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

Sponsor
Örebro University, Sweden (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01672034
Collaborator
(none)
0
1
5.9
0

Study Details

Study Description

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 Phase
  • 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 Design

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 :
Nov 1, 2012
Anticipated Primary Completion Date :
May 1, 2013
Anticipated Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Obese, BMI > 35

Procedure: Laparoscopic gastric bypass surgery

Outcome Measures

Primary Outcome Measures

  1. Variation in lower esophageal sphincter tone due to bariatric surgery and weight reduction [12-18 months after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18-60 year,

  • BMI prior to surgery > 35,

  • ASA-classification 1-3

Exclusion Criteria:
  • Patient refusal

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anesthesiology and Intensive care, University Hospital of Örebro Örebro Sweden 70162

Sponsors and Collaborators

  • Örebro University, Sweden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alex de Leon, PhD, Specialist in Anaesthesia and Intensive Care, Örebro University, Sweden
ClinicalTrials.gov Identifier:
NCT01672034
Other Study ID Numbers:
  • 2011/477
First Posted:
Aug 24, 2012
Last Update Posted:
Nov 5, 2014
Last Verified:
Nov 1, 2014
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 5, 2014