E-assisted Follow up Diagnosis of Post Operative Digestive Complications

Summary

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.

Conditions

• Post-operative Complications After Colorectal Surgery
• Post-operative Complications After Gastric Surgery
• Post-operative Complications After Bariatric Surgery

Interventions

DEVICE

E-assessed clinical and biological follow up

Clinical questionnaire: self-evaluation of pain (0 to 10), resumption of transit, bleeding, fever, pulse. In case of no filling, the patient is contacted. An automatic alert system is defined and divide the patient according to three situations: * Normal situation * Situation requiring the nurse to call back the patient and contact the surgeon if the assessment requires medical advice * Disturbing situation requiring contact of the first-line surgeon if a potentially serious event is suspected. Each speaker's place is described for each item in the detailed protocols Biological questionnaire: Biological monitoring (blood count, Ionogram, C-Reactive Protein, urea, creatinine) is performed on D1, D3 and D7. All information is accessible in real time by the surgeon who receives notifications by email and on his smartphone in case of clinical or biological abnormality on patient monitoring.

OTHER

Usual at home follow up

An information sheet on the clinical parameters to be monitored will be given to patients and will include the following information: 1. Immediate complications and warning signs: * Tachycardia\> 120 bpm * Dyspnea * Rectorragies and / or melena * Vomiting with or without presence of blood * Major abdominal pain (visual analogue scale\> 6/10) * Fever\> 38 2. Management to deal with complications: call the service and / or the surgeon 3. Actions to be performed by the patient after the exit:passage of the nurse during 10 days for anticoagulant morning and evening (identical in both study groups) Each patient will be given a prescription to perform a C-Reactive Protein assay on D1, D3 and D7, similarly.

Sponsors & Collaborators

• Hospices Civils de Lyon

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-23

Primary Completion

2025-02-19

Completion

2025-02-19

Countries

• France

Study Locations