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出境医 / 临床实验 / E-assisted Follow up Diagnosis of Post Operative Digestive Complications (SURGICONNECT)

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

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.


Condition or disease Intervention/treatment Phase
Post-operative Complications After Colorectal Surgery Post-operative Complications After Gastric Surgery Post-operative Complications After Bariatric Surgery Device: E-assessed clinical and biological follow up Other: Usual at home follow up Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of E-assisted Connected Follow up on the Delay of Management of Postoperative Complications in Digestive Surgery
Actual Study Start Date : June 23, 2020
Estimated Primary Completion Date : December 23, 2022
Estimated Study Completion Date : December 23, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: E-assessed 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.
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.


Standard home follow-up care
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.
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.


Outcome Measures
Primary Outcome Measures :
  1. Time required for the management of post-operative complications requiring rehospitalization [ Time Frame: 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 :
  1. Severe postoperative complication rate [ Time Frame: 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.


  2. Early overall complication rate [ Time Frame: Within 30 days after surgery ]
    Rate of medical and surgical complications (each grade) within 30 days after surgery using the Dindo-Clavien classification

  3. Type of early complications [ Time Frame: Within 30 days after surgery ]
    Type (medical or surgical) of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification

  4. Severity of early complications [ Time Frame: Within 30 days after surgery ]
    Severity of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification

  5. Late overall complication rate [ Time Frame: Within 6 months after surgery ]
    Rate of medical and surgical complications (each grade) within 6 months after surgery using the Dindo-Clavien classification

  6. Type of late complications [ Time Frame: Within 6 months after surgery ]
    Type (medical or surgical) of late complications (after 6 months) for each procedure according to the Dindo-Clavien classification

  7. Severity of late complications [ Time Frame: Within 6 months after surgery ]
    Severity of late complications (after 6 months) for each procedure according to the Dindo-Clavien classification

  8. Postoperative mortality [ Time Frame: Within 30 days and 6 months after surgery ]
    Number of patients who died within 30 days and 6 months after surgery

  9. Readmission of patient [ Time Frame: Within 30 days and 6 months after surgery ]
    Number of patients readmitted within 30 days and 6 months after surgery.

  10. Quality of life assessed with SF36 questionnaire [ Time Frame: 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.


  11. Quality of life assessed with GIQLI questionnaire [ Time Frame: 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.


  12. Patient satisfaction: VAS [ Time Frame: 10 days after surgery ]
    Satisfaction will be measured using a visual analog scale, rated from 0 (no satisfaction) to 10 (Perfect Satisfaction)

  13. Patient sense of security [ Time Frame: 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)

  14. Costs [ Time Frame: 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.

  15. Consequences [ Time Frame: 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Arnaud PASQUER, MD 472.11.69.22 ext +33 arnaud.pasquer@chu-lyon.fr
Contact: Dominique DELAUNAY 472.11.00.64 ext +33 Dominique.delaunay@chu-lyon.fr

Locations
Layout table for location information
France
Service de Chirurgie Digestive, Hôpital d'Estaing, CHU de Clermont-Fd Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Denis PEZET, MD         
Principal Investigator: Denis PEZET, MD         
Service de Chirurgie Digestive, Hôpital Le Bocage, CHU Dijon Not yet recruiting
Dijon, France, 21000
Contact: Olivier FACY, MD         
Principal Investigator: Olivier FACY, MD         
Département de Chirurgie Digestive, Hôpital Michallon, CHU Grenoble Recruiting
Grenoble, France, 38043
Contact: Jean-Luc FAUCHERON, MD         
Principal Investigator: Jean-Luc FAUCHERON, MD         
Service de Chirurgie Générale, Digestive et de la Transplantation Hépatique, Hôpital de la Croix Rousse, Hospices Civils de Lyon Recruiting
Lyon, France, 69004
Contact: Kayvan MOHKAM, MD         
Principal Investigator: Kayvan MOHKAM, MD         
Service de Chirurgie Digestive, Hôpital Edouard Herriot, Hospices Civils de Lyon Recruiting
Lyon, France, 69437
Contact: Arnaud PASQUER, MD    472.11.69.22 ext +33    arnaud.pasquer@chu-lyon.fr   
Principal Investigator: Arnaud PASQUER, MD         
Service de Chirurgie Digestive, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon Recruiting
Pierre-Bénite, France, 69310
Contact: Eddy COTTE, MD         
Principal Investigator: Eddy COTTE, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date June 4, 2021
Actual Study Start Date  ICMJE June 23, 2020
Estimated Primary Completion Date December 23, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
Time required for the management of post-operative complications requiring rehospitalization [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Severe postoperative complication rate [ Time Frame: 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.
  • Early overall complication rate [ Time Frame: Within 30 days after surgery ]
    Rate of medical and surgical complications (each grade) within 30 days after surgery using the Dindo-Clavien classification
  • Type of early complications [ Time Frame: Within 30 days after surgery ]
    Type (medical or surgical) of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification
  • Severity of early complications [ Time Frame: Within 30 days after surgery ]
    Severity of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification
  • Late overall complication rate [ Time Frame: 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 [ Time Frame: Within 6 months after surgery ]
    Type (medical or surgical) of late complications (after 6 months) for each procedure according to the Dindo-Clavien classification
  • Severity of late complications [ Time Frame: Within 6 months after surgery ]
    Severity of late complications (after 6 months) for each procedure according to the Dindo-Clavien classification
  • Postoperative mortality [ Time Frame: Within 30 days and 6 months after surgery ]
    Number of patients who died within 30 days and 6 months after surgery
  • Readmission of patient [ Time Frame: Within 30 days and 6 months after surgery ]
    Number of patients readmitted within 30 days and 6 months after surgery.
  • Quality of life assessed with SF36 questionnaire [ Time Frame: 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.
  • Quality of life assessed with GIQLI questionnaire [ Time Frame: 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.
  • Patient satisfaction: VAS [ Time Frame: 10 days after surgery ]
    Satisfaction will be measured using a visual analog scale, rated from 0 (no satisfaction) to 10 (Perfect Satisfaction)
  • Patient sense of security [ Time Frame: 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)
  • Costs [ Time Frame: 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.
  • Consequences [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE E-assisted Follow up Diagnosis of Post Operative Digestive Complications
Official Title  ICMJE Impact of E-assisted Connected Follow up on the Delay of Management of Postoperative Complications in Digestive Surgery
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Post-operative Complications After Colorectal Surgery
  • Post-operative Complications After Gastric Surgery
  • Post-operative Complications After Bariatric Surgery
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • Experimental: E-assessed 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.
    Intervention: Device: E-assessed clinical and biological follow up
  • Standard home follow-up care
    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: Other: Usual at home follow up
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
340
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 23, 2022
Estimated Primary Completion Date December 23, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arnaud PASQUER, MD 472.11.69.22 ext +33 arnaud.pasquer@chu-lyon.fr
Contact: Dominique DELAUNAY 472.11.00.64 ext +33 Dominique.delaunay@chu-lyon.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03956784
Other Study ID Numbers  ICMJE 69HCL19_0343
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP