Comparing the Benefits and Harms of Three Types of Weight Loss Surgery -- The PCORnet® Bariatric Study
NCT ID: NCT02741674
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
65093 participants
OBSERVATIONAL
2016-02-29
2018-04-30
Brief Summary
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Detailed Description
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Question (Aim) 1: To what extent does weight loss and weight regain differ across the three bariatric surgical procedures at 1, 3, and 5 years? This aim addresses the primary outcome of interest among most patients seeking bariatric surgery - the differential impact of these procedures on maximum weight loss as well as the extent of longer-term weight regain. We will also explore the heterogeneity in weight loss and regain across several key subgroups that may have differential response to surgical treatment, specifically groups defined by age, race/ethnicity, baseline BMI, smoking status, and pre-operative comorbidities.
Question (Aim) 2: To what extent do these bariatric procedures differ on improvements in diabetes risk at 1, 3, and 5 years? Among patients with diabetes, remission or "cure" of their disease (defined as HbA1c \<6.5% off diabetes medications) has been cited as the most important outcome of bariatric surgery. Thus, we will examine the comparative effect of these procedures on rates of diabetes remission as well as relapse (recurrence). Secondary analyses will examine the comparative impact of the procedures on glycemic control independent of diabetes remission.
Question (Aim) 3: What is the frequency of major adverse events following these three different bariatric surgical procedures at 1, 3, and 5 years? We will examine four important adverse event outcome categories across the three procedures: 1) short- and long-term (1, 3, and 5 year) mortality rates, 2) a composite end point of 30-day major adverse outcomes: based on the definition used in the Longitudinal Assessment of Bariatric Surgery (LABS) study that included death; venous thromboembolism; percutaneous, endoscopic, or operative subsequent intervention; and failure to be discharged from the hospital; 3) subsequent hospitalization (any hospitalization following initial surgery); and 4) subsequent reoperation/reintervention: defined as any additional bariatric procedure and other procedures related to device removals, gastric revisions, abdominal or incisional hernia repair, laparoscopy or laparotomy, and percutaneous endoscopic gastrostomy tube placements.
Question (Aim) 4: To what extent do bariatric surgery outcomes explored in Aims 1-3 differ with respect to baseline depression diagnosis at 1, 3, and 5 years after surgery?
Question (Aim) 5: To what extent do bariatric surgery outcomes explored in Aims 1-3 differ with respect to race and ethnicity at 1, 3, and 5 years after surgery?
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Roux-en-y gastric bypass (RYGB)
1. Adults and children ages 12 ≤79 years at time of surgery
2. Had a primary (not revision) Roux-en-y gastric bypass from years 2005-2015 (based on ICD-9-CM, CPT-4, and HCPCS codes)
3. Have a Body Mass Index (BMI) measurement in the year prior to surgery that is ≥35 kg/m2 for adults and adolescents
Roux-en-y gastric bypass (RYGB) - historical
Participant has had RYGB, as identified using existing data
Adjustable gastric banding (AGB)
1. Adults and children age 12 ≤79 years at time of surgery
2. Had a primary (not revision) adjustable gastric banding procedure from years 2005-2015 (based on ICD-9-CM, CPT-4, and HCPCS codes)
3. Have a Body Mass Index (BMI) measurement in the year prior to surgery that is ≥35 kg/m2 for adults and adolescents
Adjustable gastric banding (AGB) - historical
Participant has had AGB, as identified using existing data
Sleeve gastrectomy (SG)
1. Adults and children age 12 ≤79 years at time of surgery
2. Had a primary (not revision) sleeve gastrectomy from years 2005-2015 (based on ICD-9-CM, CPT-4, and HCPCS codes)
3. Have a Body Mass Index (BMI) measurement in the year prior to surgery that is ≥35 kg/m2 for adults and adolescents
Sleeve gastrectomy (SG) - historical
Participant has had SG, as identified using existing data
Interventions
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Roux-en-y gastric bypass (RYGB) - historical
Participant has had RYGB, as identified using existing data
Adjustable gastric banding (AGB) - historical
Participant has had AGB, as identified using existing data
Sleeve gastrectomy (SG) - historical
Participant has had SG, as identified using existing data
Eligibility Criteria
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Inclusion Criteria
* Had a primary (not revision) bariatric procedure from years 2005-2015 of one of three types:
1. Roux-en-y gastric bypass (RYGB)
2. Adjustable gastric banding (AGB)
3. Sleeve gastrectomy (SG)
* Have a Body Mass Index (BMI) measurement in the year prior to surgery that is ≥35 kg/m2
• Eligible patients must have uncontrolled or medication-controlled diabetes at the time of surgery.
