NCT06293703

Brief Summary

The investigators propose a randomized controlled trial comparing BP and roux limb lengths measuring 30 and 15% respectively of patient's total small bowel length versus current standard practice using fixed lengths. The findings would provide further insight into feasibility of standardizing RYGB limb lengths and optimizing resultant weight loss and metabolic effects. The investigators hypothesize RYGB with ratio-adjusted limb lengths (aRYGB) will result in higher total weight loss and resolution of metabolic syndrome comorbidities, including diabetes, hyperlipidemia, and hypertension compared to standard fixed-length RYGB (sRYGB). The study will also utilize the Short Form Rand 36-Item Health Survey (SF36) to determine differences in postoperative quality of life metrics.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
55mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Jan 2024Dec 2030

Study Start

First participant enrolled

January 12, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2030

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

6.9 years

First QC Date

February 19, 2024

Last Update Submit

March 18, 2026

Conditions

Morbid Obesity

Keywords

Bariatric surgeryRoux-n-Y gastric bypassgastric bypass

Outcome Measures

Primary Outcomes (1)

  • To determine change in TWL after aRYGB compared to sRYGB in morbidly obese patients

    Measured in kilograms

    6,12,24 and 60 months from surgery

Secondary Outcomes (3)

  • To compare rates of DM resolution between aRYGB Vs sRYGB by DM subgroup analysis

    6,12,24 and 60 months from surgery

  • To investigate postoperative efficacy rates of aRYGB compared to sRYGB on alleviating metabolic syndrome in morbid obesity

    6,12,24 and 60 months from surgery

  • To investigate the presence of postoperative vitamin and nutritional deficiencies between the groups.

    6,12,24 and 60 months from surgery

Study Arms (2)

aRYGB

EXPERIMENTAL

BP and roux limb lengths measuring 30% and 15% respectively of patient's total small bowel length.

Procedure: Surgery

sRYGB

ACTIVE COMPARATOR

Standard fixed-length RYGB

Procedure: Surgery

Interventions

SurgeryPROCEDURE

Biliopancreatic limb and roux limb lengths measuring 30 and 15% respectively of patient's total small bowel length in RYGB

aRYGBsRYGB

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • morbidly obese patients (defined by BMI between 40 and 60).
  • Patient who understands and accepts the need for a long-term follow-up.
  • Patient who agrees to be included in the study

You may not qualify if:

  • individuals unable to understand and sign a written consent form
  • patients with history of previous bariatric surgery procedures
  • presence of a severe and evolutive life threatening pathology unrelated to obesity
  • previous gastric or small bowel resection
  • active cancer
  • pregnancy or desired to be pregnant during the study
  • mentally unbalanced patients under supervision or guardianship, patient unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Salvador Navarrete, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Salvador Navarrete, MD

CONTACT

2162199211navarrs@ccf.org

Andrew Strong, MD

CONTACT

2162183869stronga3@ccf.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study will be a prospective, randomized controlled trial with a 1:1 recruitment allocation ratio coordinated at the Cleveland Clinic Foundation (CCF)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2024

First Posted

March 5, 2024

Study Start

January 12, 2024

Primary Completion (Estimated)

December 11, 2030

Study Completion (Estimated)

December 11, 2030

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations

US(1)