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

Leiden University Medical Center162 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

162

Conditions

Urinary Tract Infection Bladder Retention

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Leiden University Medical Center

Leiden, North Holland, Netherlands

Reinier de Graaf Groep

Delft, Netherlands

Groene Hart Ziekenhuis

Gouda, Netherlands

Alrijne Hospital

Leiden, Netherlands

Bronovo Hospital

The Hague, Netherlands

Haga Hospital

The Hague, Netherlands

Medisch Centrum Haaglanden

The Hague, Netherlands

Outcomes

Primary Outcomes

Urinary retention (inability to void)

Time frame: 6 hours after removal of urinary catheter

Secondary Outcomes

Rate of re-catheterisation

Time frame: 6 hours without voiding

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)

Patient satisfaction (self-administrated questionnaire)

Time frame: 6 hours postoperative; 24 hours and 6 weeks

Visual analogue scale score (VAS score)

Time frame: 6 hours postoperative; 24 hours