insufficiency, increased length of hospital stay, and were more likely admitted to the ICU [15].

Improved suture materials and peri-operative care have not changed the rates of abdominal wound dehiscence and mortality over the past decades. This could be related to increased risk factors within patient populations, offsetting the benefits of improved surgical techniques and better materials[16]. The identified risk factors for individual patients can be entered into a formula to calculate the probability for developing abdominal wound dehiscence. The risk factors are age (>65 years old), gender (male), smoking, obesity, chronic steroid therapy, anemia, jaundice, uremia, diabetes, low albumin level, chronic obstructive pulmonary disease (COPD), cancer, wound infection, and emergency surgery. The calculation can obviously not consider postoperative factors such as coughing and wound infection. It is worthwhile to note that broken sutures and loose knots accounted for 12% of the abdominal wound dehiscence cases, underlining the importance of good surgical technique [16].

In a literature review it was concluded that increased abdominal wall force due to rises in intra-abdominal pressure, and the chosen method of closure could play a role in the occurrence of abdominal wound dehiscence. Potential under reporting of wound dehiscence resulting from a lack of clarity around the definitions is highly likely as SSI does not translate directly into dehiscence [17].

Potential under reporting of wound dehiscence resulting from a lack of clarity around the definitions is highly likely as SSI does not translate directly into dehiscence.

Incisional Hernia (IH)

The incidence of hernia has been found to range from 2% to 20% and is significantly higher for midline incisions…

Incisional hernia can develop after any type of abdominal wall incision. The incidence of hernia has been found to range from 2% to 20% and is significantly higher for midline incisions compared with transverse incisions (11% vs. 4.7%), while the overall incidence of incisional hernia was 9.9% after laparotomy and only 0.7% after laparoscopy [18-19]. In a review of almost 15,000 patients by pooling the published literature, the incidence of IH was found to be 12.8% after about two years [20], while a five year follow-up of 200 high risk patients showed an incidence as high as 69% [21]. In an analysis of 775 patients the rate of IH increased significantly from 12.6% at one year after surgery to 22.4% three years later. This shows that a one year follow-up is not adequate to detect incisional hernia [22].

Hernia has a significantly negative effect on a patient’s quality of life and represents considerable additional health care costs. In a study of more that 12,000 patients the independent risk factors for IH were identified as ostomy reversal, recent chemotherapy, bariatric surgery, smoking history, liver disease, and obesity. Of the high-risk patients, 20.6% developed IH compared with 0.5% of low-risk patients ([23]. In the guidelines for closure of abdominal wall incisions from the European Hernia Society, postoperative surgical site infection, obesity, and abdominal aortic aneurysm were listed as risk factors for incisional hernias. Additionally, it was pointed out that suture material and the surgical technique used to close an abdominal wall incision were the most important determinants of the risk of developing an IH [24].

 

Even with the high incidence of incisional hernia there are practically no proactive strategies to prevent hernia described in the surgical literature which is contrary to how to repair a hernia.

Postoperative Pulmonary Complications (PPCs)

PPCs after major elective abdominal surgery are under-reported as they are not part of the current hospital quality measures. Yet, PPCs are a major cause of peri-operative morbidity and mortality.

Postoperative pulmonary complications (PPCs) after major elective abdominal surgery are under-reported as they are not part of the current hospital quality measures. Yet, PPCs are a major cause of peri-operative morbidity and mortality [25]. The development of any PPC is associated with significant morbidity reflected in worse 7-day and 30-day outcomes. Estimates for the incidence of PPCs have been found to be between 5% and 40%, and PPCs were associated with a 30-day mortality rate of 18% compared with 2.5% for patients without PPCs. Moreover, the hospital duration of stay was prolonged by six to nine days, and increased costs of healthcare by an additional $30,000 per patient [26]. In a prospective multi-center cohort study of 268 patients, the incidence of PPC was 11.9%, and it was confirmed that PPCs were associated with three times higher healthcare costs compared with other complications [26].

A number of factors are involved with the cause of PPCs, including ventilation-perfusion mismatch and hypoxemia
(a consequence of general anesthesia), postoperative pain, diaphragmatic dysfunction, decreased chest wall compliance, and depressed airway reflexes [27-28].

…the incidence of PPCs have been found to be between 5% and 40%,
and PPCs were associated with a 30-day mortality rate of 18%…

Chronic Post Surgical Pain (CPSP)

…CPSP is a major, largely unrecognized clinical problem, and the incidence of CPSP is most likely underestimated.

Chronic post surgical pain (CPSP) is a major, largely unrecognized clinical problem, and the incidence of CPSP is most likely underestimated. Acute postoperative pain is followed by CPSP in 10–50% of patients after common surgeries and can be severe in about 2–10% [29]. In follow-up data on longer term hernia repair, pain persisted in 8.1-19% of patients for up to six years, with severe pain present in 1.8%. Associated factors for development of CPSP are increased length of surgery, low volume surgical unit, open vs laparoscopic surgery, and standard hernia repair; all factors that may cause greater surgical trauma and point to intra-operative nerve injury as a likely cause [30].

