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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorKarolinska Institutet

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Day care

    Other intervention

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

  • Overnight stay

    Other intervention

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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Day careExperimental treatment 1 intervention
Group B: Overnight stayActive comparator 1 intervention

Trial outcomes

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.

Time frame
3 days

Secondary outcomes

1

Quality of life (QoL) day 30 after surgery.

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.

Time frame
30 days
2

Patient satisfaction with length of stay

Patient satisfaction with length of stay from the QPP (quality from patients perspective) questionnaire after 30 days.

Time frame
30 days
3

Eq5D-5L index value of QoL.

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.

Time frame
30 days
4

Complications after surgery

Complications within 30 days from surgery according to Clavien-Dindo (grouped as None, Grade 1-2, Grade 3 or Grade 4).

Time frame
30 days

Other outcomes

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