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Day-care vs Overnight Stay in Robotic Assisted Hysterectomy for Benign Disease and Endometrial Cancer: A Multicenter Randomized Controlled Trial
Led by Karolinska Institutet · Updated on 2025-11-18
300
Participants Needed
3
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the recovery and safety of patients undergoing robotic assisted hysterectomy, comparing those who go home the same day (day-care) to those who stay at least one night in the hospital. The study includes patients with both benign conditions and endometrial cancer. Quality of life after surgery will be measured using the EQ-5D-5L questionnaire at multiple time points to assess recovery speed and patient satisfaction. Participants are randomly assigned to one of two groups: the experimental group goes home the same day as surgery, while the control group stays overnight in the hospital. The study is conducted across three hospitals, with benign cases treated at two sites and endometrial cancer cases at a third. An additional questionnaire about satisfaction with hospital stay length will be given 30 days after surgery. During the study, patients will complete quality of life questionnaires before surgery and then at 3, 7, and 30 days after surgery. Researchers will also monitor surgical complications, readmissions, reoperations, and sick leave within 30 to 60 days post-surgery. Socioeconomic costs will be evaluated, and the total participation period spans from surgery to 60 days after. Safety and patient recovery outcomes are carefully recorded throughout.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned total robotic hysterectomy with or without adnexal surgery at one of the three study hospitals
- Diagnosed with either benign conditions or endometrial cancer
- All body mass index (BMI) groups and uterus sizes are eligible
You will not qualify if you...
- Older than 75 years
- No companion at home the first night after surgery
- ASA class 3 for reasons other than high BMI
- Undergoing simultaneous prolapse surgery or lymph node removal
- Severe endometriosis or chronic pain conditions requiring special pain management after surgery
- Not female gender (implied by study gender requirement, but explicitly excluded by gender criteria if needed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo robotic hysterectomy surgery and receive immediate post-operative care in the hospital. Participants are either discharged the same day or stay overnight based on their assigned group.
1 surgical visit (in-person)
Duration - 30 days
Participants are followed for recovery, quality of life assessments, and monitoring for complications after surgery.
Visits at day 3 and day 30 after surgery (in-person or remote)
Duration - Up to 60 days
Participants are observed for longer-term outcomes such as sick leave and socioeconomic impact after surgery.
Follow-up assessments up to 60 days after surgery
Trial Site Locations
Total: 3 locations
1
Södersjukhuset
Stockholm, Sweden, 11447
Actively Recruiting
2
Danderyd Hospital
Stockholm, Sweden
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3
Karolinska University hospital
Stockholm, Sweden
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Research Team
E
Emily Benér, MD
M
Malin Brunes, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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