Radical CystectomyPhase 3NCT02908061
A Study to Determine if Mesh Placement During Bladder Surgery Can Reduce the Chances of Developing a Hernia
A Phase 3 study testing Surgery Radical Cystectomy and Ultrapro mesh in people with Radical Cystectomy, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to compare any good and bad effects of using Ultrapro mesh along with the usual bladder removal surgery, versus having the usual bladder removal surgery without the use of the mesh. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radical Cystectomy
- What is being tested?
- Surgery Radical Cystectomy and Ultrapro mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2016to 25 Mar 2026
- Phase
- Phase 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
- Patients undergoing RC and IC formation in an elective setting,for cancer.
Who cannot join
- Expected survival < 12 months
- Salvage RC
- Distant metastatic disease
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (Consent and follow-up only)
Commack, New York
Memorial Sloan Kettering Westchester (Consent and follow-up only)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Consent and follow-up only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent and follow-up only)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent only and Follow Up)
Uniondale, New York, 11553
About this study
Official title: A Prospective, Randomized Trial of Preventive Mesh Placement at the Time of Radical Cystectomy to Reduce the Chances of Developing a Parastomal Hernia
The purpose of this study is to compare any good and bad effects of using Ultrapro mesh along with the usual bladder removal surgery, versus having the usual bladder removal surgery without the use of the mesh.
- Conditions
- Radical Cystectomy
- Being tested
- Surgery Radical Cystectomy, Ultrapro mesh
- Keywords
- Mesh Placement, Radical Cystectomy, 16-1285
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery Radical CystectomyProcedure or surgery
All surgeries will be performed in an open or laparoscopic fashion.
Ultrapro meshProcedure or surgery
Surgery Mesh Placement. All surgeries will be performed in an open or laparoscopic fashion.
| Study group | Role | What they receive |
|---|---|---|
| Surgery (Usual approach group) | Active comparator | standard surgery Receives: Procedure: Surgery Radical Cystectomy |
| Surgery + Mesh Placement | Experimental | prophylactic mesh at the time of standard surgery Receives: Procedure: Surgery Radical Cystectomy; Procedure: Ultrapro mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with incidence of radiographic Parastomal Hernia
Measured: within 2 years of RC and IC.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startAug 2016
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radical CystectomyStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Bochner, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908061
- Sponsor's protocol ID
- 16-1285
- Status last verified
- Mar 2026
- First submitted
- 9 Sep 2016
- Last updated
- 30 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial of Preventive Mesh Placement at the Time of Radical Cystectomy to Reduce the Chances of Developing a Parastomal Hernia
- ClinicalTrials.gov ID
- NCT02908061
- Acronym / sponsor ID
- 16-1285
- Conditions
- Radical Cystectomy
- Keywords
- Mesh Placement, Radical Cystectomy, 16-1285
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 20 Sep 2016 (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 purpose of this study is to compare any good and bad effects of using Ultrapro mesh along with the usual bladder removal surgery, versus having the usual bladder removal surgery without the use of the mesh.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery (Usual approach group) | Active comparator | Procedure: Surgery Radical Cystectomystandard surgery |
| Surgery + Mesh Placement | Experimental | Procedure: Surgery Radical Cystectomy, Procedure: Ultrapro meshprophylactic mesh at the time of standard surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing RC and IC formation in an elective setting,for cancer.
Key exclusion criteria (3 listed)
- Expected survival < 12 months
- Salvage RC
- Distant metastatic disease
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 |
|---|---|---|
| Surgery Radical CystectomyAll surgeries will be performed in an open or laparoscopic fashion. | Procedure or surgery | Surgery (Usual approach group), Surgery + Mesh Placement |
| Ultrapro meshSurgery Mesh Placement. All surgeries will be performed in an open or laparoscopic fashion. | Procedure or surgery | Surgery + Mesh Placement |
Primary outcome
Number of patients with incidence of radiographic Parastomal Hernia
Time frame: within 2 years of RC and IC.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Bernard Bochner, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgery Radical Cystectomy and Ultrapro mesh in people with Radical Cystectomy, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with incidence of radiographic Parastomal Hernia (time frame: within 2 years of RC and IC.). 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 30 Mar 2026.