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When is the best moment to remove the urinary catheter after laparoscopic hysterectomy?


- candidate number24175
- NTR NumberNTR5818
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-apr-2016
- Secondary IDsP15.382 NL55504.058.15
- Public TitleWhen is the best moment to remove the urinary catheter after laparoscopic hysterectomy?
- Scientific TitleWhen is the best moment to remove the urinary catheter after laparoscopic hysterectomy?
- ACRONYMMUCH study
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studiedHysterectomy, Catheter
- Inclusion criteriaOlder than 18 years
Scheduled for LH for benign indication or low-grade malignancy (with or without salpingo-oophorectomie)
- Exclusion criteriaConcomitant 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-apr-2016
- planned closingdate21-jun-2017
- Target number of participants160
- InterventionsGroup 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).
- Primary outcomeUrinary retention, defined as the inability to void (completely) 6 hours after catheter removal.
- Secondary outcomeRate 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
Patientˇ¦s perspectives
„X VAS (OR+6 hours; OR+24 hours)
„X Satisfaction (OR+24 hours; OR+6weeks)
- Timepoints6 hours after urinary catheter is removed
6 hours postoperative; 24 hours postoperative; 6 weeks postoperative
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. F.W. Jansen
- CONTACT for SCIENTIFIC QUERIESDr. F.W. Jansen
- Sponsor/Initiator Leiden University Medical Center (LUMC), MCH-Westeinde-Bronovo, Haga Hospital, Reinier de Graaf Gasthuis, Delft , Groene Hart Ziekenhuis, Alrijne ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsN/A
- Brief summaryDuring 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 doctorˇ¦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 patientˇ¦s experience on this subject.

Study design: Randomized Controlled trial, non-inferiority study.
- Main changes (audit trail)
- RECORD1-apr-2016 - 27-aug-2017


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