search
Back to results

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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
E-assessed clinical and biological follow up
Usual at home follow up
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Post-operative Complications After Colorectal Surgery focused on measuring Bariatric surgery, Colorectal surgery, Gastric surgery, One day surgery, Post-operative complications, Follow-up care via Mobile App

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Service de Chirurgie Digestive, Hôpital d'Estaing, CHU de Clermont-Fd
  • Service de Chirurgie Digestive, Hôpital Le Bocage, CHU Dijon
  • Département de Chirurgie Digestive, Hôpital Michallon, CHU GrenobleRecruiting
  • Service de Chirurgie Viscérale et Digestive, CH Emile RouxRecruiting
  • Service de Chirurgie Générale, Digestive et de la Transplantation Hépatique, Hôpital de la Croix Rousse, Hospices Civils de LyonRecruiting
  • Service de Chirurgie Digestive, Hôpital Edouard Herriot, Hospices Civils de LyonRecruiting
  • Service de Chirurgie Digestive, Centre Hospitalier Lyon-Sud, Hospices Civils de LyonRecruiting
  • Service de Chirurgie Digestive et Oncologie Digestive, Hôpital Nord, CHU Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

E-assessed follow up

Standard home follow-up care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Severe postoperative complication rate
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.
Early overall complication rate
Rate of medical and surgical complications (each grade) within 30 days after surgery using the Dindo-Clavien classification
Type of early complications
Type (medical or surgical) of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification
Severity of early complications
Severity of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification
Late overall complication rate
Rate of medical and surgical complications (each grade) within 6 months after surgery using the Dindo-Clavien classification
Type of late complications
Type (medical or surgical) of late complications (after 6 months) for each procedure according to the Dindo-Clavien classification
Severity of late complications
Severity of late complications (after 6 months) for each procedure according to the Dindo-Clavien classification
Postoperative mortality
Number of patients who died within 30 days and 6 months after surgery
Readmission of patient
Number of patients readmitted 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, 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.
Quality of life assessed with GIQLI questionnaire
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.
Patient satisfaction: VAS
Satisfaction will be measured using a visual analog scale, rated from 0 (no satisfaction) to 10 (Perfect Satisfaction)
Patient sense of security
Sence of security will be measured using a visual analog scale, rated from 0 (no security felt) to 10 (Complete security felt Satisfaction)
Costs
Costs associated with the strategy including the Follow-up care via Mobile App compared to the standard follow-up care strategy.
Consequences
Consequences associated with the strategy including the Follow-up care via Mobile App compared to the standard follow-up care strategy.

