Use of a Mesh to Prevent Parastomal Hernia

This study has been completed.
Sponsor:
Information provided by:
Corporacion Parc Tauli
ClinicalTrials.gov Identifier:
NCT00691860
First received: June 4, 2008
Last updated: June 11, 2008
Last verified: June 2008
  Purpose

Randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the lower third of the rectum with a permanent end colostomy. The aim of the study was to reduce parastomal hernia (PH) occurrence by implanting a lightweight mesh in the sublay position. Patients were followed up a) clinically and b) radiologically by means of abdominal CT. In the clinical follow-up, hernias were observed in four out of 27 patients (14.8%) in the study group and in eleven out of 27 (40.7%) in the control group (p=0.03). The implantation of the mesh reduces the appearance of PH, is well tolerated, and does not increase morbidity


Condition Intervention
Parastomal Hernia
Device: Mesh (Ultrapro ®)
Procedure: Conventional sigmoid end colostomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia

Resource links provided by NLM:


Further study details as provided by Corporacion Parc Tauli:

Primary Outcome Measures:
  • the reduction in the incidence of Parastomal Hernia after the mesh placement [ Time Frame: 6 months ]

Enrollment: 54
Study Start Date: April 2006
Study Completion Date: February 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients receiving conventional sigmoid end colostomy plus a lightweight mesh Ultrapro®
Device: Mesh (Ultrapro ®)
In the mesh group, the mesh was placed in the sublay position, above the peritoneum and the posterior rectus sheath of the rectus abdominis muscles, with a minimum of 5 cm of mesh around the colostomy
Other Name: Ultrapro ®
No Intervention: 2
Patients receiving conventional sigmoid end colostomy, without mesh
Procedure: Conventional sigmoid end colostomy
Patients receiving conventional sigmoid end colostomy, without mesh

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients scheduled for permanent end colostomy to treat cancer of the lower third of the rectum,
  • Aged over 18,
  • Charlson comorbidity index below 7
  • Elective surgery
  • Radical surgery

Exclusion Criteria:

  • Loop colostomies,
  • Emergency surgery,
  • Body mass index above 35 kg/sq.m.,
  • Palliative surgery,
  • Hepatic cirrhosis,
  • Severe COPD (requiring home oxygen treatment),
  • Corticoid treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691860

Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
Study Chair: Salvador Navarro-Soto, MD Corporacio Sanitaria Parc Tauli
  More Information

No publications provided

Responsible Party: Xavier Serra-Aracil, Corporacio Sanitaria Parc Tauli
ClinicalTrials.gov Identifier: NCT00691860     History of Changes
Other Study ID Numbers: CSPT-SerraA-01
Study First Received: June 4, 2008
Last Updated: June 11, 2008
Health Authority: Spain: Ethics Committee

Keywords provided by Corporacion Parc Tauli:
Parastomal hernias
Tolerance of lightweight meshes
Paracolostomy hernias
Peristomal hernias

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 24, 2014