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CompletedNCT03607305Updated Jul 31, 2018

Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric Bypass

A Phase 3 interventional study of BP limb 70cm and BP limb 120cm in Weight Loss, sponsored by Hospital General Universitario Elche. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-31.

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

From the registry’s dates

  • Registered 7 years 6 months after the study started (first participant enrolled Jan 2011, registered Jul 2018).
Phase
Phase 3
Study type
Interventional
Enrollment
506
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Patients were randomly assigned into 2 groups: those patients undergoing RYGB with a BPL of 70cm and those ones undergoing RYGB with a BPL of 120 cm.

Excess BMI loss 5 years after surgery was investigated

Read the detailed description

Patients were randomly assigned into 2 groups: those patients undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 70cm and those ones undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 120 cm. Alimentary limb was constant in both groups (150cm).

Excess BMI loss 5 years after surgery was investigated

02

Conditions studied

  • Weight Loss
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 506 is above the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

Hospital General Universitario Elche is the lead sponsor of 43 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 and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • BMI >40 Kg/m2
  • BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
  • Age older than 18 years

Exclusion criteria

Exclusion Criteria:

  • Patients undergoing other bariatric techniques than RYGB
  • Patients undergoing RYGB with different BPL or AL lengths than that reported for this study
  • Any other surgical procedure added to the bariatric surgery
  • Impossibility to comply with pre-established clinical follow-up.
05

Study design

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

Study arms

  • Active comparator
    BP limb 70cm

    Patients underwent a RYGB with a biliopancreatic limb of 70cm

    Procedure: BP limb 70cm

  • Experimental
    BP limb 120cm

    Patients underwent a RYGB with a biliopancreatic limb of 120cm

    Procedure: BP limb 120cm

Interventions

  • ProcedureBP limb 70cm

    Performance of RYGB with a BP limb of 70cm

  • ProcedureBP limb 120cm

    Performance of RYGB with a BP limb of 120cm

06

What researchers measure

Primary outcomes

  1. Weight loss

    Weight loss was evaluated

    Time frame: 5 years after surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Ruiz-Tovar J, Vorwald P, Gonzalez-Ramirez G, Posada M, Salcedo G, Llavero C, Garcia-Olmo D. Impact of Biliopancreatic Limb Length (70 cm vs 120 cm), with Constant 150 cm Alimentary Limb, on Long-Term Weight Loss, Remission of Comorbidities and Supplementation Needs After Roux-En-Y Gastric Bypass: a Prospective Randomized Clinical Trial. Obes Surg. 2019 Aug;29(8):2367-2372. doi: 10.1007/s11695-019-03717-7. PubMed 31104282 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03607305
Lead sponsor
Hospital General Universitario Elche
Responsible party
Jaime Ruiz-Tovar, MD, PhD (Professor of Surgery, Hospital General Universitario Elche) — Principal investigator
First posted
Jul 31, 2018
Start date
Jan 2011
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Jul 31, 2018

Study contacts

Jaime Ruiz-Tovar
principal investigator · HOSPITAL REY JUAN CARLOS

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 Jul 2018. You cannot join it, but the record below documents what was studied.

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