Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection

Study Overview
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Brief Summary
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Introduction: parastomal hernia (PH) is a frequent complication after an ostomy, despite the many prevention and treatment techniques that have been described. Since the introduction of laparoscopy, the frequency of PH is even higher than in open surgery. This type of hernia remains a surgical problem of considerable importance, requiring significant consumption of public health and economic resources, and representing a major alteration of the quality of life of these patients. Objective: to evaluate the effectiveness of the insertion of a prosthesis to prevent PH in elective surgery for laparoscopic abdominoperineal resection. Methodology: prospective, multidisciplinary, multi-center randomized controlled study. Control group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal resection. Study group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25). Sample size was calculated based on a proportion of parastomal hernia of 65% in the control group and 15% in the study group. With an α risk =0.05 and 1- β= 0.8, 28 patients are required, 14 per group. Estimating a drop-out rate of 10%, the final number will be 32 patients. The efficacy will be evaluated clinically at six months and abdominal CT will be performed at 12 months along with another clinical evaluation.

Official Title
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Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection

Conditions
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Parastomal Hernia

Intervention / Treatment
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* Procedure: laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of either sex intervened electively for colorectal surgery (rectal cancer) in whom definitive colostomy is indicated after laparoscopic abdominoperineal amputation. Life expectancy above 12 months Exclusion Criteria: - Patients with allergy or intolerance of the compounds in the mesh Carriers of prosthetic meshes in the area of the ostomy Patients electively intervened for colorectal surgery (neo de reco) in whom definitive colostomy is indicated after abdominoperineal amputation but not via a laparoscopic approach. Cirrhotic patients Patients with life expectancy below 12 months due to underlying disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesh Group<br>Patients receiving conventional sigmoid end colostomy plus a preperitoneal lightweight mesh Physiomesh® by laparoscopic procedure | Procedure: laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25)<br> <br> |
| No Intervention: Control Group<br>Patients receiving conventional sigmoid end colostomy by laparoscopic procedure, without mesh | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The reduction in the incidence of Parastomal Hernia after the mesh placement |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parastomal hernias, Tolerance of lightweight meshes, laparoscopic abdominoperineal resection