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

NCT06928220 | Completed

• 1 other identifier: 181184
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Anastomosis; Complications; Ileus Paralytic

Keywords

bladder Cancer; Cystectomy; hand sewn anastamosis; stapled anastamosis; intestinal complications

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• To evaluate the predictive factors of postoperative complications.

  1 year

Study Arms (2)

Manual anastamosis

ACTIVE COMPARATOR

Intestinal anastamosis will be performed manually

Procedure: cystectomy with ileal conduit, using manual bowel anastomosis

Mechanical anastamosis

ACTIVE COMPARATOR

Intestinal anastamosis will be performed using stapling device

Procedure: cystectomy with ileal conduit, using mechanical bowel anastomosis

Interventions

cystectomy with ileal conduit, using mechanical bowel anastomosis PROCEDURE

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

Mechanical anastamosis

cystectomy with ileal conduit, using manual bowel anastomosis PROCEDURE

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

Manual anastamosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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..

Sponsors & Collaborators

• Fundacio Puigvert: lead

Study Sites (1)

Fundacio Puigvert

Barcelona, Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Ileus

Interventions

Cystectomy; Urinary Diversion

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant surgeon

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: April 15, 2025
• Study Start: October 19, 2020
• Primary Completion: April 4, 2025
• Study Completion: April 7, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

ES (1)