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

Obesity Clinical Trial

— PBS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741674
• Other study ID #: OBS-1505-30683
• Status: Completed
• Start date: February 2016
• Est. completion date: April 30, 2018

Study information

• Verified date: December 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65093
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (16)

Lead Sponsor

Collaborator

Kaiser Permanente

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

References & Publications (7)

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 Effecti — View 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 — View 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, Courcoul — View Citation

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 Operatio — View 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 Collaborat — View 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 Outco — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (BMI)	Change in Body Mass Index (BMI)	1, 3, and 5 years after primary bariatric procedure
Primary	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
Primary	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	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
Secondary	Diabetes relapse	Diabetes relapse defined as restarting diabetes medications or HbA1c >=6.5%	1, 3 and 5 years after primary bariatric procedure
Secondary	Change in hemoglobin A1C (HbA1c)	Change in HbA1c measures.	1, 3, and 5 years after primary bariatric procedure
Secondary	Mortality Rate	Any death during the study period	1, 3, and 5 years after primary bariatric procedure
Secondary	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

External Links

•   Comparative Effectiveness and Safety of Bariatric Procedures for Weight Loss: A PCORnet Cohort Study
•   Comparative effectiveness of bariatric procedures among adolescents: the PCORnet bariatric study.
•   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
•   Comparing the 5-Year Diabetes Outcomes of Sleeve Gastrectomy and Gastric Bypass: The National Patient-Centered Clinical Research Network (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
•   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)
•   Preoperative Depression Status and 5 Year Metabolic and Bariatric Surgery Outcomes in the PCORnet Bariatric Study Cohort