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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Day care | Experimental | The patient returns to home the same day as the surgery is performed (before midnight) |
|
| Overnight stay | Active Comparator | The patient stay at the hospital overnight after their surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Day care | Other | The patient return to home the same day as the surgery is performed. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Patient satisfaction with length of stay |
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Inclusion Criteria:
Exclusion Criteria:
Only people with uterus undergoing a hysterectomy can participate in the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Benér, MD | Contact | +46705554427 | emily.bener@ki.se | |
| Malin Brunes, MD, PhD | Contact | +46722350385 | malin.brunes@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Malin Brunes, MD,PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södersjukhuset | Recruiting | Stockholm | 11447 | Sweden |
Anonymized individual participant data that underlie the reported results.
Beginning 9 month following article publication. Ending 36 month after publication.
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
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| Overnight stay |
| Other |
The patient spend the night at the hospital and can not go home until the next morning. |
|
Patient satisfaction with length of stay from the QPP (quality from patients perspective) questionnaire after 30 days.
| 30 days |
| 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. | 30 days |
| Complications after surgery | Complications within 30 days from surgery according to Clavien-Dindo (grouped as None, Grade 1-2, Grade 3 or Grade 4). | 30 days |
| Readmission | Readmission to the hospital within 30 days (yes/no | 30 days |
| Reoperation | Reoperation within 30 days (yes/no) | 30 days |
| Sick leave after suregery | Length of sick leave after operation, information from the Swedish Social insurance system. | 60 days. |
| Socioeconomic costs | 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. | 30 days |
| Danderyd Hospital | Recruiting | Stockholm | Sweden |
|
| Karolinska University hospital | Recruiting | Stockholm | Sweden |
|
| ID | Term |
|---|---|
| D003631 | Day Care, Medical |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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