Achalasia: Outcome of Symptoms in Patients Undergoing a Heller Myotomy

• Sponsor: University of South Florida (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00519220
• Collaborator: (none)
• Enrollment: 800
• Location: 1
• Duration (Months): 132
• Patients Per Site Per Month: 6.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Achalasia	Other: Symptom questionnaire

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 800 participants
• Official Title: Short and Long Term Outcomes of Heller Myotomy
• Study Start Date: Dec 1, 2006
• Anticipated Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
I Patients will answer symptom questionnaires and have their charts reviewed for relevant medical information.	Other: Symptom questionnaire; Patients will answer questionnaires evaluating their symptoms of achalasia.

Outcome Measures

Primary Outcome Measures

1. 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 [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampa General Hospital/University of South Florida	Tampa	Florida	United States	33606

Sponsors and Collaborators

• University of South Florida

Investigators

• Principal Investigator: Alexander S Rosemurgy, MD, University of South Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kenneth Luberice, Principal Investigator, University of South Florida
• ClinicalTrials.gov Identifier: NCT00519220
• Other Study ID Numbers: 105235
• First Posted: Aug 22, 2007
• Last Update Posted: Aug 15, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Kenneth Luberice, Principal Investigator, University of South Florida: achalasia, Heller myotomy
• Additional relevant MeSH terms: Esophageal Achalasia

Study Results

No Results Posted as of Aug 15, 2012