Effect of Stitch Technique on the Occurrence of Incisional Hernia After Abdominal Wall Closure

Study Overview
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Brief Summary
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The major long term complication of abdominal wall closure after a median laparotomy is the development of an incisional hernia. Several suture technique and suture material have been used but the incidence of this complication still lies between 9 -20%. Synthetic suture material which have become available over the last decades have the advantage that they are degraded by the body system and fully absorbed within 70-180 days; however they loss 50% of their initial strength already after 14-30 days and may not be the optimal suture material for abdominal wall closure. A new suture material (Monomax®) was developed with an extra-long absorption profile, high elasticity and with a superior initial strength. Therefore, the ESTOIH-Study was designed to investigate the influence of the stitch length on the occurrence of incisional hernia using the extra-long term absorbable, elastic, monofilament suture (Monomax®).

Official Title
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Short Stitch Versus Long Stitch Suture Technique Using Monomax® for Abdominal Wall Closure After Primary Median Laparotomy. A Randomized, Controlled, Double-blinded, Multicenter, International Trial

Conditions
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Injury of Abdominal Wall

Intervention / Treatment
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* Device: Long stitch
* Device: Short Stitch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Patients undergoing an elective, primary median laparotomy with an incision length of ≥ 15 cm Expected survival time longer than 1 year ASA I-III Written informed consent Exclusion Criteria: Emergency surgery Patient undergoing surgery due to a pancreas carcinoma Patients who will be operated due to an abdominal aortic aneurysm Peritonitis Coagulopathy Current immunosuppressive therapy (more than 40 mg of a corticoid per day or azathioprin) Chemotherapy within the last 2 weeks before operation Radiotherapy of the abdomen within the last 6 weeks before operation Pregnant women (pregnancy test has to be performed) Severe neurologic and psychiatric disease Lack of compliance

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Long stitch group<br>Long stitch suture technique Stitch interval = 10 mm; Lateral = 10 mm | Device: Long stitch<br>* AWC with the long stitch technique using MonoMax USP 1, 150 cm loop, HR48 mm<br>|
| Experimental: Short stitch group<br>Short stitch technique for AWC stitch interval = 5 mm; Lateral 5 - 8 mm | Device: Short Stitch<br>* Short stitch suture technique using MonoMax USP 2/0, 150 cm, HR26 mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional hernia rate | Incisional hernia rate 1 year postoperatively (assessment by ultrasound). | 1 year postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of burst abdomen | Burst abdomen is defined as a clinically evident rupture of the laparotomy wound | participants will be followed for the duration of hospital stay, an expected average of 10 days | 
| Reoperation due to burst abdomen | Burst abdomen is defined as a clinically evident rupture of the laparotomy wound | participants will be followed for the duration of hospital stay, an expected average of 10 days | 
| Frequency of wound infections | Wound infections are classified according to the US centres for disease control and prevention (CDC) as either deep or superficial. | participants will be followed for the duration of hospital stay, an expected average of 10 days and 30 days postop | 
| Wound healing complications | Wound healing complications: Seroma, hematoma, necrosis, fistula | until 30 days postoperatively | 
| Long Term Incisional hernia rate | assessment by ultrasound | 3 and 5 years postoperatively | 
| Long term Wound infections | Wound infections are classified according to the US centres for disease control and prevention (CDC) as either deep or superficial. | 1 year postoperatively | 
| Long Term Wound healing complications | Wound healing complications: Seroma, hematoma, necrosis, fistula | until 1 year postoperatively | 
| Costs | Costs including material cost, cost per operation minute, cost per hospital stay, cost saving per incisional hernia. | until 5 years postop | 
| Length of postoperative hospital stay | Number of days the patient has to stay in hospital after the intervention | participants will be followed for the duration of hospital stay, an expected average of 10 days | 
| Course of Health status with EQ-5D Score | The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Each answer results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. | preop, 30 days postop, 1 year, 3 years, 5 years postop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparotomy, short stitch, long stitch, MonoMax