Bariatric Surgery CandidateNCT04847037
Place of Connected Tools in Bariatric Patients Follow-up.
A study testing Connected tools in people with Bariatric Surgery Candidate, run by Elsan at 1 site in France.
Trial summary
The aim of this study is to assess the safety (in terms of post-operative complications) of the use of connected devices for the monitoring of patients operated on by longitudinal laparoscopic gastrectomy (LSG) and discharged 24 hours after surgery according to the protocol Enhanced Recovery After Surgery (ERAS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Connected tools
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2020to 5 Mar 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a BMI between 35 and 40 and comorbidity (type II diabetes, arterial hypertension, sleep apnea syndrome, dyslipidemia, fatty liver disease, arthropathy linked to overweight) related to obesity
- Patients with a BMI greater than 40 with or without comorbidity
- Patients affiliated to the social security scheme, with or without mutual health insurance
- Collection of signed informed consent
- Patients with one of the following sets of tools:
- Computer tablet and computer with an internet connection
Show all 10Show fewer
- Computer tablet and smartphone with an internet connection
- Smartphone and computer with an internet connection
- Patients without a history of bariatric surgery
- Patients with surgical indication for a sleeve gastrectomy
Who cannot join
- Patients who have had obesity surgery
- Patients who have the indication but want another surgery such as the sleeve
- Patients who do not have an internet connection and / or an email address
- Patients with a BMI less than 35
- Patients with a major contraindication to surgery and / or American Society of Anesthesiologists (ASA) 4
- Patients without social security
Show all 9Show fewer
- Patients refusing to sign consent
- Patients living abroad and / or living more than two hours from the hospital
- Minors or patients over 70 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Place of Connected Tools in the Follow-up of the Bariatric Patient: Can They Allow Rapid Management of Complications and Reduce Lost of Follow-up During Postoperative Period?
The aim of this study is to assess the safety (in terms of post-operative complications) of the use of connected devices for the monitoring of patients operated on by longitudinal laparoscopic gastrectomy (LSG) and discharged 24 hours after surgery according to the protocol Enhanced Recovery After Surgery (ERAS).
Read the detailed description
Connected devices, such as electronic scales and brachial cuffs used during the preoperative period, can help patients to self-control their weight and blood pressure and to better control certain risk factors for surgery. In addition, in order to reduce the number of deaths in the wards after surgery, connected devices have been designed to continuously monitor the vital parameters of patients. Subbe et al. recently showed that the use of wireless sensors to continuously monitor heart rate, respiratory rate, blood pressure and Oxygen Saturation by Pulse Oximetry (SpO2) reduced the number of cardiac arrests and mortality during hospitalization. Likewise, connected devices could potentially be used to monitor the patient directly at home and thus allow a faster discharge from the hospital without increasing the risks for the patient. At the current stage, there are no studies that have demonstrated the benefit of using the tools connected in postoperative follow-up in bariatric surgery.
Recently, thanks to the growth of experience and the application of the ERAS method, the postoperative stay at LSG has significantly decreased. Despite this, there are still very few centers that perform this operation in outpatient surgery or with a 24-hour hospital stay. This is probably due not only to a strict selection criteria, but also to the surgeon's concern to discharge the patient too early without medical supervision. In this context, the use of connected devices making it possible to monitor the patient directly at home and therefore theoretically continue a kind of medical surveillance could make it possible to increase the number of LSG performed in outpatient surgery. In addition, another advantage of this postoperative monitoring system is that it gives the patient a central role in the healing process after surgery. Thanks to devices and the Internet platform, the patient actively participates in his monitoring and remains in permanent contact with the surgical department. In this way, the feeling of fragility and loneliness that often feels the patient when he quickly returns home is reduced. Thus, compared to a small expense related to the purchase of devices, this would result in a significant reduction in hospital costs for the health system. The more important limitation of this procedure remains the degree of familiarity of the patient with the connected tools, and therefore will not necessarily be applicable to the entire population of obese patients without the risks of having a significant lack of follow-up during the first postoperative days.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Connected tools
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected toolsProcedure or surgery
Use of connected tools in postoperative bariatric follow-up vs no use of connected tools.