The ability to cough or breathe deeply after surgery is compromised by pain and may result in atelectasis or pneumonia. Reduced mobility and subsequent venous thrombosis have also been connected to unrelieved pain. Although most patients receive some form of pain assessment and management after surgery, it is estimated that between 50% and 75% of patients do not get adequate pain relief. Severe unrelieved postoperative pain is a common reason for delayed discharge and can radically complicate patient recovery, resulting in higher healthcare costs. CPSP has a major impact on health-related quality of life, physical functioning and emotional well-being, as well as economic productivity. It is difficult and costly to treat, and increased health service use is associated with higher costs.

The ability to cough or breathe deeply after surgery is compromised by pain and may result in atelectasis or pneumonia.
…it is estimated that between 50 and 75% of patients do not get adequate pain relief.

The burden of CPSP is enormous considering the volume of surgical procedures performed annually. For this reason, the development of interventions that prevent chronic pain after surgery has the potential to have a major impact on public health [31-33].

Status of postoperative complications after MAS

In summary, postoperative complications after major abdominal surgeries (MAS) represents a significant burden for healthcare providers worldwide. Table 1, shows the overall incidence of complications and readmission rates after MAS including the additional duration of stay and the related costs per case. Table 2, shows the incidence, mortality and costs (where available) for each of the common complications.

Table 1. Overall complication rates after MAS, additional duration of stay and costs.
Overall rate of complications after MAS: Incidence post discharge: Readmission rate: Extra duration of stay: Extra cost per readmission:
16,7 % within 30 days [3] 40% after discharge - of which 75% within 2 weeks [3] 11.4% - 12.6% at 30 days 23.3% at 90 days [5,6] Average 8 days [5] $9000 [5]

 

Table 2. Incidence, mortality, cost per complication.
Complication after MAS: Incidence: Mortality: Cost per case:
Surgical site infections 15% to 25% [9, 10] “doubling” of risk [14] $10,497 to $20,842 [7, 8]
Abdominal wound dehiscence 0.3% to 3.5% [15, 16] 25% to 45% [15, 16] -
Incisional hernia 2% to 20% [18, 19] - -
Incisional hernia 2% to 20% [18, 19] - -
Postoperative pulmonary complications 5% to 40% [26] 18% [26] $30,000 [26]
Chronic post surgical pain 10% to 50% [29] - -

As developing countries most likely continue to increase health care spending per capita, the numbers of MAS will increase, including the related additional costs of treating complications. It is striking to note that 40% of complications after MAS occur after discharge. This should lead to further examination of the postoperative period, and particularly the period after leaving the hospital. It is therefore crucial to evaluate effective methods to prevent and to decrease the incidence of postoperative complications.

Prevention of complications

Prevention of postoperative complications are being addressed preoperatively by seeking to identify the patients at risk and prescribe breathing exercises, weight loss, smoking cessation and other preventive measures before surgery. Other common preventive methods include scrupulous sterile technique, reduction of surgery time to avoid intra-operative contamination, the use of an antibiotics regime, control of postoperative pain by proper pain medication administration, prevention of respiratory complications by respiratory exercises, early mobilization, and gentle manipulation of tissues. In spite of preventive measures, the incidence of complications has not changed over the last decade and readmission rates remain high.

Stabilization of the abdominal wound is an important aspect of postoperative care to prevent wound complications…

Stabilization of the abdominal wound is an important aspect of postoperative care to prevent wound complications such as dehiscence, infections, and hernia formations. At the same time, coughing is a necessary postoperative activity to expel accumulated secretions after anesthesia in order to clear the lungs of atelectasis. However, engaging the abdominal muscles and the diaphragm in the process of coughing results in a brief, yet significant increase in intra-abdominal pressure (IAP) of up to 300 mmHg. Likewise, when patients use the Valsalva Maneuver (attempting to exhale against closed airways) when getting out of bed and into an upright position, it may increase the IAP pressure from 150 up to 340 mmHg [53]. Deep breathing, sneezing, laughing, or straining during defecation likewise increase the IAP, causing tension and pain in the postoperative wound.

Patients instinctively tend to avoid pain by supporting the abdomen with their hands after abdominal surgery, particularly when they have to cough, sneeze, strain, or get out of bed. They will make a conscious glottis closure, which engages the diaphragm and postural muscles to contract, and while the intention is to reduce pain, it will increase the intra-abdominal pressure, which may instead increase pain. Moreover, when patients are sitting on the edge of the bed to get up, they most likely will stabilize the wound with their hands, when they should be using their arms to preserve balance in getting to an upright position.

The use of an effective abdominal binder to support the wound in the early postoperative period may be crucial for wound stabilization, pain control and to give a better support than the patient’s own hands can give.

