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

NCT ID: NCT03607305

Last Updated: 2018-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-12-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BP limb 70cm

Patients underwent a RYGB with a biliopancreatic limb of 70cm

Group Type ACTIVE_COMPARATOR

BP limb 70cm

Intervention Type PROCEDURE

Performance of RYGB with a BP limb of 70cm

BP limb 120cm

Patients underwent a RYGB with a biliopancreatic limb of 120cm

Group Type EXPERIMENTAL

BP limb 120cm

Intervention Type PROCEDURE

Performance of RYGB with a BP limb of 120cm

Interventions

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BP limb 70cm

Performance of RYGB with a BP limb of 70cm

Intervention Type PROCEDURE

BP limb 120cm

Performance of RYGB with a BP limb of 120cm

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Jaime Ruiz-Tovar, MD, PhD

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaime Ruiz-Tovar

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL REY JUAN CARLOS

References

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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.

Reference Type DERIVED
PMID: 31104282 (View on PubMed)

Other Identifiers

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HGUE 2012-12

Identifier Type: -

Identifier Source: org_study_id