Use of a Mesh to Prevent Parastomal Hernia

Corporacion Parc Tauli54 enrolled

Overview

Randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the lower third of the rectum with a permanent end colostomy. The aim of the study was to reduce parastomal hernia (PH) occurrence by implanting a lightweight mesh in the sublay position. Patients were followed up a) clinically and b) radiologically by means of abdominal CT. In the clinical follow-up, hernias were observed in four out of 27 patients (14.8%) in the study group and in eleven out of 27 (40.7%) in the control group (p=0.03). The implantation of the mesh reduces the appearance of PH, is well tolerated, and does not increase morbidity

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Parastomal Hernia

Interventions

Mesh (Ultrapro ®)DEVICE

In the mesh group, the mesh was placed in the sublay position, above the peritoneum and the posterior rectus sheath of the rectus abdominis muscles, with a minimum of 5 cm of mesh around the colostomy

Conventional sigmoid end colostomyPROCEDURE

Patients receiving conventional sigmoid end colostomy, without mesh

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients scheduled for permanent end colostomy to treat cancer of the lower third of the rectum, * Aged over 18, * Charlson comorbidity index below 7 * Elective surgery * Radical surgery Exclusion Criteria: * Loop colostomies, * Emergency surgery, * Body mass index above 35 kg/sq.m., * Palliative surgery, * Hepatic cirrhosis, * Severe COPD (requiring home oxygen treatment), * Corticoid treatment

Outcomes

Primary Outcomes

the reduction in the incidence of Parastomal Hernia after the mesh placement

Time frame: 6 months

Data from ClinicalTrials.gov

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