NCT00519220

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
10.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 15, 2012

Status Verified

August 1, 2012

First QC Date

August 21, 2007

Last Update Submit

August 14, 2012

Conditions

Achalasia

Keywords

achalasia, Heller myotomy

Outcome Measures

Primary Outcomes (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

Study Arms (1)

I

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

Other: Symptom questionnaire

Interventions

Symptom questionnaireOTHER

Patients will answer questionnaires evaluating their symptoms of achalasia.

I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with achalasia who have had laparoscopic Heller myotomies at Tampa General Hospital.

You may qualify if:

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

You may not qualify if:

  • No patients under the age of 18 will be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampa General Hospital/University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Alexander S Rosemurgy, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Luberice

CONTACT

813-844-8219kluberic@mail.usf.edu

Carl B Bowers, RN

CONTACT

813-844-7529cbowers@health.usf.edu

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2007

First Posted

August 22, 2007

Study Start

December 1, 2006

Study Completion

December 1, 2017

Last Updated

August 15, 2012

Record last verified: 2012-08

Locations

US(1)