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Same day discHarge aftEr Laparoscopic hysTERectomy (SHELTER trial)

RCT to determine patient satisfaction and recovery after total laparoscopic hysterectomy when randomizing between discharge on day of surgery versus admittance.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21121
Enrollment
100
Registered
2017-07-16
Start date
2017-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Total laparoscopic hysterectomy, benign indication, discharge. Totale laparoscopische hysterectomie, benigne indic

Interventions

Same-day discharge vs one night admittance after Total Laparoscopic Hysterectomy

Sponsors

Maxima Medical Centre
Lead Sponsor

Eligibility

Inclusion criteria

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

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

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), quality of life and anxiety (EQ-5D) and direct and indirect costs (corrected for RTW).

Contacts

Public ContactSuzanne Dedden
suzanne.dedden@mmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)