E-assisted Follow up Diagnosis of Post Operative Digestive Complications

Not Applicable

Recruiting

• 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; Other: Usual at home follow up

• Registration Number: NCT03956784
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-21
• Study Start: 2020-06-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-12-23
• Study Completion: 2024-12-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E-assessed follow up	E-assessed clinical and biological follow up	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.
Standard home follow-up care	Usual at home follow up	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.

Primary Outcome Measures

Name	Time	Method
Time required for the management of post-operative complications requiring rehospitalization	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.

Secondary Outcome Measures

Name	Time	Method
Severity of early complications	Within 30 days after surgery	Severity of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification
Readmission of patient	Within 30 days and 6 months after surgery	Number of patients readmitted within 30 days and 6 months after surgery.
Severity of late complications	Within 6 months after surgery	Severity of late complications (after 6 months) for each procedure according to the Dindo-Clavien classification
Postoperative mortality	Within 30 days and 6 months after surgery	Number of patients who died within 30 days and 6 months after surgery
Severe postoperative complication rate	Within 30 days after surgery	Rate of medical and surgical (\> or = grade 3) complications within 30 days after surgery using the Dindo-Clavien classification, described as: Grade I = Any deviation from the normal postoperative course. Grade 2 = Requiring pharmacological treatment with drugs other than such allowed for grade I complications.; Grade III = Requiring surgical, endoscopic or radiological intervention, not under (Grade IIIa) or under general anesthesia (Grade IIIb) Grade IV = Life-threatening complication with single organ (Grade IVa) or Multiorgan dysfunction (Grade IVb) Grade V = Death of a patient.
Type of early complications	Within 30 days after surgery	Type (medical or surgical) of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification
Late overall complication rate	Within 6 months after surgery	Rate of medical and surgical complications (each grade) within 6 months after surgery using the Dindo-Clavien classification
Type of late complications	Within 6 months after surgery	Type (medical or surgical) of late complications (after 6 months) for each procedure according to the Dindo-Clavien classification
Quality of life assessed with SF36 questionnaire	Before surgery and at 10 and 30 days after surgery	Before surgery and at 10 and 30 days after surgery, according to the SF36 (Short Form (36) Health Survey) questionnaire.; This questionnaire taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/tiredness, and general health perceptions. It also includes a single item that provides an indication of a perceived change in health.
Patient satisfaction: VAS	10 days after surgery	Satisfaction will be measured using a visual analog scale, rated from 0 (no satisfaction) to 10 (Perfect Satisfaction)
Consequences	7 months post-inclusion	Consequences associated with the strategy including the Follow-up care via Mobile App compared to the standard follow-up care strategy.
Early overall complication rate	Within 30 days after surgery	Rate of medical and surgical complications (each grade) within 30 days after surgery using the Dindo-Clavien classification
Costs	7 months post-inclusion	Costs associated with the strategy including the Follow-up care via Mobile App compared to the standard follow-up care strategy.
Patient sense of security	10 days after surgery	Sence of security will be measured using a visual analog scale, rated from 0 (no security felt) to 10 (Complete security felt Satisfaction)
Quality of life assessed with GIQLI questionnaire	Before surgery and at 10 and 30 days after surgery	Before surgery and at 10 and 30 days after surgery, according to the GIQLI (Gastrointestinal Quality of Life index) questionnaire.; This questionnaire consists of 36 items exploring 5 dimensions or subscales: symptoms, physical condition, emotions, social integration and the effect of any medical treatment. For each item, 5 responses will be proposed to the patients and for each answer, a score ranging from 0 to 4 (highest score = 144) will be assigned. A high score defines a more favorable health state.

Trial Locations

Locations (8)

Service de Chirurgie Digestive, Hôpital d'Estaing, CHU de Clermont-Fd; 🇫🇷 Clermont-Ferrand, France

Service de Chirurgie Digestive, Hôpital Le Bocage, CHU Dijon; 🇫🇷 Dijon, France

Service de Chirurgie Digestive, Hôpital Edouard Herriot, Hospices Civils de Lyon; 🇫🇷 Lyon, France

Service de Chirurgie Digestive et Oncologie Digestive, Hôpital Nord, CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France

Département de Chirurgie Digestive, Hôpital Michallon, CHU Grenoble; 🇫🇷 Grenoble, France

Service de Chirurgie Viscérale et Digestive, CH Emile Roux; 🇫🇷 Le Puy en Velay, France

Service de Chirurgie Générale, Digestive et de la Transplantation Hépatique, Hôpital de la Croix Rousse, Hospices Civils de Lyon; 🇫🇷 Lyon, France

Service de Chirurgie Digestive, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon; 🇫🇷 Pierre-Bénite, France