Loop Duodenal Switch: Outcomes at One Year

NCT03206736 | Terminated

• 1 other identifier: 0281-17-FB
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Excess weight loss

  Excess weight loss at 1 year will be measured by comparing BMI at 1 year to the presurgical BMI. Body mass index (BMI) is calculated using the patient's height and weight. Height will be measured using a stadiometer and weight will be measured using the clinic's bariatric scale

  1 year

Secondary Outcomes (11)

• anesthesia

  at surgery

• Blood loss

  at surgery

• Surgery conversion

  at surgery

• Concomitant procedures

  at surgery

• Hospital LOS

  at surgery

Study Arms (1)

Loop DS Patients

EXPERIMENTAL

Patients who receive a Loop DS procedure

Other: Loop DS surgery

Interventions

Loop DS surgery OTHER

these patients will receive a loop DS bariatric procedure

Loop DS Patients

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must be 19-70 years of age at the time of enrollment.
• The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent.
• The subject is under consideration for surgery for obesity or metabolic disease and elects to undergo a primary loop duodenal switch procedure or as a conversion procedure for failed, sustained weight loss after a sleeve gastrectomy or laparoscopic adjustable gastric band performed more than 12 months prior to time of evaluation.
• The subject has a BMI of greater than or equal to 40 kg/m2 at time of surgical consultation.

You may not qualify if:

• Subjects under 19 years of age or older than 70 years of age
• Subject is not willing or able to participate in the study procedures and understand the informed consent.
• The subject wishes to under a different bariatric procedure other than the loop duodenal switch.
• The subject has a BMI of less than 40 kg/m2 at the time of surgical consultation.
• Any female subject who is pregnant, or is actively breast-feeding
• Any subject who is considered to be part of a vulnerable population (eg. prisoners or those with psychological concerns or those without sufficient mental capacity)
• The procedure is an emergency procedure

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-6245, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vishal Kothari, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 2, 2017
• Study Start: August 9, 2018
• Primary Completion: May 7, 2020
• Study Completion: May 7, 2020
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)