When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy? (MUCH)

When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy: MUCH Study.

Objective: The aim of this study is to evaluate if direct removal of the urine catheter after an laparoscopic hysterectomy (total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy) is associated with similar (or better) outcomes compared to delayed catheter removal after surgery, which is the current treatment. In addition, we want to investigate patient's experience on this subject.

Study design: Randomized Controlled trial, non-inferiority study.

Study population: Women older than 18 years old, who are a laparoscopic hysterectomy for benign indication or low-grade malignancy.

Intervention:

• Group A (treatment group): the patients in this group will have their catheter directly removed in the OR after LH.
• Group B (control group): the patients in the control group will have their catheter removed according to the regular protocol of the hospital (at least 6 hours in place).

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infection; Bladder Retention
• Intervention / Treatment: Device: Foley catheter

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Delft, Netherlands
    • Reinier de Graaf Groep
  • Gouda, Netherlands
    • Groene Hart Ziekenhuis
  • Leiden, Netherlands
    • Alrijne Hospital
  • The Hague, Netherlands
    • Bronovo Hospital
  • the Hague, Netherlands
    • Haga Hospital
  • the Hague, Netherlands
    • Medisch Centrum Haaglanden
  • Noord-Holland
    • Leiden, Noord-Holland, Netherlands, 2311 AZ
      • Leiden University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Older than 18 years
• Scheduled for LH for benign indication or low-grade malignancy (with or without salpingo-oophorectomy)

Exclusion Criteria:

• Concomitant procedures such as prolapse surgery, severe endometrioses and/or bowel resection
• Preoperative known urinary voiding problems (incontinence)
• Preoperative known urinary tract infection
• Patients suffering from diseases potentially associated with inability to void (e.g. MS)
• A Gravid or postpartum hysterectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (treatment group); The patients in this group will have their catheter directly removed in the OR after LH.	Device: Foley catheter; The aim of this study is to evaluate if direct removal of the urine catheter after an LH (total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy) is associated with similar (or better) outcomes compared to delayed catheter removal after surgery.
Active Comparator: Group B (control group); The patients in the control group will have their catheter removed according to the regular protocol of the hospital (at least 6 hours in place).	Device: Foley catheter; The aim of this study is to evaluate if direct removal of the urine catheter after an LH (total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy) is associated with similar (or better) outcomes compared to delayed catheter removal after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urinary retention (inability to void)	6 hours after removal of urinary catheter

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of re-catheterisation	6 hours without voiding
Urinary tract infection (by performing a urine dipstick test and based on clinical symptoms)	Dipstick: first urine after removal of catheter (group 1: direct after OR, group 2: at least 6 hours after OR), clinical symptoms through study period (up to 6 weeks postoperative)
Patient satisfaction (self-administrated questionnaire)	6 hours postoperative; 24 hours and 6 weeks
Visual analogue scale score (VAS score)	6 hours postoperative; 24 hours

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Collaborators: Medical Center Haaglanden; Groene Hart Ziekenhuis; Reinier de Graaf Groep; Haga Hospital; Alrijne Hospital; Bronovo Hospital

Publications and helpful links

General Publications

• Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2016
• Primary Completion (Actual): June 21, 2017
• Study Completion (Actual): June 21, 2017

Study Registration Dates

• First Submitted: April 1, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urination Disorders; Urinary Tract Infections; Urinary Retention
• Other Study ID Numbers: P15.382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No