Full Information

First Posted
May 15, 2019
Last Updated
April 18, 2023
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT03956784
Brief Title
E-assisted Follow up Diagnosis of Post Operative Digestive Complications
Acronym
SURGICONNECT
Official Title
Impact of E-assisted Connected Follow up on the Delay of Management of Postoperative Complications in Digestive Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2020 (Actual)
Primary Completion Date
December 23, 2023 (Anticipated)
Study Completion Date
December 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E-assessed follow up
Arm Type
Experimental
Arm 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.
Arm Title
Standard home follow-up care
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
E-assessed clinical and biological follow up
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual at home follow up
Intervention Description
An information sheet on the clinical parameters to be monitored will be given to patients and will include the following information: 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 Management to deal with complications: call the service and / or the surgeon 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.
Primary Outcome Measure Information:
Title
Time required for the management of post-operative complications requiring rehospitalization
Description
Number of hours between discharge from hospitalization after digestive surgery and readmission for hospitalization during which medical, surgical, radiological or endoscopic treatment is performed.
Time Frame
Within 6 months after surgery
Secondary Outcome Measure Information:
Title
Severe postoperative complication rate
Description
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.
Time Frame
Within 30 days after surgery
Title
Early overall complication rate
Description
Rate of medical and surgical complications (each grade) within 30 days after surgery using the Dindo-Clavien classification
Time Frame
Within 30 days after surgery
Title
Type of early complications
Description
Type (medical or surgical) of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification
Time Frame
Within 30 days after surgery
Title
Severity of early complications
Description
Severity of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification
Time Frame
Within 30 days after surgery
Title
Late overall complication rate
Description
Rate of medical and surgical complications (each grade) within 6 months after surgery using the Dindo-Clavien classification
Time Frame
Within 6 months after surgery
Title
Type of late complications
Description
Type (medical or surgical) of late complications (after 6 months) for each procedure according to the Dindo-Clavien classification
Time Frame
Within 6 months after surgery
Title
Severity of late complications
Description
Severity of late complications (after 6 months) for each procedure according to the Dindo-Clavien classification
Time Frame
Within 6 months after surgery
Title
Postoperative mortality
Description
Number of patients who died within 30 days and 6 months after surgery
Time Frame
Within 30 days and 6 months after surgery
Title
Readmission of patient
Description
Number of patients readmitted within 30 days and 6 months after surgery.
Time Frame
Within 30 days and 6 months after surgery
Title
Quality of life assessed with SF36 questionnaire
Description
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.
Time Frame
Before surgery and at 10 and 30 days after surgery
Title
Quality of life assessed with GIQLI questionnaire
Description
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.
Time Frame
Before surgery and at 10 and 30 days after surgery
Title
Patient satisfaction: VAS
Description
Satisfaction will be measured using a visual analog scale, rated from 0 (no satisfaction) to 10 (Perfect Satisfaction)
Time Frame
10 days after surgery
Title
Patient sense of security
Description
Sence of security will be measured using a visual analog scale, rated from 0 (no security felt) to 10 (Complete security felt Satisfaction)
Time Frame
10 days after surgery
Title
Costs
Description
Costs associated with the strategy including the Follow-up care via Mobile App compared to the standard follow-up care strategy.
Time Frame
7 months post-inclusion
Title
Consequences
Description
Consequences associated with the strategy including the Follow-up care via Mobile App compared to the standard follow-up care strategy.
Time Frame
7 months post-inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud PASQUER, MD
Phone
472.11.69.22
Ext
+33
Email
arnaud.pasquer@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique DELAUNAY
Phone
472.11.00.64
Ext
+33
Email
Dominique.delaunay@chu-lyon.fr
Facility Information:
Facility Name
Service de Chirurgie Digestive, Hôpital d'Estaing, CHU de Clermont-Fd
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Withdrawn
Facility Name
Service de Chirurgie Digestive, Hôpital Le Bocage, CHU Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Withdrawn
Facility Name
Département de Chirurgie Digestive, Hôpital Michallon, CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc FAUCHERON, MD
First Name & Middle Initial & Last Name & Degree
Jean-Luc FAUCHERON, MD
Facility Name
Service de Chirurgie Viscérale et Digestive, CH Emile Roux
City
Le Puy en Velay
ZIP/Postal Code
43012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Matias BRUNAS, MD
First Name & Middle Initial & Last Name & Degree
Luis Matias BRUNAS, MD
Facility Name
Service de Chirurgie Générale, Digestive et de la Transplantation Hépatique, Hôpital de la Croix Rousse, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kayvan MOHKAM, MD
First Name & Middle Initial & Last Name & Degree
Kayvan MOHKAM, MD
Facility Name
Service de Chirurgie Digestive, Hôpital Edouard Herriot, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69437
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud PASQUER, MD
Phone
472.11.69.22
Ext
+33
Email
arnaud.pasquer@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Arnaud PASQUER, MD
Facility Name
Service de Chirurgie Digestive, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eddy COTTE, MD
First Name & Middle Initial & Last Name & Degree
Eddy COTTE, MD
Facility Name
Service de Chirurgie Digestive et Oncologie Digestive, Hôpital Nord, CHU Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand LE ROY, MD
First Name & Middle Initial & Last Name & Degree
Bertrand LE ROY, MD

12. IPD Sharing Statement

Learn more about this trial

E-assisted Follow up Diagnosis of Post Operative Digestive Complications

We'll reach out to this number within 24 hrs