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 catheter removal the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Urinewegen (urineretentie en urineweginfectie)
Research involving
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
Financial outcomes (cost-effectiveness)
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 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.
Study 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
catheter removal the next day after surgery (between 18 and 24 hours
postoperative), 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.
Intervention
Treatment group: the patients in this group will have their catheter directly
removed in the OR after LH.
Control group: the patients in the control group will have their catheter
removed one day after the OR (between 18 and 24 hours postoperative, regular
treatment)
Study burden and risks
In this study, no additional risk or burden is associated with participation.
Patients will be monitored by the nurses in the same way as they are now. One
urine sample will be taken from the patients to see if there are having a
urinary tract infection. Patients will also be asked to fill in a questionnaire
three times after surgery (6 hours; 24 hours and 1 week), about pain and their
experience in the hospital.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- Older than 18 years
- Laparoscopic hysterectomy (with or without salpingo-oophorectomie)
Exclusion criteria
- Younger than 18 years old
- 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
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| CCMO | NL55504.058.15 |