- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04480034
Obesity Surgery During 2020 Italian Pandemic
Laparoscopic Bariatric Surgery During Phase 2-3 Covid-19 Pandemic in Italy: a Multicenter, Prospective, Observational Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) . The disease was first identified in December 2019 in Wuhan, the capital of China's Hubei province, and has since spread globally, resulting in the ongoing 2019-20 coronavirus pandemic . As of 08.05.2020, more than 3.91 million cases have been reported across 185 countries and territories, resulting in more than 218,000 deaths. More than 1.344.000 people have recovered . Even though there are very few available data on BMI for patients with COVID-19 infections, the role of obesity in the COVID-19 epidemic must not be ignored. A recent study on patients admitted in China for pneumonia from SARS-CoV-2, showed that obesity is associated with higher risks to develop severe pneumonia, especially in men . Obesity plays an important role in the pathogenesis of COVID-19 infection . In fact, the immune system, which is a key player in the pathogenesis of COVID-19, also plays an important role in obesity-induced adipose tissue inflammation. This inflammation of adipose tissue results in metabolic dysfunction potentially leading to dyslipidaemia, insulin resistance, type 2 diabetes mellitus, hypertension, and cardiovascular disease. A systematic review and meta-analysis demonstrated that severe obesity (body mass index BMI ≥ 40 kg/m2) represents a major risk factor of intensive care unit admission or death in individuals affected by H1N1 influenza . Thereafter, obesity is associated with a higher risk of infectious diseases, in particular of the respiratory tract.
There are a number of factors predisposing subjects with obesity to viral infections. These factors include low-grade chronic inflammation with hyper-production of pro-inflammatory cytokines, reduced natural killer (NK) cell number and activity, altered CD4:CD8T cell balance, impaired response to antigen stimulation and high expression of adipocyte angiotensin type 1 and 2 receptors.
Furthermore, obesity is associated with, and responsible for, comorbidity conditions that may represent risk factors for serious COVID-19 infection (i.e. type II diabetes, ischemic cardiac disease, etc.). Extra attention and precautions for patients with obesity during this epidemic is recommended. Whenever COVID-19 infection is suspected, screening must be systematic, particularly if the patient has obesity.
So far, bariatric surgery represents the most effective treatment to obtain a long-term meaningful weight reduction and resolution of comorbidities including respiratory disorders. In a very large case series study including 56277 subjects who underwent bariatric surgery in the United States, the overall risk of developing common infectious diseases including respiratory infections decreased significantly in men during the first two years after surgery (aOR, 0.69 [95% CI, 0.60-0.79]; P<0.001).
The first person-to-person transmission in Italy was reported on February 21st, 2020, in Lombardy region, the most crowded and rich region in Italy, causing the most massive Covid-19 outbreak in Europe so far. First positive cases of Sars-Co-v-2 were registered in Italy by 29th of January 2020. The COVID-19 outbreak stopped all elective surgical procedures by 9th of March, including bariatric/metabolic surgery except emergency conditions as suggested by recent IFSO recommendations . All elective surgical and endoscopic cases for metabolic and bariatric surgery should be postponed during the phase one outbreak. This would minimize risks to both patient and healthcare team, as well as reducing the utilization of unnecessary resources, such as beds, ventilators and personal protective equipment (PPE). In addition, postponing these services will minimize potential exposure of the COVID-19 virus to unsuspecting healthcare providers and patients.
To understand what could have been the impact of operating a population at risk of infection without specific precautions, we gathered a group of eight high-volume Italian bariatric centers, which performed 840 laparoscopic bariatric procedures during January and February 2020. Five are located in regions with high infection rates (Lombardy, Veneto, Piedmont, Emilia Romagna), and 3 are in areas with infection rate close to the Italian average (Tuscany, Lazio). A structured phone interview was administered to all patients operated during that period. We found five infections (5.9 cases out of 1000 inhabitants), four in Lombardy, and one in Veneto. The overall rate of infection on May 2, 2020, was similar in the 2 regions, 7.19 out of 1.000 inhabitants . Among infected patients, 2 had mild symptoms and home care, and three were hospitalized for fever and dyspnea; none died. Four out of five cases were over 60 years, all were female, and 3 out of 5 cases, reported an extra-hospital contact with positive COVID-19 people. All 5 cases healed eventually, with a negative swab.
During the last days of April 2020, a sensitive decrease of epidemic has been observed in Italy and Government planned a gradual and progressive stop of the lockdown (the so-called phase 2). That means the start of a new period when the virus is supposed to be under control and protocol are coming in the National Health Care System (SSN) to restart the elective surgical practice.
Several open questions are currently waiting the answers useful for the settlement of the management of obese patients, considering bariatric surgery effective for weight loss and co-morbidity control as well protective against eventual recurrent outbreak.
- Laparoscopic bariatric surgery is safe in the phase 2 outbreak?
- What's the expected complication rate of laparoscopic bariatric surgery in COVID-19 phase 2?
- The hospital protocols are effective to minimize the risk of postoperative Covid 19 infection after elective bariatric surgery in selected patients? Aim: to analyze results of laparoscopic bariatric surgery during phase 2 COVID-19 pandemic in Italy.
Primary end point: 30 days COVID-19 infection, mortality and complications. Secondary end points: readmission rate 30 days, reoperations for any reason related to bariatric surgery.
Study design: prospective multicenter observational Time interval: 12 months (July 2020 - May 2021): recruitment and therapy July 2020-December 2020, follow-up January 2021, data collection and analysis, manuscript preparation and publication Feb-May 2021).
Setting: Italian National Health Service' high-volume bariatric centres, academic hospitals.
Hospital admission protocol
Two to three days before admission, a doctor must interview the patient by telephone with the following questionnaire:
- Did you have fever (threshold value > 37.5ºC / 99.5ºF), especially in the last 48 hours?
- Do you have any new respiratory symptoms, especially when you walk?
- Do you have other symptoms: vomiting, diarrhea, conjunctivitis, changes in smell, or taste, osteoarticular pain, excessive fatigue?
- Have you had contact in the last two weeks with a confirmed case (clinical diagnosis - positive swab) of COVID-19?
- 24-48 hours before hospitalization, the patient must arrive at the hospital: outside the hospital, the medical staff must repeat the interview as above and must swab the patient. In the case of a positive swab, surgery must be suspended. In the case of negativity, the patient must receive and sign a specific COVID-19 consent, and the operation can be carried out, with hospitalization on the same day of the procedure.
These procedures are in line with international and national guidelines for the screening of patients before entry the hospital (12) Screening at admission
- Standard interview (National accepted Covid-19 questionnaire, see attachment 1)
- Fever check
- Chest X-ray / Thoracic CT scan Surgical informed consent
1. SICOB approved informed consent for standard bariatric procedures (2014 version); 2. A modified informed consent including the risk of COVID-1919 infection, will be adopted and added by all centers to the standard, above listed official consent: "I am aware that this bariatric procedure may lead to an increase in the possibility of contracting the COVID-19 infection, due to the general situation currently present, with a possible further increase in postoperative complications. I am also aware that, following the intervention, I will have to undergo a 14-day postoperative quarantine period, I will have to measure the temperature twice a day, I will be prohibited from traveling and traveling. The first postoperative check-up will be performed at the end of this period, unless complications related to surgery arise." Operating Room (OR) protocol
- For surgeon standard personal protective equipment (PPE) plus N95 mask
- For anesthesiologists and nurses who manage the airways and gastric bougie positioning, we recommend using N99 mask, face shield, single-use waterproof gown, and double gloves
- At the end of each procedure, every PPE must be changed
- Restrict access to people in OR
- Expert surgeons and anesthesiologists must perform the procedures to minimize the OR occupation time.
- A smoke evacuator system should be employed to avoid aerosol contamination; in the alternative, a filter must be connected to the exsufflation system.
- A negative pressure in the OR is not mandatory, but it is crucial to allow enough time between cases for complete room air exchange. In case the OR had been used for intensive care during phase 1 pandemic, proper sanitization is required.
