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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Danderyd Hospital
RECRUITING
Stockholm
Karolinska University hospital
RECRUITING
Stockholm
Södersjukhuset
RECRUITING
Stockholm
Contact Information
Primary
Emily Benér, MD
emily.bener@ki.se
+46705554427
Backup
Malin Brunes, MD, PhD
malin.brunes@ki.se
+46722350385
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2028-01
Participants
Target number of participants: 300
Treatments
Experimental: Day care
The patient returns to home the same day as the surgery is performed (before midnight)
Active_comparator: Overnight stay
The patient stay at the hospital overnight after their surgery.
Related Therapeutic Areas
Sponsors
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov

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