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

NCT ID: NCT01722565

Last Updated: 2015-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mesh Group

Patients receiving conventional sigmoid end colostomy plus a preperitoneal lightweight mesh Physiomesh® by laparoscopic procedure

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

Control Group

Patients receiving conventional sigmoid end colostomy by laparoscopic procedure, without mesh

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corporacion Parc Tauli

OTHER

Sponsor Role: lead

Responsible Party

Xavier Serra-Aracil

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xavier Serra-Aracil, MD

Role: PRINCIPAL_INVESTIGATOR

Corporacion Sanitaria Universitaria Parc Tauli

Manuel Lopez-Cano, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebron

Locations

Corporacion Sanitaria Universitaria Parc Tauli

Sabadell, Barcelona, Spain

Countries

Spain

Other Identifiers

LAP-APR-2012-028

Identifier Type: -

Identifier Source: org_study_id