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

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

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Procedure: Modified ileal conduit

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Cancer Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-75 years old, gender not limited, life expectancy is greater than or equal to 24 months；
2. ECOG score of patients: 0-1；
3. Volunteer to participate in this study and sign the informed consent；
4. 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;
5. 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:

1. A history of major middle and lower abdominal surgery;
2. Obese patients （BMI≥40kg/m2）;
3. Failure to receive regular follow-up review as required;
4. Severe cardiovascular disease;
5. History of immunodeficiency and organ transplantation；
6. History of severe central nervous system disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified ileal conduit; With our modified ileal conduit technique	Procedure: Modified ileal conduit; Modified ileal conduit (Extraperitonealization)
No Intervention: Conventional ileal conduit

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): March 11, 2020
• Study Completion (Actual): March 11, 2020

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: B2018-104-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No