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ObesityDSvsSADINCT02692469

Laparoscopic Single-Anastomosis Duodenal-Jejunal Bypass With Sleeve Gastrectomy vs Laparoscopic Duodenal Switch

A study testing Duodenal Switch and Duodenal-ileal Bypass with Sleeve Gastrectomy in people with Obesity, run by McMaster University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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? Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
What is being tested?
Duodenal Switch and Duodenal-ileal Bypass with Sleeve Gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
No sites listed yet
Study dates
Apr 2016to Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet ALL of the following inclusion criteria:
  • 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

Who cannot join

  • 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)

Trial locations and contacts

No sites are listed yet.

Dennis Hong, MD FRCSC contact

905 522-1155 ext. 32938

dennishong70@gmail.com

About this study

Official title: Laparoscopic Single-Anastomosis Duodenal-Jejunal Bypass With Sleeve Gastrectomy vs Laparoscopic Duodenal Switch as a Primary Bariatric Procedure. 5 Year Patient Follow

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?

Read the detailed description

The aims of this study are: (a) to compare SADI vs DS as a primary bariatric procedure for weight loss; (b) to compare the minor and major complications of SADI vs DS (c) to compare SADI vs DS for remission rates of type 2 diabetes (d) to compare SADI vs DS for remission rates of hypertension (e) to compare SADI vs DS for weight regain at 5 years (f) to compare SADI vs DS for metabolic alterations. The investigators hypothesize that both procedures will have similar weight loss and metabolic remission results. If the complication rates of SADI are similar or superior to the complication rates of the DS, then the investigators could propose the SADI as a viable alternative to the DS in patients with high BMIs requiring increased weight loss.

The investigators will conduct a prospective randomized study. The study will include 140 patients who are scheduled for bariatric procedures. The patients will be stratified into 2 groups. The first group will continue according to the standard bariatric preoperative protocol and will be assigned to a DS. The second group will also follow standard bariatric preoperative protocol but will be assigned to a SADI. Follow up of all patients will continue according to the usual bariatric clinic guidelines.

From literature, the mean excess body weight loss is 77.65% with standard deviation of 21% for Duodenal Switch bariatric surgery. If there is in truth no difference between the Duodenal Switch and SADI for excess body weight loss, then 140 patients (70 per group) are required to have 80% power for the lower limit of a one-sided 97.5% confidence interval (or equivalently a 95% two-sided confidence interval) will be above the non-inferiority limit of -10%.

Participants must meet ALL of the following inclusion criteria:

  • 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

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)
Conditions
Obesity
Being tested
Duodenal Switch, Duodenal-ileal Bypass with Sleeve Gastrectomy
Keywords
Bariatric Surgery, Obesity, Laparoscopy
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Duodenal SwitchProcedure or surgery

    Also called DS

    Bariatric procedure

  • Duodenal-ileal Bypass with Sleeve GastrectomyProcedure or surgery

    Also called SADI

    Bariatric procedure

Study groups in NCT02692469
Study groupRoleWhat they receive
Duodenal Switch Surgical InterventionActive comparatora DS procedure involves creating a sleeve gastrectomy with preservation of the pylorus, and creation of a Roux limb with a short common channel
Receives: Procedure: Duodenal Switch
Single Anastomosis Duodenal-Ileal BypassExperimentalThe 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
Receives: Procedure: Duodenal-ileal Bypass with Sleeve Gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Excess weight loss

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

    Measured: 5 years

Secondary outcomes (4)

  1. Remission of type 2 diabetes

    The presence and remission of type 2 diabetes will be diagnosed according to the American Diabetes Association's current criteria:

    1. A1C ≥6.5 percent, OR
    2. FPG ≥126 mg/dL (7.0 mmol/L), OR
    3. Two-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during an OGTT, OR
    4. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L).

    Measured: 5 years

  2. Remission of hypertension

    The presence and remission of hypertension will be diagnosed by the definitions suggested in 2003 by the seventh report of the Joint National Committee (JNC 7) and are based upon the average of two or more properly measured readings at each of two or more office visits after an initial screen:

    • Normal blood pressure: systolic <120 mmHg and diastolic <80 mmHg
    • Prehypertension: systolic 120 to 139 mmHg or diastolic 80 to 89 mmHg (see "Prehypertension")
    • Hypertension:
    • Stage 1: systolic 140 to 159 mmHg or diastolic 90 to 99 mmHg
    • Stage 2: systolic ≥160 mmHg or diastolic ≥100 mmHg

    Measured: 5 years

  3. Surgical complications

    According to the Clavien-Dindo Classification of surgical complications

    Measured: 1 year

  4. Metabolic alterations

    Blood levels will be measured pre-operatively a on a regular schedule after surgery for:

    zinc, magnesium, phosphate, albumin, PTH, HbA1C, ferritin, calcium, Iron binding capacity, total proteins, Hb, Cholesterol levels, LDL, Vit. D, Vit. A and Vit. B12 to ensure they are in normal range.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionApr 2021 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02692469
Sponsor's protocol ID
1366
Acronym
DSvsSADI
Status last verified
Feb 2016
First submitted
3 Feb 2016
Last updated
26 Feb 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18040751

  • 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.

    PubMed 20798995

  • 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.

    PubMed 22963820

  • 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.

    PubMed 20035530

Questions about this trial

What is this clinical trial studying?

A study testing Duodenal Switch and Duodenal-ileal Bypass with Sleeve Gastrectomy in people with Obesity, run by McMaster University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dennis Hong, MD FRCSC (905 522-1155 ext. 32938, dennishong70@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Excess weight loss (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02692469, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.

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