Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07233811

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.

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Danderyd Hospital, Stockholm, Sweden

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Day care

Other

The patient return to home the same day as the surgery is performed.

Overnight stay

Other

The patient spend the night at the hospital and can not go home until the next morning.

Primary outcomes

  1. 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

  1. Quality of life (QoL) day 30 after surgery.

    Time frame: 30 days

    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.

  2. Patient satisfaction with length of stay

    Time frame: 30 days

    Patient satisfaction with length of stay from the QPP (quality from patients perspective) questionnaire after 30 days.

  3. Eq5D-5L index value of QoL.

    Time frame: 30 days

    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.

  4. Complications after surgery

    Time frame: 30 days

    Complications within 30 days from surgery according to Clavien-Dindo (grouped as None, Grade 1-2, Grade 3 or Grade 4).

  5. Readmission

    Time frame: 30 days

    Readmission to the hospital within 30 days (yes/no

  6. Reoperation

    Time frame: 30 days

    Reoperation within 30 days (yes/no)

  7. Sick leave after suregery

    Time frame: 60 days.

    Length of sick leave after operation, information from the Swedish Social insurance system.

  8. Socioeconomic costs

    Time frame: 30 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Benér, MD

CONTACT

[email protected]

+46705554427

Malin Brunes, MD, PhD

CONTACT

[email protected]

+46722350385

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: DARSH

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.