The Effect of Postoperative Abdominal Binder to Improve Outcomes After Incisional Hernia Repair

Study Overview
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Brief Summary
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Postoperative seroma formation is one of the most common complications after ventral hernia repair with mesh. Although some seromas may not have clinical impact postoperative seroma formation often causes pain and discomfort and may even compromise wound healing. Abdominal binders (also called trusses, girdle, ostomy belt, longuette or abdominal belt) (AB) are commonly used in abdominal and plastic surgery to prevent seroma formation and diminish pain and discomfort after operation. The primary aim of the present study is to investigate the effect of postoperative abdominal binders after laparoscopic incisional hernia repair on postoperative pain, discomfort and quality of life. Secondary, we register seroma formation. A randomized, controlled, investigator-blinded study supplemented with blinded statistical analysis. We include 60 (2x30) incisional hernia repairs. Patients are randomized either to abdominal binder or no abdominal binder (controls). The abdominal binder is worn from immediately after the operation and continuously for 7 days and nights. All patients have a standardized operation with standardized intra- and postoperative medication regimen. Endpoints measurements are clinically detectable seroma formation scored with seroma classification system buý S. Morales-Conde, pain scored with self-registrations with VAS, and quality of life scored with EQ-5D, recurrence and other complications are also registered. Patients are followed until 90 days after the operation.

Official Title
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The Effect of Postoperative Abdominal Binder to Reduce Seroma Formation and Improve Early Clinical Outcome After Incisional Hernia Repair.

Conditions
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Incisional Hernia

Intervention / Treatment
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* Device: Abdominal binder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective, primary and recurrent laparoscopic and open incisional hernia repair hernia with mesh reinforcement fascia defects 6-20 cm measured preoperatively by the surgeon at the out-patient clinic patients between 18-80 years Exclusion Criteria: expected low compliance (language problems, dementia and abuse etc.) fascia defects >20 cm measured at the preoperative clinical examination. acute operation decompensated liver cirrhosis (Child-Pugh 3-4) patients with a stoma if a secondary operation is performed during the hernia repair procedure. if a patient withdraws his inclusion consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: abdominal binder<br>use of postoperative abdominal binder 30 days after the hernia repair | Device: Abdominal binder<br>* The abdominal binder is worn from immediately after the operation and continuously for 7 days and nights. The belts are standard abdominal binders (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done for all included patients before the operation by waist measurement according to the recommendation from the company (see below). When applied, the patients are advised to apply the belt in a lying position.<br>* Other names: abdominal belt;|
| No Intervention: No abdominal binder<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seroma formation | clinically detectable seroma formation | 30 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | Measured with self-registration VAS scales | pain during the postoperative days 1-3, 7, and 30. |