About this trial
Patients undergoing robotic assisted hysterectomy in three different hospitals in Stockholm will be randomized to day-care (going home the same day as the surgery) or admission (staying at least one night after surgery). The aim with this study is to investigate if patients in day-care recover as fast/faster as the other group that stays in the hospital. Both patients with benign disease and malign disease (endometrial cancer) will be included in the study.
Patients quality of life (QoL) will be measured before surgery and after surgery at day 3,7 and 30 with a questionnaire called Eq-5D-5L from Euroqol. The questionnaire is validated for postoperative QoL and widely used.
Complications due to surgery within the 30 first days after surgery will also be recorded in the two groups to make sure it is safe for the patients to go home the same day as their surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient that are planned to undergo total robotic hysterectomy with or without adnexal surgery at the three sites.
Both benign conditions and endometrial cancer.
All BMI groups and all uterus sizes.
Disqualifiers
Age not over 75 years old,
No company at home first night after surgery
ASA class 3 that is not only because of high BMI.
Simultaneous prolapse surgery/lymph node evacuation.
Trial design
Parallel
Treatments tested in this trial
Day care
Other interventionThe patient return to home the same day as the surgery is performed.
Overnight stay
Other interventionThe patient spend the night at the hospital and can not go home until the next morning.
Treatment groups
Trial outcomes
Primary outcomes
Quality of life (QoL) day 3 after surgery compared to before surgery
Patients self reported quality of life (QoL) at a visual analog scale (VAS-scale) as reported in the 5-level EQ-5D Euroqol form (Eq-5d-5L) before surgery, compared with day 3 after surgery. The VAS-Scale goes from 0 to 100 where 0 i labeled "The worst health you can imagine" and 100 is labeled "The best health you can imagine". Compared between the two groups: day care and overnight stay.
Secondary outcomes
Quality of life (QoL) day 30 after surgery.
The patients self-reported value at the VAS-Scale (0-100) as reported in the EQ-5D-5L questionnaire at day 30 compared to their value before surgery.
Patient satisfaction with length of stay
Patient satisfaction with length of stay from the QPP (quality from patients perspective) questionnaire after 30 days.
Eq5D-5L index value of QoL.
The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. These five questions generate an index value ranging from -0,59 to 1, where 1 signifies excellent health and below 0 is worse than death.
Complications after surgery
Complications within 30 days from surgery according to Clavien-Dindo (grouped as None, Grade 1-2, Grade 3 or Grade 4).
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