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CompletedNCT03467646Updated Mar 16, 2018

Long-term Follow up After SG vs RYGB vs OAGB

A Phase 3 interventional study of Sleeve Gastrectomy and Roux-en-Y gastric bypass in Weight Loss, sponsored by Hospital General Universitario Elche. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-16.

Sponsored by Hospital General Universitario Elche · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 9 months after the study started (first participant enrolled Jun 2010, registered Mar 2018).
Phase
Phase 3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing SG, those ones undergoing RYGB and those ones undergoing OAGB. BMI, excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT) and dyslipidemia (DL) were assessed.

Read the detailed description

A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing Sleeve Gastrectomy, those ones undergoing Roux-en-Y Gastric Bypass and those ones undergoing One-Anastomosis Gastric Bypass. Body Mass Index (BMI), excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT) and dyslipidemia (DL) were assessed.

02

Conditions studied

  • Weight Loss

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03

In context

Weight Loss

1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.

This study's enrollment of 600 is above the median of 80 across 1,561 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

Hospital General Universitario Elche is the lead sponsor of 44 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (BMI) >40 Kg/m2
  • BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
  • age older than 18 years
  • Patients willing to participate in the study and giving their written consent

Exclusion criteria

Exclusion Criteria:

  • patients undergoing other bariatric techniques than SG, RYGB and OAGB
  • Patients undergoing any other surgical procedure added to the bariatric surgery
  • patients with medical or surgical pathologies that at the discretion of the investigators do not allow their participation in the study
  • inability to understand the nature and purpose of the study and / or to accept written participation in the study
  • impossibility to comply with pre-established clinical follow-up.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (actual)

Study arms

  • Active comparator
    Sleeve Gastrectomy

    Patients undergo a laparoscopic sleeve gastrectomy as bariatric procedure

    Procedure: Sleeve Gastrectomy

  • Active comparator
    Roux-en-Y gastric bypass

    Patients undergo a laparoscopic Roux-en-Y gastric bypass as bariatric procedure

    Procedure: Roux-en-Y gastric bypass

  • Experimental
    One-Anastomosis gastric bypass

    Patients undergo a laparoscopic One-Anastomosis gastric bypass as bariatric procedure

    Procedure: One-Anastomosis Gastric Bypass

Interventions

  • ProcedureSleeve Gastrectomy

    The patients undergo a Sleeve Gastrectomy as bariatric procedure

  • ProcedureRoux-en-Y gastric bypass

    The patients undergo a Roux-en-Y gastric bypass as bariatric procedure

  • ProcedureOne-Anastomosis Gastric Bypass

    The patients undergo a One-Anastomosis Gastric Bypass as bariatric procedure

06

What researchers measure

Primary outcomes

  1. Weight loss

    The postoperative weight loss is investigated at 1, 2 and 5 years after surgery

    Time frame: 1 , 2 and 5 years after surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Ruiz-Tovar J, Carbajo MA, Jimenez JM, Castro MJ, Gonzalez G, Ortiz-de-Solorzano J, Zubiaga L. Long-term follow-up after sleeve gastrectomy versus Roux-en-Y gastric bypass versus one-anastomosis gastric bypass: a prospective randomized comparative study of weight loss and remission of comorbidities. Surg Endosc. 2019 Feb;33(2):401-410. doi: 10.1007/s00464-018-6307-9. Epub 2018 Jun 25. PubMed 29943058 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2010 to primary completion in Dec 2017, 90 months.

Of 23 phase 3 interventional studies under Weight Loss, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 28. This study's 90 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2018
First posted
Mar 16, 2018
StartActual
Jun 2010
Primary completionActual
Dec 2017
CompletionActual
Dec 2017
Last update
Mar 16, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03467646
Lead sponsor
Hospital General Universitario Elche
Responsible party
Jaime Ruiz-Tovar, MD, PhD (Head of Bariatric Surgery Unit. Hospital general Elche, Hospital General Universitario Elche) — Principal investigator
First posted
Mar 16, 2018
Start date
Jun 2010
Primary completion
Dec 2017
Completion
Dec 2017
Last update
Mar 16, 2018

Study contacts

Miguel Angel Carbajo
study director · Centro de Tratamiento de la Obesidad

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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