Management of in-hospital patients
- No Covid-19 hospital/section should be used for elective bariatric surgery.
- Standard PPE for staff is mandatory.
- Social distance must be respected even in case of post-surgical mobilization; patients should always wear a surgical mask.
- Each patient should have a single room, or in the case of a large room, he must be assigned a suitable space to comply with the laws in force on social distancing.
- ERAS protocol is welcomed whenever is possible.
After discharge:
- In case of intra-hospital contact with Covid-19 patient or healthcare professional, 14 days self-quarantine after discharge is mandatory
- Home physical activity (same proposed program for all groups)
- Implement Oral supplementation (proposed recommendation for all groups)
- Low dose heparin for at least three weeks (proposed treatment for all groups)
- After 7 and 15 days the patients receive a follow-up phone with specific questions about Covid-19 (attached structured phone interview) Follow-up: Scheduled outpatient visit: 30 postoperative day.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Gianfranco Silecchia, Prof
- Phone Number: 003907736513304
- Email: gianfranco.silecchia@uniroma1.it
Study Contact Backup
- Name: Cristian E Boru, Dr
- Phone Number: 003907736513304
- Email: drcrisb@gmail.com
Study Locations
-
-
LT
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Latina, LT, Italy, 04100
- Recruiting
- University La Sapienza of Rome, Department of Medico-Surgical Sciences and Biotechnologies
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Since July 2020, all the bariatric cases performed in the 8 participating centers will be collected in a prospective database, to monitor the postoperative course of the patients until WHO will declare the end of the pandemic, in order to determine the incidence of Sars-Cov-2 infection after bariatric surgery.
All the data will be collected anonymously on a database by an independent data manager. The results will be evaluated in January 2021. As comparative group will be considered the patients operated during the period July/December 2019 in the same centers
Description
Inclusion Criteria:
- Primary bariatric surgery;
- Compensated DMT2;
- Controlled hypertension;
- Patients with OSAS can only be admitted if therapy with home CPAP is effective
- Laparoscopic standard bariatric procedure;
- Procedure duration less than 120 minutes;
- Official SICOB's surgical informed consent given, including Covid-19 addendum.
Exclusion Criteria:
- previous Covid-19 infection;
- patients who may need an extended stay or intensive care (BMI > 60).
- concomitant procedure;
- previous major abdominal surgery
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group Pisa
All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UOC Chirurgia Bariatrica, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy (Head Prof. Marco Anselmino) will be collected in a prospective database, to monitor the postoperative course.
|
All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve.
The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery).
All the participating centers will follow the usual recruitment protocol.
Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.
|
Group Padova
All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UOSD Week Surgery, Azienda Ospedaliera, Università di Padova, Italy (Head Dr. Mirto Foletto) will be collected in a prospective database, to monitor the postoperative course.
|
All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve.
The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery).
All the participating centers will follow the usual recruitment protocol.
Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.
|
Group Bologna
All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit Chirurgia Bariatrica, Azienda Ospedaliera Universitaria di Bologna, Italy (Head Dr. Paolo Bernante) will be collected in a prospective database, to monitor the postoperative course.
|
All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve.
The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery).
All the participating centers will follow the usual recruitment protocol.
Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.
|
Group Bergamo
All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UOC Chirurgia Generale e Oncologica, Policlinico San Marco di Zingonia, Bergamo, Italy (Head Prof. Stefano Olmi) will be collected in a prospective database, to monitor the postoperative course.
|
All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve.
The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery).
All the participating centers will follow the usual recruitment protocol.
Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.
|
Group Tor Vergata
All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit U.O.S.D. Chirurgia Mininvasiva e dell'Apparato Digerente, Università Tor Vergata, Rome, Italy (Head Prof. Paolo Gentileschi) will be collected in a prospective database, to monitor the postoperative course.
|
All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve.
The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery).
All the participating centers will follow the usual recruitment protocol.
Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.
|
Group Torino
All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit Dipartimento di Scienze Chirurgiche, Azienda Ospedaliera Universitaria Citta della Salute e della Scienza, Università di Torino, Italy (Head Prof. Mario Morino) will be collected in a prospective database, to monitor the postoperative course.
|
All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve.
The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery).
All the participating centers will follow the usual recruitment protocol.
Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.
|
Group Milano
All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UO di Chirurgia Bariatrica, Humanitas Research Hospital, Rozzano, Milano, Italy (Head Dr. Giuseppe Marinari) will be collected in a prospective database, to monitor the postoperative course.
|
All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve.
The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery).
All the participating centers will follow the usual recruitment protocol.
Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.
|
Group Rome
All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UOC Chirurgia Generale & Bariatric Center of Excellence IFSO-EC, University La Sapienza of Rome, Italy (Head Prof. Gianfranco Silecchia) will be collected in a prospective database, to monitor the postoperative course.
|
All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve.
The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery).
All the participating centers will follow the usual recruitment protocol.
Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative COVID-19 infection
Time Frame: 30 postoperative days
|
Postbariatric surgery COVID-19 infection, mortality and complications
|
30 postoperative days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications related to bariatric surgery
Time Frame: 30 postoperative days
|
Complications, reoperations for any reason related to bariatric surgery.
|
30 postoperative days
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
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- Chen Q, Zheng Z, Zhang C, Zhang X, Wu H, Wang J, Wang S, Zheng C. Clinical characteristics of 145 patients with corona virus disease 2019 (COVID-19) in Taizhou, Zhejiang, China. Infection. 2020 Aug;48(4):543-551. doi: 10.1007/s15010-020-01432-5. Epub 2020 Apr 28.
- Kassir R. Risk of COVID-19 for patients with obesity. Obes Rev. 2020 Jun;21(6):e13034. doi: 10.1111/obr.13034. Epub 2020 Apr 13. No abstract available.
- Honce R, Schultz-Cherry S. Impact of Obesity on Influenza A Virus Pathogenesis, Immune Response, and Evolution. Front Immunol. 2019 May 10;10:1071. doi: 10.3389/fimmu.2019.01071. eCollection 2019.
- Kornum JB, Norgaard M, Dethlefsen C, Due KM, Thomsen RW, Tjonneland A, Sorensen HT, Overvad K. Obesity and risk of subsequent hospitalisation with pneumonia. Eur Respir J. 2010 Dec;36(6):1330-6. doi: 10.1183/09031936.00184209. Epub 2010 Mar 29.
- Shapouri-Moghaddam A, Mohammadian S, Vazini H, Taghadosi M, Esmaeili SA, Mardani F, Seifi B, Mohammadi A, Afshari JT, Sahebkar A. Macrophage plasticity, polarization, and function in health and disease. J Cell Physiol. 2018 Sep;233(9):6425-6440. doi: 10.1002/jcp.26429. Epub 2018 Mar 1.
- Cheng CI, Chen PH, Lin YC, Kao YH. High glucose activates Raw264.7 macrophages through RhoA kinase-mediated signaling pathway. Cell Signal. 2015 Feb;27(2):283-92. doi: 10.1016/j.cellsig.2014.11.012. Epub 2014 Nov 14.
- Torres-Castro I, Arroyo-Camarena UD, Martinez-Reyes CP, Gomez-Arauz AY, Duenas-Andrade Y, Hernandez-Ruiz J, Bejar YL, Zaga-Clavellina V, Morales-Montor J, Terrazas LI, Kzhyshkowska J, Escobedo G. Human monocytes and macrophages undergo M1-type inflammatory polarization in response to high levels of glucose. Immunol Lett. 2016 Aug;176:81-9. doi: 10.1016/j.imlet.2016.06.001. Epub 2016 Jun 4. Erratum In: Immunol Lett. 2017 Dec;192:106.
- Sun JC, Beilke JN, Lanier LL. Adaptive immune features of natural killer cells. Nature. 2009 Jan 29;457(7229):557-61. doi: 10.1038/nature07665. Epub 2009 Jan 11. Erratum In: Nature. 2009 Feb 26;457(7233):1168.
