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Loop Duodenal Switch: Outcomes at One Year

NCT03206736 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-08-29

No results posted yet for this study

Summary

The biliopancreatic diversion and duodenal switch (BPD-DS) is an accepted and published type of bariatric surgery in the United States. The BPD-DS procedure produces the most weight loss of any bariatric surgery commonly performed but has the highest risk of malnutrition and gastrointestinal side effects. The loop duodenal switch (L-DS) is a bariatric surgery which has been modified from a biliopancreatic diversion and duodenal switch to maintain excellent weight loss while possibly reducing side effects. The surgical modifications in this procedure include reducing the number of intestinal reconnections from two to one and reducing the amount of small intestine which is bypassed. The L-DS operation is considered experimental by the American Society of Metabolic and Bariatric Surgery as long-term data in large numbers of patients is not available for weight loss or side effects. The purpose of this study is to examine weight loss and other outcomes in the L-DS operation up to 1 year after the procedure.

Study participants will be seen in the clinic at 2 and 6 weeks, and 3, 6, 9, and 12 months per the bariatric surgery center protocol. As part of these normally scheduled visits, weight loss and health status will be recorded. Labs will be checked at 3, 6, and 12 months for nutritional status. A survey to reassess health-related quality of life and gastrointestinal symptoms will be performed at 3 months, 6 months and 12 months.

Conditions

  • Obesity, Morbid

Interventions

OTHER

Loop DS surgery

these patients will receive a loop DS bariatric procedure

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Vishal Kothari, MD · University of Nebraska

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-09
Primary Completion
2020-05-07
Completion
2020-05-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03206736 on ClinicalTrials.gov