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

Not Applicable

Completed

• Conditions: Urinary Tract Infection; Bladder Retention
• Interventions: Device: Foley catheter

• Registration Number: NCT02742636
• Lead Sponsor: Leiden University Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-01
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-19
• Study Start: 2016-05-31
• Primary Completion: 2017-06-21
• Study Completion: 2017-06-21
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 162

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (control group)	Foley catheter	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).
Group A (treatment group)	Foley catheter	The patients in this group will have their catheter directly removed in the OR after LH.

Primary Outcome Measures

Name	Time	Method
Urinary retention (inability to void)	6 hours after removal of urinary catheter

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction (self-administrated questionnaire)	6 hours postoperative; 24 hours and 6 weeks
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)
Visual analogue scale score (VAS score)	6 hours postoperative; 24 hours

Trial Locations

Locations (7)

Bronovo Hospital; 🇳🇱 The Hague, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Noord-Holland, Netherlands

Medisch Centrum Haaglanden; 🇳🇱 the Hague, Netherlands

Reinier de Graaf Groep; 🇳🇱 Delft, Netherlands

Groene Hart Ziekenhuis; 🇳🇱 Gouda, Netherlands

Alrijne Hospital; 🇳🇱 Leiden, Netherlands

Haga Hospital; 🇳🇱 the Hague, Netherlands