Comparing the Benefits and Harms of Three Types of Weight Loss Surgery -- The PCORnet® Bariatric Study (PBS)

National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study

The main goal of this research project is to conduct a comparative effectiveness research study involving existing data in the PCORnet Common Data Model to provide accurate estimates of the 1-, 3-, and 5-year benefits and risks of the three most common bariatric procedures - Roux-en-y gastric bypass, adjustable gastric banding, and sleeve gastrectomy - with a focus on outcomes that are important to adults and adolescents with severe obesity: 1) changes in weight, 2) rates of remission and relapse of diabetes, and 3) major adverse events.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus; Body Weight; Weight Loss; Roux-en-Y Gastric Bypass; Gastric Bypass; Bariatrics
• Intervention / Treatment: Procedure: Roux-en-y gastric bypass (RYGB) - historical; Procedure: Adjustable gastric banding (AGB) - historical; Procedure: Sleeve gastrectomy (SG) - historical

Detailed Description

The main aims of this study will compare the effectiveness and safety of the three most common bariatric surgical procedures: Roux-en-y gastric bypass (RYGB), adjustable gastric banding (AGB), and sleeve gastrectomy (SG).

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?

• Study Type: Observational
• Enrollment (Actual): 65093

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 79 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population are children and adults (aged 12 through 79 years of age) who have undergone one of the three most common bariatric procedures performed in the United Sates - Roux-en-y gastric bypass, adjustable gastric banding, and sleeve gastrectomy. The population will be identified using participating sites' PCORnet Common Data Model (CDM).

Description

ALL STUDY AIMS

• Inclusion Criteria:

  • Adults and children ages 12 ≤79 years at time of surgery

  • 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

• Exclusion Criteria:

  • First bariatric procedure during the study period is a revision procedure, a vertical banded gastroplasty procedure or Biliopancreatic Diversion Procedure
  • 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

ADDITIONAL INCLUSION CRITERIA FOR AIM 2 (Diabetes)

• 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).

ADDITIONAL INCLUSION CRITERIA FOR AIM 3 (Adverse Events)

• 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

AIM 4 (Surgery Outcomes and Baseline Depression) and AIM 5 (Surgery Outcomes and Race/Ethnicity): Inclusion criteria for Aims 1, 2, and 3 will be used for the outcomes from these aims.

ADDITIONAL INCLUSION CRITERIA FOR AIM 5 (Surgery Outcomes and Race/Ethnicity)

• Race and ethnicity available in study data

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Roux-en-y gastric bypass (RYGB); Adults and children ages 12 ≤79 years at time of surgery; Had a primary (not revision) Roux-en-y gastric bypass from years 2005-2015 (based on ICD-9-CM, CPT-4, and HCPCS codes); Have a Body Mass Index (BMI) measurement in the year prior to surgery that is ≥35 kg/m2 for adults and adolescents	Procedure: Roux-en-y gastric bypass (RYGB) - historical; Participant has had RYGB, as identified using existing data
Adjustable gastric banding (AGB); Adults and children age 12 ≤79 years at time of surgery; Had a primary (not revision) adjustable gastric banding procedure from years 2005-2015 (based on ICD-9-CM, CPT-4, and HCPCS codes); Have a Body Mass Index (BMI) measurement in the year prior to surgery that is ≥35 kg/m2 for adults and adolescents	Procedure: Adjustable gastric banding (AGB) - historical; Participant has had AGB, as identified using existing data
Sleeve gastrectomy (SG); Adults and children age 12 ≤79 years at time of surgery; Had a primary (not revision) sleeve gastrectomy from years 2005-2015 (based on ICD-9-CM, CPT-4, and HCPCS codes); Have a Body Mass Index (BMI) measurement in the year prior to surgery that is ≥35 kg/m2 for adults and adolescents	Procedure: Sleeve gastrectomy (SG) - historical; Participant has had SG, as identified using existing data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI)	Change in Body Mass Index (BMI)	1, 3, and 5 years after primary bariatric procedure
Diabetes Remission	Remission of diabetes after primary bariatric procedure. Defined as individual no longer using any diabetes medication for at least 3 months and hemoglobin A1c (HbA1c) <6.5% after 3 months off of diabetes medication.	1, 3, and 5 years after primary bariatric procedure
Reoperation/Rehospitalization Rate	Reoperation: 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. Rehospitalization: Any inpatient hospitalization following surgery that is not associated with a delivery, miscarriage, or abortion procedure.	1, 3, and 5 years after primary bariatric procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight regain	At 3 and 5 years after primary bariatric procedure; estimated as percent regain from the maximum weight (in kg) loss in the first 2 years following bariatric surgery.	3 and 5 years after primary bariatric procedure
Diabetes relapse	Diabetes relapse defined as restarting diabetes medications or HbA1c >=6.5%	1, 3 and 5 years after primary bariatric procedure
Change in hemoglobin A1C (HbA1c)	Change in HbA1c measures.	1, 3, and 5 years after primary bariatric procedure
Mortality Rate	Any death during the study period	1, 3, and 5 years after primary bariatric procedure
Composite Adverse Event	Event is defined using criteria from the Longitudinal Assessment of Bariatric Surgery (LABS) study and includes death; venous thromboembolism; percutaneous, endoscopic, or operative subsequent intervention; and, failure to be discharged from the hospitalization where the bariatric surgery was performed	30-days after primary bariatric procedure

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Patient-Centered Outcomes Research Institute; Harvard Pilgrim Health Care; OneFlorida Clinical Research Consortium; National Patient-Centered Clinical Research Network; Research Action for Health Network (REACHnet); Patient-Centered SCAlable National Network for Effectiveness Research (pSCANNER); New York City Clinical Data Research Network; PaTH: Towards a Learning Health System Clinical Data Research Network; Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN); Greater Plains Collaborative Clinical Data Research Network; Mid-South Clinical Data Research Network; PEDSnet: A Pediatric Learning Health System CDRN; Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS); COPD Patient-Powered Research Network; Obesity Action Coalition
• Investigators: Principal Investigator: David E. Arterburn, MD, MPH, Kaiser Permanente; Principal Investigator: Kathleen M. McTigue, MD, MS, MPH, University of Pittsburgh; Principal Investigator: Neely A. Williams, M.Div, Mid-South CDRN

Publications and helpful links

General Publications

• 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.

Helpful Links

• 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
• 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

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (Estimated): April 18, 2016

Study Record Updates

• Last Update Posted (Actual): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Observational Study; Comparative Effectiveness Research
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: OBS-1505-30683

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All study data will be made available for re-analysis of the primary aims within 12 months of the date of study completion. To request access to the data contact Jane Anau at anau.j@ghc.org.