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Role of Mesh Stoma Reinforcement Technique (MSRT) in Prevention of Parastomal Hernia After Ileal Conduit Urinary Diversion

NCT02387333 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-03-22

No results posted yet for this study

Summary

The aim of this clinical trial is to investigate the safety and efficacy of prophylactic mesh on prevention of parastomal hernia(PSH) after ileal conduit urinary diversion (IC) in a randomized controlled fashion.

Conditions

  • Ileal Conduit
  • Parastomal Hernia

Interventions

PROCEDURE

Polypropylene Mesh Stoma reinforcement technique with ileal conduit urinary diversion

After standard steps of radical cystectomy and sparing of distal 15 cm of ileum as a conduit for diversion. A preferred rectal muscle splitting approach is preferred for IC exteriorization. Dissection of subcutaneous fat off the rectus sheath will be accomplished to create a potential space for mesh placement. Then, 5 x 5 cm polypropylene mesh will be placed and incised at the center to create an orifice to allow IC exteriorization. The mesh is then fixed to underlying rectus sheath with 1-0 non-absorbable proline sutures. The IC is exteriorized through the central orifice and then fixed to the peritoneum and to the cut-edges of the rectus muscle using 3-0 polyglactin sutures. A 12 CH subcutaneous tube drain will be left and the subcutaneous tissue is closed to collapse the dissected space around the mesh. The stoma is then everted and fixed to the skin.

PROCEDURE

Ileal conduit urinary diversion

In this group, no mesh will be applied with ileal conduit urinary diversion

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Ahmed E. Mosbah, MD · Urology And Nephrology Center, Mansoura University, Mansoura

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2018-10-31
Completion
2019-02-28

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02387333 on ClinicalTrials.gov