Evaluation of a Telemedicine System for Patients Carried for Bariatric Surgery

NCT03834181 | Completed

• 1 other identifier: 18-003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to study the feasibility of a telemedicine system to monitor and control certain vital parameters before and after surgery for obesity. During the preoperative preparation phase, weight, exercise, blood pressure and heart rate are recorded and transmitted to the patient's surgeon. In the immediate post operative period, the heart rate is a sensitive and reliable indicator of the occurrence of a complication. A telemetry system will allow rapid home return, continuous monitoring and early warning in the event of a problem. Prolonged follow-up identical to that started preoperatively should allow improvement and better control of weight loss by monitoring especially physical exercise.

Conditions

Bariatric Surgery Candidate

Keywords

Connected devices; Telemetry; Obesity surgery

Outcome Measures

Primary Outcomes (1)

• Reliability of a remote monitoring system during treatment for bariatric surgery evaluated in days between two failures

  The reliability of the system, corresponding to the average time between two failures, over the 9 months of study for each of the 30 patients. A failure is a momentary and abrupt loss of the ability of the system to transmit data.

  From the inclusion to 6 months after the surgery

Secondary Outcomes (4)

• Patient acceptance of adding a telemonitoring device to their care evaluated in percentage of patients who signed a consent

  Inclusion period of 4 months

• Relevance of the data received from each connected object (activity bracelet, scales, blood pressure monitor, thermometer and pulse oximeter) evaluated in percentage of data sent and verified

  Study duration of 18 months

• Durability of the data over a defined period evaluated in number of connections.

  From the inclusion to 6 months after the surgery

• Ratio of the number of patients who performed all the prescribed autonomic measures requested on the total number of patients included in the study

  Study duration of 18 months

Study Arms (1)

Monitoring evaluation

EXPERIMENTAL

Monitoring evaluation by connected devices: Wristband activity tracker "Garmin Vivosmart® 3", "Fora® Scale 550", "Terraillon® Tensioscreen", Pulse oximeter "Nonin® 3230", thermometer "Fora® IR20b"

Device: Monitoring evaluation by connected devices: Wristband activity tracker "Garmin Vivosmart® 3", "Fora® Scale 550", "Terraillon® Tensioscreen", Pulse oximeter "Nonin® 3230", thermometer "Fora® IR20b"

Interventions

Monitoring evaluation by connected devices: Wristband activity tracker "Garmin Vivosmart® 3", "Fora® Scale 550", "Terraillon® Tensioscreen", Pulse oximeter "Nonin® 3230", thermometer "Fora® IR20b" DEVICE

All patients will be monitored before and after the bariatric surgery: * During the preoperative preparation phase: weight, exercise, blood pressure and heart rate * In the immediate post operative period: continuous monitoring of the heart rate with a telemetry system * Prolonged follow-up: weight, exercise, blood pressure and heart rate

Monitoring evaluation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient (s) applying for bariatric surgery
• Patient aged 18 to 65
• Compliance with the High Authority of Health (HAS) criteria:
• BMI\> 40 without comorbidities
• BMI\> 35 with cardiovascular, metabolic, respiratory or rheumatic comorbidity,
• Psychological follow-up well followed for 4 to 6 months
• Patient with an ASA (American Society of Anesthesiologists) score less than or equal to 2
• Patient able to receive and understand information about the study
• Patient able to manipulate connected objects
• Patient (e) affiliated to the French social security system
• Patient who does not live in the white area of wireless telephone coverage.

You may not qualify if:

• Patient unable to give informed consent
• Patient unable to use the connected tools (Internet)
• Patient whose general condition is not favorable to participation in the study
• Patient presenting, in the opinion of the investigator, a condition that may prevent participation in the procedures provided for in the study
• Patient under the protection of justice
• Patient under guardianship or trusteeship
• Patient with epilepsy
• Patient who is sensitive to light flashes
• Patient with deformity of the ear
• Patient with bleeding ear
• Patient whose home is in a white GSM (Global System for Mobile Communications) zone or white zone in reception and 3G (third generation) transmission
• Patient (e) not knowing how to use connected objects.

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne, NHC

Strasbourg, 67 091, France

Location

Related Publications (8)

• Loots E, Sartorius B, Paruk IM, Clarke DL. The Successful Implementation of a Modified Enhanced Recovery After Surgery (ERAS) Program for Bariatric Surgery in a South African Teaching Hospital. Surg Laparosc Endosc Percutan Tech. 2018 Feb;28(1):26-29. doi: 10.1097/SLE.0000000000000488.

  PMID: 29064879 BACKGROUND

• Lemanu DP, Singh PP, Berridge K, Burr M, Birch C, Babor R, MacCormick AD, Arroll B, Hill AG. Randomized clinical trial of enhanced recovery versus standard care after laparoscopic sleeve gastrectomy. Br J Surg. 2013 Mar;100(4):482-9. doi: 10.1002/bjs.9026. Epub 2013 Jan 21.

  PMID: 23339040 BACKGROUND

• Jonsson A, Lin E, Patel L, Patel AD, Stetler JL, Prayor-Patterson H, Singh A, Srinivasan JK, Sweeney JF, Davis SS Jr. Barriers to Enhanced Recovery after Surgery after Laparoscopic Sleeve Gastrectomy. J Am Coll Surg. 2018 Apr;226(4):605-613. doi: 10.1016/j.jamcollsurg.2017.12.028. Epub 2018 Jan 5.

  PMID: 29309941 BACKGROUND

• Aman MW, Stem M, Schweitzer MA, Magnuson TH, Lidor AO. Early hospital readmission after bariatric surgery. Surg Endosc. 2016 Jun;30(6):2231-8. doi: 10.1007/s00464-015-4483-4. Epub 2015 Oct 19.

  PMID: 26482158 BACKGROUND

• Kampmeijer R, Pavlova M, Tambor M, Golinowska S, Groot W. The use of e-health and m-health tools in health promotion and primary prevention among older adults: a systematic literature review. BMC Health Serv Res. 2016 Sep 5;16 Suppl 5(Suppl 5):290. doi: 10.1186/s12913-016-1522-3.

  PMID: 27608677 BACKGROUND

• Wang Y, Xue H, Huang Y, Huang L, Zhang D. A Systematic Review of Application and Effectiveness of mHealth Interventions for Obesity and Diabetes Treatment and Self-Management. Adv Nutr. 2017 May 15;8(3):449-462. doi: 10.3945/an.116.014100. Print 2017 May.

  PMID: 28507010 BACKGROUND

• Chen SY, Stem M, Schweitzer MA, Magnuson TH, Lidor AO. Assessment of postdischarge complications after bariatric surgery: A National Surgical Quality Improvement Program analysis. Surgery. 2015 Sep;158(3):777-86. doi: 10.1016/j.surg.2015.04.028. Epub 2015 Jun 19.

  PMID: 26096563 BACKGROUND

• Montravers P, Augustin P, Zappella N, Dufour G, Arapis K, Chosidow D, Fournier P, Ribeiro-Parienti L, Marmuse JP, Desmard M. Diagnosis and management of the postoperative surgical and medical complications of bariatric surgery. Anaesth Crit Care Pain Med. 2015 Feb;34(1):45-52. doi: 10.1016/j.accpm.2014.06.002. Epub 2015 Mar 5.

  PMID: 25829315 BACKGROUND

Study Officials

• Michel Vix, MD

  Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 7, 2019
• Study Start: April 15, 2019
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)