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

Urinary Tract Infection Clinical Trial

— MUCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742636
• Other study ID #: P15.382
• Status: Completed
• Phase: N/A
• First received: April 1, 2016
• Last updated: August 22, 2017
• Start date: May 31, 2016
• Est. completion date: June 21, 2017

Study information

• Verified date: August 2017
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: June 21, 2017
• Est. primary completion date: June 21, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Retention
• Urinary Retention
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Reinier de Graaf Groep	Delft
Netherlands	Groene Hart Ziekenhuis	Gouda
Netherlands	Alrijne Hospital	Leiden
Netherlands	Leiden University Medical Center	Leiden	Noord-Holland
Netherlands	Bronovo Hospital	The Hague
Netherlands	Haga Hospital	the Hague
Netherlands	Medisch Centrum Haaglanden	the Hague

Sponsors (7)

Lead Sponsor	Collaborator
Leiden University Medical Center	Alrijne Hospital, Bronovo Hospital, Groene Hart Ziekenhuis, Haga Hospital, Medical Center Haaglanden, Reinier de Graaf Groep

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary retention (inability to void)		6 hours after removal of urinary catheter
Secondary	Rate of re-catheterisation		6 hours without voiding
Secondary	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)
Secondary	Patient satisfaction (self-administrated questionnaire)		6 hours postoperative; 24 hours and 6 weeks
Secondary	Visual analogue scale score (VAS score)		6 hours postoperative; 24 hours