Day Care in Robotic Surgery Hysterectomy. Investigate Quality of Life and Safety With Same Day Discharge After Robotic Hysterectomy for Patients With Benign and Malignant Disease. A Multicenter Randomized Study With 3 Hospitals in Stockholm Sweden.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Day care, Overnight stay.
- Who it may be relevant to
- Registry conditions: Hysterectomy, Same Day Discharge, Robotic Surgical Procedures. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
DARSH - A Multicenter Randomized Controlled Trial: Day-care vs Overnight Stay in Robotic Assisted Hysterectomy in Patients With Bening Disease and Endometrial Cancer.
Overview
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.
Interventions
- Other Day care
The patient return to home the same day as the surgery is performed. - Other Overnight stay
The patient spend the night at the hospital and can not go home until the next morning.
Primary outcome measures
- Quality of life (QoL) day 3 after surgery compared to before surgery [Time frame: 3 days]
Secondary outcome measures (8)
- Quality of life (QoL) day 30 after surgery. [Time frame: 30 days]
- Patient satisfaction with length of stay [Time frame: 30 days]
- Eq5D-5L index value of QoL. [Time frame: 30 days]
- Complications after surgery [Time frame: 30 days]
- Readmission [Time frame: 30 days]
- Reoperation [Time frame: 30 days]
- Sick leave after suregery [Time frame: 60 days.]
- Socioeconomic costs [Time frame: 30 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 3 centers
- Södersjukhuset — Stockholm
- Danderyd Hospital — Stockholm
- Karolinska University hospital — Stockholm
Identifiers
NCT: NCT07233811 · 2023-05648-01