Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Do Patients Who Have Had Surgery for Achalasia Suffer From Reflux

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenneth Luberice, University of South Florida
ClinicalTrials.gov Identifier:
NCT00519441
First received: August 21, 2007
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Reflux
Other: pH study

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Gastroesophageal Reflux in Patients With Achalasia

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: June 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I
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
All patients will have 48 hour pH study
Other Name: Bravo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519441

Locations
United States, Florida
Harbourside Medical Tower
Tampa, Florida, United States, 33606
Sponsors and Collaborators
Kenneth Luberice
Investigators
Principal Investigator: Sarah M Cowgill, MD University of South Florida
  More Information

No publications provided

Responsible Party: Kenneth Luberice, Clinical Research Coordinator, University of South Florida
ClinicalTrials.gov Identifier: NCT00519441     History of Changes
Other Study ID Numbers: 104802
Study First Received: August 21, 2007
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
laparoscopic Heller myotomy, achalasia, reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 19, 2014