NCT02692469

Brief Summary

Will a laparoscopic Single-Anastomosis Duodenal-ileal Bypass with Sleeve Gastrectomy produce similar or superior results when compared to a laparoscopic Duodenal Switch, as a primary surgical procedure for weight loss in bariatric patients over a 5 year period?

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable obesity

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

5 years

First QC Date

February 3, 2016

Last Update Submit

February 22, 2016

Conditions

Obesity

Keywords

Bariatric Surgery, Obesity, Laparoscopy

Outcome Measures

Primary Outcomes (1)

  • Excess weight loss

    BMI and body weight will be measured and compared to preoperative reference values

    5 years

Secondary Outcomes (4)

  • Remission of type 2 diabetes

    5 years

  • Remission of hypertension

    5 years

  • Surgical complications

    1 year

  • Metabolic alterations

    5 years

Study Arms (2)

Duodenal Switch Surgical Intervention

ACTIVE COMPARATOR

a DS procedure involves creating a sleeve gastrectomy with preservation of the pylorus, and creation of a Roux limb with a short common channel

Procedure: Duodenal Switch

Single Anastomosis Duodenal-Ileal Bypass

EXPERIMENTAL

The SADI defers from the DS in that after the duodenum is separated from the stomach, preserving the pylorus, a loop of bowel 200 cm from the ileo-cecal valve is anastomosed with the pylorus, thus requiring only one anastomosis

Procedure: Duodenal-ileal Bypass with Sleeve Gastrectomy

Interventions

Duodenal SwitchPROCEDURE

Bariatric procedure

Also known as: DS
Duodenal Switch Surgical Intervention
Duodenal-ileal Bypass with Sleeve GastrectomyPROCEDURE

Bariatric procedure

Also known as: SADI
Single Anastomosis Duodenal-Ileal Bypass

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fulfilled criteria for bariatric surgery as coined by National Institutes of Health.
  • Their age is ≥18 years and ≤70 years
  • Able and willing to give written consent

You may not qualify if:

  • Participants who meet any of the following criteria at the time of the baseline visit are NOT eligible to be enrolled in this study:
  • Contra-indication to general anesthesia
  • Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
  • Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)
  • History of alcohol abuse (\>30 g/day in men or \>20 g/day in women)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Sanchez-Pernaute A, Rubio Herrera MA, Perez-Aguirre E, Garcia Perez JC, Cabrerizo L, Diez Valladares L, Fernandez C, Talavera P, Torres A. Proximal duodenal-ileal end-to-side bypass with sleeve gastrectomy: proposed technique. Obes Surg. 2007 Dec;17(12):1614-8. doi: 10.1007/s11695-007-9287-8. Epub 2007 Nov 27.

    PMID: 18040751RESULT

  • Sanchez-Pernaute A, Herrera MA, Perez-Aguirre ME, Talavera P, Cabrerizo L, Matia P, Diez-Valladares L, Barabash A, Martin-Antona E, Garcia-Botella A, Garcia-Almenta EM, Torres A. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S). One to three-year follow-up. Obes Surg. 2010 Dec;20(12):1720-6. doi: 10.1007/s11695-010-0247-3.

    PMID: 20798995RESULT

  • Sanchez-Pernaute A, Rubio MA, Perez Aguirre E, Barabash A, Cabrerizo L, Torres A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy: metabolic improvement and weight loss in first 100 patients. Surg Obes Relat Dis. 2013 Sep-Oct;9(5):731-5. doi: 10.1016/j.soard.2012.07.018. Epub 2012 Aug 7.

    PMID: 22963820RESULT

  • Sovik TT, Taha O, Aasheim ET, Engstrom M, Kristinsson J, Bjorkman S, Schou CF, Lonroth H, Mala T, Olbers T. Randomized clinical trial of laparoscopic gastric bypass versus laparoscopic duodenal switch for superobesity. Br J Surg. 2010 Feb;97(2):160-6. doi: 10.1002/bjs.6802.

    PMID: 20035530RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dennis Hong, MD FRCSC

    St. Joseph Healthcare Hamilton, McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis Hong, MD FRCSC

CONTACT

905 522-1155dennishong70@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, General Surgeon

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 26, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2021

Study Completion

April 1, 2026

Last Updated

February 26, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share