* Hemoglobin A1c (HbA1c) ≥6.5 % at the most recent measurement prior to surgery, or
* Current prescription for diabetes medication at the time of surgery with the most recent HbA1c \<6.5% Patients taking only metformin will be excluded unless they also have an ICD-9-CM code for Diabetes (250.x) or have HbA1c \>=6.5% in the year prior to surgery. This includes patients with polycystic ovarian syndrome (PCOS).
* Eligible patients must be linked to relevant data sources:
* State or national death index (mortality outcomes);
* Payer data/insurance claims (for Adverse Events outcomes)
* Patients must be aged 20 through 79 years of age at time of surgery.
ADDITIONAL EXCLUSION CRITIERA FOR AIM 3 (Adverse Events)
* Exclude any patient with \>=365 inpatient hospitalization days in the year prior to surgery.
* Exclude any patient without male or female sex indicated in the study data
• Race and ethnicity available in study data
Exclusion Criteria
* Have multiple bariatric procedures coded on the same day
* Have a diagnosis related to GI cancer occurring on day of surgery or during index hospitalization (Diagnosis determined using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM)
* Emergency department visit on the same day as hospitalization for bariatric procedure
12 Years
79 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
National Patient-Centered Clinical Research Network
OTHER
Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN)
OTHER
Greater Plains Collaborative Clinical Data Research Network
OTHER
Research Action for Health Network (REACHnet)
OTHER
Mid-South Clinical Data Research Network
OTHER
PEDSnet: A Pediatric Learning Health System CDRN
UNKNOWN
New York City Clinical Data Research Network
OTHER
OneFlorida Clinical Research Consortium
OTHER
The Patient-Oriented Scalable National Network for Effectiveness Research
OTHER
PaTH: Towards a Learning Health System Clinical Data Research Network
UNKNOWN
Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS)
UNKNOWN
COPD Patient-Powered Research Network
UNKNOWN
Obesity Action Coalition
UNKNOWN
Harvard Pilgrim Health Care
OTHER
Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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David E. Arterburn, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Kathleen M. McTigue, MD, MS, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Neely A. Williams, M.Div
Role: PRINCIPAL_INVESTIGATOR
Mid-South CDRN
References
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Toh S, Rasmussen-Torvik LJ, Harmata EE, Pardee R, Saizan R, Malanga E, Sturtevant JL, Horgan CE, Anau J, Janning CD, Wellman RD, Coley RY, Cook AJ, Courcoulas AP, Coleman KJ, Williams NA, McTigue KM, Arterburn D, McClay J; PCORnet Bariatric Surgery Collaborative. The National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study Cohort: Rationale, Methods, and Baseline Characteristics. JMIR Res Protoc. 2017 Dec 5;6(12):e222. doi: 10.2196/resprot.8323.
McTigue KM, Wellman R, Nauman E, Anau J, Coley RY, Odor A, Tice J, Coleman KJ, Courcoulas A, Pardee RE, Toh S, Janning CD, Williams N, Cook A, Sturtevant JL, Horgan C, Arterburn D; PCORnet Bariatric Study Collaborative. Comparing the 5-Year Diabetes Outcomes of Sleeve Gastrectomy and Gastric Bypass: The National Patient-Centered Clinical Research Network (PCORNet) Bariatric Study. JAMA Surg. 2020 May 1;155(5):e200087. doi: 10.1001/jamasurg.2020.0087. Epub 2020 May 20.
Courcoulas A, Coley RY, Clark JM, McBride CL, Cirelli E, McTigue K, Arterburn D, Coleman KJ, Wellman R, Anau J, Toh S, Janning CD, Cook AJ, Williams N, Sturtevant JL, Horgan C, Tavakkoli A; PCORnet Bariatric Study Collaborative. Interventions and Operations 5 Years After Bariatric Surgery in a Cohort From the US National Patient-Centered Clinical Research Network Bariatric Study. JAMA Surg. 2020 Mar 1;155(3):194-204. doi: 10.1001/jamasurg.2019.5470.
Arterburn D, Wellman R, Emiliano A, Smith SR, Odegaard AO, Murali S, Williams N, Coleman KJ, Courcoulas A, Coley RY, Anau J, Pardee R, Toh S, Janning C, Cook A, Sturtevant J, Horgan C, McTigue KM; PCORnet Bariatric Study Collaborative. Comparative Effectiveness and Safety of Bariatric Procedures for Weight Loss: A PCORnet Cohort Study. Ann Intern Med. 2018 Dec 4;169(11):741-750. doi: 10.7326/M17-2786. Epub 2018 Oct 30.
Inge TH, Coley RY, Bazzano LA, Xanthakos SA, McTigue K, Arterburn D, Williams N, Wellman R, Coleman KJ, Courcoulas A, Desai NK, Anau J, Pardee R, Toh S, Janning C, Cook A, Sturtevant J, Horgan C, Zebrick AJ, Michalsky M; PCORnet Bariatric Study Collaborative. Comparative effectiveness of bariatric procedures among adolescents: the PCORnet bariatric study. Surg Obes Relat Dis. 2018 Sep;14(9):1374-1386. doi: 10.1016/j.soard.2018.04.002. Epub 2018 Apr 17.
Coughlin JW, Nauman E, Wellman R, Coley RY, McTigue KM, Coleman KJ, Jones DB, Lewis KH, Tobin JN, Wee CC, Fitzpatrick SL, Desai JR, Murali S, Morrow EH, Rogers AM, Wood GC, Schlundt DG, Apovian CM, Duke MC, McClay JC, Soans R, Nemr R, Williams N, Courcoulas A, Holmes JH, Anau J, Toh S, Sturtevant JL, Horgan CE, Cook AJ, Arterburn DE; PCORnet Bariatric Study Collaborative. Preoperative Depression Status and 5 Year Metabolic and Bariatric Surgery Outcomes in the PCORnet Bariatric Study Cohort. Ann Surg. 2023 Apr 1;277(4):637-646. doi: 10.1097/SLA.0000000000005364. Epub 2022 Jan 19.
Coleman KJ, Wellman R, Fitzpatrick SL, Conroy MB, Hlavin C, Lewis KH, Coley RY, McTigue KM, Tobin JN, McBride CL, Desai JR, Clark JM, Toh S, Sturtevant JL, Horgan CE, Duke MC, Williams N, Anau J, Horberg MA, Michalsky MP, Cook AJ, Arterburn DE, Apovian CM; PCORnet Bariatric Study Collaborative. Comparative Safety and Effectiveness of Roux-en-Y Gastric Bypass and Sleeve Gastrectomy for Weight Loss and Type 2 Diabetes Across Race and Ethnicity in the PCORnet Bariatric Study Cohort. JAMA Surg. 2022 Oct 1;157(10):897-906. doi: 10.1001/jamasurg.2022.3714.
Provided Documents
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Document Type: Statistical Analysis Plan
Related Links
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PCORnet Bariatric Surgery Collaborative. The National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study Cohort: Rationale, Methods, and Baseline Characteristics. (Journal link)
PCORnet Bariatric Surgery Collaborative. The National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study Cohort: Rationale, Methods, and Baseline Characteristics. (PMC link)
Comparing the 5-Year Diabetes Outcomes of Sleeve Gastrectomy and Gastric Bypass: The National Patient-Centered Clinical Research Network (PCORNet) Bariatric Study
Comparative effectiveness of bariatric procedures among adolescents: the PCORnet bariatric study.
Interventions and Operations 5 Years After Bariatric Surgery in a Cohort From the US National Patient-Centered Clinical Research Network Bariatric Study
Comparative Effectiveness and Safety of Bariatric Procedures for Weight Loss: A PCORnet Cohort Study
Preoperative Depression Status and 5 Year Metabolic and Bariatric Surgery Outcomes in the PCORnet Bariatric Study Cohort
Other Identifiers
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OBS-1505-30683
Identifier Type: -
Identifier Source: org_study_id