NCT02872493

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

87
On Track

Trial Health Score

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

Enrollment
470

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

8.6 years

First QC Date

August 8, 2016

Last Update Submit

July 2, 2025

Conditions

Keywords

obesitybariatric surgerybowel length

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.

Procedure: Small bowel length measurement

VSG

Vertical Sleeve Gastrectomy - these are patients that undergo a vertical sleeve gastrectomy operation for their bariatric operation.

Procedure: Small bowel length measurement

Interventions

The total length of the small bowel with be measured at the time of the bariatric surgical operation.

RYGBVSG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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.

Related Links

MeSH Terms

Conditions

MalnutritionObesityWeight Loss

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Charles R Flynn, PhD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

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

Locations