| Study group | Role | What they receive |
|---|---|---|
| Connected Tools | Experimental | For the experimental group, the postoperative procedure requires the use of personal connected tools: a smartphone, a digital tablet or a computer with internet connection. A scale and a connected watch will also be loaned to patients so that they can take the necessary measures. Before returning home, patients must be trained to take correct measures and inform them on the dedicated platform. Receives: Procedure: Connected tools |
| No Connected Tools | No intervention | Patients randomized to the control group will be operated according to the same protocol as the experimental group. For them, there will be no home follow-up, so no special procedure to follow. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Rate measured at 30 days.
The complication rate will be compared in the both treatment groups.
Measured: 30 days after gastrectomy intervention.
Secondary outcomes (11)
Rate of lost to follow-up at 3 years.
The rate of lost to follow-up will be compared in the both treatment groups.
Measured: 3 years after gastrectomy intervention/
Change in the lost to follow-up rate at 1 year.
In order to evaluate the evolution of the lost to follow-up, the change from baseline will be analyzed between the two treatment groups.
Measured: 1 year after gastrectomy intervention.
Change in the lost to follow-up rate at 2 years.
In order to evaluate the evolution of the lost to follow-up, the change from baseline will be analyzed between the two treatment groups.
Measured: 2 years after gastrectomy intervention.
Change in the loss to follow-up rate at 3 years.
In order to evaluate the evolution of the lost to follow-up, the change from baseline will be analyzed between the two treatment groups.
Measured: 3 years after gastrectomy intervention.
Patient satisfaction regarding the use of tools.
A satisfaction questionnaire adapted to the study will be presented to patients in order to evaluate the satisfaction of tools' using, only for experimental group.
Measured: 15 days after gastrectomy intervention.
Quality of life assessment at 3 months.
The BAROS quality of life questionnaire will be presented to patients in order to evaluate the quality of life.
Measured: 3 months after gastrectomy intervention.
Quality of life assessment at 6 months.
The BAROS quality of life questionnaire will be presented to patients in order to evaluate the quality of life.
Measured: 6 months after gastrectomy intervention.
Quality of life assessment at 12 months.
The BAROS quality of life questionnaire will be presented to patients in order to evaluate the quality of life.
Measured: 12 months after gastrectomy intervention.
Post-operative complications at 3 months
The post-operative complications will be collected in both groups to evaluate the complication rate.
Measured: 3 months after gastrectomy intervention.
Post-operative complications at 6 months
The post-operative complications will be collected in both groups to evaluate the complication rate.
Measured: 6 months after gastrectomy intervention.
Post-operative complications at 12 months
The post-operative complications will be collected in both groups to evaluate the complication rate.
Measured: 12 months after gastrectomy intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start5 Mar 2020
- Primary completion5 Apr 2022
- Study completion5 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot, prospective, single-center, comparative, randomized, open-label study.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847037
- Sponsor's protocol ID
- Dr CARANDINA
- Other IDs
- 2019-A01371-56
- Status last verified
- May 2023
- First submitted
- 14 Apr 2021
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stevens GA, Singh GM, Lu Y, Danaei G, Lin JK, Finucane MM, Bahalim AN, McIntire RK, Gutierrez HR, Cowan M, Paciorek CJ, Farzadfar F, Riley L, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Body Mass Index). National, regional, and global trends in adult overweight and obesity prevalences. Popul Health Metr. 2012 Nov 20;10(1):22. doi: 10.1186/1478-7954-10-22.
PubMed 23167948Bult MJ, van Dalen T, Muller AF. Surgical treatment of obesity. Eur J Endocrinol. 2008 Feb;158(2):135-45. doi: 10.1530/EJE-07-0145.
PubMed 18230819Nguyen NT, Nguyen B, Gebhart A, Hohmann S. Changes in the makeup of bariatric surgery: a national increase in use of laparoscopic sleeve gastrectomy. J Am Coll Surg. 2013 Feb;216(2):252-7. doi: 10.1016/j.jamcollsurg.2012.10.003. Epub 2012 Nov 21.
