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

Primary Purpose

Urinary Tract Infection, Bladder Retention

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Foley catheter
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Leiden University Medical Center
  • Reinier de Graaf Groep
  • Groene Hart Ziekenhuis
  • Alrijne Hospital
  • Bronovo Hospital
  • Haga Hospital
  • Medisch Centrum Haaglanden

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A (treatment group)

Group B (control group)

Arm Description

The patients in this group will have their catheter directly removed in the OR after LH.

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).

Outcomes

Primary Outcome Measures

Urinary retention (inability to void)

Secondary Outcome Measures

Rate of re-catheterisation
Urinary tract infection (by performing a urine dipstick test and based on clinical symptoms)
Patient satisfaction (self-administrated questionnaire)
Visual analogue scale score (VAS score)

Full Information

First Posted
April 1, 2016
Last Updated
August 22, 2017
Sponsor
Leiden University Medical Center
Collaborators
Bronovo Hospital, Haga Hospital, Alrijne Hospital, Reinier de Graaf Groep, Groene Hart Ziekenhuis, Medical Center Haaglanden
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1. Study Identification

Unique Protocol Identification Number
NCT02742636
Brief Title
When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy?
Acronym
MUCH
Official Title
When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy: MUCH Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 31, 2016 (Actual)
Primary Completion Date
June 21, 2017 (Actual)
Study Completion Date
June 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
Bronovo Hospital, Haga Hospital, Alrijne Hospital, Reinier de Graaf Groep, Groene Hart Ziekenhuis, Medical Center Haaglanden

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection, Bladder Retention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (treatment group)
Arm Type
Experimental
Arm Description
The patients in this group will have their catheter directly removed in the OR after LH.
Arm Title
Group B (control group)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Foley catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urinary retention (inability to void)
Time Frame
6 hours after removal of urinary catheter
Secondary Outcome Measure Information:
Title
Rate of re-catheterisation
Time Frame
6 hours without voiding
Title
Urinary tract infection (by performing a urine dipstick test and based on clinical symptoms)
Time Frame
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)
Title
Patient satisfaction (self-administrated questionnaire)
Time Frame
6 hours postoperative; 24 hours and 6 weeks
Title
Visual analogue scale score (VAS score)
Time Frame
6 hours postoperative; 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
Noord-Holland
ZIP/Postal Code
2311 AZ
Country
Netherlands
Facility Name
Reinier de Graaf Groep
City
Delft
Country
Netherlands
Facility Name
Groene Hart Ziekenhuis
City
Gouda
Country
Netherlands
Facility Name
Alrijne Hospital
City
Leiden
Country
Netherlands
Facility Name
Bronovo Hospital
City
The Hague
Country
Netherlands
Facility Name
Haga Hospital
City
the Hague
Country
Netherlands
Facility Name
Medisch Centrum Haaglanden
City
the Hague
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34184246
Citation
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.
Results Reference
derived

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

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