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RCT to determine Quality of Life after total laparoscopic hysterectomy when randomizing between discharge on day of surgery vs admittance.

RCT to determine Quality of Life after total laparoscopic hysterectomy when randomizing between discharge on day of surgery vs admittance. - Same day discHarge aftEr Laparoscopic hysTERectomy (SHELTER trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53000
Enrollment
220
Registered
2017-12-04
Start date
2018-02-26
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Laparoscopic Hysterectomy

Interventions

Same day discharge.

Sponsors

Maxima Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: All consenting women who undergo a total laparoscopic hysterectomy with a benign or premalignant indication Age 18-65 years ASA-classification I-II Dutch speaking transmen undergoing transgender surgery.

Exclusion criteria

Exclusion criteria: - Women who do not speak Dutch - Women younger than 18 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 - 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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), direct and indirect costs (corrected for RTW).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)