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ObesityPBSNCT02741674

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

An observational study of Obesity and Bariatrics, run by Kaiser Permanente.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 12 to 79 years
Conditions the study is for
Obesity, Bariatrics, Body Weight
What is being tested?
Roux-en-y gastric bypass (RYGB) - historical, Adjustable gastric banding (AGB) - historical and Sleeve gastrectomy (SG) - historical
Type of treatment
Surgery or procedure
How many people
65,093 participants
Where
No sites listed yet
Study dates
Feb 2016to 30 Apr 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 79 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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).

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 19Show fewer
  • 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

About this study

Official title: 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.

Read the 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?

Being tested
Roux-en-y gastric bypass (RYGB) - historical, Adjustable gastric banding (AGB) - historical, Sleeve gastrectomy (SG) - historical
Keywords
Observational Study, Comparative Effectiveness Research
Medical subject headings
Obesity, Body Weight, Diabetes Mellitus, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Roux-en-y gastric bypass (RYGB) - historicalProcedure or surgery

    Participant has had RYGB, as identified using existing data

  • Adjustable gastric banding (AGB) - historicalProcedure or surgery

    Participant has had AGB, as identified using existing data

  • Sleeve gastrectomy (SG) - historicalProcedure or surgery

    Participant has had SG, as identified using existing data

Study groups in NCT02741674
Study groupRoleWhat they receive
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
Receives: 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
Receives: 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
Receives: Procedure: Sleeve gastrectomy (SG) - historical

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Mass Index (BMI)

    Change in Body Mass Index (BMI)

    Measured: 1, 3, and 5 years after primary bariatric procedure

  2. 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.

    Measured: 1, 3, and 5 years after primary bariatric procedure

  3. 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.

    Measured: 1, 3, and 5 years after primary bariatric procedure

Secondary outcomes (5)

  1. 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.

    Measured: 3 and 5 years after primary bariatric procedure

  2. Diabetes relapse

    Diabetes relapse defined as restarting diabetes medications or HbA1c >=6.5%

    Measured: 1, 3 and 5 years after primary bariatric procedure

  3. Change in hemoglobin A1C (HbA1c)

    Change in HbA1c measures.

    Measured: 1, 3, and 5 years after primary bariatric procedure

  4. Mortality Rate

    Any death during the study period

    Measured: 1, 3, and 5 years after primary bariatric procedure

  5. 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

    Measured: 30-days after primary bariatric procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completion30 Apr 2018
  4. Study completion30 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
65,093 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02741674
Sponsor's protocol ID
OBS-1505-30683
Acronym
PBS
Status last verified
Dec 2023
First submitted
11 Apr 2016
Last updated
21 Dec 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29208590

  • 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.

    PubMed 32129809

  • 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.

    PubMed 31940024

  • 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.

    PubMed 30383139

  • 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.

    PubMed 29793877

  • 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.

    PubMed 35058404

  • 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.

    PubMed 36044239

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Bariatrics, run by Kaiser Permanente.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index (BMI) (time frame: 1, 3, and 5 years after primary bariatric procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02741674, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.

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