Breathing exercises and early mobilization are the foundations of postoperative management after major abdominal surgeries. The use of proper technique to get in and out of bed is one of the most important teachings to patients after surgery to prevent complications resulting from uncontrolled pressure increase and dangerous tension on the wound. The use of an effective abdominal binder to support the wound in the early postoperative period may be crucial for wound stabilization, pain control, and to provide a better support than the patient’s own hands can give. Logically, binders may assist in preventing postoperative complications such as dehiscence, infections, and hernia, as well as decreasing pain during activities, providing comfort and giving the patient a sense of security.

Publications of abdominal binder usage

Relatively few researchers have evaluated whether abdominal binders could be a cost effective adjunctive method to reduce the risk of complications after MAS. Postoperative care depends mostly on tradition, surgeons’ habits, and common beliefs. For example, 94% of French surgeons who responded to a questionnaire survey, said they tended to apply binders after abdominal surgery because they believed the binder would increase the comfort for patients, decrease pain, and prevent the formation of hernia [34].

One of the first prospective randomized trials of using binders after MAS was published in 1983. A small group of 31 patients were evaluated for postoperative respiratory function, comfort and pain. Both an elastic and a rigid binder (none of them identified) were used and compared with a control group. The elastic binder group appeared to improve both respiratory function and comfort of patients, while the rigid binder made them worse [35].

The elastic binder group appeared to improve both respiratory function and comfort of patients…

Perhaps due to the fact that there was just a weak indication of a potentially simple method to decrease postoperative complications, it took about 25 years before additional investigations of the use of abdominal binders appeared. In a prospective trial of 54 patients undergoing midline laparotomy incisions, patients were randomized in an unidentified elasticized binder and a no-binder group. The effect on postoperative pulmonary function was evaluated, and the conclusion was that abdominal binders had no significant negative effect on pulmonary function, and they seemed to help with controlling pain [36].

… the conclusion was that abdominal binders had no significant negative effect on pulmonary function, and they seemed to help with controlling pain.

In another trial including a total of 37 patients randomized to use an elasticized binder (not identified) against a no-binder group, no significant difference could be observed between the groups when investigating treatment with oxygen and bronchodilators, signs of pulmonary complications, rate of mobilization, pain when changing position from supine to sitting, and length of hospital stay. The authors concluded there was no objective clinical effect of a routine use of an elastic binder after MAS, although the majority of patients found it comfortable especially during the first postoperative days [37].

…no objective clinical effect of a routine use of an elastic binder after MAS, although the majority of patients found it comfortable especially during the first postoperative days.

Another prospective trial included 75 patients randomized to wear an elasticized binder (not identified) or nothing after MAS. The effect of the binder on postoperative walk performance (mobility), perceived distress, pain, and pulmonary function was evaluated. These authors described that the elasticized binder was applied over the abdominal surgical incision with the upper border not higher than the lower margin of the rib cage to ensure minimal restriction of lateral costal expansion and diaphragmatic movement. Holes were cut in the binder for patients who had stomas, drains, other lines or tubes inserted during surgery to ensure that no pressure was applied over these devices.

Furthermore, patient comfort determined the tension of the binder, although to achieve the best benefits from the binder the aim was to apply it firmly with the binder circumference 10-20% smaller than the patient’s postoperative abdominal circumference measured at the level of the umbilicus. The binder group improved significantly in walk performance on the 5th postoperative day, had less perceived stress, and reported significantly less pain getting in and out of bed and when walking around, and there was no difference in the suppression of pulmonary function between the groups. Since immobility and pain are modifiable risk factors for development of venous thromboembolism and pulmonary morbidity after MAS, these authors supported that abdominal binders can improve early mobilization, decrease pain, and possibly prevent other postoperative complications [38].

The binder group improved significantly in walk performance on the 5th postoperative day, had less perceived stress and had significantly less pain getting in and out of bed and when walking around, and there was no difference in the suppression of pulmonary function between the groups.

In the aforementioned studies there was no identification and none, or limited description of the elasticized binder used, such as type of material, elasticity, degree and method of closure, or abdominal area covered by the binder, particularly with regards to the upper abdominal region and lower part of the rib cage.

…if a binder makes rehabilitation after surgery better and more patients could benefit, the result would be cost savings for the health care system.

A study of 46 patients randomized to wear an elastic binder postoperatively or no binder after midline laparotomy was the first to identify the binder used (Nordicare, Sweden). However, there was no further description of the device such as elasticity, degree of closure, or other variables in binder design. The authors pointed out that a standard elastic binder has a cost from 80 to 155 euros, and a tailor-made girdle could cost as much as 1,600 euros. It was contended that if a binder makes rehabilitation after surgery better and more patients could benefit, the result would be cost savings for the health care system. The trial did not show any significant difference in pulmonary function, coughing, intra-abdominal pressure, or wound healing, but did confirm a significant decrease in pain in the binder group. It was thought that reasons for the reduction in pain could be related to less displacement of the abdominal wall and support of the natural muscle girdle [39].

Another study, involving some of the same authors and the same type of binder was the first study to investigate compliance and patient experience by means of a questionnaire in patients with giant ventral hernia. Binder usage pre- and postoperatively for a period up to 2 years was evaluated and showed that 40% of binder users felt it helped to relieve pain and eased movements and 98% felt much more secure. However, 97% of binder users felt discomfort (e.g. 45% from warmth, 30% from chafing, 10% from pain and 7% from rash). Furthermore, 37% felt the binder did not fit, 33% that it was uncomfortable, and 20% that it was difficult to put on. The authors concluded that this particular binder had subjective benefits, but discomfort like warmth and chafing were significant problems, and suggested that individual fitting and better information in written and verbal form could result in improvements [40].

…this particular binder had subjective benefits, but discomfort like warmth and chafing were significant problems…
…no significant difference between the two groups in terms of gastro-intestinal and pulmonary functions, however, the abdominal binder group walked further and their pain scores were significantly lower.

A recent controlled trial randomized 84 patients into 2 groups after MAS to evaluate the effect of an abdominal binder on system function, mobilization, pulmonary function, and pain. The binder (Nilstyle, Nokta Medikal) was described as elastic, made of breathable nylon thread fabric, with a height of 26 cm, applied with adhesive tapes, and covering the entire abdomen.

The authors described the binder’s elasticity as “minimizing unwarranted pressure on the abdomen”. They found no significant difference between the two groups in terms of gastrointestinal and pulmonary functions, however, the abdominal binder group walked further and their pain scores were significantly lower. The authors speculated that binder usage might decrease the time of first flatus after surgery and enable bowel movement to return to normal after surgery due to increased patient activities. They also felt that abdominal binder usage not only contributed to a greater walking distance, but also improved quality of life and prevented complications related to shorter walking distance.

…lower pain scores in the binder group had a positive effect on the efficiency of respiratory exercises performed by the patients, and using a binder does not negatively impact pulmonary function.

It was suggested that lower pain scores in the binder group had a positive effect on the efficiency of respiratory exercises performed by the patients, and using a binder does not negatively impact pulmonary function. The conclusion was that abdominal binder usage can be accepted as a non-pharmacological, cost-efficient, easy-to-use method, that should be employed in treating acute incision pain. Also abdominal binders enable a patient to move more comfortably, which might decrease complications resulting from long-term immobility after surgery [41].

The first randomized study on the role abdominal binders can play after laparoscopic interventions was published in 2015. Reduction of pain and the formation of seroma was investigated in 54 patients undergoing laparoscopic umbilical and epigastric hernia repair. No effect on pain, seroma formation, movement limitation, fatigue, general well-being, or quality of life could be shown between the two groups.

…since no adverse effects were seen, a postoperative abdominal binder could be considered after laparoscopic repairs for small ventral hernias.

The authors recognized that the lack of positive effect of the binders ( ETO garments, Denmark) could be due to the laparoscopic procedure with incisions too small to cause a surgical trauma and too small an amount of seroma. No adverse effects were found from wearing the abdominal binder, especially no pulmonary or thromboembolic adverse events were registered, and the majority of patients reported beneficial effects. The authors concluded that since no adverse effects were seen, a postoperative abdominal binder could be considered after laparoscopic repairs for small ventral hernias [42].

In a systematic review of literature to analyze the evidence for clinical effects of routine use of abdominal binders after laparotomy, laparoscopic surgical procedures and abdominoplasty, the authors complained of poor quality of existing studies, but specified that abdominal binders may reduce early postoperative pain after laparotomy, may reduce seroma formation after open or laparoscopic ventral hernia repair, and may improve physical function after MAS. They called for more studies in order to make final conclusions, however, they confirmed that evidence supports the use of abdominal binders to reduce psychological distress during the first five days after MAS, and binders can be used without compromising pulmonary function. They found weak evidence that abdominal binders increase IAP, but stated the clinical implications remain unknown [43].

…evidence supports the use of abdominal binders to reduce psychological distress during the first 5 days after MAS, and binders can be used without compromising pulmonary function.
…elastic binders have relatively little effect on IAP and are better to promote postoperative recovery than non-elastic binders.

The intra abdominal pressure was the focus of a prospective trial comparing 2 types of abdominal binders, a rigid and an elastic one in 57 patients. It was concluded that elastic binders have relatively little effect on IAP and are better to promote postoperative recovery than non-elastic binders [44]. Other authors evaluated a non-elastic binder (a weight-lifter waist belt) and its influence on increased abdominal pressure, particularly the effect on intra-gastric pressure in patients with gastro-esophageal reflux disease. It was found that the tight rigid belt could cause a rise in intra-gastric pressure and thereby an increased acid reflux. The conclusion was that this relationship was likely relevant to the association between obesity and reflux disease [45]. Another case report on the development of an acute trans-diaphragmatic intercostal hernia caused by the use of a tight rigid belt in combination with violent coughing has also been published [46]. Although the latter two studies [45-46] are not in direct relation to MAS, they confirm that rigid binders should be used with caution, and it is reasonable to conclude they should be an unlikely choice for MAS patients due to the risk of increased IAP.

