跳至主要内容
临床试验/NCT07186738
NCT07186738招募中不适用

Study of a Patient Cohort Following Digestive Surgical Care After the Implementation of a Telemonitoring and Tele-coordination Platform for Medical, Paramedical, and Social Management

Nantes University Hospital2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
2
主要终点
To assess the feasibility of implementing the EPOCA discharge program in the digestive surgery department of Nantes University Hospital

研究概览

简要总结

Postoperative hospital stays and complications vary widely after digestive surgery. Enhanced Recovery After Surgery (ERAS) protocols have shortened stays and accelerated recovery after elective procedures, but they remain challenging in emergency surgery and among frail or elderly patients. While theoretical discharge after colorectal surgery is possible between postoperative days 2 and 7, average stays in practice are 12-14 days. Bariatric surgery similarly targets discharge on days 2-3, yet typical stays are 8-10 days. Patients successfully managed under ERAS may face higher readmission risk, often due to worsening comorbidities or serious complications.

Prolonged hospitalization and readmissions impact patient safety, comfort, and healthcare costs. Daily hospital costs in surgical units range from €350 to €400. Post-acute care facilities can reduce readmissions but often have long waiting periods. To minimize readmission risk, many surgeons prefer in-hospital postoperative monitoring, limiting early discharge.

Recent studies show that connected devices and teleconsultation can provide safe and effective postoperative follow-up. Teleconsultation follow-up is feasible for most patients, with satisfaction rates comparable to in-person visits. Remote monitoring of stoma care has been associated with reduced readmissions. Home-based monitoring using connected vital sign devices in high-risk patients reduces readmissions and emergency visits. In colorectal and bariatric surgery, daily remote monitoring after early discharge (24-48 hours) did not increase morbidity or readmission, suggesting that telemonitoring can safely enable earlier discharge while maintaining patient safety. Continuous monitoring is particularly important for high-risk patients due to rapid deterioration from potential complications.

EPOCA is a telemonitoring and telecoordination platform providing medical, paramedical, and social follow-up at home. It combines connected devices, a digital platform for data analysis, and a dedicated medical and paramedical team. Services include teleconsultations, home paramedical care, support for families or care facilities, and 24/7 emergency management.

EPOCA reassures patients and caregivers, supports primary care and home care teams, and integrates hospital and emergency services. It addresses challenges posed by aging populations, chronic disease prevalence, and increasingly complex patients. By enabling earlier discharge without increasing readmissions, EPOCA offers a holistic solution bridging hospital and home care. It has already demonstrated success in preventing hospitalizations in high-risk elderly patients and is authorized for telemonitoring of chronic conditions including diabetes, respiratory, renal, and cardiac insufficiency.

This study aims to evaluate the feasibility of implementing EPOCA over two years in the CHU Nantes digestive surgery unit. It will target patients undergoing elective or urgent colorectal or bariatric surgery who are at risk of prolonged hospitalization or readmission. High-risk scenarios include anticipated early discharge within 24 hours and patients identified as having elevated readmission risk according to predefined criteria

详细描述

Postoperative hospital stays and complications vary widely after digestive surgery. Enhanced Recovery After Surgery (ERAS) protocols have shortened stays and accelerated recovery after elective procedures, but they remain challenging in emergency surgery and among frail or elderly patients. While theoretical discharge after colorectal surgery is possible between postoperative days 2 and 7, average stays in practice are 12-14 days. Bariatric surgery similarly targets discharge on days 2-3, yet typical stays are 8-10 days. Patients successfully managed under ERAS may face higher readmission risk, often due to worsening comorbidities or serious complications.

Prolonged hospitalization and readmissions impact patient safety, comfort, and healthcare costs. Daily hospital costs in surgical units range from €350 to €400. Post-acute care facilities can reduce readmissions but often have long waiting periods. To minimize readmission risk, many surgeons prefer in-hospital postoperative monitoring, limiting early discharge.

Recent studies show that connected devices and teleconsultation can provide safe and effective postoperative follow-up. Teleconsultation follow-up is feasible for most patients, with satisfaction rates comparable to in-person visits. Remote monitoring of stoma care has been associated with reduced readmissions. Home-based monitoring using connected vital sign devices in high-risk patients reduces readmissions and emergency visits. In colorectal and bariatric surgery, daily remote monitoring after early discharge (24-48 hours) did not increase morbidity or readmission, suggesting that telemonitoring can safely enable earlier discharge while maintaining patient safety. Continuous monitoring is particularly important for high-risk patients due to rapid deterioration from potential complications.

EPOCA is a telemonitoring and telecoordination platform providing medical, paramedical, and social follow-up at home. It combines connected devices, a digital platform for data analysis, and a dedicated medical and paramedical team. Services include teleconsultations, home paramedical care, support for families or care facilities, and 24/7 emergency management.

EPOCA reassures patients and caregivers, supports primary care and home care teams, and integrates hospital and emergency services. It addresses challenges posed by aging populations, chronic disease prevalence, and increasingly complex patients. By enabling earlier discharge without increasing readmissions, EPOCA offers a holistic solution bridging hospital and home care. It has already demonstrated success in preventing hospitalizations in high-risk elderly patients and is authorized for telemonitoring of chronic conditions including diabetes, respiratory, renal, and cardiac insufficiency.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Male or female patients over 18 years of age.
  • •Patients undergoing colorectal or bariatric surgery not routinely managed as outpatient procedures at Nantes University Hospital.
  • •At least one of the following criteria:
  • •Anticipated early discharge (within 24 hours post-surgery) for procedures not routinely managed as outpatient at the hospital.
  • •Estimated risk of readmission greater than 6% according to the Tevis et al. nomogram, adapted to the postoperative context in digestive surgery (>50 points on this score).
  • •Patients enrolled in a health insurance plan

排除标准

  • •Discharge to a rehabilitation center requested by the patient
  • •Condition routinely managed as an outpatient procedure
  • •Patient under home hospitalization care
  • •Suicidal or heteroaggressive risk in a patient living alone at home
  • •Homeless patients
  • •Pregnant or breastfeeding women
  • •Patients under legal guardianship, conservatorship, or judicial protection

研究组 & 干预措施

telemonitoring patient after digestive surgery

EPOCA telemonitoring at home for patients following digestive surgery

干预措施: EPOCA telemonitoring (Device)

结局指标

主要结局

To assess the feasibility of implementing the EPOCA discharge program in the digestive surgery department of Nantes University Hospital

时间窗: 90 days post surgery

Cumulative duration of re-hospitalization days up to 90 days post-surgery (number of day)

次要结局

  • Morbidity rate(90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

bp-prom-regl

MD PhD

Nantes University Hospital

研究点 (2)

Loading locations...

相似试验