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WithdrawnNCT01672034Updated Nov 5, 2014

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

An observational study in Obesity, sponsored by Örebro University, Sweden. Withdrawn at 1 site in Sweden. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-11-05.

Sponsored by Örebro University, Sweden · Observational

Why this study was withdrawn
no patient enrolled
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Obesity

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03

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

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Lead sponsor

Örebro University, Sweden is the lead sponsor of 84 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

Exclusion Criteria:

  • Patient refusal
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)

Groups and cohorts

  • Obese, BMI > 35

    Procedure: Laparoscopic gastric bypass surgery

Interventions

  • ProcedureLaparoscopic gastric bypass surgery
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What researchers measure

Primary outcomes

  1. Variation in lower esophageal sphincter tone due to bariatric surgery and weight reduction

    Time frame: 12-18 months after surgery

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Study locations

1 site
  • Department of Anesthesiology and Intensive care, University Hospital of Örebro
    Örebro, 70162, Sweden
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01672034
Lead sponsor
Örebro University, Sweden
Responsible party
Alex de Leon (PhD, Specialist in Anaesthesia and Intensive Care, Örebro University, Sweden) — Principal investigator
First posted
Aug 24, 2012
Start date
Nov 2012
Primary completion
May 2013 (estimated)
Completion
May 2013 (estimated)
Last update
Nov 5, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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