Bladder Retention, Urinary Tract Infection
Conditions
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).
Interventions
DEVICEFoley 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.
Sponsors
Bronovo Hospital
Haga Hospital
Alrijne Hospital
Reinier de Graaf Groep
Groene Hart Ziekenhuis
Medical Center Haaglanden
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary retention (inability to void) | 6 hours after removal of urinary catheter |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| Patient satisfaction (self-administrated questionnaire) | 6 hours postoperative; 24 hours and 6 weeks |
| Visual analogue scale score (VAS score) | 6 hours postoperative; 24 hours |
Countries
Netherlands
Outcome results
None listed