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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
History of Changes
  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:

MedlinePlus related topics: Hernia
U.S. FDA Resources

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
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 May 21, 2013