Suspended

Impact of Laparoscopic Gastric Bypass Surgery and Weight Reduction an Lower Esophageal Sphincter. A Study of Morbidly Obese Patients Before and After Surgery.

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What is being collected

Procedure Data

Collected from today forward - Prospective
Procedure
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 60 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: November 2012
See protocol details

Summary

Principal SponsorÖrebro University, Sweden
Last updated: November 5, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

The prevalence of obesity has increased dramatically in recent decades. The gastrointestinal changes associated with obesity have clinical significance for the anesthesiologist in the perioperative period. The upper and lower esophageal sphincters (UES and LES) play a central role in preventing regurgitation and aspiration. The barrier pressure, defined as the difference between the LES pressure and the Intragastric pressure is known to be lower in obese patients compared to lean patients. This might result in a higher risk of regurgitation and aspiration of stomach contents in during induction of anesthesia. Some studies are made on patients before and after bariatric surgery but results are sparse. In this study the investigators will examine 30 patients before and after bariatric surgery. Our group have performed the measurements on patients before surgery and presented the results in another article. Those patients will be asked to take part of another measurement now 12-18 months after surgery. 30 patients will be consecutively asked and enrolled in this study. Measurements will be performed using high-resolution-solid state manometry.

Principal SponsorÖrebro University, Sweden
Last updated: November 5, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweightObesity

Criteria

3 inclusion criteria required to participate
18-60 year

ASA-classification 1-3

BMI prior to surgery > 35

1 exclusion criteria prevent from participating
Patient refusal

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Anesthesiology and Intensive care, University Hospital of Örebro

Örebro, SwedenOpen Department of Anesthesiology and Intensive care, University Hospital of Örebro in Google Maps
SuspendedOne Study Center