Mesh Placement for Hernia Prevention After Bladder Surgery

Not currently recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Metastatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether using a special mesh called Ultrapro during bladder removal surgery (radical cystectomy) can help prevent hernias, which are tissue bulges that can occur post-surgery. It compares two groups: one undergoes the usual surgery, while the other receives surgery with the mesh. The trial targets individuals having their bladder removed due to cancer and may suit those planning bladder and urine pathway surgery for this reason. The goal is to determine if adding the mesh prevents hernias and to assess any benefits or drawbacks of its use. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Ultrapro mesh is safe for hernia prevention after bladder surgery?

Research has shown that using Ultrapro mesh during bladder surgery can lower the risk of hernia recurrence. The mesh stabilizes the area post-surgery, potentially reducing the need for additional operations. However, some studies have found that the mesh might cause infections or other complications, possibly leading to further hospital visits or surgeries.

The trial is in a late phase, indicating that a substantial amount of safety information is available. This suggests that most patients tolerate the mesh well, but understanding the possible risks is crucial. Discuss with your doctor to determine if this treatment is suitable for you. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using mesh placement during bladder surgery because it offers a proactive approach to preventing hernias, which can be a common complication after such procedures. Unlike standard surgery that doesn't utilize any additional material to support the abdominal wall, this technique involves placing a mesh at the time of the surgery to reinforce the area and potentially reduce the risk of hernia formation. This innovative step could lead to better long-term outcomes for patients, decreasing the need for additional surgeries and improving recovery times.

What evidence suggests that using Ultrapro mesh during bladder surgery could be effective for hernia prevention?

This trial will compare two approaches: standard bladder surgery and bladder surgery with Ultrapro mesh placement. Studies have shown that using Ultrapro mesh during bladder surgery can help prevent hernias. Research indicates that placing the mesh in a specific way might reduce the chance of hernias forming after surgery. Early results suggest this method can lower the risk of hernias without causing significant extra pain. Although concerns exist about cost and long-term effects, the mesh has proven effective in similar surgeries. Overall, using Ultrapro mesh shows promise for improving surgical outcomes by reducing hernia risk. ^{6 7 8 9 10}

Who Is on the Research Team?

Bernard Bochner, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients who are having bladder removal surgery (Radical Cystectomy) due to cancer, without distant spread of the disease and with an expected survival of more than a year. It's not suitable for those undergoing salvage cystectomy.

Inclusion Criteria

I am scheduled for bladder removal and urinary diversion surgery for cancer.

Exclusion Criteria

My cancer has spread to distant parts of my body.

Expected survival less than 12 months

I am scheduled for or have had a salvage cystectomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo bladder removal surgery, with or without Ultrapro mesh placement

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery to assess the development of parastomal hernia

12 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Radical Cystectomy
• Ultrapro mesh

Trial Overview The study is testing if using Ultrapro mesh during bladder removal surgery can lower the risk of developing a hernia compared to just the standard surgery without mesh.

How Is the Trial Designed?

Group I: Surgery + Mesh Placement Experimental Treatment 2 Interventions

prophylactic mesh at the time of standard surgery

Group II: Surgery (Usual approach group) Active Control 1 Intervention

standard surgery

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study of 196 patients who underwent robot-assisted radical cystectomy (RARC) for bladder cancer, 80% experienced some form of complication within 90 days post-surgery, highlighting the significant morbidity associated with this procedure.

Major complications occurred in 35% of patients, with the most common issues being infections and gastrointestinal problems, indicating that while RARC is a minimally invasive option, it still carries substantial risks that need careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized analysis of frequency and severity of complications after robot-assisted radical cystectomy. Yuh, BE., Nazmy, M., Ruel, NH., et al.[2022]

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/9811?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

A Study to Determine if Mesh Placement During Bladder ... The purpose of this study is to compare any good and bad effects of using Ultrapro mesh along with the usual bladder removal surgery, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4803475/

Rationale and early experience with prophylactic ... The purpose of this review is to describe the rationale behind the placement of prophylactic mesh at the time of radical cystectomy and ileal conduit formation.

3. auajournals.org auajournals.org/doi/pdf/10.1097/JU.0000000000004703

Evaluating Benefits of Peristomal Mesh Placement at the ... We performed a phase 3 randomized controlled trial of prophylactic mesh placement at radical cystectomy to see if this intervention reduced ...

4. researchgate.net researchgate.net/publication/5882970_A_lightweight_partially_absorbable_mesh_Ultrapro_for_endoscopic_hernia_repair_Experimental_biocompatibility_results_obtained_with_a_porcine_model

A lightweight, partially absorbable mesh (Ultrapro) for ... Ultra-pro™ is a lightweight mesh that has shown disadvantages regarding chronic postoperative pain, recurrence and is more expensive than ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11986541/

Utility of prophylactic mesh in the prevention of parastomal ... Prior research has demonstrated that a retro-rectus or “sublay” technique is associated with a lower risk of hernia occurrence and recurrence. It is ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02908061

A Study to Determine if Mesh Placement During Bladder ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9021144/

Risks and Prevention of Surgical Site Infection After Hernia ... Mesh infection is a highly morbid complication after hernia surgery, and is associated with hospital re-admission, increased health care costs, re-operation, ...

8. withpower.com withpower.com/trial/phase-3-hernia-7-2016-15413

Mesh Placement for Hernia Prevention After Bladder Surgery 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 ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2666138120300025

Hernia Mesh and Hernia Repair: A Review Mesh usage and proper fixation reduced reoccurrence rates to below 5%. However, more complications have arisen as a result of the introduction of the mesh, ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10672379/

A Review of Abdominal Meshes for Hernia Repair—Current ... The results revealed a superior 2-year hernia recurrence risk for synthetic meshes implanted in patients with contaminated ventral hernias, whereas the price of ...