NCT06928220

The Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence of Postoperative Complications Following Cystectomy With Ileal Conduit

A Single-Center, Prospective, Randomized Clinical Trial Investigating the Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence and Management of Postoperative Complications in Patients Undergoing Radical Cystectomy With Ileal Conduit.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Fundacio Puigvert · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence and Management of Postoperative Complications in Patients Undergoing Radical Cystectomy with Ileal Conduit.

Detailed description

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

Conditions

• Bladder Cancer
• Anastomosis; Complications
• Ileus Paralytic

Interventions

Type	Name	Description
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
PROCEDURE	cystectomy with ileal conduit, using manual 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

Timeline

• Start date: 2020-10-19
• Primary completion: 2025-04-04
• Completion: 2025-04-07
• First posted: 2025-04-15
• Last updated: 2025-04-15

Locations

1 site across 1 country: Spain