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.

NCT07233811 | Recruiting

• 1 other identifier: 2023-05648-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Hysterectomy; Same Day Discharge; Robotic Surgical Procedures

Keywords

Hysterectomy; Same day discharge; Robotic assisted Hysterectomy; Robotic suregery

Outcome Measures

Primary Outcomes (1)

• Quality of life (QoL) day 3 after surgery compared to before surgery

  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.

  3 days

Secondary Outcomes (8)

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

  30 days

• Patient satisfaction with length of stay

  30 days

• Eq5D-5L index value of QoL.

  30 days

• Complications after surgery

  30 days

• Readmission

  30 days

Study Arms (2)

Day care

EXPERIMENTAL

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

Other: Day care

Overnight stay

ACTIVE COMPARATOR

The patient stay at the hospital overnight after their surgery.

Other: Overnight stay

Interventions

Day care OTHER

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

Day care

Overnight stay OTHER

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

Overnight stay

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Only people with uterus undergoing a hysterectomy can participate in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (3)

Södersjukhuset

Stockholm, 11447, Sweden

RECRUITING

Danderyd Hospital

Stockholm, Sweden

RECRUITING

Karolinska University hospital

Stockholm, Sweden

RECRUITING

MeSH Terms

Interventions

Day Care, Medical

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Malin Brunes, MD,PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Benér, MD

CONTACT

+46705554427; emily.bener@ki.se

Malin Brunes, MD, PhD

CONTACT

+46722350385; malin.brunes@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: November 18, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: Beginning 9 month following article publication. Ending 36 month after publication.
• Access Criteria: Researchers that provides a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee. A data-sharing agreement will be required. contact: malin.brunes@regionstockholm.se

Locations

SE (3)