178 Participants Needed

Mesh Placement for Hernia Prevention After Bladder Surgery

Recruiting at 6 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

Trial Summary

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 data supports the effectiveness of the treatment Radical Cystectomy, Ultrapro mesh for hernia prevention after bladder surgery?

Research shows that using a lightweight mesh can reduce the chances of developing a hernia after bladder surgery, as seen in a study where mesh placement lowered the incidence of hernias after similar procedures.12345

Is mesh placement for hernia prevention after bladder surgery safe?

The use of lightweight mesh in bladder surgery has been studied and shown to reduce the risk of hernias, but the surgery itself can have complications, with some studies reporting a 31% complication rate within 30 days. It's important to discuss potential risks with your doctor.16789

How is the treatment Radical Cystectomy unique for preventing hernias after bladder surgery?

Radical cystectomy, which involves removing the bladder, is unique because it can be combined with mesh placement to prevent hernias after surgery. This approach is different from other treatments as it directly addresses the risk of hernia formation by reinforcing the surgical area with mesh, which is not a standard practice in all bladder surgeries.12101112

What is the purpose of this trial?

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.

Research Team

BB

Bernard Bochner, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Surgery + Mesh PlacementExperimental Treatment2 Interventions
prophylactic mesh at the time of standard surgery
Group II: Surgery (Usual approach group)Active Control1 Intervention
standard surgery

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Findings from Research

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

References

Cost Effectiveness of the Use of Prophylactic Mesh To Prevent Parastomal Hernia After Urinary Diversion with an Ileal Conduit. [2022]
Cumulative incidence of midline incisional hernia and its surgical treatment after radical cystectomy and urinary diversion for bladder cancer: A nation-wide population-based study. [2021]
Radical Cystectomy Perioperative Care Redesign. [2022]
Orthotopic neobladder perforation: an unusual presentation of small bowel obstruction. [2021]
Incisional and Parastomal Hernia following Radical Cystectomy and Urinary Diversion: The University of Southern California Experience. [2018]
Standardized analysis of frequency and severity of complications after robot-assisted radical cystectomy. [2022]
Defining morbidity of robot-assisted radical cystectomy using a standardized reporting methodology. [2022]
Rational peri-operative management of antithrombotic therapy in patients undergoing radical cystectomy: A 30-day morbidity analysis based on the updated European Association of Urology guidelines for standardized complication reporting. [2023]
Re-operation within 30 days of radical cystectomy: Identifying high-risk patients and complications using American College of Surgeons National Surgical Quality Improvement Program database. [2023]
Urothelial carcinoma of the urinary bladder related to a migrated mesh after inguinal hernioplasty: A case report. [2022]
Clinical characteristics of patients with inguinal hernia mesh migration into the bladder. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Laparoscopic inguinal herniorrhaphy complicating radical cystoprostatectomy. [2007]
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