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Outcome of Symptoms in Patients Undergoing a Heller Myotomy (Achalasia)

Primary Purpose

Achalasia

Status
Unknown status
Phase
Locations
United States
Study Type
Observational
Intervention
Symptom questionnaire
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Achalasia focused on measuring achalasia, Heller myotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • No patients under the age of 18 will be included

Sites / Locations

  • Tampa General Hospital/University of South FloridaRecruiting

Arms of the Study

Arm 1

Arm Type

Arm Label

I

Arm Description

Patients will answer symptom questionnaires and have their charts reviewed for relevant medical information.

Outcomes

Primary Outcome Measures

The objective of this study is to review pre-operative and post-operative studies and patient evaluation reports to evaluate patient outcomes following laparoscopic surgery for achalasia

Secondary Outcome Measures

Full Information

First Posted
August 21, 2007
Last Updated
August 14, 2012
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00519220
Brief Title
Outcome of Symptoms in Patients Undergoing a Heller Myotomy
Acronym
Achalasia
Official Title
Short and Long Term Outcomes of Heller Myotomy
Study Type
Observational

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to review studies and patient symptoms before and after laparoscopic Heller myotomy to assess outcomes following laparoscopic surgery for achalasia.
Detailed Description
Patients will answer questionnaires before and after surgery to evaluate their symptoms of achalasia and will also have their charts reviewed for relevant medical information.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia
Keywords
achalasia, Heller myotomy

7. Study Design

Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Description
Patients will answer symptom questionnaires and have their charts reviewed for relevant medical information.
Intervention Type
Other
Intervention Name(s)
Symptom questionnaire
Intervention Description
Patients will answer questionnaires evaluating their symptoms of achalasia.
Primary Outcome Measure Information:
Title
The objective of this study is to review pre-operative and post-operative studies and patient evaluation reports to evaluate patient outcomes following laparoscopic surgery for achalasia
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with achalasia who have had laparoscopic Heller myotomies for the treatment of achalasia Exclusion Criteria: No patients under the age of 18 will be included
Study Population Description
Patients with achalasia who have had laparoscopic Heller myotomies at Tampa General Hospital.
Sampling Method
Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Luberice
Phone
813-844-8219
Email
kluberic@mail.usf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Carl B Bowers, RN
Phone
813-844-7529
Ext
7529
Email
cbowers@health.usf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander S Rosemurgy, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Hospital/University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer C. Cooper, B.S.
Phone
813-844-4218
Ext
4218
Email
jcooper@health.usf.edu
First Name & Middle Initial & Last Name & Degree
Carl B Bowers, R.N.
Phone
813-844-7529
Ext
7529
Email
cbowers@health.usf.edu

12. IPD Sharing Statement

Learn more about this trial

Outcome of Symptoms in Patients Undergoing a Heller Myotomy

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