Same-day discharge after robotic-assisted hysterectomy
DARSH - A Multicenter Randomized Controlled Trial: Day-care vs Overnight Stay in Robotic Assisted Hysterectomy in Patients With Bening Disease and Endometrial Cancer.
This will see if people having robotic-assisted hysterectomy for benign conditions or endometrial cancer can safely go home the same day instead of staying overnight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 3 sites (Stockholm and 2 other locations) |
| Trial ID | NCT07233811 on ClinicalTrials.gov |
What this trial studies
This is a multicenter randomized non-inferiority trial across three Stockholm hospitals comparing same-day discharge to overnight admission after robotic-assisted total hysterectomy. Patients with benign indications and those with endometrial cancer are randomized 1:1 with stratification by malignancy, and care pathways are standardized across sites. Quality of life is measured before surgery and on days 3, 7 and 30 using the EQ-5D-5L instrument, and surgical complications within 30 days are recorded to compare safety. Additional patient satisfaction at day 30 is captured with a Swedish-validated QPP questionnaire.
Who should consider this trial
Good fit: People 75 years old or younger scheduled for total robotic hysterectomy (benign or endometrial cancer), who have someone at home the first night, do not require concurrent complex procedures, and have no major uncontrolled comorbidities are the ideal candidates.
Not a fit: Patients over 75, those without someone at home the first night, patients needing simultaneous prolapse or lymph node surgery, those with severe endometriosis or chronic pain regimens, or with significant non-BMI-related ASA class 3 comorbidity are unlikely to benefit from same-day discharge.
Why it matters
Potential benefit: If successful, same-day discharge could reduce hospital stays and speed recovery while keeping complication rates similar.
How similar studies have performed: Previous observational and some randomized studies of minimally invasive hysterectomy, including robotic series, have shown same-day discharge can be feasible and safe in selected patients, but randomized multicenter data that include cancer cases remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Stockholm and 2 other locations
- Södersjukhuset — Stockholm, Sweden (Recruiting)
- Danderyd Hospital — Stockholm, Sweden (Recruiting)
- Karolinska University hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Malin Brunes, MD,PhD — Karolinska Institutet
- Study coordinator: Emily Benér, MD
- Email: emily.bener@ki.se
- Phone: +46705554427
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.