APEMESH- Preventing Perineal Complications After Abdominoperineal Resection

Study Overview
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Brief Summary
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Abdominoperineal resection leaves an empty space to be filled by mesh or musculocutaneus flap. Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy is a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity. The role of omentoplasty at APR is controversial. Previous studies on synthetic mesh repair on perineum are almost lacking.

Detailed Description
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The objective of this pilot study is to assess the feasibility and the potential benefits of synthetic mesh reconstruction in perineum in case-control setting. 30 subjects will be prospectively enrolled to this study as intervention group. Controls matched with age, gender and preoperative radiotherapy are selected from retrospective data collected from Oulu University database and operated for rectal adenocarcinoma 2009-2017 with otherwise identical methods.

Official Title
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APEMESH- Preventing Perineal Complications After Abdominoperineal Resection

Conditions
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Rectal Cancer, Abdominoperineal Resection, Wound Heal

Intervention / Treatment
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* Device: Composite mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Abdominoperineal resection and permanent colostoma Exclusion Criteria: Patient with a comorbid illness of condition that would preclude the use of surgery (ASA5) Potentially curable resection not possible Patient undergoing emergency procedure Metastatic disease Pregnant or suspected pregnancy

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mesh group<br>After resection, pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) and covered with subcutaneous flap. | Device: Composite mesh<br>* Pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) to improve healing and prevent perineal herniation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive Complication index | Comprehensive Complication index is used to evaluate outcome | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | Surgical site infection classified by Clavien-Dindo score | 30 days | 
| Reoperation rate | Reoperations during primary stay at the hospital | 30 days | 
| Operative time | Operative time | 30 days | 
| Length of stay | Length of stay at the hospital during primary operation and recovery | 30 days | 
| Costs | Costs by materials used | 30 days | 
| Total perineal healing time | Time to point when perineum is closed and healed | 30 days | 
| Perineal sinus | Presence of perineal sinus at 30 days follow-up | 30 days | 
| Perineal hernia | Perineal hernia by CT scan at 12 months follow-up | 12 months |