Feasibility of a Telematics Pre-operative Assessment in a Bariatric Surgery During Covid-19

NCT04486417 | Unknown DMC

• 1 other identifier: 66.20
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Coronavirus (COVID-19) is a respiratory disease caused by a newly discovered coronavirus, SARS-CoV-2. Several recent papers on the pandemic recognized obesity as a risk factor for the COVID-19 infection. Therefore, an effective treatment for obesity even during COVID-19 outbreak is needed. Bariatric surgery, is considered an effective treatment in the reduction of obesity-related comorbidities and mortality risk. However, during Covid-19 phase 1 (lockdown) the near totality of elective non-oncologic procedures, including bariatric surgery, has been postponed, and all the outpatients' visits too. Therefore, phase 1 led to completely change the way of managing the pre-operative multidisciplinary visits considering the hospital limitation access and the restriction. In the present study the investigators explored the use of telemedicine as a possible strategy to face this new situation. Specifically, this study aims to test the efficacy of an online structured protocol based on pre-operative multidisciplinary assessment using telemedicine instruments. In particular, the primary end point is to test the feasibility of a telematics pre-operative work-up. The secondary end points are evaluating patient's compliance and satisfaction to the online assessment.

Conditions

Obesity; Telemedicine; Bariatric Surgery

Keywords

Bariatric Surgery; Telemedicine; Covid-19; Pre-operative psychological assessment; Pre-operative nutritional counseling

Outcome Measures

Primary Outcomes (2)

• Rejection rate (%)

  The rejection rate to the online assessment modality will be calculated (% of people who refuse to participate to the online assessment procedure).

  During the recruitment process

• Drop out rate

  The drop out rate will be calculated (% of people who drop out during the assessment procedure)

  1 month

Secondary Outcomes (2)

• Excess Weight Loss percentage (EWL%)

  1 month

• Satisfaction degree

  3 weeks

Eligibility Criteria

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

Study Population

Obese people asking for bariatric surgery, who are in the waiting list of the bariatric center

You may qualify if:

• not being positive to Covid-19 (according to Covid-19 telephone interview)
• age \>18 and \<65 years
• availability of a stable internet connection
• having a mailbox and possibility to send and receive pdf documents via e-mail

You may not qualify if:

• Not having a stable internet connection and a mailbox
• not having practicality with telematic tools
• having possible Covid-19 symptoms (according to Covid-19 telephone interview)

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Gianfranco Silecchia

Latina, Italy

RECRUITING

Related Publications (14)

• Zheng KI, Gao F, Wang XB, Sun QF, Pan KH, Wang TY, Ma HL, Chen YP, Liu WY, George J, Zheng MH. Letter to the Editor: Obesity as a risk factor for greater severity of COVID-19 in patients with metabolic associated fatty liver disease. Metabolism. 2020 Jul;108:154244. doi: 10.1016/j.metabol.2020.154244. Epub 2020 Apr 19. No abstract available.

  PMID: 32320741 BACKGROUND

• Caussy C, Wallet F, Laville M, Disse E. Obesity is Associated with Severe Forms of COVID-19. Obesity (Silver Spring). 2020 Jul;28(7):1175. doi: 10.1002/oby.22842. Epub 2020 May 21. No abstract available.

  PMID: 32314861 BACKGROUND

• Lighter J, Phillips M, Hochman S, Sterling S, Johnson D, Francois F, Stachel A. Obesity in Patients Younger Than 60 Years Is a Risk Factor for COVID-19 Hospital Admission. Clin Infect Dis. 2020 Jul 28;71(15):896-897. doi: 10.1093/cid/ciaa415. No abstract available.

  PMID: 32271368 BACKGROUND

• Andolfi C, Fisichella PM. Epidemiology of Obesity and Associated Comorbidities. J Laparoendosc Adv Surg Tech A. 2018 Aug;28(8):919-924. doi: 10.1089/lap.2018.0380. Epub 2018 Jul 16.

