Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465829
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2007-04-24
Brief Title:
Long-term Effects of Bariatric Surgery
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Longitudinal Assessment of Bariatric Surgery LABS-2
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LABS-2
Brief Summary:
The primary objective of LABS-2 is to use standardized techniques and measures to assess the longer-term safety and efficacy of bariatric surgery by
1 comparing post-surgical outcomes to pre-operative status
2 examining risks and benefits of surgery
LABS-2 will determine the associations between clinicaldemographic patient characteristics components of the surgical procedure and peri-operative and post-operative care with post-operative risks and changes in patient status
Funds are not available to pay for the surgery for patients only to address research questions
1 comparing post-surgical outcomes to pre-operative status
2 examining risks and benefits of surgery
LABS-2 will determine the associations between clinicaldemographic patient characteristics components of the surgical procedure and peri-operative and post-operative care with post-operative risks and changes in patient status
Funds are not available to pay for the surgery for patients only to address research questions
Detailed Description:
The primary goal of LABS-2 is to evaluate the efficacy and safety of bariatric surgery over a longer term than LABS-1 ie more than 30 days Using a sample of the LABS-1 cohort approximately 2400 patients will be recruited over 3 years LABS-2 will include clinical assessments and detailed interviews and questionnaires pre-operatively and at several post-operative time points 30 days 6 months 12 months following surgery and annually thereafter to assess risks of surgery and changes in clinical metabolic and psychosocial characteristics in patients and health care utilization following bariatric surgery Detailed data about the surgical procedure and peri- and post-operative care will also be collected to determine if components of the surgical procedure and peri-operative and post-operative care as well as clinicaldemographic patient characteristics are associated with post-operative risks and changes in patient status Patients enrolled in LABS-2 will provide blood specimens pre-operatively and post-operatively to address LABS-2 hypotheses and additional samples will be stored at the NIDDK tissue repository for serologic pathologic and genomic testing of other hypotheses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DK066557 | NIH | None | httpsreporternihgovquickSearchU01DK066557 |