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.

Not Applicable

Recruiting

• Conditions: Hysterectomy; Robotic Surgical Procedures; Same Day Discharge

• Registration Number: NCT07233811
• Lead Sponsor: Karolinska Institutet

Brief 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.

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 Timeline

• Study Start: 2025-01-01
• Study First Submitted: 2025-10-02
• Status Verified: 2025-11
• Study First Submitted QC: 2025-11-16
• Last Update Submitted: 2025-11-16
• Study First Posted: 2025-11-18
• Last Update Posted: 2025-11-18
• Primary Completion: 2027-06
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of life (QoL) day 3 after surgery compared to before surgery	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 Outcome Measures

Name	Time	Method
Readmission	30 days	Readmission to the hospital within 30 days (yes/no
Quality of life (QoL) day 30 after surgery.	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.
Complications after surgery	30 days	Complications within 30 days from surgery according to Clavien-Dindo (grouped as None, Grade 1-2, Grade 3 or Grade 4).
Reoperation	30 days	Reoperation within 30 days (yes/no)
Sick leave after suregery	60 days.	Length of sick leave after operation, information from the Swedish Social insurance system.
Socioeconomic costs	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.
Patient satisfaction with length of stay	30 days	Patient satisfaction with length of stay from the QPP (quality from patients perspective) questionnaire after 30 days.
Eq5D-5L index value of QoL.	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.

Trial Locations

Locations (3)

Södersjukhuset; 🇸🇪 Stockholm, Sweden

Danderyd Hospital; 🇸🇪 Stockholm, Sweden

Karolinska University hospital; 🇸🇪 Stockholm, Sweden