Clinical trial NCT02872493: Small Bowel Length and Bariatric Surgery Outcomes
Official title: Observational Study of the Effect of Small Intestine Length on Bariatric Surgical Patient Outcomes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Malnutrition
Obesity
Weight Loss
Micronutrient Deficiency
Keywords: obesity
bariatric surgery
bowel length
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body Weight
timeFrame: Up to 10 years postoperatively as measured for routine clinical care
Secondary outcomes:
Other outcomes:
measure: Vitamin A
timeFrame: Up to 10 years postoperatively
measure: Vitamin D
timeFrame: Up to 10 years postoperatively
measure: Vitamin E
timeFrame: Up to 10 years postoperatively
measure: Vitamin B1
timeFrame: Up to 10 years postoperatively
measure: Vitamin B2
timeFrame: Up to 10 years postoperatively
measure: Vitamin B6
timeFrame: Up to 10 years postoperatively
measure: Vitamin B12
timeFrame: Up to 10 years postoperatively
measure: Iron
timeFrame: Up to 10 years postoperatively
measure: Parathyroid Hormone
timeFrame: Up to 10 years postoperatively
measure: Total Iron Binding Capacity
timeFrame: Up to 10 years postoperatively
measure: Ferritin
timeFrame: Up to 10 years postoperatively
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Charles R Flynn, PhD
role: PRINCIPAL_INVESTIGATOR
References: