E-assisted Follow up Diagnosis of Post Operative Digestive Complications (SURGICONNECT)

Civil Hospices of Lyon

Status: Completed

Conditions: Post-operative Complications After Bariatric Surgery; Post-operative Complications After Colorectal Surgery; Post-operative Complications After Gastric Surgery

Treatments: Other: Usual at home follow up; Device: E-assessed clinical and biological follow up

Study type: Interventional

Funder types: Other

Identifiers

NCT03956784

69HCL19_0343

Details and patient eligibility

About

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.

Enrollment: 233 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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233 participants in 2 patient groups

E-assessed follow up

Experimental group

Description:

Patients undergoing colorectal surgery (colectomy, sigmoidectomy, proctectomy, digestive stoma closure), bariatric or gastric, for whom an early discharge has been programmed, and followed by a connected application and a nursing logistics platform at home.

Treatment:

Device: E-assessed clinical and biological follow up

Standard home follow-up care

Other group

Description:

Patients undergoing surgery for colorectal surgery (colectomy, sigmoidectomy, proctectomy, digestive stoma closure), bariatric or gastric surgery, for whom an early discharge has been programmed, and followed by usual way.

Treatment:

Other: Usual at home follow up