NCT01672034

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

6 months

First QC Date

August 21, 2012

Last Update Submit

November 4, 2014

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

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

    12-18 months after surgery

Study Arms (1)

Obese, BMI > 35

Procedure: Laparoscopic gastric bypass surgery

Interventions

Laparoscopic gastric bypass surgeryPROCEDURE
Obese, BMI > 35

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive care, University Hospital of Örebro

Örebro, 70162, Sweden

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Specialist in Anaesthesia and Intensive Care

Study Record Dates

First Submitted

August 21, 2012

First Posted

August 24, 2012

Study Start

November 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

SE(1)