Small Bowel Length and Bariatric Surgery Outcomes
Observational Study of the Effect of Small Intestine Length on Bariatric Surgical Patient Outcomes
1 other identifier
observational
470
1 country
1
Brief Summary
The purpose of this study is to determine whether or not the total length of small intestine effects outcomes after bariatric surgery in a cohort of patients preoperatively and up to ten years postoperatively. Roux-en-Y gastric bypass and vertical sleeve gastrectomy will be the surgical groups in this study. We aim to determine if bowel length has a significant effect on long term weight loss or other nutritional deficiencies in this bariatric cohort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 8, 2016
CompletedFirst Posted
Study publicly available on registry
August 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedJuly 8, 2025
July 1, 2025
8.6 years
August 8, 2016
July 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body Weight
Body weight will be measured preoperatively (within 30 days of the operation) as the baseline body weight, then postoperatively up to ten years from the time of initial surgery. Measurements will be made per routine clinical care and not solely for research purposes. Exact time points before and after surgery that body weight will be measured, except for the day of surgery, will differ between patients in the study. Change in body weight over time will be measured annually, adjusted for baseline body weight at the time of surgery. Regression will be used to test for a significant interaction of "total bowel length" and "body weight" over time in the patient cohorts (RYGB vs. VSG) - this is our primary outcome measurement. We are examining whether there is a significant interaction between any change in body weight over time and the small bowel length in the patient cohorts.
Up to 10 years postoperatively as measured for routine clinical care
Other Outcomes (11)
Vitamin A
Up to 10 years postoperatively
Vitamin D
Up to 10 years postoperatively
Vitamin E
Up to 10 years postoperatively
- +8 more other outcomes
Study Arms (2)
RYGB
Roux-en-Y Gastric Bypass - these are patients that undergo a Roux-en-Y gastric bypass operation for their bariatric operation.
VSG
Vertical Sleeve Gastrectomy - these are patients that undergo a vertical sleeve gastrectomy operation for their bariatric operation.
Interventions
The total length of the small bowel with be measured at the time of the bariatric surgical operation.
Eligibility Criteria
We will be studying two cohorts of patients prior to and following either Roux-en-Y gastric bypass or vertical sleeve gastrectomy for up to ten years.
You may qualify if:
- Patients undergoing laparoscopic bariatric surgery, either vertical sleeve gastrectomy or Roux-en-Y gastric bypass
- Able to give informed consent
You may not qualify if:
- Prior small intestine resection.
- Inability to safely obtain total small intestinal length measurements in the operating room.
- Any small bowel tethering due to intestinal adhesions identified in the operating room.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Related Publications (1)
Albaugh VL, Weinberg JL, Yu D, Spann MD, Williams DB, Samuels JM, Flynn CR, English WJ. Total Alimentary Limb Length Is Not Associated with Weight Loss Following Proximal Roux-en-Y Gastric Bypass. Obes Surg. 2025 May;35(5):1693-1701. doi: 10.1007/s11695-025-07817-5. Epub 2025 Mar 27.
PMID: 40146457RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles R Flynn, PhD
Vanderbilt University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 8, 2016
First Posted
August 19, 2016
Study Start
August 1, 2016
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
July 8, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share