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

Parastomal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02387333
• Other study ID #: AEl-Sawy132015
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 28, 2015
• Last updated: March 21, 2018
• Start date: February 2015
• Est. completion date: February 2019

Study information

• Verified date: March 2018
• Source: Mansoura University
• Contact: Amr A. Elsawy, MB BCh
• Phone: 0020502202222
• Email: amrelsawy.unc[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Ileal Conduit
• Parastomal Hernia

Intervention

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

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of parastomal hernia 2 years after surgery	The primary outcome of this study will be the incidence of parastomal hernia at 2 years after surgery	2 years
Secondary	Adverse events related to mesh placement	The secondary outcome will be the adverse events related to mesh placement.	2 years
Secondary	Health related quality of life as measured by Body Image Scale (BIS) questionnaire	Health related quality of life issues will be assessed also in both groups.	2 years