Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients undergoing laparoscopic bariatric surgery, either vertical sleeve gastrectomy or Roux-en-Y gastric bypass
  • Able to give informed consent

Exclusion Criteria

  • 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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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
    The total length of the small bowel with be measured at the time of the bariatric surgical operation.
VSG Vertical Sleeve Gastrectomy - these are patients that undergo a vertical sleeve gastrectomy operation for their bariatric operation.
  • Procedure: Small bowel length measurement
    The total length of the small bowel with be measured at the time of the bariatric surgical operation.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Vance L Albaugh, MD, PhD
615-343-0045
vance.albaugh@vanderbilt.edu

More Details

NCT ID
NCT02872493
Status
Recruiting
Sponsor
Vanderbilt University

Study Contact

Vance L Albaugh, MD, PhD
615-343-0045
vance.albaugh@vanderbilt.edu

Detailed Description

Bariatric surgery (also known as "weight loss surgery") is the most effective treatment for obesity as well as a number of other obesity-related conditions, including type 2 diabetes, hypertension, and hypercholesterolemia. Interestingly, not all patients respond with significant weight loss following surgery and some patients even lack much weight loss at all over the long-term. Even though variability in treatment response is observed in a variety of diseases, the biological basis for this variability in weight loss after bariatric surgery is poorly understood. Recent data from our group as well as others, however, suggest that differences in the total length of the small intestine may significantly contribute to these differences in weight loss over time. For example, Roux-en-Y gastric bypass is thought to exert its weight loss effect because of a bypass of small intestine that causes a degree of nutrient malabsorption. The bypassed small intestine (<100cm) is near the proximal end of the intestines closest to the stomach. Hypothetically, an individual with the greater total small intestine length may not benefit as much from the bypass as someone who has a much shorter length of total small intestine. Whether or not this hypothetical relationship is true remains unknown, but a recent study demonstrated that small intestine length does differ significantly between individuals with lengths ranging from 300cm to >1200cm. The total length of small intestine is not routinely measured during any bariatric procedure, as the lengths of the bypass limbs are determined from the portion of the intestines closest to the stomach. The purpose of this study is to determine whether the amount of total small intestine significantly affects weight loss in patients undergoing bariatric surgery - both the Roux-en-Y gastric bypass (RYGB) or the Vertical Sleeve Gastrectomy (VSG). If there is a significant effect of total small intestine length on long-term weight loss in bariatric patients, then it would justify the conduct of a further study to determine whether or not these operations should be performed differently in individuals to account for the differences in small intestine length. This is an observational study that will be looking at body weight (primary endpoint) and other nutritional endpoints (other pre-specified outcome measure) over time up to ten years in this patient cohort. The body weight measurements and any laboratory data will be collected that are part of the routine clinical care of these patients.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.