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,…
ID
Bron
Verkorte titel
Aandoening
Urinary catheter
Laparoscopic hysterectomy
Urinary retention
Urinary tract infection
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Urinary retention, defined as the inability to void (completely) 6 hours after catheter removal.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
6 hours after urinary catheter is removed
6 hours postoperative; 24 hours postoperative; 6 weeks postoperative
Onderzoeksproduct en/of interventie
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).
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Older than 18 years
Scheduled for LH for benign indication or low-grade malignancy (with or without salpingo-oophorectomie)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL5496 |
NTR-old | NTR5818 |
Ander register | NL55504.058.15 : P15.382 |