Ileal ConduitPhase 2/3NCT02387333
Role of Mesh Stoma Reinforcement Technique (MSRT) in Prevention of Parastomal Hernia After Ileal Conduit Urinary Diversion
A Phase 2/3 study testing Polypropylene Mesh Stoma reinforcement technique with ileal conduit urinary diversion and Ileal conduit urinary diversion in people with Ileal Conduit and Parastomal Hernia, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileal Conduit, Parastomal Hernia
- What is being tested?
- Polypropylene Mesh Stoma reinforcement technique with ileal conduit urinary diversion and Ileal conduit urinary diversion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2015to Feb 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Inability to give informed consent.
- Patients who documented previous allergic reaction to synthetic mesh.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and Nephrology Center
Al Mansurah, DK, 35516
Amr A. Elsawy, MB BCh, 0020502202222, amrelsawy.unc@hotmail.com
Ahmed M. Harraz, MD, 0020502202222, ahmed.harraz@hotmail.com
About this study
Official title: Role of Mesh Stoma Reinforcement Technique (MSRT) in Prevention of Parastomal Hernia After Ileal Conduit Urinary Diversion: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Polypropylene Mesh Stoma reinforcement technique with ileal conduit urinary diversion, Ileal conduit urinary diversion
- Keywords
- Radical cystectomy, Urinary diversion, Ileal conduit, Parastomal hernia, Prophylactic mesh, Mesh stoma reinforcement technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polypropylene Mesh Stoma reinforcement technique with ileal conduit urinary diversionProcedure or surgery
Also called Implantable polypropylene monofilament mesh
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 diversionProcedure or surgery
In this group, no mesh will be applied with ileal conduit urinary diversion
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | in this arm -study group- : patients will receive mesh stoma reinforcement technique with ileal conduit urinary diversion. Receives: 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. Receives: Procedure: Ileal conduit urinary diversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (2)
Adverse events related to mesh placement
The secondary outcome will be the adverse events related to mesh placement.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileal ConduitStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdel-Lateif El-Sawy, Mansoura University
- Investigators
- Ahmed E. Mosbah, MD, Study chair, Urology And Nephrology Center, Mansoura University, Mansoura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387333
- Sponsor's protocol ID
- AEl-Sawy132015
- Status last verified
- Mar 2018
- First submitted
- 28 Feb 2015
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Mesh Stoma Reinforcement Technique (MSRT) in Prevention of Parastomal Hernia After Ileal Conduit Urinary Diversion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02387333
- Acronym / sponsor ID
- AEl-Sawy132015
- Conditions
- Ileal Conduit, Parastomal Hernia
- Keywords
- Radical cystectomy, Urinary diversion, Ileal conduit, Parastomal hernia, Prophylactic mesh, Mesh stoma reinforcement technique
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Polypropylene Mesh Stoma reinforcement technique with ileal conduit urinary diversionin this arm -study group- : patients will receive mesh stoma reinforcement technique with ileal conduit urinary diversion. |
| Control group | Sham comparator | Procedure: Ileal conduit urinary diversionin this arm -sham comparator- : patients will not receive mesh stoma reinforcement technique with ileal conduit urinary diversion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to give informed consent.
- Patients who documented previous allergic reaction to synthetic mesh.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polypropylene Mesh Stoma reinforcement technique with ileal conduit urinary diversionAlso: Implantable polypropylene monofilament meshAfter 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. | Procedure or surgery | Study group |
| Ileal conduit urinary diversionIn this group, no mesh will be applied with ileal conduit urinary diversion | Procedure or surgery | Control group |
Primary outcome
Incidence of parastomal hernia 2 years after surgery
Time frame: 2 years
The primary outcome of this study will be the incidence of parastomal hernia at 2 years after surgery
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed E. Mosbah, MD study chair
Urology And Nephrology Center, Mansoura University, Mansoura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Polypropylene Mesh Stoma reinforcement technique with ileal conduit urinary diversion and Ileal conduit urinary diversion in people with Ileal Conduit and Parastomal Hernia, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr A. Elsawy, MB BCh (0020502202222, amrelsawy.unc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of parastomal hernia 2 years after surgery (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.