Do Patients Who Have Had Surgery for Achalasia Suffer Fro... | NCT00519441

Studies
Do Patients Who Have Had Surgery for Achalasia Suffer From Reflux

NCT00519441

Sponsor

Kenneth Luberice

Status

Completed

Last Update Posted

Aug 15, 2012Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Reflux

Interventions

pH study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Aug 21, 2007

First Submission Date that Met QC Criteria

Aug 21, 2007

First Posted Date

Aug 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2012

Last Update Posted Date

Aug 15, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The purpose of this study is to determine if patients who have laparoscopic Heller myotomies for the treatment of achalasia suffer from reflux after the surgery. Patients at our institution who have had surgery for achalasia will be asked to have pH studies done to determine whether or not these patients have reflux.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
pH study	Other	All patients will have 48 hour pH study	I	Bravo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah M Cowgill, MD	University of South Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Harbourside Medical Tower		Tampa	Florida	33606	United States

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux
D004931	Esophageal Achalasia

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C005806	tetrachloroisophthalonitrile

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided