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

March 21, 2018 updated by: Amr Abdel-Lateif El-Sawy, Mansoura University

Role of Mesh Stoma Reinforcement Technique (MSRT) in Prevention of Parastomal Hernia After Ileal Conduit Urinary Diversion: A Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

All patients will be recruited from the urology practice of the study's investigators, Urology department of Urology and Nephrology Center (UNC), Mansoura university, Egypt. Patients will be asked to participate after the patient and physician have made a decision that ileal conduit urinary diversion of choice. Those patients meeting all inclusion criteria will be asked to participate in this study with informed consent then obtained. No monetary income will be offered for participation in the study.

Those patients will be evaluated clinically and radiologically according to the specified protocol.

After enrollment in the study, the stoma site will be marked on the skin the day prior to surgery by the stoma therapist. All patients will be operated by high volume surgeon experienced in IC urinary diversion. The procedure started by radical cystectomy and bilateral pelvic lymphadenectomy. After sparing the distal 15 cm of the terminal ileum, a 15 cm ileal segment will be isolated and the bowel continuity will be restored and the mesenteric defect will be closed. The distal end of the isolated bowel segment will be mobilized and exteriorized at the predetermined site on the abdominal wall followed by stoma eversion. A preferred rectal muscle splitting approach is preferred for IC exteriorization. In case of MSRT, 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 fixed and the subcutaneous tissue is closed to collapse the dissected space around the mesh. The stoma is then everted and fixed to the skin. Sham group patients will undergo the same technique without mesh placement. The ureters will be mobilized and anastomosed to the proximal end of the conduit using direct ureteroileal anastomosis.

All patients will undergo the routine protocol at the investigators' center including enrollment in fast track restoration of bowel habits, ileal conduit catheter to be removed on the 5th day and the ureteral stents on the 7th and 8th days. Any deviation from normal postoperative course will be recorded using the modified Clavien-Dindo system.

At followup, patients will be asked to attend the outpatient clinic at 1, 3, 6, and 12 months after discharge clinically and radiologically to assess the intended outcomes of the study.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ability to give informed consent.
  2. Patients with history of chronic liver disease
  3. Patients with history of systemic chemotherapy, radiotherapy or maintenance on systemic corticosteroids
  4. Patients with chronic causes of increased intra-abdominal pressure as chronic cough (COPD) or chronic constipation
  5. Patients with surgical history of hernia repair
  6. Patients with body mass index (BMI) more than 30 kg/m2
  7. Patients with other hernias (inguinal, umbilical or incisional) at preoperative evaluation
  8. Patients with low serum albumin < 3 gm/dl
  9. Patients who will be highly candidates for adjuvant or palliative chemo-radiotherapy such those with histopathologically proved residual tumor

Exclusion Criteria:

  1. Inability to give informed consent.
  2. Patients who documented previous allergic reaction to synthetic mesh.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
in this arm -study group- : patients will receive mesh stoma reinforcement technique with ileal conduit urinary diversion.
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.

Other Names:
  • Implantable polypropylene monofilament mesh
Sham Comparator: Control group
in this arm -sham comparator- : patients will not receive mesh stoma reinforcement technique with ileal conduit urinary diversion.
Procedure: Ileal conduit urinary diversion
In this group, no mesh will be applied with ileal conduit urinary diversion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of parastomal hernia 2 years after surgery
Time Frame: 2 years
The primary outcome of this study will be the incidence of parastomal hernia at 2 years after surgery
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events related to mesh placement
Time Frame: 2 years
The secondary outcome will be the adverse events related to mesh placement.
2 years
Health related quality of life as measured by Body Image Scale (BIS) questionnaire
Time Frame: 2 years
Health related quality of life issues will be assessed also in both groups.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: Ahmed E. Mosbah, MD, Urology And Nephrology Center, Mansoura University, Mansoura

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

February 28, 2015

First Submitted That Met QC Criteria

March 7, 2015

First Posted (Estimate)

March 13, 2015

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEl-Sawy132015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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