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Completed

NCT Number: NCT06928220

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundacio Puigvert

Barcelona, 08025, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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..

Treatment and study plan

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

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

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.

    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

  1. To evaluate the predictive factors of postoperative complications.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fundacio Puigvert

Other

Registry information

Official study title

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.

Acronym: CIMMIS

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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