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 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 |
| 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:
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:
Each patient will be given a prescription to perform a C-Reactive Protein assay on D1, D3 and D7, similarly. |
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.
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.
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| 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 |
| 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 | |
| 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 |
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 |
|
||||||||
| 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. |
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| 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 |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| 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 |
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| 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 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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