NCT01703897

Brief Summary

The purpose of this study is to evaluate the effects of anesthesia on the esophageal body in obese patients before and during anesthesia.

Trial Health

35
At Risk

Trial Health Score

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

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withdrawn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

Study Start

First participant enrolled

October 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

First QC Date

October 8, 2012

Last Update Submit

November 4, 2014

Conditions

Obesity

Keywords

gastric by-pass surgery

Outcome Measures

Primary Outcomes (1)

  • Esophageal pressures after laparoscopic gastric by pass

    2 years after surgery

Study Arms (1)

Obese patients

Device: Manometry and Impedance analysis

Interventions

Manometry and Impedance analysisDEVICE
Obese patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Obese patients

You may qualify if:

  • Male and female patients
  • aged 18-60 years
  • BMI\>35
  • ASA classification I-III

You may not qualify if:

  • Use of drugs that interfere with esophageal motility
  • Gastro-esophageal reflux disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive care, University Hospital of Örebro

Örebro, 70162, Sweden

Location

MeSH Terms

Conditions

Obesity

Interventions

Manometry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 8, 2012

First Posted

October 11, 2012

Study Start

October 1, 2012

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

SE(1)