RecruitingNot ApplicableNCT07233811

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


Sponsor

Karolinska Institutet

Enrollment

300 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study in Sweden is comparing whether patients can safely go home the same day (day surgery) after robotic hysterectomy — surgical removal of the uterus — versus staying overnight in hospital. It covers both benign conditions and early uterine cancer, and involves three hospitals in Stockholm. **You may be eligible if...** - You are scheduled for a total robotic hysterectomy at one of the three participating hospitals - Your reason for surgery is a benign (non-cancerous) condition or endometrial (uterine) cancer - You fall into any BMI or uterus size category **You may NOT be eligible if...** - You are over 75 years old - You will not have someone at home with you on the first night after surgery - You have a health status (ASA class 3) that is not related to BMI alone - You are having simultaneous prolapse repair or lymph node removal - You have severe endometriosis or chronic pain that requires a special pain management plan after surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDay care

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

OTHEROvernight stay

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


Locations(3)

Södersjukhuset

Stockholm, Sweden

Danderyd Hospital

Stockholm, Sweden

Karolinska University hospital

Stockholm, Sweden

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NCT07233811


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