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)

Karolinska Institute

Status: Enrolling

Conditions: Same Day Discharge; Hysterectomy; Robotic Surgical Procedures

Treatments: Other: Overnight stay; Other: Day care

Study type: Interventional

Funder types: Other

Identifiers

NCT07233811

2023-05648-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Day care

Experimental group

Description:

The patient returns to home the same day as the surgery is performed (before midnight)

Treatment:

Other: Day care

Overnight stay

Active Comparator group

Description:

The patient stay at the hospital overnight after their surgery.

Treatment:

Other: Overnight stay