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Use of a Mesh to Prevent Parastomal Hernia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00691860
First Posted: June 6, 2008
Last Update Posted: September 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Corporacion Parc Tauli
  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
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

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 ®
Procedure: Conventional sigmoid end colostomy
Patients receiving conventional sigmoid end colostomy, without mesh
2
Patients receiving conventional sigmoid end colostomy, without mesh
Procedure: Conventional sigmoid end colostomy
Patients receiving conventional sigmoid end colostomy, without mesh

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00691860


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

Responsible Party: Xavier Serra-Aracil, Corporacio Sanitaria Parc Tauli
ClinicalTrials.gov Identifier: NCT00691860     History of Changes
Other Study ID Numbers: CSPT-SerraA-01
First Submitted: June 4, 2008
First Posted: June 6, 2008
Last Update Posted: September 15, 2015
Last Verified: June 2008

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

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical