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Completed

NCT Number: NCT05249192

Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection

The primary aim of this study is to compare the rate of acute urinary retention (AUR) after immediate compared to early (24-hours) removal of urinary catheter (UC) in patients undergoing minimally invasive colorectal resection. The study hypothesis is that immediate UC removal is non-inferior to 24-hours UC removal in terms of AUR rate.

The secondary outcomes focus on goals that could be positively impacted by the immediate removal of the UC at the end of the surgery. In particular, the rate of urinary tract infections, perception of pain, time-to-return of bowel and physical functions, postoperative complications and postoperative length of stay will all be measured.

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Key information

Conditions

Surgical Complication Colonic Disease Colonic Diseases Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Infections Intestinal Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Urinary Retention Postoperative Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of General and Hepatobiliary Surgery

Verona, Italy, 37134

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 years and 80 years old
  • Patients scheduled to undergo minimally invasive resection of the colon under general anesthesia
  • Willingness to participate
  • Compliance to study purpose
  • Written informed consent

Exclusion criteria

  • Need for an anastomosis below the anterior peritoneal reflection
  • Need for a major resection other than colorectal
  • Need for post-operative intensive care monitoring or intensive care unit (ICU) stay
  • Anesthesia time longer than 300 minutes
  • Presence of chronic indwelling UC
  • Presence of an entero-vesical fistula
  • Need for ureteral stent placement, bladder resection or repair
  • A previous and unsolved history of AUR or overt voiding dysfunction

Treatment and study plan

Immediate urinary catheter removal

Device

Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.

Early urinary catheter removal

Device

urinary catheter removal on the first postoperative day (6 a.m)

Primary outcomes

  1. Acute urinary retention rate

    Time frame: 3 days postoperatively

    Occurrence of urinary retention after removal of urinary catheter

Secondary outcomes

  1. Urinary tract infections

    Time frame: 30 days postoperatively

    Occurrence of urinary tract infections

  2. UC reinsertion

    Time frame: 30 days postoperatively

    need for urinary catheter reinsertion after first removal

  3. Pain scores

    Time frame: 6,12,24,48 and 72 hours after surgery

    Numeric Rating Scores (NRS) for abdominal pain (0-10)

  4. Bowel function

    Time frame: 10 days postoperatively

    Time for return of bowel function as for flatus and stools postoperatively

  5. Mobilization

    Time frame: 10 days postoperatively

    Return to passive and active mobilization postoperatively

  6. Morbility

    Time frame: first 30 days after surgery

    Postoperative morbility according to the Clavien-Dindo classification

  7. Length of hospital stay

    Time frame: 30 days postoperatively

    postoperative stay

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Collaborators

  • Faenza Hospital
  • Humanitas Research Hospital IRCCS, Rozzano-Milan
  • Humanitas University
  • Ravenna Hospital
  • Universita di Verona

Registry information

Official study title

Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection: Study Protocol for a Randomized, Multicenter, Non-inferiority Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2022
Registry last updated
Nov 29, 2024

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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