Clinical trial NCT02742636: When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy?
Official title: When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy: MUCH Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infection
Bladder Retention
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Bronovo Hospital
name: Haga Hospital
name: Alrijne Hospital
name: Reinier de Graaf Groep
name: Groene Hart Ziekenhuis
name: Medical Center Haaglanden
First posted: 2016-04-19
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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

Primary outcomes:
measure: Urinary retention (inability to void)
timeFrame: 6 hours after removal of urinary catheter
Secondary outcomes:
measure: Rate of re-catheterisation
timeFrame: 6 hours without voiding
measure: Urinary tract infection (by performing a urine dipstick test and based on clinical symptoms)
timeFrame: 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)
measure: Patient satisfaction (self-administrated questionnaire)
timeFrame: 6 hours postoperative; 24 hours and 6 weeks
measure: Visual analogue scale score (VAS score)
timeFrame: 6 hours postoperative; 24 hours
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Noord-Holland
city: Delft
country: Netherlands
facility: Reinier de Graaf Groep
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Leiden
country: Netherlands
facility: Alrijne Hospital
city: The Hague
country: Netherlands
facility: Bronovo Hospital
city: the Hague
country: Netherlands
facility: Haga Hospital
city: the Hague
country: Netherlands
facility: Medisch Centrum Haaglanden
Study officials:
References:
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.