NCT02387333

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

3.7 years

First QC Date

February 28, 2015

Last Update Submit

March 21, 2018

Conditions

Ileal ConduitParastomal Hernia

Keywords

Radical cystectomyUrinary diversionIleal conduitParastomal herniaProphylactic meshMesh stoma reinforcement technique

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Adverse events related to mesh placement

    2 years

  • Health related quality of life as measured by Body Image Scale (BIS) questionnaire

    2 years

Study Arms (2)

Study group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Procedure: Ileal conduit urinary diversion

Interventions

Polypropylene Mesh Stoma reinforcement technique with ileal conduit urinary diversionPROCEDURE

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.

Also known as: Implantable polypropylene monofilament mesh
Study group
Ileal conduit urinary diversionPROCEDURE

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, DK, 35516, Egypt

RECRUITING

MeSH Terms

Interventions

Urinary Diversion

Intervention Hierarchy (Ancestors)

Urologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ahmed E. Mosbah, MD

    Urology And Nephrology Center, Mansoura University, Mansoura

    STUDY CHAIR

Central Study Contacts

Amr A. Elsawy, MB BCh

CONTACT

0020502202222amrelsawy.unc@hotmail.com

Ahmed M. Harraz, MD

CONTACT

0020502202222ahmed.harraz@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt

Study Record Dates

First Submitted

February 28, 2015

First Posted

March 13, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2018

Study Completion

February 1, 2019

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

EG(1)