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

Fundacio Puigvert120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Bladder Cancer Anastomosis; Complications Ileus Paralytic

Interventions

cystectomy with ileal conduit, using mechanical bowel anastomosisPROCEDURE

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

cystectomy with ileal conduit, using manual bowel anastomosisPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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..

Locations (1)

Fundacio Puigvert

Barcelona, Barcelona, Spain

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.

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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