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

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

178 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{1 6 10 11 12}

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. Netherlands pubmed.ncbi.nlm.nih.gov

Cost Effectiveness of the Use of Prophylactic Mesh To Prevent Parastomal Hernia After Urinary Diversion with an Ileal Conduit. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

Radical Cystectomy Perioperative Care Redesign. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Orthotopic neobladder perforation: an unusual presentation of small bowel obstruction. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Incisional and Parastomal Hernia following Radical Cystectomy and Urinary Diversion: The University of Southern California Experience. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Standardized analysis of frequency and severity of complications after robot-assisted radical cystectomy. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Defining morbidity of robot-assisted radical cystectomy using a standardized reporting methodology. [2022]

8. England pubmed.ncbi.nlm.nih.gov

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]

9. Canada pubmed.ncbi.nlm.nih.gov

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]

10. Australia pubmed.ncbi.nlm.nih.gov

Urothelial carcinoma of the urinary bladder related to a migrated mesh after inguinal hernioplasty: A case report. [2022]

11. Australia pubmed.ncbi.nlm.nih.gov

Clinical characteristics of patients with inguinal hernia mesh migration into the bladder. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic inguinal herniorrhaphy complicating radical cystoprostatectomy. [2007]