MedTrace Logo

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

NCT01722565 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-09-10

No results posted yet for this study

Summary

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.

Conditions

  • Parastomal Hernia

Interventions

PROCEDURE

laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25)

Sponsors & Collaborators

  • Corporacion Parc Tauli

    lead OTHER

Principal Investigators

  • Xavier Serra-Aracil, MD · Corporacion Sanitaria Universitaria Parc Tauli

  • Manuel Lopez-Cano, MD · Hospital Vall d'Hebron

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-12-31
Completion
2014-12-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01722565 on ClinicalTrials.gov