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

NCT02741674 | Completed

• 1 other identifier: OBS-1505-30683
• Study Type: observational
• Target: 65,093
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity; Bariatrics; Body Weight; Diabetes Mellitus; Weight Loss; Roux-en-Y Gastric Bypass; Gastric Bypass

Keywords

Observational Study; Comparative Effectiveness Research

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Weight regain

  3 and 5 years after primary bariatric procedure

• Diabetes relapse

  1, 3 and 5 years after primary bariatric procedure

• Change in hemoglobin A1C (HbA1c)

  1, 3, and 5 years after primary bariatric procedure

• Mortality Rate

  1, 3, and 5 years after primary bariatric procedure

• Composite Adverse Event

  30-days after primary bariatric procedure

Study Arms (3)

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

Procedure: Roux-en-y gastric bypass (RYGB) - historical

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

Procedure: Adjustable gastric banding (AGB) - historical

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

Procedure: Sleeve gastrectomy (SG) - historical

Interventions

Roux-en-y gastric bypass (RYGB) - historical PROCEDURE

Participant has had RYGB, as identified using existing data

Roux-en-y gastric bypass (RYGB)

Adjustable gastric banding (AGB) - historical PROCEDURE

Participant has had AGB, as identified using existing data

Adjustable gastric banding (AGB)

Sleeve gastrectomy (SG) - historical PROCEDURE

Participant has had SG, as identified using existing data

Sleeve gastrectomy (SG)

Eligibility Criteria

• Age: 12 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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:
• Roux-en-y gastric bypass (RYGB)
• Adjustable gastric banding (AGB)
• Sleeve gastrectomy (SG)
• Have a Body Mass Index (BMI) measurement in the year prior to surgery that is ≥35 kg/m2

You may not qualify if:

• 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
• 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.
• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Patient-Centered Outcomes Research Institute: collaborator
• National Patient-Centered Clinical Research Network: collaborator
• Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN): collaborator
• Greater Plains Collaborative Clinical Data Research Network: collaborator
• Research Action for Health Network (REACHnet): collaborator
• Mid-South Clinical Data Research Network: collaborator
• PEDSnet: A Pediatric Learning Health System CDRN: collaborator
• New York City Clinical Data Research Network: collaborator
• OneFlorida Clinical Research Consortium: collaborator
• The Patient-Oriented Scalable National Network for Effectiveness Research: collaborator
• PaTH: Towards a Learning Health System Clinical Data Research Network: collaborator
• Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS): collaborator
• COPD Patient-Powered Research Network: collaborator
• Obesity Action Coalition: collaborator
• Harvard Pilgrim Health Care: collaborator

Related Publications (7)

• 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.

  PMID: 29208590 BACKGROUND

• 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.

  PMID: 32129809 RESULT

• 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.

  PMID: 31940024 RESULT

• 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.

  PMID: 30383139 RESULT

• 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.

  PMID: 29793877 RESULT

• 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.

  PMID: 35058404 RESULT

• 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.

  PMID: 36044239 RESULT

Related 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

MeSH Terms

Conditions

Obesity; Body Weight; Diabetes Mellitus; Weight Loss

Interventions

Gastric Bypass; Health Records, Personal

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight Changes

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 18, 2016
• Study Start: February 1, 2016
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share