Impact of E-assisted Connected Follow up on the Delay of Management of Postoperative Complications in Digestive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 12
- 主要终点
- Time required for the management of post-operative complications requiring rehospitalization
研究概览
简要总结
Postoperative management in digestive surgery has been modernized thanks to improved rehabilitation measures. These measures include an earlier refeeding, mobilization, restriction of infusions (out of a total of 22) and showed their benefit in colorectal, gastric and bariatric surgery. It is thus possible to perform sleeve gastrectomy, bypass, restorations of digestive continuity and colectomies with early discharge or one day surgery.
The most serious complications (fistula, sepsis) occur in the first 10 days postoperatively with an average readmission rate of 10%. Their screening is based on clinical signs (tachycardia, pain) or biological (C-Reactive Protein (CRP) assay on Day 3 or Day 4). It is important to manage these complications early so that their morbidity is lower, resulting in shorter stays and less severity.
The monitoring and safety of patients discharged early are therefore essential and for the moment poorly codified, ranging from simple nursing to follow-up via a health provider. Recently, coordination structures including nurse platform and smartphone follow up app have emerged. Thanks to this system, the patient collects his own history and biological results which allows him to be monitored continuously, as in the hospital. In case of no filling or sign of complication, the nurse platform contacts the patient.
This connected follow-up would make it possible to reinforce the safety of the patient discharged early after a complex digestive procedure performed on an outpatient basis. Its benefit has been poorly evaluated but it is however more and more used by surgeons convinced of its interest especially as it goes in the direction of the development of the outpatient activity requested by the High Authority of Health with economic benefits interesting also the administration of the care structures.
The purpose of the investigator's study is to evaluate the impact of e-assessed follow-up during 10 days after surgery compared to a conventional follow-up. The hypothesis is that this connected follow-up would allow earlier detection of complications requiring rehospitalization (within 48 hours), resulting in faster and less severe treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Patient, male or female, age ≥18 years
- •Patient hospitalized for colorectal, gastric or bariatric surgery
- •Patient for whom an outpatient or enhanced recovery after surgery is performed (expected discharge no later than 4 days after surgery)
- •Patient with a computer, tablet or mobile connected to internet
- •Patient who agrees to be included in the study and who signs the informed consent form,
- •Patient affiliated with a healthcare insurance plan.
排除标准
- •Minor patient
- •Patient who does not understand French, under supervision or guardianship
- •Mentally unbalanced patients or unable to follow the instructions of a connected follow-up, from the point of view of the investigator
- •Patient who is unable to give consent
结局指标
主要结局
Time required for the management of post-operative complications requiring rehospitalization
时间窗: Within 6 months after surgery
Number of hours between discharge from hospitalization after digestive surgery and readmission for hospitalization during which medical, surgical, radiological or endoscopic treatment is performed.
次要结局
- Severity of early complications(Within 30 days after surgery)
- Readmission of patient(Within 30 days and 6 months after surgery)
- Severity of late complications(Within 6 months after surgery)
- Severe postoperative complication rate(Within 30 days after surgery)
- Type of early complications(Within 30 days after surgery)
- Late overall complication rate(Within 6 months after surgery)
- Type of late complications(Within 6 months after surgery)
- Postoperative mortality(Within 30 days and 6 months after surgery)
- Quality of life assessed with SF36 questionnaire(Before surgery and at 10 and 30 days after surgery)
- Patient satisfaction: VAS(10 days after surgery)
- Consequences(7 months post-inclusion)
- Early overall complication rate(Within 30 days after surgery)
- Costs(7 months post-inclusion)
- Quality of life assessed with GIQLI questionnaire(Before surgery and at 10 and 30 days after surgery)
- Patient sense of security(10 days after surgery)