No registrations found.
ID
Source
Brief title
Health condition
Urinary catheter
Laparoscopic hysterectomy
Urinary retention
Urinary tract infection
Sponsors and support
Intervention
Outcome measures
Primary outcome
Urinary retention, defined as the inability to void (completely) 6 hours after catheter removal.
Secondary outcome
Rate of re-catheterization
Urinary tract infection, based on clinical symptoms and urine sample after catheter removal
Length of hospital stay
Moment of ambulation (defined as first time out of bed)
Presence of urine (objectified with bladder scan) after voiding before discharge
Patient¡¦s perspectives
„X VAS (OR+6 hours; OR+24 hours)
„X Satisfaction (OR+24 hours; OR+6weeks)
Background summary
During laparoscopic hysterectomy (LH), an indwelling catheter is placed to avoid iatrogenic injuries to the bladder by keeping it empty. After surgery the catheter is in most hospitals left in place until the next day as direct removal of the catheter increases the risk of developing urinary retention. However no evidence based guideline about the best moment to remove the catheter exists 1 and currently in most hospitals protocols are based on doctor¡¦s experience. As prolonged stay of catheter is associated with delayed mobilisation, a higher risk of urinary tract infection and discomfort for the patients, it is important to investigate when the best moment to remove the catheter is.
Objective: 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, 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 objective
We hypotheze that 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, which is the current treatment.
Study design
6 hours after urinary catheter is removed
6 hours postoperative; 24 hours postoperative; 6 weeks postoperative
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).
Department of Gynaecology,
P.O. Box 9600
F.W. Jansen
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262871
F.W.Jansen@lumc.nl
Department of Gynaecology,
P.O. Box 9600
F.W. Jansen
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262871
F.W.Jansen@lumc.nl
Inclusion criteria
Older than 18 years
Scheduled for LH for benign indication or low-grade malignancy (with or without salpingo-oophorectomie)
Exclusion criteria
Concomitant procedures such as prolapse surgery, severe endometriose 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5496 |
| NTR-old | NTR5818 |
| Other | NL55504.058.15 : P15.382 |