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A Prospective Study Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia

Primary Purpose

Achalasia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Toupet
Dor
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achalasia focused on measuring Randomized, Toupet, Dor, Achalasia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >18 years of age
  • Typical achalasia according to manometry
  • Eckhardt score >3
  • Informed consent

Exclusion Criteria:

  • Severe comorbidity precluding surgery
  • Pseudo achalasia
  • Inability to participate in follow-up

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Toupet

Dor

Arm Description

Laparoscopic Myotomy + Toupet 180 degree partial posterior fundoplication.

Laparoscopic Myotomy + Dor anterior partial fundoplication. 90 degree partial fundoplication being the standard of care.

Outcomes

Primary Outcome Measures

Dysphagia symptoms according to Eckhardt

Secondary Outcome Measures

Ambulatory esophageal PH
Health-related quality of life according to Velanovich
Timed barium esophagogram at 1, 2 and 5 minutes

Full Information

First Posted
June 19, 2013
Last Updated
August 30, 2013
Sponsor
Karolinska University Hospital
Collaborators
Ersta Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT01933373
Brief Title
A Prospective Study Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia
Official Title
A Prospective Randomized Trial Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia. Comparing Toupet Versus DOR.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Ersta Hospital, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Achalasia is a rare motor disorder of the gastroesophageal junction which is associated with an increased pressure of the esophageal sphincter. This leads to impairment to swallow and heartburn. Esophageal myotomy, which is a surgical longitudinal incision of the esophageal muscle layer extending over to the gastroesophageal junction is the treatment of choice for achalasia. In order to prevent reflux of stomach content into the esophagus this has to be combined with an antireflux procedure where the upper part of the stomach (fundus) is wrapped around the esophagus (fundoplication). This procedure can be performed with the wrapped fundus either in front of the esophagus (Dor procedure) or behind (Toupet). The latter introduces an angulation of the esophagus, which possibly may lead to an impairment of swallowing ability and passage of food to the stomach. On the other hand, the Toupet procedure may give a better control of reflux. The primary endpoint of the study is symptoms of impaired swallowing 1 year after treatment. Secondary outcomes include reflux (pH measurements in the esophagus), radiological imaging of swallowing and quality of life.
Detailed Description
By the end of 2012 40 patients have been enrolled and passed the one year follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia
Keywords
Randomized, Toupet, Dor, Achalasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toupet
Arm Type
Active Comparator
Arm Description
Laparoscopic Myotomy + Toupet 180 degree partial posterior fundoplication.
Arm Title
Dor
Arm Type
Experimental
Arm Description
Laparoscopic Myotomy + Dor anterior partial fundoplication. 90 degree partial fundoplication being the standard of care.
Intervention Type
Procedure
Intervention Name(s)
Toupet
Other Intervention Name(s)
Laparascopic posterior partial fundoplication plus myotomy.
Intervention Description
Laparoscopic posterior partial fundoplication plus myotomy.
Intervention Type
Procedure
Intervention Name(s)
Dor
Other Intervention Name(s)
Anterior partial fundoplication plus myotomy.
Intervention Description
Anterior partial fundoplication plus myotomy.
Primary Outcome Measure Information:
Title
Dysphagia symptoms according to Eckhardt
Time Frame
up to five years follow up
Secondary Outcome Measure Information:
Title
Ambulatory esophageal PH
Time Frame
One and five years follow up
Title
Health-related quality of life according to Velanovich
Time Frame
One and five years follow up
Title
Timed barium esophagogram at 1, 2 and 5 minutes
Time Frame
One and five years follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >18 years of age Typical achalasia according to manometry Eckhardt score >3 Informed consent Exclusion Criteria: Severe comorbidity precluding surgery Pseudo achalasia Inability to participate in follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars R Lundell, Professor
Organizational Affiliation
Gastrocentrum Karolinska University Hospital, Stockholm Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24892729
Citation
Kumagai K, Kjellin A, Tsai JA, Thorell A, Granqvist S, Lundell L, Hakanson B. Toupet versus Dor as a procedure to prevent reflux after cardiomyotomy for achalasia: results of a randomised clinical trial. Int J Surg. 2014;12(7):673-80. doi: 10.1016/j.ijsu.2014.05.077. Epub 2014 Jun 2.
Results Reference
derived

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A Prospective Study Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia

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