Suture Techniques to Reduce the Incidence of The inCisional Hernia

Study Overview
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Brief Summary
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The objective of the study is reduction of the incidence of the most frequent complication of abdominal surgery, incisional hernia. In this multi center double-blinded prospective randomized controlled trial, in which a new suture technique using small bites is compared with the traditionally applied large bites (mass closure) technique for midline incisions.

Official Title
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Suture Techniques to Reduce the Incidence of The inCisional Hernia

Conditions
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Hernia, Wound Infection, Burst Abdomen, Pain, Quality of Life

Intervention / Treatment
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* Procedure: Closure of the abdominal wall after midline incisions


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Signed informed consent All laparotomies with a midline incision Age > 18 years Exclusion criteria Previous incisional hernia after midline incision Previous surgery through a midline incision within 3 months Pregnancy (in women)

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: Large tissue bites<br>As control the conventional large bites technique (mass closure) will be applied in with bites widths of 1 cm and inter-suture spacing of 1 cm with the use of PDS plus ll 1-0 double loop suture material with a 48 mm needle. | Procedure: Closure of the abdominal wall after midline incisions<br>* Closure of the midline incision after any abdominal operation. Suturing of the fascia of the abdominal wall with two different techniques<br>|
| Experimental: small tissue bites<br>In the other group of 288 patients the small bites technique will be applied with bite widths of 0,5 cm and inter suture spacing of 0,5 cm with the use of PDS plus ll 2-0 single suture material with a 31 mm needle placed in the linea alba. In the small bites technique, twice as many stitches will be placed per sutured cm, with a smaller needle and thinner suture material. | Procedure: Closure of the abdominal wall after midline incisions<br>* Closure of the midline incision after any abdominal operation. Suturing of the fascia of the abdominal wall with two different techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional hernia occurrence within one year after operation clinical and/or radiographically detected |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications; in particular wound infection (during admission), burst abdomen (during admission) and wound pain (measured with a visual analog scale (VAS) during the first 6 days after surgery). |  | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, incisional hernia, woundinfection, burst abdomen, pain