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Same day discHarge aftEr Laparoscopic hysTERectomy (SHELTER trial)


- candidate number27556
- NTR NumberNTR6570
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-jul-2017
- Secondary IDs60291 
- Public TitleSame day discHarge aftEr Laparoscopic hysTERectomy (SHELTER trial)
- Scientific TitleRCT to determine patient satisfaction and recovery after total laparoscopic hysterectomy when randomizing between discharge on day of surgery versus admittance.
- ACRONYMSHELTER trial
- hypothesisWe hypothesize that performing a total laparoscopic hysterectomy with same day discharge is safe and leads to equal levels of patient satisfaction when compared to admittance for 1 night.
- Healt Condition(s) or Problem(s) studiedTotal laparoscopic hysterectomy (TLH)
- Inclusion criteriaWomen between 25-65 years of age, ASA classification I-II, who are planned for a TLH with a benign indication.
- Exclusion criteria- Women who do not speak Dutch
- Women younger than 25 years
- Women with a history of a midline laparotomy
- Women without a supporting person at home
- Concomitant procedures, other than tubectomy or ovariectomy
- Indication malignant or atypical hyperplasia of the endometrial tissue
- Deep invasive endometriosis
- Endtime of surgery past 14.00 o clock
- Patients living further than 1 hr drive from the hospital
- Contra-indications for NSAIDs
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-sep-2017
- planned closingdate1-sep-2018
- Target number of participants100
- InterventionsSame-day discharge vs one night admittance after Total Laparoscopic Hysterectomy
- Primary outcomeThe primary outcome of this RCT is the recovery and satisfaction after surgery, measured with the Promis Physical Function – Short Form at 1, 3 and 7 days post-operative. The quality of life will be measured at these same time points by the EuroQol-5.
- Secondary outcomeThe secondary outcomes are the post-operative complications, operative characteristics, duration of surgery, operating room occupancy, time to discharge, time to first voiding, admission days, (re)admission, (re) evaluation, pain (NRS), pain medication usage, recovery index (RI-10), return to normal activities (RNA), return to work (RTW), quality of life and anxiety (EQ-5D) and direct and indirect costs (corrected for RTW).
- Timepoints1,3 and 7 days and 6 weeks after surgery.
- Trial web sitenone
- status[default]
- CONTACT FOR PUBLIC QUERIES Suzanne Dedden
- CONTACT for SCIENTIFIC QUERIES Suzanne Dedden
- Sponsor/Initiator Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Maxima Medical Center
- PublicationsNone
- Brief summaryPrevious studies show that performing the total laparoscopic hysterectomy with same day discharge is safe, it is associated with low minor and major complications. Literature shows low numbers of (re) evaluation and (re) admission. Participants fill out short questionnaires 5 different intervals; day of surgery, day 1,3 and 7 and 6 weeks after surgery. The expected benefit is a similar quality life and a decrease in institutional costs.
- Main changes (audit trail)
- RECORD16-jul-2017 - 4-aug-2017


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