NCT01722565

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 10, 2015

Status Verified

September 1, 2015

Enrollment Period

1.9 years

First QC Date

November 4, 2012

Last Update Submit

September 9, 2015

Conditions

Parastomal Hernia

Keywords

Parastomal herniasTolerance of lightweight mesheslaparoscopic abdominoperineal resection

Outcome Measures

Primary Outcomes (1)

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

    12 months

Study Arms (2)

Mesh Group

EXPERIMENTAL

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)

Control Group

NO INTERVENTION

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

Interventions

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporacion Sanitaria Universitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Interventions

Polypropylenesglycolide E-caprolactone copolymer

Intervention Hierarchy (Ancestors)

PolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Xavier Serra-Aracil, MD

    Corporacion Sanitaria Universitaria Parc Tauli

    PRINCIPAL INVESTIGATOR

  • Manuel Lopez-Cano, MD

    Hospital Vall d'Hebron

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 4, 2012

First Posted

November 7, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

September 10, 2015

Record last verified: 2015-09

Locations

ES(1)