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

Puigvert Foundation

Status: Completed

Conditions: Bladder Cancer; Ileus Paralytic; Anastomosis; Complications

Treatments: Procedure: cystectomy with ileal conduit, using manual bowel anastomosis; Procedure: cystectomy with ileal conduit, using mechanical bowel anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT06928220

181184

Details and patient eligibility

About

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

Full 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

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient who consents to participate and signs the informed consent.
• Patient candidate for radical open cystectomy and ileal conduit.

Exclusion criteria

• Patient who is unable to complete the study questionnaires.
• Patient who has a life expectancy of less than 1 year.
• Candidate patients for other urinary diversions other than ileal conduit as a first option
• Candidate patients for laparoscopic or robotic cystectomy..

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Manual anastamosis

Active Comparator group

Description:

Intestinal anastamosis will be performed manually

Treatment:

Procedure: cystectomy with ileal conduit, using manual bowel anastomosis

Mechanical anastamosis

Active Comparator group

Description:

Intestinal anastamosis will be performed using stapling device

Treatment:

Procedure: cystectomy with ileal conduit, using mechanical bowel anastomosis