No registrations found.
ID
Source
Brief title
Health condition
Total laparoscopic hysterectomy, benign indication, discharge.
Totale laparoscopische hysterectomie, benigne indic
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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).
Background summary
Previous 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.
Study objective
We 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.
Study design
1,3 and 7 days and 6 weeks after surgery.
Intervention
Same-day discharge vs one night admittance after Total Laparoscopic Hysterectomy
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6396 |
| NTR-old | NTR6570 |
| Other | : 60291 |