Hernia After Colorectal Cancer Surgery

Study Overview
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Brief Summary
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Defects in the abdominal wall (incisional hernia) is a frequent negative outcome after surgery. Reinforcing the incision with mesh seem to lower the incidence but in surgery that includes bowel resection a simple alternative, cheaper and less prone to infection than a synthetic mesh, would be of interest. The primary aim of this multicentre randomized controlled trial is to compare the incisional hernia incidence one year after planned colorectal cancer surgery performed through a midline incision which is closed either by a standardized small stitch 4:1 technique (the incision is closed with the use of suture of 4 times the length of the incision) or with the same technique plus a reinforced tension-line suture (a suture is applied in the fibrous tissue parallel to the incision which is then embraced by the 4:1 suture when the incision is closed). A difference in incisional hernia of 15% (20% without and 5% with reinforced tension-line suture) is assumed. Secondary aims are to evaluate incidences of wound dehiscence, other wound complications and incisional hernia after 3 years. Furthermore we aim to evaluate patient satisfaction and quality of life.

Detailed Description
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The primary aim of this multicentre randomized controlled trial is to compare the incisional hernia incidence one year after planned colorectal cancer surgery performed through a midline incision which is closed either by a standardized small stitch 4:1 technique or with the same technique plus a reinforced tension-line suture. A difference in incisional hernia of 15% (20% without and 5% with reinforced tension-line suture) is assumed and requires inclusion of 76 patients in each group (significance level=5%, power=80%). Patients planned for colorectal surgery due to a cancer are eligible for inclusion. Exclusion criteria are: age below 18, ASA>3, former operation for incisional hernia in the midline, present hernia, perop findings of peritoneal carcinomatosis eligible for peritonealectomy, patient unable to take part in planned follow-up and patient not willing to take part in the study. Secondary aims are to evaluate incidences of wound dehiscence, other wound complications and incisional hernia after 3 years. Furthermore we aim to evaluate patient satisfaction and quality of life. Patient base-line characteristics, operative and postop characteristics will be recorded in inclusion- and op-protocols and protocols for clinical follow-up at 1 month, 1 and 3 years. Standard 1 and 3 years CT-scans will be examined for incisional hernia. At 1 and 3 years the patients will be asked to fill out an abdominal wall discomfort enquiry as well as the QoL questionnaire EQ-5D-5L. The study will be performed at 3 surgical clinics in the Region of Skane in Sweden: Malmö, Kristianstad and Ystad. Inclusion started Oct 2017 and was estimated to be completed after somewhat more than 2 years. The pandemic added 2 years to the inclusion period.The last follow-up will thereby take place after an additional 3 years (2024).

Official Title
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Rein4CeTo1: Incisional Hernia After Colorectal Cancer Surgery - a Randomized Controlled Multicentre Trial Comparing Small Stitch 4:1-technique With Respectively Without a Reinforced Tension-line Suture for Abdominal Closure

Conditions
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Incisional Hernia, Wound Dehiscence, Wound Complication, Quality of Life

Intervention / Treatment
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* Procedure: 4:1 closure group
* Procedure: RTL plus 4:1 closure group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients ≥ 18 years planned for colorectal cancer surgery through a midline incision Exclusion Criteria: Former incisional hernia surgery in the midline Present incisional hernia in the midline ASA>3 Peritoneal carcinomatosis eligible for peritonealectomy/HIPEC Patient not able to participate in follow-up Patient not willing to take part in the study

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4:1 closure group<br>Patients randomized to and receiving the intervention small stitch 4:1 technique for closure of the abdominal wall. | Procedure: 4:1 closure group<br>* In this arm the incisions are closed by the 4:1-technique<br>|
| Active Comparator: RTL plus 4:1 closure group<br>Patients randomized to and receiving the intervention reinforced tension-line suture plus small stitch 4:1 technique for closure of the abdominal wall. | Procedure: RTL plus 4:1 closure group<br>* In this arm the incisions are closed by a reinforced tension-line suture in addition to the 4:1-technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional hernia one year after colorectal cancer surgery comparing a standardized 4:1-technique with and without a reinforced tension-line suture | Evaluated by clinical investigation and CT-scan | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound dehiscence and other wound complications | Early outcome measures investigated during hospitalization and at 1 month follow-up and until wound complication is healed | One month or longer | 
| Incisional hernia after 3 years | Evaluated by clinical investigation and CT-scan | 3 years | 
| Abdominal wall discomfort at 1- and 3 years follow-up | Measured by a modified version of the Ventral Hernia Pain Questionnaire | 1 and 3 years | 
| Quality of life after 1- and 3 years | Measured by the EQ-5D-5L questionnaire | 1 and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incisional hernia, 4:1-technique, RTL-suture