PubMed 23177371Simonelli V, Goergen M, Orlando GG, Arru L, Zolotas CA, Geeroms M, Poulain V, Azagra JS. Fast-Track in Bariatric and Metabolic Surgery: Feasibility and Cost Analysis Through a Matched-Cohort Study in a Single Centre. Obes Surg. 2016 Aug;26(8):1970-7. doi: 10.1007/s11695-016-2255-4.
PubMed 27272321Malczak P, Pisarska M, Piotr M, Wysocki M, Budzynski A, Pedziwiatr M. Enhanced Recovery after Bariatric Surgery: Systematic Review and Meta-Analysis. Obes Surg. 2017 Jan;27(1):226-235. doi: 10.1007/s11695-016-2438-z.
PubMed 27817086Khorgami Z, Petrosky JA, Andalib A, Aminian A, Schauer PR, Brethauer SA. Fast track bariatric surgery: safety of discharge on the first postoperative day after bariatric surgery. Surg Obes Relat Dis. 2017 Feb;13(2):273-280. doi: 10.1016/j.soard.2016.01.034. Epub 2016 Feb 2.
PubMed 27986577Rebibo L, Dhahri A, Badaoui R, Dupont H, Regimbeau JM. Laparoscopic sleeve gastrectomy as day-case surgery (without overnight hospitalization). Surg Obes Relat Dis. 2015 Mar-Apr;11(2):335-42. doi: 10.1016/j.soard.2014.08.017. Epub 2014 Sep 16.
PubMed 25614354Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29.
PubMed 20116145Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011 Feb 16;2011(2):CD007635. doi: 10.1002/14651858.CD007635.pub2.
PubMed 21328298Berg K, Arestedt K, Kjellgren K. Postoperative recovery from the perspective of day surgery patients: a phenomenographic study. Int J Nurs Stud. 2013 Dec;50(12):1630-8. doi: 10.1016/j.ijnurstu.2013.05.002. Epub 2013 May 30.
PubMed 23726224Svensson M, Nilsson U, Svantesson M. Patients' experience of mood while waiting for day surgery. J Clin Nurs. 2016 Sep;25(17-18):2600-8. doi: 10.1111/jocn.13304. Epub 2016 Jun 27.
PubMed 27349201Michard F. Smartphones and e-tablets in perioperative medicine. Korean J Anesthesiol. 2017 Oct;70(5):493-499. doi: 10.4097/kjae.2017.70.5.493. Epub 2017 Sep 28.
PubMed 29046768Jaensson M, Dahlberg K, Eriksson M, Nilsson U. Evaluation of postoperative recovery in day surgery patients using a mobile phone application: a multicentre randomized trial. Br J Anaesth. 2017 Nov 1;119(5):1030-1038. doi: 10.1093/bja/aex331.
PubMed 29077818Topol EJ. Transforming medicine via digital innovation. Sci Transl Med. 2010 Jan 27;2(16):16cm4. doi: 10.1126/scitranslmed.3000484.
PubMed 20371472Noar SM, Black HG, Pierce LB. Efficacy of computer technology-based HIV prevention interventions: a meta-analysis. AIDS. 2009 Jan 2;23(1):107-15. doi: 10.1097/QAD.0b013e32831c5500.
PubMed 19050392
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Place of Connected Tools in the Follow-up of the Bariatric Patient: Can They Allow Rapid Management of Complications and Reduce Lost of Follow-up During Postoperative Period?
- ClinicalTrials.gov ID
- NCT04847037
- Acronym / sponsor ID
- Dr CARANDINA
- Conditions
- Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Mar 2025 (estimated)
- First posted
- 15 Apr 2021 (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.
The aim of this study is to assess the safety (in terms of post-operative complications) of the use of connected devices for the monitoring of patients operated on by longitudinal laparoscopic gastrectomy (LSG) and discharged 24 hours after surgery according to the protocol Enhanced Recovery After Surgery (ERAS).
