Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
FEMALE
ID07233811

Day-care vs Overnight Stay in Robotic Assisted Hysterectomy for Benign Disease and Endometrial Cancer: A Multicenter Randomized Controlled Trial

Led by Karolinska Institutet · Updated on 2025-11-18

300

Participants Needed

3

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the recovery and safety of patients undergoing robotic assisted hysterectomy, comparing those who go home the same day (day-care) to those who stay at least one night in the hospital. The study includes patients with both benign conditions and endometrial cancer. Quality of life after surgery will be measured using the EQ-5D-5L questionnaire at multiple time points to assess recovery speed and patient satisfaction. Participants are randomly assigned to one of two groups: the experimental group goes home the same day as surgery, while the control group stays overnight in the hospital. The study is conducted across three hospitals, with benign cases treated at two sites and endometrial cancer cases at a third. An additional questionnaire about satisfaction with hospital stay length will be given 30 days after surgery. During the study, patients will complete quality of life questionnaires before surgery and then at 3, 7, and 30 days after surgery. Researchers will also monitor surgical complications, readmissions, reoperations, and sick leave within 30 to 60 days post-surgery. Socioeconomic costs will be evaluated, and the total participation period spans from surgery to 60 days after. Safety and patient recovery outcomes are carefully recorded throughout.

CONDITIONS

Brief Title

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.

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Planned total robotic hysterectomy with or without adnexal surgery at one of the three study hospitals
  • Diagnosed with either benign conditions or endometrial cancer
  • All body mass index (BMI) groups and uterus sizes are eligible
Not Eligible

You will not qualify if you...

  • Older than 75 years
  • No companion at home the first night after surgery
  • ASA class 3 for reasons other than high BMI
  • Undergoing simultaneous prolapse surgery or lymph node removal
  • Severe endometriosis or chronic pain conditions requiring special pain management after surgery
  • Not female gender (implied by study gender requirement, but explicitly excluded by gender criteria if needed)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo robotic hysterectomy surgery and receive immediate post-operative care in the hospital. Participants are either discharged the same day or stay overnight based on their assigned group.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 30 days

Participants are followed for recovery, quality of life assessments, and monitoring for complications after surgery.

Visits at day 3 and day 30 after surgery (in-person or remote)

Extended Recovery Monitoring

Duration - Up to 60 days

Participants are observed for longer-term outcomes such as sick leave and socioeconomic impact after surgery.

Follow-up assessments up to 60 days after surgery

Trial Site Locations

Total: 3 locations

1

Södersjukhuset

Stockholm, Sweden, 11447

Actively Recruiting

2

Danderyd Hospital

Stockholm, Sweden

Actively Recruiting

3

Karolinska University hospital

Stockholm, Sweden

Actively Recruiting

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Research Team

E

Emily Benér, MD

M

Malin Brunes, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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