Clinical trial NCT01055054: Bariatric Surgery Registry
Official title: Analysis Bariatric Surgery Data
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Obesity, Morbid
Keywords: bariatrics
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2010-01-25
Enrollment: 8000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone bariatric surgical procedures at the Virginia Commonwealth University (VCU) Medical Center.

Brief summary: Periodic analyses of our extensive database with regards to different surgical procedures for severe obesity and different obesity co-morbidities will be of benefit to our severely obese patients as well as to others world-wide.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of morbid obesity
* Have undergone a bariatric surgical procedure at the VCU Medical Center

Primary outcomes:
measure: weight loss
timeFrame: 1 year, 5 years
Secondary outcomes:
measure: surgical mortality
timeFrame: 90 day post-surgery
measure: surgical morbidity
timeFrame: 90 day post-surgery
measure: resolution of co-morbidities
timeFrame: 1 year, 5 years
Other outcomes:
Locations:
city: Richmond
country: United States
facility: VCU Health Systems
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Guilherme M Campos, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Chikunguwo SM, Wolfe LG, Dodson P, Meador JG, Baugh N, Clore JN, Kellum JM, Maher JW. Analysis of factors associated with durable remission of diabetes after Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2010 May-Jun;6(3):254-9. doi: 10.1016/j.soard.2009.11.003. Epub 2009 Nov 10.
citation: Kellum JM, Chikunguwo SM, Maher JW, Wolfe LG, Sugerman HJ. Long-term results of malabsorptive distal Roux-en-Y gastric bypass in superobese patients. Surg Obes Relat Dis. 2011 Mar-Apr;7(2):189-93. doi: 10.1016/j.soard.2010.08.018. Epub 2010 Oct 11.
citation: Browning MG, Baugh NG, Wolfe LG, Kellum JK, Maher JW, Evans RK. Evaluation of pre- and postoperative physical activity participation in laparoscopic gastric banding patients. Obes Surg. 2014 Nov;24(11):1981-6. doi: 10.1007/s11695-014-1283-1.
citation: Browning MG, Khoraki J, DeAntonio JH, Mazzini G, Mangino MJ, Siddiqui MS, Wolfe LG, Campos GM. Protective effect of black relative to white race against non-alcoholic fatty liver disease in patients with severe obesity, independent of type 2 diabetes. Int J Obes (Lond). 2018 Apr;42(4):926-929. doi: 10.1038/ijo.2017.309. Epub 2017 Dec 21.
citation: Khoraki J, Mazzini GS, Shah AS, Del Prado PAR, Wolfe LG, Campos GM. Early small bowel obstruction after laparoscopic gastric bypass: a surgical emergency. Surg Obes Relat Dis. 2018 Aug;14(8):1118-1125. doi: 10.1016/j.soard.2018.05.009. Epub 2018 May 23.
citation: Pessoa BM, Browning MG, Mazzini GS, Wolfe L, Kaplan A, Khoraki J, Campos GM. Factors Mediating Type 2 Diabetes Remission and Relapse after Gastric Bypass Surgery. J Am Coll Surg. 2020 Jan;230(1):7-16. doi: 10.1016/j.jamcollsurg.2019.09.012. Epub 2019 Oct 28.
citation: Mazzini GS, Khoraki J, Browning MG, Pessoa BM, Wolfe LG, Campos GM. Population Diversity Challenge the External Validity of the European Randomized Controlled Trials Comparing Laparoscopic Gastric Bypass and Sleeve Gastrectomy. Obes Surg. 2020 Mar;30(3):992-1000. doi: 10.1007/s11695-019-04247-y.