Clinical trial NCT02741674: Comparing the Benefits and Harms of Three Types of Weight Loss Surgery -- The PCORnet® Bariatric Study
Official title: National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Bariatrics
Body Weight
Diabetes Mellitus
Weight Loss
Roux-en-Y Gastric Bypass
Gastric Bypass
Keywords: Observational Study
Comparative Effectiveness Research
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: National Patient-Centered Clinical Research Network
name: Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN)
name: Greater Plains Collaborative Clinical Data Research Network
name: Research Action for Health Network (REACHnet)
name: Mid-South Clinical Data Research Network
name: PEDSnet: A Pediatric Learning Health System CDRN
name: New York City Clinical Data Research Network
name: OneFlorida Clinical Research Consortium
name: The Patient-Oriented Scalable National Network for Effectiveness Research
name: PaTH: Towards a Learning Health System Clinical Data Research Network
name: Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS)
name: COPD Patient-Powered Research Network
name: Obesity Action Coalition
name: Harvard Pilgrim Health Care
First posted: 2016-04-18
Enrollment: 65093
Sex: ALL
Minimum age (years): 12
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.

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?

Eligibility criteria: 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

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 1, 3, and 5 years after primary bariatric procedure
measure: Diabetes Remission
timeFrame: 1, 3, and 5 years after primary bariatric procedure
measure: Reoperation/Rehospitalization Rate
timeFrame: 1, 3, and 5 years after primary bariatric procedure
Secondary outcomes:
measure: Weight regain
timeFrame: 3 and 5 years after primary bariatric procedure
measure: Diabetes relapse
timeFrame: 1, 3 and 5 years after primary bariatric procedure
measure: Change in hemoglobin A1C (HbA1c)
timeFrame: 1, 3, and 5 years after primary bariatric procedure
measure: Mortality Rate
timeFrame: 1, 3, and 5 years after primary bariatric procedure
measure: Composite Adverse Event
timeFrame: 30-days after primary bariatric procedure
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Permanente
name: David E. Arterburn, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Kathleen M. McTigue, MD, MS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Mid-South CDRN
name: Neely A. Williams, M.Div
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.