Do Patients Who Have Had Surgery for Achalasia Suffer From Reflux

Reflux Clinical Trial

Official title:

Gastroesophageal Reflux in Patients With Achalasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519441
• Other study ID #: 104802
• Status: Completed
• Phase: N/A
• First received: August 21, 2007
• Last updated: August 14, 2012
• Start date: June 2007
• Est. completion date: June 2009

Study information

• Verified date: August 2012
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Reflux

Intervention

Other:
• pH study
All patients will have 48 hour pH study

Locations

Country	Name	City	State
United States	Harbourside Medical Tower	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Kenneth Luberice

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No