Clinical trial NCT03956784: E-assisted Follow up Diagnosis of Post Operative Digestive Complications
Official title: Impact of E-assisted Connected Follow up on the Delay of Management of Postoperative Complications in Digestive Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Complications After Colorectal Surgery
Post-operative Complications After Gastric Surgery
Post-operative Complications After Bariatric Surgery
Keywords: Bariatric surgery
Colorectal surgery
Gastric surgery
One day surgery
Post-operative complications
Follow-up care via Mobile App
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time required for the management of post-operative complications requiring rehospitalization
timeFrame: Within 6 months after surgery
Secondary outcomes:
measure: Severe postoperative complication rate
timeFrame: Within 30 days after surgery
measure: Early overall complication rate
timeFrame: Within 30 days after surgery
measure: Type of early complications
timeFrame: Within 30 days after surgery
measure: Severity of early complications
timeFrame: Within 30 days after surgery
measure: Late overall complication rate
timeFrame: Within 6 months after surgery
measure: Type of late complications
timeFrame: Within 6 months after surgery
measure: Severity of late complications
timeFrame: Within 6 months after surgery
measure: Postoperative mortality
timeFrame: Within 30 days and 6 months after surgery
measure: Readmission of patient
timeFrame: Within 30 days and 6 months after surgery
measure: Quality of life assessed with SF36 questionnaire
timeFrame: Before surgery and at 10 and 30 days after surgery
measure: Quality of life assessed with GIQLI questionnaire
timeFrame: Before surgery and at 10 and 30 days after surgery
measure: Patient satisfaction: VAS
timeFrame: 10 days after surgery
measure: Patient sense of security
timeFrame: 10 days after surgery
measure: Costs
timeFrame: 7 months post-inclusion
measure: Consequences
timeFrame: 7 months post-inclusion
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Département de Chirurgie Digestive, Hôpital Michallon, CHU Grenoble
city: Le Puy en Velay
country: France
facility: Service de Chirurgie Viscérale et Digestive, CH Emile Roux
city: Lyon
country: France
facility: Service de Chirurgie Générale, Digestive et de la Transplantation Hépatique, Hôpital de la Croix Rousse, Hospices Civils de Lyon
city: Lyon
country: France
facility: Service de Chirurgie Digestive, Hôpital Edouard Herriot, Hospices Civils de Lyon
city: Pierre-Bénite
country: France
facility: Service de Chirurgie Digestive, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon
city: Saint-Étienne
country: France
facility: Service de Chirurgie Digestive et Oncologie Digestive, Hôpital Nord, CHU Saint-Etienne
Study officials:
References: