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PCORnet Bariatric Study (PBS)

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ClinicalTrials.gov Identifier: NCT02741674
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : September 13, 2018
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
National Patient-Centered Clinical Research Network (PCORnet)
Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN)
Greater Plains Collaborative (GPC)
Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL)
Research Action for Health Network (REACHnet)
Mid-South Clinical Data Research Network
PEDSnet: A Pediatric Learning Health System CDRN
New York City Clinical Data Research Network
OneFlorida Clinical Research Consortium
Patient-Centered SCAlable National Network for Effectiveness Research (pSCANNER)
PaTH: Towards a Learning Health System Clinical Data Research Network
Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS)
COPD Patient-Powered Research Network
Obesity Action Coalition
Harvard Pilgrim Health Care
Information provided by (Responsible Party):
Kaiser Permanente

April 11, 2016
April 18, 2016
September 13, 2018
February 2016
April 30, 2018   (Final data collection date for primary outcome measure)
  • Change in Body Mass Index (BMI) [ Time Frame: 1, 3, and 5 years after primary bariatric procedure ]
  • Diabetes Remission [ Time Frame: Through 5 years after primary bariatric procedure ]
    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.
  • Reoperation/Rehospitalization Rate [ Time Frame: 1 year after primary bariatric procedure ]
  • Reoperation/Rehospitalization Rate [ Time Frame: 3 years after primary bariatric procedure ]
  • Reoperation/Rehospitalization Rate [ Time Frame: 5 years after primary bariatric procedure ]
  • Adverse Events Rates [ Time Frame: 30-days after primary bariatric procedure ]
    A composite adverse events rate
  • Mortality Rate [ Time Frame: 1 year after primary bariatric procedure ]
  • Mortality Rate [ Time Frame: 3 years after primary bariatric procedure ]
  • Mortality Rate [ Time Frame: 5 years after primary bariatric procedure ]
Same as current
Complete list of historical versions of study NCT02741674 on ClinicalTrials.gov Archive Site
  • Weight regain [ Time Frame: 3 and 5 years after primary bariatric procedure ]
  • Diabetes relapse [ Time Frame: Through 5 years after primary bariatric procedure ]
    Diabetes relapse defined as restarting diabetes medications or HbA1c >=6.5%
  • Change in HbA1c [ Time Frame: 1, 3, and 5 years after primary bariatric procedure ]
Same as current
Not Provided
Not Provided
 
PCORnet Bariatric Study
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
The study population are children and adults 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).
  • Obesity
  • Bariatrics
  • Body Weight
  • Diabetes Mellitus
  • Weight Loss
  • Roux-en-Y Gastric Bypass
  • Gastric Bypass
  • Procedure: Roux-en-y gastric bypass (RYGB) - historical
    Participant has had RYGB, as identified using existing data
  • Procedure: Adjustable gastric banding (AGB) - historical
    Participant has had AGB, as identified using existing data
  • Procedure: Sleeve gastrectomy (SG) - historical
    Participant has had SG, as identified using existing data
  • Roux-en-y gastric bypass (RYGB)
    1. Adults and children age ≤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
    Intervention: Procedure: Roux-en-y gastric bypass (RYGB) - historical
  • Adjustable gastric banding (AGB)
    1. Adults and children age ≤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
    Intervention: Procedure: Adjustable gastric banding (AGB) - historical
  • Sleeve gastrectomy (SG)
    1. Adults and children age ≤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
    Intervention: Procedure: Sleeve gastrectomy (SG) - historical
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65870
100000
April 30, 2018
April 30, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults and children age ≤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)

      We will use ICD-9-CM, CPT-4, and HCPCS codes to identify bariatric cases

  • Have a Body Mass Index (BMI) measurement in the year prior to surgery that is ≥35 kg/m2 for adults and adolescents.

Exclusion Criteria:

  • First bariatric procedure during the study period is a revision procedure, a vertical banded gastroplasty procedure (not used regularly since early 2000s) and the rarely used Biliopancreatic Diversion Procedure
  • Have multiple bariatric procedures coded on the same day
  • Have a ICD-9 diagnosis related to GI cancer occurring on day of surgery or during index hospitalization
  • Emergency department visit on the same day as hospitalization for bariatric procedure
Sexes Eligible for Study: All
up to 79 Years   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02741674
OBS-1505-30683
No
Not Provided
Plan to Share IPD: Yes
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.
Kaiser Permanente
Kaiser Permanente
  • Patient-Centered Outcomes Research Institute
  • National Patient-Centered Clinical Research Network (PCORnet)
  • Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN)
  • Greater Plains Collaborative (GPC)
  • Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL)
  • Research Action for Health Network (REACHnet)
  • Mid-South Clinical Data Research Network
  • PEDSnet: A Pediatric Learning Health System CDRN
  • New York City Clinical Data Research Network
  • OneFlorida Clinical Research Consortium
  • Patient-Centered SCAlable National Network for Effectiveness Research (pSCANNER)
  • PaTH: Towards a Learning Health System Clinical Data Research Network
  • Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS)
  • COPD Patient-Powered Research Network
  • Obesity Action Coalition
  • Harvard Pilgrim Health Care
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
Kaiser Permanente
September 2018