Elastic binders are widely recognized as the standard type of abdominal binders when applied after major abdominal surgical procedures. They are also routinely used after aesthetic surgeries such as abdominoplasty interventions. There are reports of a higher incidence of deep venous thrombosis and pulmonary embolism after these procedures. Although the reason is unknown, it is thought there could be a relation between the manipulations and tightening of the abdominal wall structures that may increase IAP and could possibly interfere with venous drainage from the lower limbs and pelvis after the procedure. Several authors speculate that compression garments could add to such increase of IAP and cause a higher incidence of deep venous thrombosis and pulmonary embolism after abdominoplasty [47, 48].

Elastic binders are widely recognized as the standard type of abdominal binders when applied after major abdominal surgical procedures. They are also routinely used after aesthetic surgeries…

One study used ultrasonographic measurements to identify venous changes at the common femoral vein when using two types of compression garments (no detailed description) commonly used after abdominoplasty procedures in Brazil. They showed that both compression garments increased venous stasis in the lower limbs and it increased even more when patients were in the Fowler position (head of bed elevated 90 degrees). The conclusion was that although binder design and concept were different, both affected venous flow in a similar fashion, leading to stasis, therefore two of the possible complications caused by not using compression garments (seroma and recurrence of rectus diastasis) should be controlled by surgical technique [48]. However, the authors did not disclose any specific details of the compression garments used, such as degree of compression, body area covered, and other factors that could have an effect on IAP and venous drainage, nor whether the garments had an effect on postoperative activity. Complications like deep venous thrombosis and pulmonary embolism are well known to be related to inactivity and too much horizontal time in bed. More studies are needed to verify whether there is a relationship between the use of compression binders and IAP in abdominoplasty.

Table 3 summarizes the conclusions from the referenced literature on evaluations of abdominal binders. There is general agreement on advantages for patients with regards to better pain control increased mobilization and comfort, and that there are no adverse effect on pulmonary function, and only weak concerns whether binders could increase intra abdominal pressure after abdominoplasty procedures.

Table 3. Conclusions from evaluations of abdominal binders.
Reference and type of incision: Summary of conclusions:
[35] Laparotomy (open cholecystectomy) …elastic binders appeared to improve both respiratory function and comfort of patients…
[36] Midline laparotomy …abdominal binders had no significant negative effect on pulmonary function, and seemed to help controlling pain.
[37] Laparotomy …no objective clinical effect of a routine use of an elastic binder after MAS, although the majority of patients found it comfortable especially during the first postoperative days.
[38] Laparotomy …binders improved significantly walk performance on the 5th postoperative day, resulted in less perceived stress, significantly less pain getting in and out of bed and walking around, …no difference in pulmonary function between the groups. …abdominal binders can improve early mobilization, decrease pain and possibly other postoperative complications.
[39] Midline laparotomy (Nordicare, Sweden) …if a binder makes rehabilitation after surgery better and more patients could benefit, the result would be cost savings for the health care system …no significant difference in pulmonary function, coughing, intra-abdominal pressure, or wound healing, … significant decrease in pain in the binder group.
[40] Giant ventral hernia (Nordicare, Sweden) Binder usage pre- and postoperatively for 2 years showed 40% felt it helped to relieve pain and ease movements, 98% felt much more secure, however, 97% felt discomfort e.g. 45% from warmth, 30% from chafing, 10% from pain and 7% from rash. Furthermore 37% felt the binder did not fit, 33% that it was uncomfortable and 20% that it was difficult to put on. This binder had subjective benefits, but discomfort like warmth and chafing were significant problems…
[41] Laparotomy (Nilstyle, Nokta Medikal) …no significant difference between 2 groups in gastrointestinal and pulmonary functions, …binder group walked further and pain scores were significantly lower. …binder usage might enable bowel movement to return to normal after surgery due to increased patient activities. …abdominal binder usage contributed to greater walking distance, improved quality of life and prevented complications related to shorter walking distance.…lower pain scores in the binder group had a positive effect on the efficiency of respiratory exercises performed by the patients, …using a binder does not negatively impact pulmonary function.
[42] Laparoscopy (ETO garments, Denmark) No effect on pain, seroma formation, movement limitation, fatigue, general well-being, or quality of life between 2 groups.…the lack of positive effect of the binders could be due to the laparoscopic procedure with incisions too small to cause a surgical trauma and too small amount of seroma. …no adverse effects of wearing the binder, no pulmonary or trombo-embolic adverse events and the majority of patients reported beneficial effects. …no adverse effects … a postoperative abdominal binder could be considered after laparoscopic repairs for small ventral hernias
[43] Literature review …evidence supports the use of abdominal binders to reduce psychological distress during the first 5 days after MAS, … binders can be used without compromising pulmonary function. …weak evidence that abdominal binders increase IAP, but stated the clinical implications remain unknown
[44] Laparotomy …elastic binders have relatively little effect on IAP and are better to promote postoperative recovery than non-elastic binders.
[47, 48] Abdominoplasty …higher incidence of deep venous thrombosis and pulmonary embolism after abdomino-plasty procedures. … manipulations and tightening of the abdominal wall structures may increase the IAP and could possibly interfere with the venous drainage from the lower limbs and pelvis after the procedure. …compression garments could add to increase of IAP and cause a higher incidence of deep venous thrombosis and pulmonary embolism after abdominoplasty.