Detailed description
Connected devices, such as electronic scales and brachial cuffs used during the preoperative period, can help patients to self-control their weight and blood pressure and to better control certain risk factors for surgery. In addition, in order to reduce the number of deaths in the wards after surgery, connected devices have been designed to continuously monitor the vital parameters of patients. Subbe et al. recently showed that the use of wireless sensors to continuously monitor heart rate, respiratory rate, blood pressure and Oxygen Saturation by Pulse Oximetry (SpO2) reduced the number of cardiac arrests and mortality during hospitalization. Likewise, connected devices could potentially be used to monitor the patient directly at home and thus allow a faster discharge from the hospital without increasing the risks for the patient. At the current stage, there are no studies that have demonstrated the benefit of using the tools connected in postoperative follow-up in bariatric surgery.
Recently, thanks to the growth of experience and the application of the ERAS method, the postoperative stay at LSG has significantly decreased. Despite this, there are still very few centers that perform this operation in outpatient surgery or with a 24-hour hospital stay. This is probably due not only to a strict selection criteria, but also to the surgeon's concern to discharge the patient too early without medical supervision. In this context, the use of connected devices making it possible to monitor the patient directly at home and therefore theoretically continue a kind of medical surveillance could make it possible to increase the number of LSG performed in outpatient surgery. In addition, another advantage of this postoperative monitoring system is that it gives the patient a central role in the healing process after surgery. Thanks to devices and the Internet platform, the patient actively participates in his monitoring and remains in permanent contact with the surgical department. In this way, the feeling of fragility and loneliness that often feels the patient when he quickly returns home is reduced. Thus, compared to a small expense related to the purchase of devices, this would result in a significant reduction in hospital costs for the health system. The more important limitation of this procedure remains the degree of familiarity of the patient with the connected tools, and therefore will not necessarily be applicable to the entire population of obese patients without the risks of having a significant lack of follow-up during the first postoperative days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pilot, prospective, single-center, comparative, randomized, open-label study.
| Arm | Type | Receives |
|---|---|---|
| Connected Tools | Experimental | Procedure: Connected toolsFor the experimental group, the postoperative procedure requires the use of personal connected tools: a smartphone, a digital tablet or a computer with internet connection. A scale and a connected watch will also be loaned to patients so that they can take the necessary measures. Before returning home, patients must be trained to take correct measures and inform them on the dedicated platform. |
| No Connected Tools | No intervention | –Patients randomized to the control group will be operated according to the same protocol as the experimental group. For them, there will be no home follow-up, so no special procedure to follow. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with a BMI between 35 and 40 and comorbidity (type II diabetes, arterial hypertension, sleep apnea syndrome, dyslipidemia, fatty liver disease, arthropathy linked to overweight) related to obesity
- Patients with a BMI greater than 40 with or without comorbidity
- Patients affiliated to the social security scheme, with or without mutual health insurance
- Collection of signed informed consent
- Patients with one of the following sets of tools:
Key exclusion criteria (9 listed)
- Patients who have had obesity surgery
- Patients who have the indication but want another surgery such as the sleeve
- Patients who do not have an internet connection and / or an email address
- Patients with a BMI less than 35
- Patients with a major contraindication to surgery and / or American Society of Anesthesiologists (ASA) 4
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 |
|---|---|---|
| Connected toolsUse of connected tools in postoperative bariatric follow-up vs no use of connected tools. | Procedure or surgery | Connected Tools |
Primary outcome
Complication Rate measured at 30 days.
Time frame: 30 days after gastrectomy intervention.
The complication rate will be compared in the both treatment groups.
11 secondary outcomes
Rate of lost to follow-up at 3 years.
Time frame: 3 years after gastrectomy intervention/
Change in the lost to follow-up rate at 1 year.
Time frame: 1 year after gastrectomy intervention.
Change in the lost to follow-up rate at 2 years.
Time frame: 2 years after gastrectomy intervention.
Change in the loss to follow-up rate at 3 years.
Time frame: 3 years after gastrectomy intervention.
Patient satisfaction regarding the use of tools.
Time frame: 15 days after gastrectomy intervention.
Quality of life assessment at 3 months.
Time frame: 3 months after gastrectomy intervention.
Quality of life assessment at 6 months.
Time frame: 6 months after gastrectomy intervention.
Quality of life assessment at 12 months.
