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. (DARSH)

DARSH - A Multicenter Randomized Controlled Trial: Day-care vs Overnight Stay in Robotic Assisted Hysterectomy in Patients With Bening Disease and Endometrial Cancer.

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.

Study Overview

• Status: Recruiting
• Conditions: Hysterectomy; Robotic Surgical Procedures; Same Day Discharge
• Intervention / Treatment: Other: Day care; Other: Overnight stay

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Benér, MD; Phone Number: +46705554427; Email: emily.bener@ki.se
• Study Contact Backup: Name: Malin Brunes, MD, PhD; Phone Number: +46722350385; Email: malin.brunes@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Karolinska University Hospital
    • Contact: Emily Benér, MD; Phone Number: +46705554427; Email: emily.bener@ki.se
    • Contact: Vilhelm Mörlin, MD; Phone Number: +460812380000; Email: vilhelm.morlin@regionstockholm.se
  • Stockholm, Sweden
    • Recruiting
    • Danderyd Hospital
    • Contact: Ulrika Johannesson, MD, Docent; Phone Number: +460812355000; Email: ulrika.johannesson@ki.se
    • Contact: Emily Benér, MD; Email: emily.bener@ki.se
  • Stockholm, Sweden, 11447
    • Recruiting
    • Södersjukhuset
    • Contact: Emily Rebecka Benér, MD; Phone Number: +460705554427; Email: emily.bener@ki.se
    • Contact: Malin Brunes, MD, PhD; Email: malin.brunes@ki.se
    • Principal Investigator: Emily Bener, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Day care; The patient returns to home the same day as the surgery is performed (before midnight)	Other: Day care; The patient return to home the same day as the surgery is performed.
Active Comparator: Overnight stay; The patient stay at the hospital overnight after their surgery.	Other: Overnight stay; The patient spend the night at the hospital and can not go home until the next morning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days
Patient satisfaction with length of stay	Patient satisfaction with length of stay from the QPP (quality from patients perspective) questionnaire after 30 days.	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.	30 days
Complications after surgery	Complications within 30 days from surgery according to Clavien-Dindo (grouped as None, Grade 1-2, Grade 3 or Grade 4).	30 days
Readmission	Readmission to the hospital within 30 days (yes/no	30 days
Reoperation	Reoperation within 30 days (yes/no)	30 days
Sick leave after suregery	Length of sick leave after operation, information from the Swedish Social insurance system.	60 days.
Socioeconomic costs	Socioeconomic cost, "Quality-adjusted life years" (QALY´s). The cost is calculated from the patients Eq5D-5L ratio combined with sick leave and costs for the surgery and care at hospital.	30 days

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Malin Brunes, MD,PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: October 2, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Hysterectomy; Same day discharge; Robotic assisted Hysterectomy; Robotic suregery
• Additional Relevant MeSH Terms: Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Day Care, Medical
• Other Study ID Numbers: 2023-05648-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant data that underlie the reported results.
• IPD Sharing Time Frame: Beginning 9 month following article publication. Ending 36 month after publication.
• IPD Sharing Access Criteria: Researchers that provides a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee. A data-sharing agreement will be required. contact: malin.brunes@regionstockholm.se
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No