Postoperative Mobilization after MAS

Almost all authors who evaluated abdominal binders concluded that more extensive randomized controlled prospective studies are needed to accurately assess binder usage.

Evidence based medicine will most likely increase evaluations of preventive methods after major abdominal surgery (MAS) including investigating the period after discharge in order to decrease the unacceptably high incidence of complications, mortality, and readmissions, and to reduce the related health care costs. Almost all authors who evaluated abdominal binders concluded that more extensive randomized controlled prospective studies are needed to accurately assess binder usage. This is underlined by the European Hernia Society who, in their guidelines, call for long-term follow-up studies to evaluate the impact a prescription of abdominal binders can have on the occurrence of incisional hernias [24].

Promoting early mobility, an evidence-based strategy to improve patient outcomes, is widely recognized, and early and progressive mobility is an important part of postoperative care which can reduce the total length of hospital stay. Nevertheless, just a few publications describe early mobilization as an intervention. The Enhanced Recovery After Surgery society (ERAS) has developed guidelines for both professionals and patients to encourage fast track recovery after surgery. Patients are advised to be out-of-bed after colon and rectal surgery for two hours on the day of surgery and for six hours per day on each following day until hospital discharge [49].

…just a few publications describe early mobilization as an intervention.
…lack of compliance could be attributed to pain, fatigue, lack of motivation and surgical attachments…

However, compliance with these targets has been reported to be low. In a multi-institutional ERAS society registry compliance was 48% on the first post-operative day and 28% on the following day. It was speculated that lack of compliance could be attributed to pain, fatigue, lack of motivation, and surgical attachments such as drains, nasogastric tubes, urinary catheters, intravenous lines, and epidurals that require a pole to be transported by the patient or caregiver. Standing and walking even on the first postoperative day, instead of “time out-of-bed” including sitting, have been found to be the most important activities to promote return of gastrointestinal function, overall recovery, and to shorten length of stay in the hospital.

Early and aggressive mobilization has the potential to reduce inflammation, increase muscle force at discharge, facilitate recovery of functional exercise capacity, prevent respiratory complications, improve self-perceived functional status, and promote a quicker return of gastrointestinal function [50-52].

The question is how to make sure patients comply with enhanced recovery programs (ERPs) in and beyond the hospital stay. The availability of hospital staff, particularly nurses and physical therapists, to help patients mobilize and to increase the intervals and duration of such assistance may have an important impact on a speedy recovery. Some patients are transferred to the ward from the recovery room late in the day or evening. As such, they are less likely to get out of bed or walk due to lack of assistance, as there are fewer nurses and allied health professionals working during the evening and night shifts. There is little evidence in the literature concerning best strategies to promote compliance with early mobilization.

Standing and walking even on the first postoperative day, instead of “time out-of-bed” including sitting, have been found to be the most important activities to promote return of gastrointestinal function, overall recovery, and to shorten length of stay in the hospital.
There is little evidence in the literature concerning best strategies to promote compliance with early mobilization.

A potential approach to add personnel dedicated to mobilizing patients has been suggested; such as a physiotherapist. However the additional benefit of this resource-intensive approach is unknown [50, 51].

It has been shown that time out of bed was decreased when surgical attachments such as drains were present, and a direct relation between the number of surgical drains and the amount of time patients spent out of bed has been documented [51].

Before mobilization can take place, nurses will have to assess and organize all drains and devices to make a secure attachment and ensure displacement does not occur. This procedure is important for patient safety. The same procedure has to be performed after the mobilization. This can have a negative effect on compliance with mobilization programs since it is time consuming. In addition, staff must spend time explaining to the patient how important mobility is, even when drainage systems are attached to the patient, in order to eliminate any anxiety or undue stress. The slightest movement or device displacement may create pain or discomfort for the patient, reducing the amount of activity he or she may feel they can perform. They may not have confidence to get out of bed unassisted, leaving them dependent on help from hospital staff, further decreasing compliance with activity programs. Encouraging independence with activity and applying effective pain relief will provide confidence that safe mobility can be achieved despite the presence of drainage tubes.

…even though ERAS (Enhanced Recovery After Surgery) recognizes the possible positive effect reached by using abdominal binders and, that no adverse effects have been reported after MAS, patients are not advised to wear one.

It is interesting to note that even though the ERAS society recognizes the possible positive effect reached by using abdominal binders, and that no adverse effects have been reported after MAS, patients are not advised to wear one. As an example, ERAS gives this advice to patients when coughing: “try holding your abdomen to reduce the pain”, and “Take a deep breath and cough using a small blanket or pillow to support your incision” [49].

