NCT00490750

Brief Summary

The primary aim of this study is to test the hypothesis that Heller myotomy and Toupet fundoplication result in a lower rate of reflux symptoms and positive 24-hour pH testing when compared to Heller myotomy and Dor fundoplication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2003

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

8.4 years

First QC Date

June 21, 2007

Last Update Submit

December 7, 2015

Conditions

Esophageal Achalasia

Keywords

Heller DorHeller ToupetMyotomy

Outcome Measures

Primary Outcomes (1)

  • Primary outcomes are 24 hour pH testing results

    pH testing at 6-12 months after surgical treatment

Secondary Outcomes (1)

  • Symptomatic response measured by detailed patient questionnaire and results of barium swallow radiographs

    6-12 months after surgical intervention

Study Arms (2)

Laparoscopic Dor fundoplication

ACTIVE COMPARATOR

Heller myotomy followed by Dor fundoplication

Procedure: Dor fundoplication

Laparoscopic Toupet fundoplication

ACTIVE COMPARATOR

Heller myotomy followed by Toupet fundoplication

Procedure: Toupet fundoplication

Interventions

Dor fundoplicationPROCEDURE

Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Dor fundoplication

Laparoscopic Dor fundoplication
Toupet fundoplicationPROCEDURE

Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Toupet fundoplication

Laparoscopic Toupet fundoplication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Achalasia

You may not qualify if:

  • Prior heller myotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • L. Michael Brunt, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

June 21, 2007

First Posted

June 25, 2007

Study Start

March 1, 2003

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

US(1)