Prospective, Controlled, Randomized Multicentric Study on the Management of the Vesical Catheter in Colon Surgery.

NCT04070898 | Unknown

• 1 other identifier: CR-Vesical Cath-2019-01
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION: Recommendations for peroperative bladder catheterization remain a controversial issue since it is a procedure that is not without complications. Most of the current suggestions derive from open surgery data that have been extrapolated to Enhanced Recovery After Surgery (ERAS) or Fast-Track programs ranging between 24-48 hours. The objective of the present study is to find the perfect balance with a better degree of evidence than the current one between the reduction of the probing time and the non-increase of the acute retention of urine in the patients operated in a programmed way of laparoscopic colon surgery. Methods: Multicenter, prospective, controlled, randomized non-inferiority study on the management of the bladder catheter in patients undergoing scheduled laparoscopic colon surgery, randomized in two study groups: experimental group (removal of the bladder catheter after surgery ) and control group (removal of the catheter at 24 hours) after the surgical intervention. The main objective of the present study is to reduce the permanence of the bladder catheter trying to find the balance of the probing time and the non-increase of the acute retention of urine in the patients operated in a programmed way of laparoscopic colon surgery As secondary objectives we will consider the decrease in the incidence of urinary tract infections within the first 30 days as well as the reduction in hospital stay and morbidity related to the bladder catheter.

Conditions

Colon Cancer

Keywords

Laparoscopic colectomy; urinary catheter; acute urinary retention

Outcome Measures

Primary Outcomes (1)

• Development of acute urine retention after removal of the bladder catheter after colon surgery.

  Acute urine retention is defined as * the inability to spontaneous urination at 8 hours after the removal of the bladder catheter * obtaining after urinary catheterization of more than 400 cc of urine or the need for repeated probing due to the impossibility of spontaneous urination

  8 hours

Secondary Outcomes (3)

• Change incidence of urinary tract infections

  30 days

• Change of hospital stay

  30 days

• Morbidity changes

  30 days

Study Arms (2)

control group

NO INTERVENTION

Bladder catheter removal 24 hours after surgery

experimental group

EXPERIMENTAL

Removal of the bladder catheter after the surgical intervention

Procedure: Remove urinary catheter after surgery

Interventions

Remove urinary catheter after surgery PROCEDURE

Remove bladder catheter after surgery

experimental group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient who understands, agrees to participate and signs the informed consent
• older than 18 years-old
• electively operated and programmed laparoscopically of the colon and upper rectum in which peritoneal reflection has not been opened
• duration of the surgical act less than 180 minutes
• Prior anesthetic assessment of ASA I-III
• International prostate symptom score (IPSS) of less than 19 with / without treatment for BPH (alpha-blocker).

You may not qualify if:

• \- Open surgery or conversion to open surgery
• Performing periodic anesthesia or being ASA IV
• Preoperative diagnosis of recurrent urinary tract infections (more than 3 episodes / year documented by urinoculture or two urinary tract infections in the last 6 months);
• Moderate-severe prostate clinic (IPSS\> 19)
• Presence of positive urine culture in men in preoperative tests
• Urinary infection clinic in women with positive urine culture
• Previous history of acute urine retention
• be a permanent bladder catheter or ureteral catheter and perform intermittent autocatheterization.
• men who underwent prostate surgery
• patients with a history of treatment for urological tumor - patients with a history of urethral stricture, enterovesical fistula or previous pelvic surgery.
• urinary incontinence or neurogenic bladder
• chronic renal failure (CRF) with creatinine levels greater than 2 (including terminal CRI stage or dialysis)
• emergency surgery pregnant
• have received pelvic radiotherapy
• Administration of serum during the operative time\> 2,000ml.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Hospital Universitario Parc Tauli de Sabadell

Sabadell, Barcelona, 08208, Spain

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Xavier Serra-Aracil, MD, PhD

  Corporacio Parc Tauli. Parc Tauli University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Serra-Aracil, MD,PhD

CONTACT

34-93-723-1010; jserraa@tauli.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head Colorectal Unit, Clinical Professor

Model Details: A multicenter prospective, controlled, randomized, non-inferiority study on the management of the bladder catheter in scheduled laparoscopic colon surgery

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: September 15, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

ES (1)