NCT00361985

Brief Summary

The purpose of this study is to determine whether suppressing acid production by administration of daily proton pump inhibitors in the early post-operative period will reduce the gastrojejunal anastomosis stricture rate in patients undergoing laparoscopic gastric bypass surgery for morbid obesity.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2006

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

August 7, 2006

Last Update Submit

October 31, 2016

Conditions

Anastomotic StrictureMorbid Obesity

Keywords

Gastric bypassAnastomotic strictureMorbid obesityBariatric surgeryOmeprazole

Outcome Measures

Primary Outcomes (1)

  • Gastrojejunal stricture

    6 months after surgery

Secondary Outcomes (1)

  • Gastrojejunal ulcer

    6 months after surgery

Study Arms (1)

1

EXPERIMENTAL

Nexium group

Drug: Esomeprazole

Interventions

EsomeprazoleDRUG

Esomeprazole 40mg once daily orally.

Also known as: Nexium
1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Any patient who satisfies the requirements of the Weill-Cornell Weight Loss Surgery program to undergo laparoscopic Roux-en-Y gastric bypass surgery as treatment for morbid obesity.

You may not qualify if:

  • Patients with a history of ulcer disease, patients taking chronic acid suppression medicine, and patients taking NSAIDS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Medical College of Cornell Unversity

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Gregory F. Dakin, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 7, 2006

First Posted

August 9, 2006

Study Start

January 1, 2008

Primary Completion

January 1, 2011

Study Completion

July 1, 2011

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

US(1)