ClinicalTrials.gg
Status unknownNCT04377230Updated May 6, 2020

BP Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass

A Phase 3 interventional study of biliopancreatic limb length of 60cm. and biliopancreatic limb length of 100cm. in Osteopenia, sponsored by Hospital General Universitario Elche. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-05-06.

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

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Patients will be randomized into 2 groups:

  • Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm
  • Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm

Bone mineral density will be evaluated before surgery and 2 years after it.

Read the detailed description

Patients will be randomized into 2 groups:

  • Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm
  • Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm Alimentary limb will be constant in both groups (150cm length)

Bone mineral density will be evaluated before surgery and 2 years after it, by means of X ray absorptiometry (DEXA). Changes in bone mineral density in lumbar column will be assessed.

02

Conditions studied

  • Osteopenia
03

In context

Bone Diseases, Metabolic

661 studies on the registry are indexed under Bone Diseases, Metabolic; 93 are open to participants now.

This study's planned enrollment of 200 is above the median of 60 across 509 interventional studies indexed under Bone Diseases, Metabolic.

Browse Bone Diseases, Metabolic 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 70 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

  • >40 Kg/m2
  • Body mass index >35 Kg/m2 associated to obesity related comorbidities

Exclusion criteria

Exclusion Criteria:

  • Bone pathologies
  • Active neoplasms
  • Disorders in calcium or vitamin D metabolism
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
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Biliopancreatic limb 60cm

    Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.

    Procedure: biliopancreatic limb length of 60cm.

  • Active comparator
    Biliopancreatic limb 100cm

    Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.

    Procedure: biliopancreatic limb length of 100cm.

Interventions

  • Procedurebiliopancreatic limb length of 60cm.

    Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.

  • Procedurebiliopancreatic limb length of 100cm.

    Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.

06

What researchers measure

Primary outcomes

  1. Bone mineral density

    Bone mineral density will be evealuated by absorptiometry at the level of lumbar column

    Time frame: 2 years after surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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

Start is estimated for May 2020; primary completion for May 2022, 23 months later.

Of 26 phase 3 interventional studies under Bone Diseases, Metabolic, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 57. This study's planned 23 months is below that.

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

Registered
May 2, 2020
First posted
May 6, 2020
StartEst.
May 7, 2020
Primary completionEst.
May 1, 2022
CompletionEst.
May 1, 2022
Last update
May 6, 2020
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 May 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04377230
Lead sponsor
Hospital General Universitario Elche
Collaborators
Instituto de Seguridad Social del Estado de Mexico y Municipios
Responsible party
Jaime Ruiz-Tovar, MD, PhD (Department of Surgery, Hospital General Universitario Elche) — Principal investigator
First posted
May 6, 2020
Start date
May 7, 2020 (estimated)
Primary completion
May 1, 2022 (estimated)
Completion
May 1, 2022 (estimated)
Last update
May 6, 2020

Study contacts

Carolina LLavero Garrido
Contact
carolinallavero@gmail.com
649593020
Gilberto Gonzalez
Contact
gilpchmd@yahoo.com.mx
+5213322545864
Jaime Ruiz-Tovar
principal investigator · Garcilaso Clinic

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 status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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