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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Örebro University, Sweden.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Alex de Leon, Örebro University, Sweden
ClinicalTrials.gov Identifier:
NCT01672034
First received: August 21, 2012
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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 Intervention
Obesity
Procedure: Laparoscopic gastric bypass surgery

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Örebro University, Sweden:

Primary Outcome Measures:
  • Variation in lower esophageal sphincter tone due to bariatric surgery and weight reduction [ Time Frame: 12-18 months after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Obese, BMI > 35 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672034

Locations
Sweden
Department of Anesthesiology and Intensive care, University Hospital of Örebro Not yet recruiting
Örebro, Sweden, 70162
Contact: Alex de Leon, PhD, Specialist    +46 19 6021000      
Principal Investigator: Alex de Leon         
Sponsors and Collaborators
Örebro University, Sweden
  More Information

No publications provided

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
Study First Received: August 21, 2012
Last Updated: August 23, 2012
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014