- van der Weerd K, Dik WA, Schrijver B, Schweitzer DH, Langerak AW, Drexhage HA, Kiewiet RM, van Aken MO, van Huisstede A, van Dongen JJ, van der Lelij AJ, Staal FJ, van Hagen PM. Morbidly obese human subjects have increased peripheral blood CD4+ T cells with skewing toward a Treg- and Th2-dominated phenotype. Diabetes. 2012 Feb;61(2):401-8. doi: 10.2337/db11-1065. Epub 2012 Jan 6.
- Smith AG, Sheridan PA, Harp JB, Beck MA. Diet-induced obese mice have increased mortality and altered immune responses when infected with influenza virus. J Nutr. 2007 May;137(5):1236-43. doi: 10.1093/jn/137.5.1236.
- Mauro C, Smith J, Cucchi D, Coe D, Fu H, Bonacina F, Baragetti A, Cermenati G, Caruso D, Mitro N, Catapano AL, Ammirati E, Longhi MP, Okkenhaug K, Norata GD, Marelli-Berg FM. Obesity-Induced Metabolic Stress Leads to Biased Effector Memory CD4+ T Cell Differentiation via PI3K p110delta-Akt-Mediated Signals. Cell Metab. 2017 Mar 7;25(3):593-609. doi: 10.1016/j.cmet.2017.01.008. Epub 2017 Feb 9.
- Walls AC, Park YJ, Tortorici MA, Wall A, McGuire AT, Veesler D. Structure, Function, and Antigenicity of the SARS-CoV-2 Spike Glycoprotein. Cell. 2020 Apr 16;181(2):281-292.e6. doi: 10.1016/j.cell.2020.02.058. Epub 2020 Mar 9. Erratum In: Cell. 2020 Dec 10;183(6):1735.
- Schling P, Mallow H, Trindl A, Loffler G. Evidence for a local renin angiotensin system in primary cultured human preadipocytes. Int J Obes Relat Metab Disord. 1999 Apr;23(4):336-41. doi: 10.1038/sj.ijo.0800821.
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- Maggard MA, Shugarman LR, Suttorp M, Maglione M, Sugerman HJ, Livingston EH, Nguyen NT, Li Z, Mojica WA, Hilton L, Rhodes S, Morton SC, Shekelle PG. Meta-analysis: surgical treatment of obesity. Ann Intern Med. 2005 Apr 5;142(7):547-59. doi: 10.7326/0003-4819-142-7-200504050-00013.
- Mingrone G, Panunzi S, De Gaetano A, Guidone C, Iaconelli A, Nanni G, Castagneto M, Bornstein S, Rubino F. Bariatric-metabolic surgery versus conventional medical treatment in obese patients with type 2 diabetes: 5 year follow-up of an open-label, single-centre, randomised controlled trial. Lancet. 2015 Sep 5;386(9997):964-73. doi: 10.1016/S0140-6736(15)00075-6.
- Capoccia D, Guida A, Coccia F, Guarisco G, Testa M, Leonetti F, Silecchia G. Weight Regain and Diabetes Evolution After Sleeve Gastrectomy: a Cohort Study with over 5 Years of Follow-Up. Obes Surg. 2020 Mar;30(3):1046-1051. doi: 10.1007/s11695-019-04350-0.
- Sjostrom L. Review of the key results from the Swedish Obese Subjects (SOS) trial - a prospective controlled intervention study of bariatric surgery. J Intern Med. 2013 Mar;273(3):219-34. doi: 10.1111/joim.12012. Epub 2013 Feb 8.
- Goto T, Hirayama A, Faridi MK, Camargo CA Jr, Hasegawa K. Association of Bariatric Surgery With Risk of Infectious Diseases: A Self-Controlled Case Series Analysis. Clin Infect Dis. 2017 Oct 15;65(8):1349-1355. doi: 10.1093/cid/cix541.
- Sharma P, McCarty TR, Ngu JN, O'Donnell M, Njei B. Impact of bariatric surgery in patients with HIV infection: a nationwide inpatient sample analysis, 2004-2014. AIDS. 2018 Sep 10;32(14):1959-1965. doi: 10.1097/QAD.0000000000001915.
- Yang W, Wang C, Shikora S, Kow L. Recommendations for Metabolic and Bariatric Surgery During the COVID-19 Pandemic from IFSO. Obes Surg. 2020 Jun;30(6):2071-2073. doi: 10.1007/s11695-020-04578-1. No abstract available.
- Di Lorenzo N, Antoniou SA, Batterham RL, Busetto L, Godoroja D, Iossa A, Carrano FM, Agresta F, Alarcon I, Azran C, Bouvy N, Balague Ponz C, Buza M, Copaescu C, De Luca M, Dicker D, Di Vincenzo A, Felsenreich DM, Francis NK, Fried M, Gonzalo Prats B, Goitein D, Halford JCG, Herlesova J, Kalogridaki M, Ket H, Morales-Conde S, Piatto G, Prager G, Pruijssers S, Pucci A, Rayman S, Romano E, Sanchez-Cordero S, Vilallonga R, Silecchia G. Clinical practice guidelines of the European Association for Endoscopic Surgery (EAES) on bariatric surgery: update 2020 endorsed by IFSO-EC, EASO and ESPCOP. Surg Endosc. 2020 Jun;34(6):2332-2358. doi: 10.1007/s00464-020-07555-y. Epub 2020 Apr 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia
- Lung Diseases
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- COVID-19
- Obesity
- Virus Diseases
- Obesity, Morbid
- Pneumonia, Viral
Other Study ID Numbers
- 008758/27.05.2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Clinical Trials on Pneumonia, Viral
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Hospices Civils de LyonTerminatedCOVID-19 | Viral Pneumonia Human CoronavirusFrance
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University of Texas Southwestern Medical CenterWithdrawnBacterial Pneumonia | Viral PneumoniaUnited States
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Cairo UniversityUnknown
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Zhong WangNot yet recruiting
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Wecare Probiotics Co., Ltd.Not yet recruitingViral Pneumonia
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Instituto Nacional de Ciencias Medicas y Nutricion...CompletedCoronavirus Infections | COVID-19 | Viral Pneumonia Human CoronavirusMexico
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Francesco De CobelliCompleted
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South Egypt Cancer InstituteRecruiting
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University Hospital, LilleCompleted
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University of TriesteCentro di Riferimento Oncologico - Aviano; National Institute for the Infectious...CompletedSevere Acute Respiratory Syndrome | Covid19 | Viral Pneumonia Human CoronavirusItaly
Clinical Trials on Bariatric procedures
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Methodist Health SystemRecruiting
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Central Hospital, Nancy, FranceCompletedObesity, Morbid | Anal Incontinence | Image, BodyFrance
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University of Roma La SapienzaRecruitingObesity, Morbid | Complication of Surgical Procedure | Bariatric Surgery Candidate | Complication,Postoperative | Safety Issues | RemissionItaly
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Christopher C. Thompson, MD, MScEnrolling by invitationObesity | Abdominal Pain | Weight Loss | Obesity, Morbid | Complication of Surgical Procedure | Weight Gain | Bariatric Surgery Candidate | Complication,Postoperative | Abdominal Obesity | Complication of Treatment | Roux-en-y Anastomosis Site | Ulcer, Gastric | Obesity Associated Disorder | Leak, Anastomotic | Fistula... and other conditionsUnited States
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Centre Hospitalier Universitaire de NiceTerminatedObesity | Chronic Kidney DiseaseFrance
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University of Missouri-ColumbiaRecruitingBreast Cancer FemaleUnited States
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Duke UniversityTerminatedPre-Eclampsia | Neurocognitive DysfunctionUnited States
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Imperial College LondonRecruitingObesity | Type 2 DiabetesIreland
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Federal University of São PauloCompleted
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VA Office of Research and DevelopmentAugusta UniversityNot yet recruitingAge-related Macular Degeneration (AMD)United States