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

Phase 2

• Conditions: Ileal Conduit; Parastomal Hernia
• Interventions: Procedure: Polypropylene Mesh Stoma reinforcement technique with ileal conduit urinary diversion; Procedure: Ileal conduit urinary diversion

• Registration Number: NCT02387333
• Lead Sponsor: Mansoura University

Brief 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.

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-28
• Study First Submitted QC: 2015-03-07
• Study First Posted: 2015-03-13
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-22
• Primary Completion: 2018-10
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Polypropylene Mesh Stoma reinforcement technique with ileal conduit urinary diversion	in this arm -study group- : patients will receive mesh stoma reinforcement technique with ileal conduit urinary diversion.
Control group	Ileal conduit urinary diversion	in this arm -sham comparator- : patients will not receive mesh stoma reinforcement technique with ileal conduit urinary diversion.

Primary Outcome Measures

Name	Time	Method
Incidence of parastomal hernia 2 years after surgery	2 years	The primary outcome of this study will be the incidence of parastomal hernia at 2 years after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, DK, Egypt