NCT01002352

Brief Summary

The primary purpose of the Bariatric Outcomes Longitudinal Database (BOLD) study is to assess the mid- and long-term outcomes of bariatric surgeries and to analyze the relationship between these outcomes and 1) patient demographics and comorbidities, 2) clinical and surgical characteristics, and 3) pre-operative, peri-operative and post-operative care and treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

Enrollment Period

10 years

First QC Date

October 26, 2009

Last Update Submit

November 21, 2011

Conditions

ObesityOverweightDiabetes

Keywords

obesitybariatricBOLDweightlossdatabasedata registry

Outcome Measures

Primary Outcomes (1)

  • Improvement of comorbidities

    Within 1 year

Secondary Outcomes (1)

  • Mortality, weight loss, surgical complications

    Within 1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who qualify for bariatric surgery

You may qualify if:

  • Bariatric surgery patients
  • Males and Females
  • All races

You may not qualify if:

  • Negative psychological evaluation
  • Surgeon's evaluation that patient is not a candidate for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Review Corporation

Raleigh, North Carolina, 27609, United States

Location

Related Publications (1)

  • Li W, Gorecki P, Semaan E, Briggs W, Tortolani AJ, D'Ayala M. Concurrent prophylactic placement of inferior vena cava filter in gastric bypass and adjustable banding operations in the Bariatric Outcomes Longitudinal Database. J Vasc Surg. 2012 Jun;55(6):1690-5. doi: 10.1016/j.jvs.2011.12.056. Epub 2012 Feb 22.

    PMID: 22360915DERIVED

Related Links

MeSH Terms

Conditions

ObesityOverweightDiabetes MellitusWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBody Weight Changes

Study Officials

  • Deborah Winegar, PH.D.

    Surgical Review Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

June 1, 2007

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 22, 2011

Record last verified: 2011-11

Locations

US(1)