Anastomosis; Complications, Bladder Cancer, Ileus Paralytic
Conditions
Keywords
bladder Cancer, Cystectomy, hand sewn anastamosis, stapled anastamosis, intestinal complications
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
Interventions
PROCEDUREcystectomy 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
PROCEDUREcystectomy 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
Sponsors
Fundacio Puigvert
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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..
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the predictive factors of postoperative complications. | 1 year | 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. |
Countries
Spain
Outcome results
None listed