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

NCT03822234 | Completed DMC

• 1 other identifier: B2018-104-01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of parastomal hernia in 2 years

  Incidence of parastomal hernia in 2 years

  2 years

Secondary Outcomes (5)

• Incidence of stomal retraction in 2 years

  2 years

• Incidence of stomal stenosis in 2 years

  2 years

• Incidence of stomal prolapse in 2 years

  2 years

• 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

  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

Study Arms (2)

Modified ileal conduit

EXPERIMENTAL

With our modified ileal conduit technique

Procedure: Modified ileal conduit

Conventional ileal conduit

NO INTERVENTION

Conventional ileal conduit

Interventions

Modified ileal conduit PROCEDURE

Modified ileal conduit (Extraperitonealization)

Modified ileal conduit

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 30, 2019
• Study Start: January 15, 2019
• Primary Completion: March 11, 2020
• Study Completion: March 11, 2020
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)