DARSH - A Multicenter Randomized Controlled Trial: Day-care vs Overnight Stay in Robotic Assisted Hysterectomy in Patients With Bening Disease and Endometrial Cancer.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 300
- Locations
- 3
- Primary Endpoint
- Quality of life (QoL) day 3 after surgery compared to before surgery
Study Overview
Brief Summary
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.
Detailed Description
The study is a multicenter randomized non-inferiority trial. Three hospitals will participate in the study, Södersjukhuset and Danderyds sjukhus for benign indications, and Karolinska Sjukhuset Solna in case of endometrial cancer. The experimental group consisting of patients undergoing same-day discharge, while the control group consisting of patients admitted overnight. The study will use a 1:1 randomization ratio between the experimental and the control group with stratification for malignant and benign cases, given that Karolinska University Hospital Solna only handles endometrial cancer cases, while the other two sites handle benign cases exclusively.
To measure Quality of Life, the validated Euroqol instrument EQ-5D-5L will be used. The EQ-5D-5L instrument is well validated and used in several studies. The literature support that a 5 points difference at the visaul analog scale (VAS) scale is significant for better/worse health QoL.
To measure patient satisfaction with the length of hospital stay and care given they will at day 30 receive an additional questionnaire, the "Quality in patent perspective" (QPP), which is a validated questionnaire in Swedish.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •Severe endometriosis or patients with chronic pain conditions that have a special pain regimen after surgery.
Arms & Interventions
Day care
The patient returns to home the same day as the surgery is performed (before midnight)
Intervention: Day care (Other)
Overnight stay
The patient stay at the hospital overnight after their surgery.
Intervention: Overnight stay (Other)
Outcomes
Primary Outcomes
Quality of life (QoL) day 3 after surgery compared to before surgery
Time Frame: 3 days
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
- Readmission(30 days)
- Quality of life (QoL) day 30 after surgery.(30 days)
- Complications after surgery(30 days)
- Reoperation(30 days)
- Sick leave after suregery(60 days.)
- Socioeconomic costs(30 days)
- Patient satisfaction with length of stay(30 days)
- Eq5D-5L index value of QoL.(30 days)
Investigators
Malin Brunes
Principal Investigator
Karolinska Institutet