Time frame: 12 months after gastrectomy intervention.
Post-operative complications at 3 months
Time frame: 3 months after gastrectomy intervention.
Post-operative complications at 6 months
Time frame: 6 months after gastrectomy intervention.
Post-operative complications at 12 months
Time frame: 12 months after gastrectomy intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Background: PubMed 23167948Stevens GA, Singh GM, Lu Y, Danaei G, Lin JK, Finucane MM, Bahalim AN, McIntire RK, Gutierrez HR, Cowan M, Paciorek CJ, Farzadfar F, Riley L, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Body Mass Index). National, regional, and global trends in adult overweight and obesity prevalences. Popul Health Metr. 2012 Nov 20;10(1):22. doi: 10.1186/1478-7954-10-22.
- Background: PubMed 18230819Bult MJ, van Dalen T, Muller AF. Surgical treatment of obesity. Eur J Endocrinol. 2008 Feb;158(2):135-45. doi: 10.1530/EJE-07-0145.
- Background: PubMed 23177371Nguyen NT, Nguyen B, Gebhart A, Hohmann S. Changes in the makeup of bariatric surgery: a national increase in use of laparoscopic sleeve gastrectomy. J Am Coll Surg. 2013 Feb;216(2):252-7. doi: 10.1016/j.jamcollsurg.2012.10.003. Epub 2012 Nov 21.
- Background: PubMed 27272321Simonelli V, Goergen M, Orlando GG, Arru L, Zolotas CA, Geeroms M, Poulain V, Azagra JS. Fast-Track in Bariatric and Metabolic Surgery: Feasibility and Cost Analysis Through a Matched-Cohort Study in a Single Centre. Obes Surg. 2016 Aug;26(8):1970-7. doi: 10.1007/s11695-016-2255-4.
- Background: PubMed 27817086Malczak P, Pisarska M, Piotr M, Wysocki M, Budzynski A, Pedziwiatr M. Enhanced Recovery after Bariatric Surgery: Systematic Review and Meta-Analysis. Obes Surg. 2017 Jan;27(1):226-235. doi: 10.1007/s11695-016-2438-z.
- Background: PubMed 27986577Khorgami Z, Petrosky JA, Andalib A, Aminian A, Schauer PR, Brethauer SA. Fast track bariatric surgery: safety of discharge on the first postoperative day after bariatric surgery. Surg Obes Relat Dis. 2017 Feb;13(2):273-280. doi: 10.1016/j.soard.2016.01.034. Epub 2016 Feb 2.
- Background: PubMed 25614354Rebibo L, Dhahri A, Badaoui R, Dupont H, Regimbeau JM. Laparoscopic sleeve gastrectomy as day-case surgery (without overnight hospitalization). Surg Obes Relat Dis. 2015 Mar-Apr;11(2):335-42. doi: 10.1016/j.soard.2014.08.017. Epub 2014 Sep 16.
- Background: PubMed 20116145Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29.
- Background: PubMed 21328298Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011 Feb 16;2011(2):CD007635. doi: 10.1002/14651858.CD007635.pub2.
- Background: PubMed 23726224Berg K, Arestedt K, Kjellgren K. Postoperative recovery from the perspective of day surgery patients: a phenomenographic study. Int J Nurs Stud. 2013 Dec;50(12):1630-8. doi: 10.1016/j.ijnurstu.2013.05.002. Epub 2013 May 30.
- Background: PubMed 27349201Svensson M, Nilsson U, Svantesson M. Patients' experience of mood while waiting for day surgery. J Clin Nurs. 2016 Sep;25(17-18):2600-8. doi: 10.1111/jocn.13304. Epub 2016 Jun 27.
- Background: PubMed 29046768Michard F. Smartphones and e-tablets in perioperative medicine. Korean J Anesthesiol. 2017 Oct;70(5):493-499. doi: 10.4097/kjae.2017.70.5.493. Epub 2017 Sep 28.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connected tools in people with Bariatric Surgery Candidate, run by Elsan at 1 site 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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Complication Rate measured at 30 days. (time frame: 30 days after gastrectomy intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04847037, which also lists 32 linked publications.
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 18 May 2023.