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Use of a Mesh to Prevent Parastomal Hernia

Primary Purpose

Parastomal Hernia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mesh (Ultrapro ®)
Conventional sigmoid end colostomy
Sponsored by
Corporacion Parc Tauli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parastomal Hernia focused on measuring Parastomal hernias, Tolerance of lightweight meshes, Paracolostomy hernias, Peristomal hernias

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    1

    2

    Arm Description

    Patients receiving conventional sigmoid end colostomy plus a lightweight mesh Ultrapro®

    Patients receiving conventional sigmoid end colostomy, without mesh

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 4, 2008
    Last Updated
    September 14, 2015
    Sponsor
    Corporacion Parc Tauli
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00691860
    Brief Title
    Use of a Mesh to Prevent Parastomal Hernia
    Official Title
    Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    February 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Corporacion Parc Tauli

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parastomal Hernia
    Keywords
    Parastomal hernias, Tolerance of lightweight meshes, Paracolostomy hernias, Peristomal hernias

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Patients receiving conventional sigmoid end colostomy plus a lightweight mesh Ultrapro®
    Arm Title
    2
    Arm Type
    Other
    Arm Description
    Patients receiving conventional sigmoid end colostomy, without mesh
    Intervention Type
    Device
    Intervention Name(s)
    Mesh (Ultrapro ®)
    Other Intervention Name(s)
    Ultrapro ®
    Intervention Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional sigmoid end colostomy
    Intervention Description
    Patients receiving conventional sigmoid end colostomy, without mesh
    Primary Outcome Measure Information:
    Title
    the reduction in the incidence of Parastomal Hernia after the mesh placement
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Salvador Navarro-Soto, MD
    Organizational Affiliation
    Corporacio Sanitaria Parc Tauli
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Use of a Mesh to Prevent Parastomal Hernia

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