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Loop Duodenal Switch: Outcomes at One Year

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ClinicalTrials.gov Identifier: NCT03206736
Recruitment Status : Enrolling by invitation
First Posted : July 2, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Vishal Kothari, University of Nebraska

Brief Summary:

The biliopancreatic diversion and duodenal switch (BPD-DS) is an accepted and published type of bariatric surgery in the United States. The surgery involves both restriction and malabsorption to achieve weight loss by creating a sleeve gastrectomy as well as two intestinal connections that bypass some of the small intestine, decreasing the amount of food that is absorbed. 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.

Patient eligibility criteria: between 19-70 years of age at enrollment, BMI ≥ 40 kg/m2, and 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. All subjects will undergo a standard comprehensive bariatric surgery evaluation which includes but is not limited to nutrition consultation, psychological evaluation, laboratory tests and supervised medical weight loss. Once the study subjects have met all of the insurance requirements, the bariatric clinic will submit for insurance approval for a duodenal switch operation. Once surgery is approved, study subjects will have a standard pre-operative history and physical visit no more than 30 days prior to surgery and will fill out a survey regarding health-related quality of life and amount of gastrointestinal symptoms experienced (diarrhea, constipation, bloating, etc).

This study does not change the number of visits, timing of visits, or laboratory blood draws surgical patients would have with the bariatric surgery clinic or staff. Study subjects 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.


Condition or disease Intervention/treatment Phase
Obesity, Morbid Other: Loop DS surgery Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Loop Duodenal Switch Surgery in Morbidly Obese Patients on Weight Los at One Year.
Actual Study Start Date : August 9, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arm Intervention/treatment
Experimental: Loop DS Patients
Patients who receive a Loop DS procedure
Other: Loop DS surgery
these patients will receive a loop DS bariatric procedure




Primary Outcome Measures :
  1. Excess weight loss [ Time Frame: 1 year ]
    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


Secondary Outcome Measures :
  1. anesthesia [ Time Frame: at surgery ]
    Anesthesia start and stop time

  2. Blood loss [ Time Frame: at surgery ]
    Estimated blood loss during surgery

  3. Surgery conversion [ Time Frame: at surgery ]
    surgical conversions to open procedure

  4. Concomitant procedures [ Time Frame: at surgery ]
    Concomitant procedures performed during the procedure

  5. Hospital LOS [ Time Frame: at surgery ]
    Length of hospital stay for the surgical procedure

  6. Surgical site infection [ Time Frame: 1 year ]
    Development of a surgical site infection.

  7. T2DM [ Time Frame: 1 year ]
    Prevalence and duration of type 2 diabetes mellitus

  8. Sleep apnea [ Time Frame: 1 year ]
    Sleep apnea

  9. Hypertension [ Time Frame: 1 year ]
    Hypertension

  10. Lipids [ Time Frame: 1 year ]
    dyslipidemia/hyperlipidemia

  11. changes in quality of life [ Time Frame: 1 year ]
    Patient quality of life will be assessed using an SF-36 questionnaire administered prior to the surgery and at 1 year postoperatively



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject must be 19-70 years of age at the time of enrollment.
  2. The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent.
  3. 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.
  4. The subject has a BMI of greater than or equal to 40 kg/m2 at time of surgical consultation.

Exclusion Criteria:

  1. Subjects under 19 years of age or older than 70 years of age
  2. Subject is not willing or able to participate in the study procedures and understand the informed consent.
  3. The subject wishes to under a different bariatric procedure other than the loop duodenal switch.
  4. The subject has a BMI of less than 40 kg/m2 at the time of surgical consultation.
  5. Any female subject who is pregnant, or is actively breast-feeding
  6. 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)
  7. The procedure is an emergency procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206736


Locations
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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6245
Sponsors and Collaborators
University of Nebraska

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Responsible Party: Vishal Kothari, Assistant Professor of Surgery, University of Nebraska
ClinicalTrials.gov Identifier: NCT03206736     History of Changes
Other Study ID Numbers: 281-17-FB
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share individual participant data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms