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NCT03607305 Clinical Trial

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

Weight Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03607305
Other study ID # HGUE 2012-12
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2011
Est. completion date December 2012

Study information
Verified date July 2018
Source Hospital General Universitario Elche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 506
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• BP limb 70cm
Performance of RYGB with a BP limb of 70cm
• BP limb 120cm
Performance of RYGB with a BP limb of 120cm

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital General Universitario Elche

Outcome
Type Measure Description Time frame Safety issue
Primary Weight loss Weight loss was evaluated 5 years after surgery
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