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Impact of Laparoscopic Gastric Bypass Surgery and Weight Reduction on Lower Esophageal Sphincter (LES)

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ClinicalTrials.gov Identifier: NCT01672034
Recruitment Status : Withdrawn (no patient enrolled)
First Posted : August 24, 2012
Last Update Posted : November 5, 2014
Information provided by (Responsible Party):
Alex de Leon, Örebro University, Sweden

Brief Summary:

The purpose with this study is to investigate whether gastric bypass surgery and the following weight reduction impact the tone in esophageal sphincters and the esophageal function.

In a previous study our group used high resolution solid-state manometry to investigate the pressure in the esophagus and esophageal sphincters in obese patients going through laparoscopic bariatric surgery. These studies showed that the barrier pressure between the stomach and esophagus is significantly lower in obese compared to lean patients. In this study the investigators will examine these patients once more, now after weight reduction to see whether the barrier pressure is back to normal compared to lean patients.

Condition or disease Intervention/treatment
Obesity Procedure: Laparoscopic gastric bypass surgery

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Laparoscopic Gastric Bypass Surgery and Weight Reduction an Lower Esophageal Sphincter. A Study of Morbidly Obese Patients Before and After Surgery.
Study Start Date : November 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Obese, BMI > 35 Procedure: Laparoscopic gastric bypass surgery

Primary Outcome Measures :
  1. Variation in lower esophageal sphincter tone due to bariatric surgery and weight reduction [ Time Frame: 12-18 months after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The initial measurements were made on a group of male and female patients 18-60 years with BMI > 35, ASA-classification 1-3 planned for laparoscopic bariatric surgery.

Inclusion Criteria:

  • 18-60 year,
  • BMI prior to surgery > 35,
  • ASA-classification 1-3

Exclusion Criteria:

  • Patient refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672034

Department of Anesthesiology and Intensive care, University Hospital of Örebro
Örebro, Sweden, 70162
Sponsors and Collaborators
Örebro University, Sweden

Responsible Party: Alex de Leon, PhD, Specialist in Anaesthesia and Intensive Care, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT01672034     History of Changes
Other Study ID Numbers: 2011/477
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms