A Study to Determine if Placement of a Mesh during Bladder Removal Surgery Can Reduce the Chance of Developing a Hernia

Full Title

A Prospective, Randomized Trial of Preventive Mesh Placement at the Time of Radical Cystectomy to Reduce the Chances of Developing a Parastomal Hernia

Purpose

Bladder removal surgery (cystectomy) is a major operation. During the procedure, the surgeon creates an outlet (ileal conduit) from inside the patient’s body to a “stomal” bag that sits outside on the abdomen, which collects urine in place of the removed bladder.

In some patients, a hernia develops after this surgery from a weakness of the abdominal wall. Fat or intestine inside the belly slides through this weakened area, forming a hernia. Hernias can result in pain, discomfort, leakage of urine from the stomal bag, or trouble keeping the bag in place. In this study, researchers are looking to see if placing a piece of mesh inside the belly, in the area where the bag is connected, can strengthen the abdominal wall and reduce the risk of a hernia. This mesh is already used to repair hernias.

Patients in this study will be randomly assigned to have bladder removal surgery with or without the mesh placement. All patients will be monitored for at least two years after completion of their operation.

Eligibility

This study is for patients with non-metastatic bladder cancer who are scheduled to have bladder removal surgery and an ileal conduit.

For more information about this study and to inquire about eligibility, please contact Dr. Bernard Bochner at 646-422-4387.

Protocol

16-1285

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator