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

Parastomal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722565
• Other study ID #: LAP-APR-2012-028
• Status: Completed
• Phase: Phase 4
• First received: November 4, 2012
• Last updated: September 9, 2015
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia
• Parastomal Hernia

Intervention

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

Locations

Country	Name	City	State
Spain	Corporacion Sanitaria Universitaria Parc Tauli	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The reduction in the incidence of Parastomal Hernia after the mesh placement		12 months	Yes