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

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ClinicalTrials.gov Identifier: NCT01722565
Recruitment Status : Completed
First Posted : November 7, 2012
Last Update Posted : September 10, 2015
Sponsor:
Information provided by (Responsible Party):
Xavier Serra-Aracil, Corporacion Parc Tauli

Study Description
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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.


Condition or disease Intervention/treatment Phase
Parastomal Hernia Procedure: laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection
Study Start Date : January 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mesh Group
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)
No Intervention: Control Group
Patients receiving conventional sigmoid end colostomy by laparoscopic procedure, without mesh


Outcome Measures
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Primary Outcome Measures :
  1. The reduction in the incidence of Parastomal Hernia after the mesh placement [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722565


Locations
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Spain
Corporacion Sanitaria Universitaria Parc Tauli
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
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Principal Investigator: Xavier Serra-Aracil, MD Corporacion Sanitaria Universitaria Parc Tauli
Principal Investigator: Manuel Lopez-Cano, MD Hospital Vall d'Hebron
More Information
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Responsible Party: Xavier Serra-Aracil, Medical Doctor, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT01722565    
Other Study ID Numbers: LAP-APR-2012-028
First Posted: November 7, 2012    Key Record Dates
Last Update Posted: September 10, 2015
Last Verified: September 2015
Keywords provided by Xavier Serra-Aracil, Corporacion Parc Tauli:
Parastomal hernias
Tolerance of lightweight meshes
laparoscopic abdominoperineal resection
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical