Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery (CONTACT-GRECCAR 21)

Официальное название

Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery - A Multicenter Randomized Study

Обзор

The goal of this Clinical Investigation is to evaluate the effectiveness of implementing the discharge protocol of the remote monitoring platform after colorectal surgery in patients at risk of hospital readmission. Participants will be randomized into either the "30 days of remote monitoring" group or the "conventional discharge" group. The patient returns to the site for their postoperative visit at 30 days and is contacted by phone 90 days after their surgery.

Вмешательства

• Устройство Remote monitoring platform
  EPOCA Intelligence Information System is a remote monitoring plateform. The medical device is used as a SaaS platform with restricted access for healthcare professionals. Patients and their families interact with the medical device via notifications and secure links, upon request. The medical device integrates the use of other medical devices such as oximeters, blood pressure monitors, glucometers, bracelets, etc., which are connected and whose use is also governed by their user manuals and trai

Первичные конечные точки

• Hospitalization days [Срок оценки: 90 days]

Вторичные конечные точки (12)

• Unplanned hospital readmission [Срок оценки: 90 days]
• Difference between the initial hospital discharge date and the hospital readmission date [Срок оценки: 90 days]
• Unplanned consultations [Срок оценки: 90 days]
• Severe postoperative morbidity [Срок оценки: 90 days]
• Visual Analog Scale at Day 3 for preoperative inclusions [Срок оценки: Day 3]
• Visual Analog Scale at Day 5 for preoperative inclusions [Срок оценки: Day 5]
• Rate of postoperative ileus at Day 3 for preoperative inclusions [Срок оценки: Day 3]
• Rate of postoperative ileus at Day 5 for preoperative inclusions [Срок оценки: Day 5]
• Postoperative morbidity [Срок оценки: 90 days]
• Return to Professional activities [Срок оценки: 90 days]
• Quality of life questionnaires "Medical Outcomes Study 36-item Short-Form Health Survey" [Срок оценки: 30 days]
• Quality of life questionnaires "Medical Outcomes Study 36-item Short-Form Health Survey" [Срок оценки: 90 days]

Критерии участия

Критерии включения

• Man or woman over 18 years old at the time of the J0 visit,
• Patient who underwent surgery less than 28 days ago, or who is scheduled to undergo colorectal surgery not managed as an outpatient procedure at the investigational center, including resection of at least one colonic or rectal segment and/or an anastomosis involving the colon or rectum,
• At least one of the following two criteria:
• Anticipated early discharge (within 24 hours following laparoscopic surgery without stoma and without diversion, and within 5 days following laparotomy and/or surgery with stoma and/or rectal surgery) for a procedure that is not usually managed as an outpatient surgery in routine practice,
• Estimated risk of hospital readmission greater than 10% according to the nomogram of Tevis et al. \[15\], adapted to the postoperative context in digestive surgery (>120 points according to this score).
• Patient affiliated with a health insurance plan,
• Patient who has signed the study consent form.

Критерии исключения

• Discharge to a rehabilitation center requested by the patient,
• Condition managed on an outpatient basis in routine practice for this type of patient,
• Patient eligible for home hospitalization services,
• Suicidal or hetero-aggressive risk in a patient living alone at home
• Homeless patient,
• Pregnant or breastfeeding women,
• Patient under legal guardianship, curatorship, or protected legal status,
• Patient already enrolled in an interventional postoperative follow-up study.

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

Профилактика

Центры проведения

Франция · 14 центров

• CHU Angers — Angers
• Clinique Tivoli- Ducos — Bordeaux
• CHU Grenoble — Grenoble
• Centre Hospitalier Lyon-Sud — Lyon
• CHU Timone - Assistance publique-Hôpitaux de Marseille — Marseille
• Hôpital Nord - Assistance publique- Hôpitaux de Marseille — Marseille
• Institut Paoli Calmettes — Marseille
• CHU Nantes — Nantes
• … и ещё 6 центров

Идентификаторы

NCT: NCT06850688 · RC22_0452 · 2024-A01770-47

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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