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Trial record 38 of 6682 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

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

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ClinicalTrials.gov Identifier: NCT03956784
Recruitment Status : Not yet recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
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.


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

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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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

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.





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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956784


Contacts
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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
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France
Service de Chirurgie Digestive, Hôpital Edouard Herriot, Hospices Civils de Lyon Not yet recruiting
Lyon, France, 69437
Contact: Arnaud PASQUER, MD    472.11.69.22 ext +33    arnaud.pasquer@chu-lyon.fr   
Principal Investigator: Arnaud PASQUER, MD         
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03956784     History of Changes
Other Study ID Numbers: 69HCL19_0343
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Bariatric surgery
Colorectal surgery
Gastric surgery
One day surgery
Post-operative complications
Follow-up care via Mobile App
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes