Same day discHarge aftEr Laparoscopic hysTERectomy (SHELTER trial)
- Conditions
- Total laparoscopic hysterectomy, benign indication, discharge.<br />Totale laparoscopische hysterectomie, benigne indic
- Registration Number
- NL-OMON21121
- Lead Sponsor
- Maxima Medical Centre
- Brief Summary
one
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Women 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The 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 Outcome Measures
Name Time Method The 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).