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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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..
Arms & Interventions
Mechanical anastamosis
Intestinal anastamosis will be performed using stapling device
Intervention: cystectomy with ileal conduit, using mechanical bowel anastomosis (Procedure)
Manual anastamosis
Intestinal anastamosis will be performed manually
Intervention: cystectomy with ileal conduit, using manual bowel anastomosis (Procedure)
Outcomes
Primary Outcomes
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.
Time Frame: 1 year
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.
Secondary Outcomes
- To evaluate the predictive factors of postoperative complications.(1 year)
Investigators
Pavel Gavrilov
Consultant surgeon
Fundacio Puigvert