NCT00519441

Brief Summary

Patients who have had laparoscopic surgery for the treatment of achalasia will be asked to have pH studies done in order to determine is these patients suffer from reflux after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

August 15, 2012

Status Verified

August 1, 2012

Enrollment Period

2 years

First QC Date

August 21, 2007

Last Update Submit

August 14, 2012

Conditions

Reflux

Keywords

laparoscopic Heller myotomy, achalasia, reflux

Outcome Measures

Primary Outcomes (1)

  • The objective of this study is to determine the degree of post-operative reflux in patients who have had laparoscopic Heller myotomies for the treatment of achalasia.

    2 years

Study Arms (1)

I

OTHER

All patients in the study will have pH studies done in order to determine the degree of reflux after laparoscopic Heller myotomies.

Other: pH study

Interventions

pH studyOTHER

All patients will have 48 hour pH study

Also known as: Bravo
I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have had laparoscopic Heller myotomies for the treatment of achalasia

You may not qualify if:

  • Patients under the age of 18 will not be included
  • Patients who are receiving anti-reflux therapy will not be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harbourside Medical Tower

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Gastroesophageal RefluxEsophageal Achalasia

Interventions

tetrachloroisophthalonitrile

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Sarah M Cowgill, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Coordinator

Study Record Dates

First Submitted

August 21, 2007

First Posted

August 22, 2007

Study Start

June 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

August 15, 2012

Record last verified: 2012-08

Locations

US(1)