A Clinical Trial of Extraperitonealization for Prevention of Parastomal Hernia After Ileal Conduit

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Multicenter Randomized Controlled Clinical Trial of Extraperitonealization for Prevention of Parastomal Hernia After Ileal Conduit

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: Modified ileal conduit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years old, gender not limited, life expectancy is greater than or equal to 24 months； ECOG score of patients: 0-1； Volunteer to participate in this study and sign the informed consent； T2-T4a, N0-x,M0 invasive bladder cancer; High risk non-muscular invasive bladder cancer T1G3(high grade) tumor; Tis in which BCG therapy failed; Recurrent non-invasive bladder cancer; TUR and bladder perfusion were used for treatment of uncontrolled extensive papillary lesions and bladder non-urothelial carcinoma; Major organ functions, such as liver, kidney, bone marrow, heart and other important organs, were not significantly abnormal: AST, ALT≤2.5 upper limit of normal value (ULN); Total bilirubin (TBIL)≤1.5 ULN; Albumin (ALB)≥25g/L; Serum creatinine (CRE)≤1.5 ULN; Leukocytes≥3.5*109/L, neutrophils≥1.5*109/L, hemoglobin≥90g/L, platelets≥80*109/L; Left ventricular ejection fraction (LVEF) ≥50%; Electrocardiogram showed no obvious abnormality or no clinical significance. Exclusion Criteria: A history of major middle and lower abdominal surgery; Obese patients （BMI≥40kg/m2）; Failure to receive regular follow-up review as required; Severe cardiovascular disease; History of immunodeficiency and organ transplantation； History of severe central nervous system disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified ileal conduit<br>With our modified ileal conduit technique | Procedure: Modified ileal conduit<br>* Modified ileal conduit (Extraperitonealization)<br>|
| No Intervention: Conventional ileal conduit<br>Conventional ileal conduit | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of parastomal hernia in 2 years | Incidence of parastomal hernia in 2 years | 2 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |