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PCORnet Bariatric Study (PBS)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02741674
First Posted: April 18, 2016
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
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.

Condition Intervention
Obesity Bariatrics Body Weight Diabetes Mellitus Weight Loss Roux-en-Y Gastric Bypass Gastric Bypass Procedure: Roux-en-y gastric bypass (RYGB) - historical Procedure: Adjustable gastric banding (AGB) - historical Procedure: Sleeve gastrectomy (SG) - historical

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100000
Study Start Date: February 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Procedure: Roux-en-y gastric bypass (RYGB) - historical
Participant has had RYGB, as identified using existing data
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
Procedure: Adjustable gastric banding (AGB) - historical
Participant has had AGB, as identified using existing data
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
Procedure: Sleeve gastrectomy (SG) - historical
Participant has had SG, as identified using existing data

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 79 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741674


Sponsors and Collaborators
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
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
  More Information

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02741674     History of Changes
Other Study ID Numbers: OBS-1505-30683
First Submitted: April 11, 2016
First Posted: April 18, 2016
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
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.

Keywords provided by Kaiser Permanente:
Observational Study
Comparative Effectiveness Research

Additional relevant MeSH terms:
Diabetes Mellitus
Body Weight
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Body Weight Changes