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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02387333
• Date of registration: 28/02/2015
• Prospective Registration: No
• Primary sponsor: Mansoura University
• Public title: Role of Mesh Stoma Reinforcement Technique (MSRT) in Prevention of Parastomal Hernia After Ileal Conduit Urinary Diversion
• Scientific title: Role of Mesh Stoma Reinforcement Technique (MSRT) in Prevention of Parastomal Hernia After Ileal Conduit Urinary Diversion: A Randomized Controlled Trial
• Date of first enrolment: February 2015
• Target sample size: 40
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02387333
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant).
• Phase: Phase 2/Phase 3

Countries of recruitment

Egypt

Contacts

• Name: Ahmed E. Mosbah, MD
• Affiliation: Urology And Nephrology Center, Mansoura University, Mansoura

• Name: Amr A. Elsawy, MB BCh

• Name: Amr A. Elsawy, MB BCh

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parastomal Hernia

Ileal Conduit

Intervention(s)

Procedure: Polypropylene Mesh Stoma reinforcement technique with ileal conduit urinary diversion

Procedure: Ileal conduit urinary diversion

Primary Outcome(s)

Incidence of parastomal hernia 2 years after surgery [Time Frame: 2 years]

Secondary Outcome(s)

Adverse events related to mesh placement [Time Frame: 2 years]

Health related quality of life as measured by Body Image Scale (BIS) questionnaire [Time Frame: 2 years]

Secondary ID(s)

AEl-Sawy132015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors