An interventional study of cystectomy with ileal conduit, using mechanical bowel anastomosis and cystectomy with ileal conduit, using manual bowel anastomosis in Bladder Cancer, Anastomosis; Complications and Ileus Paralytic, sponsored by Fundacio Puigvert. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-15.
Sponsored by Fundacio Puigvert · Not applicable, Interventional, and Treatment
Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence and Management of Postoperative Complications in Patients Undergoing Radical Cystectomy with Ileal Conduit.
Currently, no specific trial compares hand-sewn intestinal anastomosis with mechanical stapled anastomosis in patients undergoing radical cystectomy with ileal conduit.
At Fundació Puigvert, approximately one hundred radical cystectomies with ileal conduit are performed annually. Due to the lack of evidence regarding the superiority of either intestinal anastomosis technique, the decision to use hand-sewn versus stapled anastomosis depends on the surgeon's expertise, without considering the potential impact of each technique on postoperative complication rates, surgical time, or functional outcomes.
Currently, no well-designed surgical trials demonstrate differences between hand-sewn and mechanical stapled anastomosis in radical cystectomy regarding intraoperative and postoperative complications. For this reason, the investigators will conduct a trial to assess the impact of each anastomosis technique
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 120 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Fundacio Puigvert is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Intestinal anastamosis will be performed manually
Procedure: cystectomy with ileal conduit, using manual bowel anastomosis
Intestinal anastamosis will be performed using stapling device
Procedure: cystectomy with ileal conduit, using mechanical bowel anastomosis
An ileal conduit will be the new storage area for urine once the bladder is removed. GIA Device will be used to perform bowel anastomosis
An ileal conduit will be the new storage area for urine once the bladder is removed. Vycryl suture will be used to perform manual bowel anastomosis
Demonstrate the superiority of manual intestinal suturing versus mechanical suturing, defined as a lower incidence of postoperative digestive complications in patients undergoing radical cystectomy with ileal conduit.
Compare the incidence of gastrointestinal complications according to the type of suturing used in the creation of the ileo-ileal anastomosis in patients undergoing radical cystectomy with ileal conduit during the hospital admission period and at one-year follow-up.
Time frame: 1 year
To evaluate the predictive factors of postoperative complications.
Identify the predictive factors of postoperative complications during hospital admission and at one-year follow-up, both overall and according to the type of suturing.
Time frame: 1 year
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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