Commodity Abdominal Binders

Abdominal binders are common and a large selection of commodity binders are available. Typically the binders consist of a wide band made of a variety of elastic, non-elastic, or a combination of such materials. They wrap around the patient’s abdominal region and are usually closed by means of a single fabric hook and loop closure, or a series of hook and eye closures. The image to the right shows a variety of binders found online searching for “surgical abdominal compression binders”.

…existing binders are very similar in design and have no distinctive design differences.

The materials used in common binders are in many cases heavy, non-ventilated, and obtainable in white or beige colors. Such binders can be warm and uncomfortable to wear after surgery, and often have issues with crawling up, rolling, or curling on the body, making them more uncomfortable [40]. Furthermore, the binders are not designed to accommodate drainage tubes or other surgical devices. This constrains healthcare staff to cut holes in the material [38] and separate the drains or other appliances from their connecting apparatus before they can pass them from one side to the other of the binder, an action that potentially increases the risk of infection. The difficulties in applying a common binder may delay when patients can start using and benefitting from the advantages of binder usage.

The majority of the literature involving evaluations of abdominal binders does not identify the binders, nor does it describe the type of materials, whether it is ventilated or not, the degree of elasticity, sizing method used, height of the binder, degree of compression, and other design-related characteristics that can have a major impact on the results of wearing a binder. Most likely this is because existing binders are very similar in design with no distinctive design differences. In addition, they may be supplied by a local orthopedic shop that may not have particular criteria for selecting the type of abdominal binders, or the binders are custom fit by the shop. The few studies that do identify binders used also lack detailed descriptions.

Most investigators find it justified for patients to use elastic abdominal binders after major abdominal surgery, however, there are no clear guidelines given concerning the use after MAS. Potential benefits include: lower risk of dehiscence, incisional hernia, and development of wound haematoma, reduction of pain and fear of pain, improved intestinal function, and increased physical activity [24, 34-44, 52-53]. Speculated negative effects are few and include: worse blood supply in the postoperative wound, pressure on drains (if applicable), increased intra-abdominal pressure, weakening of the torso muscles, and increased tension of the abdominal wall resulting from the effort of putting the binder on [53].

Most investigators find it justified for patients to use elastic abdominal binders after major abdominal surgery, however, there are no clear guidelines given concerning the use after MAS.
Potential benefits include: lower risk of dehiscence, incisional hernia, and development of wound haematoma, reduction of pain and fear of pain, improved intestinal function, and increased physical activity.

The lack of guidelines results in no clear recommendation for the degree of pressure applied on the abdomen and the duration of time a binder should be used. One author used the cuff of a pressure meter placed between the binder and the skin in order to achieve the same pressure (10 mmHg reading) on the abdominal wall [53]. However, most authors seem to let the patient’s comfort level guide the degree of compression on the abdominal structures. Data discussing the design of an effective and comfortable abdominal compression binder, including ostomy belts, are also missing in literature.

A Radical Design Change of Abdominal Binders

The present status of complications after major abdominal surgery, the difficulties to comply with postoperative activities and enhanced recovery programs both for patients and health care staff, in addition to the ordinary style of common abdominal binders, have all been key factors that led to the development of a new, comprehensive design change of abdominal binders namely the QualiBelly Advanced abdominal support[54].

The following are extracts from the “Summary of the invention” in the patent description [55]: QualiBelly Advanced is a postoperative compression binder with advanced features for compression, wound inspection and care, drainage, ostomy, and other device accommodations, accessories for line organization and collection device support, and for stimulation of improved posture, spirit, and security sense.

QualiBelly Advanced consists of three elastic bands that overlap and are attached to each other by small, vertical stitches integrated into the material and arranged with an equal relatively short distance between them along the length of the elastic bands thereby forming the compression binder. Each elastic band has fabric hook and loop fasteners at the ends, and the vertical stitch method of conjoining the elastic bands allows for individual compression adjustments of each band. This allows compression to be varied along a vertical line on the patient’s abdomen so compression can be adapted to the type of surgery performed and to the level of comfort desired by the patient.

 

QualiBelly Advanced provides access to the compression area for wound inspection and care by opening one or two of the bands and leaving at least one or two of the bands closed. This eliminates the need to open the total compression binder, whereby pain is decreased and comfort for the patient is increased and compression support to the patient’s abdomen is maintained at all times. This is achieved by spacing the vertical stitches in a calculated distance from the ends of each of the bands resulting in the ends of each band being unattached to the adjoining bands over a length equal to the desired calculated distance. Thus, if one of the bands is open an access area is created by moving the ends of the open band apart to expose the abdomen.

 

Furthermore, QualiBelly Advanced allows drainage tubes, drainage lines, ostomy devices, driver lines from Left Ventricular Assist Devices (LVAD), and other devices that may exit from a patient’s abdomen after major surgeries or trauma, to pass from the patient’s abdomen to the external side of QualiBelly Advanced by closing the fabric hook and loop fastener on one band above such devices, and close the fabric hook and loop fastener on the adjoining band below such devices. QualiBelly Advanced thereby eliminates the need to separate drainage tubes, drainage lines, ostomy devices, driver lines from Left Ventricular Assist Devices (LVAD), and other apparatus thereby decreasing the potential for complications, infections and related health care costs. QualiBelly Advanced furthermore eliminates any need to cut holes in the compression binder material which avoids any tear and wear of the material.

QualiBelly Advanced provides for accessories to organize and attach drainage lines and collection bottles of all sizes, driver lines and other devices that may need to be fixed to the external side of the compression binder for a period of time in a secure manner

 

QualiBelly Advanced further provides the possibility to be transformed into a lower compression binder when the fabric hook and loop fastener on the upper elastic band is opened and the upper band is folded down over the adjoining band, after which the fabric hook and loop fastener is closed again. Thereby, any pressure on the upper abdomen is relieved, and comfort and back support for patients is increased when sitting down.

The distinctive features of QualiBelly Advanced, as described in the patent, are further enhanced by the choice of soft, yet strong, latex-free, ultralight material that has stripes of fabric alternating with stripes of ventilated “breathing” spaces, to ensure “temperature control”. By maintaining a tightly controlled elasticity within +/- 10%, the degree of compression is consistent for increased comfort and feeling of security. Additionally, material in an encouraging bright green color was chosen in contrast to the white or beige colors often used in ordinary binders.

QualiBelly Advanced has been nurse designed to provide an advanced postoperative binder with compression features that have the potential to decrease postoperative complications such as abdominal wound dehiscence, infections and hernia formations, and to help patients to have less pain, improved comfort, as well as to encourage a patient’s spirit in the post-operative period through an increased sense of security and freedom to use their hands during activity. By also improving a patient’s posture, it promotes deeper and more effective breathing with the potential to decrease pulmonary complications and the related costs of health care. Furthermore, the practicality in using the QualiBelly Advanced is not only timesaving for staff, it also allows a single person to open and close the binder on all sizes of patients thanks to the special 3-band design with slits and individual closures. In addition, the universal device holder makes it faster and easier to liberate the patient from the bed for mobilization, and allows for drainage bottles and other devices to be attached directly to patients when applicable.

The initial feedback from both patients and health care staff has been overwhelmingly positive. Patients particularly like the comfort of the material and the individual compression settings of the bands, and health care staff appreciates the ease of practical use and uncomplicated adaption to all kinds of surgical apparatus a patient might have after surgery.

Research studies are needed to verify the clinical evidence of QualiBelly Advanced as an adjunctive method to decrease postoperative complications after major abdominal surgery.

Conclusion

Postoperative complications after MAS represent a significant burden for health care providers worldwide. The incidence, mortality, readmission rates and related costs after MAS are unacceptably high. Developing countries will most likely continue to increase health care spending per capita, increasing the numbers of MAS further, including the related additional costs of treating complications. A significant 40% of complications after MAS occur after discharge, which should lead to a scrutinized examination of the postoperative period, particularly after leaving the hospital. It is critical to evaluate effective methods to prevent and to decrease the incidence of postoperative complications.

It has been established in literature that ordinary abdominal binders have no negative effect on pulmonary function, and they may improve early postoperative mobilization, which is important to avoid thromboembolic and other complications after surgery and improve recovery in general. Literature also supports that binders can decrease postoperative pain, seroma formation, improve comfort, feeling of security and give a positive psychological effect. In addition, there is speculation that binders could prevent the occurrence of incisional hernia formation although not proven. Except for weak doubt about a potential increase in intra abdominal pressure in relation to abdominoplasty procedures, the disadvantages that have been reported about ordinary binders were mostly in relation to feeling of warmth, discomfort, and pressure on the upper abdominal area.

Research of abdominal binders is not exhaustive and more in-depth studies are needed to establish the influence on decreasing postoperative complications such as wound dehiscence, infection,s and hernia; however, there are enough indications that abdominal binders can help patients to mobilize sooner, safer and with less pain, and that they do not cause any harm. This justifies the great need for a new generation of advanced compression binders that can address the user issues with the existing ordinary binders, which patients and health care personnel need to address on a daily basis. None of the ordinary abdominal compression binders currently in use takes an overall approach to solve such difficulties.

QualiBelly Advanced is designed with the total needs of a postoperative patient and the health care personnel in mind. This advanced abdominal binder promotes decreased pain and wound complications, improves wound access and maintains wound support during inspection and care, improves overall comfort for the patient and functional convenience for staff, and it stimulates patients to earlier mobilization in the postoperative period, which may lead to earlier discharge from the hospital with related decrease in costs of health care.

QualiBelly Advanced is the first abdominal binder specifically designed with the existing health care challenges after MAS in mind as reviewed in this document. Compared to ordinary abdominal binder designs, QualiBelly Advanced has numerous additional advantages both for patients and health care staff increasing the potential for better clinical outcomes and the related cost savings for the health care systems. Further research and evaluation studies of the clinical application of QualiBelly Advanced are needed to prove this proposition.

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