Post-operative Complications After Colorectal SurgerySURGICONNECTNCT03956784
E-assisted Follow up Diagnosis of Post Operative Digestive Complications
A study testing E-assessed clinical and biological follow up and Usual at home follow up in people with Post-operative Complications After Colorectal Surgery and Post-operative Complications After Gastric Surgery, run by Hospices Civils de Lyon at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Complications After Colorectal Surgery, Post-operative Complications After Gastric Surgery, Post-operative Complications After Bariatric Surgery
- What is being tested?
- E-assessed clinical and biological follow up and Usual at home follow up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 6 sitesFrance
- Study dates
- 23 Jun 2020to 19 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Département de Chirurgie Digestive, Hôpital Michallon, CHU Grenoble
Grenoble, 38043
Service de Chirurgie Viscérale et Digestive, CH Emile Roux
Le Puy-en-Velay, 43012
Service de Chirurgie Générale, Digestive et de la Transplantation Hépatique, Hôpital de la Croix Rousse, Hospices Civils de Lyon
Lyon, 69004
Service de Chirurgie Digestive, Hôpital Edouard Herriot, Hospices Civils de Lyon
Lyon, 69437
Service de Chirurgie Digestive, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon
Pierre-Bénite, 69310
Service de Chirurgie Digestive et Oncologie Digestive, Hôpital Nord, CHU Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Impact of E-assisted Connected Follow up on the Delay of Management of Postoperative Complications in Digestive Surgery
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.
Read more
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.
- Conditions
- Post-operative Complications After Colorectal Surgery, Post-operative Complications After Gastric Surgery, Post-operative Complications After Bariatric Surgery
- Being tested
- E-assessed clinical and biological follow up, Usual at home follow up
- Keywords
- Bariatric surgery, Colorectal surgery, Gastric surgery, One day surgery, Post-operative complications, Follow-up care via Mobile App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-assessed clinical and biological follow upDevice
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.
Usual at home follow upOther
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.
| Study group | Role | What they receive |
|---|---|---|
| E-assessed follow up | Experimental | 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. Receives: Device: E-assessed clinical and biological follow up |
| Standard home follow-up care | Other | 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. Receives: Other: Usual at home follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 6 months after surgery
Secondary outcomes (15)
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.
Measured: Within 30 days after surgery
Early overall complication rate
Rate of medical and surgical complications (each grade) within 30 days after surgery using the Dindo-Clavien classification
Measured: Within 30 days after surgery
Type of early complications
Type (medical or surgical) of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification
Measured: Within 30 days after surgery
Severity of early complications
Severity of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification
Measured: Within 30 days after surgery
Late overall complication rate
Rate of medical and surgical complications (each grade) within 6 months after surgery using the Dindo-Clavien classification
Measured: Within 6 months after surgery
Type of late complications
Type (medical or surgical) of late complications (after 6 months) for each procedure according to the Dindo-Clavien classification
Measured: Within 6 months after surgery
Severity of late complications
Severity of late complications (after 6 months) for each procedure according to the Dindo-Clavien classification
Measured: Within 6 months after surgery
Postoperative mortality
Number of patients who died within 30 days and 6 months after surgery
Measured: Within 30 days and 6 months after surgery
Readmission of patient
Number of patients readmitted within 30 days and 6 months after surgery.
Measured: 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.
Measured: Before surgery and at 10 and 30 days after surgery
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.
Measured: Before surgery and at 10 and 30 days after surgery
Patient satisfaction: VAS
Satisfaction will be measured using a visual analog scale, rated from 0 (no satisfaction) to 10 (Perfect Satisfaction)
Measured: 10 days after surgery
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)
Measured: 10 days after surgery
Costs
Costs associated with the strategy including the Follow-up care via Mobile App compared to the standard follow-up care strategy.
Measured: 7 months post-inclusion
Consequences
Consequences associated with the strategy including the Follow-up care via Mobile App compared to the standard follow-up care strategy.
Measured: 7 months post-inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start23 Jun 2020
- Primary completion19 Feb 2025
- Study completion19 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Complications After Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956784
- Sponsor's protocol ID
- 69HCL19_0343
- Acronym
- SURGICONNECT
- Status last verified
- Mar 2025
- First submitted
- 15 May 2019
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of E-assisted Connected Follow up on the Delay of Management of Postoperative Complications in Digestive Surgery
- ClinicalTrials.gov ID
- NCT03956784
- Acronym / sponsor ID
- SURGICONNECT / 69HCL19_0343
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-assessed follow up | Experimental | Device: E-assessed clinical and biological follow upPatients 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 | Other | Other: Usual at home follow upPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-assessed clinical and biological follow upClinical 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. | Device | E-assessed follow up |
| Usual at home follow upAn 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. | Other | Standard home follow-up care |
Primary outcome
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.
15 secondary outcomes
Severe postoperative complication rate
Time frame: Within 30 days after surgery
Early overall complication rate
Time frame: Within 30 days after surgery
Type of early complications
Time frame: Within 30 days after surgery
Severity of early complications
Time frame: Within 30 days after surgery
Late overall complication rate
Time frame: Within 6 months after surgery
Type of late complications
Time frame: Within 6 months after surgery
Severity of late complications
Time frame: Within 6 months after surgery
Postoperative mortality
Time frame: Within 30 days and 6 months after surgery
Readmission of patient
Time frame: 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
Quality of life assessed with GIQLI questionnaire
Time frame: Before surgery and at 10 and 30 days after surgery
Patient satisfaction: VAS
Time frame: 10 days after surgery
Patient sense of security
Time frame: 10 days after surgery
Costs
Time frame: 7 months post-inclusion
Consequences
Time frame: 7 months post-inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-assessed clinical and biological follow up and Usual at home follow up in people with Post-operative Complications After Colorectal Surgery and Post-operative Complications After Gastric Surgery, run by Hospices Civils de Lyon at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required for the management of post-operative complications requiring rehospitalization (time frame: Within 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.