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

NCT ID: NCT02387333

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2019-02-28

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.

Conditions

Ileal Conduit; Parastomal Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Study group

in this arm -study group- : patients will receive mesh stoma reinforcement technique with ileal conduit urinary diversion.

Group Type: EXPERIMENTAL

Polypropylene Mesh Stoma reinforcement technique with ileal conduit urinary diversion

Intervention Type: PROCEDURE

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.

Control group

in this arm -sham comparator- : patients will not receive mesh stoma reinforcement technique with ileal conduit urinary diversion.

Group Type: SHAM_COMPARATOR

Ileal conduit urinary diversion

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Ileal conduit urinary diversion

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

Intervention Type: PROCEDURE

Other Intervention Names

Implantable polypropylene monofilament mesh

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Amr Abdel-Lateif El-Sawy

Resident in Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed E. Mosbah, MD

Role: STUDY_CHAIR

Urology And Nephrology Center, Mansoura University, Mansoura

Locations

Urology and Nephrology Center

Al Mansurah, DK, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Amr A. Elsawy, MB BCh

Role: CONTACT

amrelsawy.unc@hotmail.com

0020502202222

Ahmed M. Harraz, MD

Role: CONTACT

ahmed.harraz@hotmail.com

0020502202222

Facility Contacts

Amr A. Elsawy, MB BCh

Role: primary

amrelsawy.unc@hotmail.com

0020502202222

Ahmed M. Harraz, MD

Role: backup

ahmed.harraz@hotmail.com

0020502202222

Other Identifiers

AEl-Sawy132015

Identifier Type: -

Identifier Source: org_study_id