Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Many complications may occur after ileal conduit, with the incidence increasing with time after surgery. Nearly half of the complications are related to stoma and ureteroileal anastomosis. The investigators believe that the surgical technique is responsible for these complications, and therefore have devised a modified technique for creating the ileal conduit that should help prevent these complications after surgery. The investigators' retrospective study shows that modified surgical technique for ileal conduit urinary diversion appears to be effective for reducing early and late complications related to the stoma. Thus the investigators would like to perform a prospective multicenter randomized controlled clinical study to prove the investigators' results.
The investigators plan to enroll 104 patients, and randomizedly divide the participants into two groups, with one group 52 patients undergoing conventional ileal conduit, another group 52 patients undergoing modified ileal conduit.
The ileal conduit (Bricker) has been used for urinary diversion for more than half a century. Widely accepted to be a simple and safe form of urinary diversion, it remains one of the most commonly used techniques for urinary diversion after radical cystectomy for bladder cancer. However, many complications may occur after ileal conduit, with the incidence increasing with time after surgery. Interestingly, nearly half of the complications are related to stoma and ureteroileal anastomosis. Among the complications, parastomal hernia is the most common. Female gender, low preoperative serum albumin level, high BMI or severe obesity, and prior laparotomy have been shown to be risk factors for parastomal hernia. But the mechanisms by which these variables lead to stoma related complications have not yet been fully elucidated. The investigators believe that the surgical technique is responsible for these complications, and therefore have devised a modified technique for creating the ileal conduit that should help prevent these complications after surgery. The investigators' retrospective study shows that modified surgical technique for ileal conduit urinary diversion appears to be effective for reducing early and late complications related to the stoma. Thus the investigators would like to perform a prospective multicenter randomized controlled clinical study to prove the investigators' results.
The investigators plan to enroll 104 patients, and randomizedly divide the participants into two groups, with one group 52 patients undergoing conventional ileal conduit, another group 52 patients undergoing modified ileal conduit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified ileal conduit | Experimental | With our modified ileal conduit technique |
|
| Conventional ileal conduit | No Intervention | Conventional ileal conduit |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified ileal conduit | Procedure | Modified ileal conduit (Extraperitonealization) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of parastomal hernia in 2 years | Incidence of parastomal hernia in 2 years | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of stomal retraction in 2 years | Incidence of stomal retraction in 2 years | 2 years |
| Incidence of stomal stenosis in 2 years | Incidence of stomal stenosis in 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center, Sun Yat-sen University | Guangzhou | Guangdong | 510060 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 years |
| Incidence of stomal prolapse in 2 years | Incidence of stomal prolapse in 2 years | 2 years |
| Overall Survival | Overall Survival | up to 2 years. From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 24 months |
| Disease-Free Survival | Disease-Free Survival | up to 2 years. From date of randomization until the date of first documented progression or recurrence or date of death from any cause, whichever came first, assessed up to 24 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |