Effectiveness of the Augmented Rehabilitation of Digestive Surgical Emergencies Pathway in Reducing Unscheduled Hospitalizations After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Occurrence of an unscheduled hospitalization readmission
研究概览
简要总结
The number of emergencies's visits (22 million visits in 2019 in France), the organization of emergencies and the sustainability of the current health system are threatened. In the CHUAP adult emergency department, 60,000 visits were recorded in 2022.
Unlike medical emergencies which have structured their care and research activities (heart, brain), and whose organization has demonstrated its general interest for society, digestive surgical emergencies, which involve complex patients (elderly people, comorbidities) , emergency situations and surgical procedures, have never been thought of globally in terms of personalized care and research pathways. Currently, patients treated in emergency are managed without a pre-established optimization program and without a dedicated pathway, where emergency constitutes a major risk factor for postoperative complications.
RAUCAMIENS evaluates a new care pathway implemented within the framework of the RHU RAUC : the implementation of the Enhanced rehabilitation after surgery (ERAS) and e-health devices for home monitoring, for patients treated in the emergency room for a digestive pathology. The purpose is to evaluate the effectiveness of the RAUC pathway in reducing the rate of unplanned hospitalization readmission after emergency digestive surgery 30 days postoperative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None (Participant)
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
- •Criterion linked to the protocol :
- •- Patient consulted in emergency for a digestive pathology requiring surgery
- •Search criteria:
- •Adult patient (≥ 18 years old),
- •Able to give consent,
- •Affiliation to a social security scheme
排除标准
- •Criterion linked to the protocol:
- •Patient leaving hospitalization to a convalescent center
- •Patient requiring direct operating room (vital emergency or surgical revision)
- •Patient presenting to the emergency room for a postoperative complication
- •Patient directly admitted to intensive care
- •Search criteria:
- •Pregnant or breastfeeding woman
- •Patient under guardianship, curatorship or deprived of liberty
研究组 & 干预措施
Control group 1
patients from CHU Rouen included over the same period as patients from CHUAP benefiting from standard care (RAUC -)
干预措施: ERAS (Other)
Experimental group
patients included in the CHUAP RAUC + course
干预措施: RDS (Other)
Experimental group
patients included in the CHUAP RAUC + course
干预措施: Get ready (Other)
Experimental group
patients included in the CHUAP RAUC + course
干预措施: Lumiradx (Other)
Experimental group
patients included in the CHUAP RAUC + course
干预措施: Digital Surgery (Other)
Experimental group
patients included in the CHUAP RAUC + course
干预措施: ERAS (Other)
Experimental group
patients included in the CHUAP RAUC + course
干预措施: ROFIM (Other)
Experimental group
patients included in the CHUAP RAUC + course
干预措施: DEEPSEN (Other)
Control group 2
patients verifying the inclusion/non-inclusion criteria and from the SNDS over the period from January 1, 2022 to December 31, 2025
干预措施: ERAS (Other)
结局指标
主要结局
Occurrence of an unscheduled hospitalization readmission
时间窗: 30 days
Occurrence of an unscheduled hospitalization readmission following digestive surgery performed urgently within 30 days
次要结局
- incremental cost-utility ratio(30 days)
- Clavien-Dindo score(30 days)
- Duration of hospitalization linked to the first admission to perform emergency digestive surgery(30 days)
- Quality of life score(0 day)
- Quality of Life score(30 days)
- STAI-Y scale(0 day)
- Transition to emergency without hospitalization(30 days)
- incremental cost-effectiveness ratio(30 days)