APEMESH II - Perineal Reconstruction

Study Overview
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Brief Summary
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The objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting.

Detailed Description
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Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy seems to be a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity.

Official Title
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Apemesh II - Perineal Reconstruction With Mesh Enhanced Gluteus Plasty

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Gluteus plasty enhanced with Progrip self gripping mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Curative intent abdominoperineal resection and permanent colostomy Exclusion Criteria: Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4- 5) Immunosupression (cortisone >10mg/day) or severe malnutrition (BMI <20) Diabetes with 1 or more organ damage Dialysis treatment Hepatic cirrhosis Child-Bugh B-C Potentially curable resection not possible Patient undergoing emergency procedures Metastatic disease Vaginal resection, pelvic exenteration and sacrum resection Vaginal perforation Pelvic abscess or perforated tumor 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All patients, who have an abdominoperineal reconstruction for rectal cancer, will have a mesh enhanced gluteus plasty. The patients will be compared to historical cohort.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gluteus plasty enhanced with Progrip self gripping mesh<br>All study patietns will have a gluteus enhanced plasty after abdominoperineal reconstruction. | Procedure: Gluteus plasty enhanced with Progrip self gripping mesh<br>* Intervention group will be compared to historical patients in a case-control setting. Intervention group will have a mesh enhanced gluteus plasty made to reconstruct perineum after abdominoperineal resection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Comprehensive complication index | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infections | Surgical site infections | 30 days | 
| Reoperation rate | Reoperation rate | 30 days | 
| Operative time | Operative time to reconstruct perineum | 30 days | 
| Length of hospital stay | Primary length of stay at the hospital | 30 days | 
| Costs of treatment materials | Costs of treatment materials | 30 days | 
| Total perineal healing time | Time from operation to complete perineal healing | 1 year | 
| Perineal fistula | Perineal sinus or fistula | 30 days | 
| Perineal hernia | Perineal hernia incidence | 12 months | 
| Gluteus muscle function measured by time stands test | Gluteus muscle function measured by time stands test | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominoperineal resection, perineal reconstruction