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.

Официальное название

DARSH - A Multicenter Randomized Controlled Trial: Day-care vs Overnight Stay in Robotic Assisted Hysterectomy in Patients With Bening Disease and Endometrial Cancer.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Day care
  The patient return to home the same day as the surgery is performed.
• Другое Overnight stay
  The patient spend the night at the hospital and can not go home until the next morning.

Первичные конечные точки

• Quality of life (QoL) day 3 after surgery compared to before surgery [Срок оценки: 3 days]

Вторичные конечные точки (8)

• Quality of life (QoL) day 30 after surgery. [Срок оценки: 30 days]
• Patient satisfaction with length of stay [Срок оценки: 30 days]
• Eq5D-5L index value of QoL. [Срок оценки: 30 days]
• Complications after surgery [Срок оценки: 30 days]
• Readmission [Срок оценки: 30 days]
• Reoperation [Срок оценки: 30 days]
• Sick leave after suregery [Срок оценки: 60 days.]
• Socioeconomic costs [Срок оценки: 30 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 3 центра

• Södersjukhuset — Stockholm
• Danderyd Hospital — Stockholm
• Karolinska University hospital — Stockholm

Идентификаторы

NCT: NCT07233811 · 2023-05648-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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