  PMID: 30010474 BACKGROUND

• Nguyen NT, Varela JE. Bariatric surgery for obesity and metabolic disorders: state of the art. Nat Rev Gastroenterol Hepatol. 2017 Mar;14(3):160-169. doi: 10.1038/nrgastro.2016.170. Epub 2016 Nov 30.

  PMID: 27899816 BACKGROUND

• Coldebella B, Armfield NR, Bambling M, Hansen J, Edirippulige S. The use of telemedicine for delivering healthcare to bariatric surgery patients: A literature review. J Telemed Telecare. 2018 Dec;24(10):651-660. doi: 10.1177/1357633X18795356.

  PMID: 30343656 BACKGROUND

• Zhang MW, Ho RC, Cassin SE, Hawa R, Sockalingam S. Online and smartphone based cognitive behavioral therapy for bariatric surgery patients: Initial pilot study. Technol Health Care. 2015;23(6):737-44. doi: 10.3233/THC-151026.

  PMID: 26409514 BACKGROUND

• Yeo C, Ahmed S, Oo AM, Koura A, Sanghvi K, Yeo D. COVID-19 and Obesity-the Management of Pre- and Post-bariatric Patients Amidst the COVID-19 Pandemic. Obes Surg. 2020 Sep;30(9):3607-3609. doi: 10.1007/s11695-020-04670-6. No abstract available.

  PMID: 32385668 BACKGROUND

• McEneaney DF, Lennie SC. Video instructions improve accuracy of self-measures of waist circumference compared with written instructions. Public Health Nutr. 2011 Jul;14(7):1192-9. doi: 10.1017/S1368980011000450. Epub 2011 Mar 31.

  PMID: 21450137 BACKGROUND

• Fried M, Hainer V, Basdevant A, Buchwald H, Deitel M, Finer N, Greve JW, Horber F, Mathus-Vliegen E, Scopinaro N, Steffen R, Tsigos C, Weiner R, Widhalm K. Interdisciplinary European guidelines on surgery of severe obesity. Obes Facts. 2008;1(1):52-9. doi: 10.1159/000113937. Epub 2008 Feb 8.

  PMID: 20054163 BACKGROUND

• Garner DM, Olmsted MP, Bohr Y, Garfinkel PE. The eating attitudes test: psychometric features and clinical correlates. Psychol Med. 1982 Nov;12(4):871-8. doi: 10.1017/s0033291700049163.

  PMID: 6961471 BACKGROUND

• HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.

  PMID: 13638508 BACKGROUND

• Hamilton M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol. 1967 Dec;6(4):278-96. doi: 10.1111/j.2044-8260.1967.tb00530.x. No abstract available.

  PMID: 6080235 BACKGROUND

• Donini LM, Brunani A, Sirtori A, Savina C, Tempera S, Cuzzolaro M, Spera G, Cimolin V, Precilios H, Raggi A, Capodaglio P; SIO-ISDCA Task Force. Assessing disability in morbidly obese individuals: the Italian Society of Obesity test for obesity-related disabilities. Disabil Rehabil. 2011;33(25-26):2509-18. doi: 10.3109/09638288.2011.575529. Epub 2011 May 4.

  PMID: 21542694 BACKGROUND

Related Links

• American Psychological Association (2020). Guidance on psychological tele-assessment during the COVID-19 crisis. Accessed 7 May 2020
• Società Italiana di Chirurgia dell'obesità (SICOb). Linee guida di chirurgia dell'obesità. Accessed 7 May 2020
• Società Italiana di Nutrizione Umana (SINU). (2014). Livelli di Assunzione di Riferimento di Nutrienti ed energia per la popolazione italiana IV Revisione (LARN 2014). Accessed 7 May 2020

MeSH Terms

Conditions

Obesity; COVID-19

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 24, 2020
• Study Start: June 1, 2020
• Primary Completion: July 22, 2020
• Study Completion: July 31, 2020
• Last Updated: July 24, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)