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

  • STATUS
    Recruiting
  • days left to enroll
    34
  • participants needed
    104
  • sponsor
    Sun Yat-sen University
Updated on 22 January 2021

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.

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.

Details
Condition urinary tract neoplasm, Urologic Cancer, bladder cancer, bladder cancer, Bladder Carcinoma, Urothelial Cancer, bladder disorder, Bladder Disorders, Urothelial Cancer, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, carcinoma of the bladder, bladder tumor
Treatment Modified ileal conduit
Clinical Study IdentifierNCT03822234
SponsorSun Yat-sen University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

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, ALT2.5 upper limit of normal value (ULN); Total bilirubin (TBIL)1.5 ULN; Albumin (ALB)25g/L; Serum creatinine (CRE)1.5 ULN; Leukocytes3.5 _109/L, neutrophils1.5_ 109/L, hemoglobin90g/L, platelets80109/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 BMI40kg/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
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