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

NCT ID: NCT01933373

Last Updated: 2013-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2012-12-31

Brief Summary

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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

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By the end of 2012 40 patients have been enrolled and passed the one year follow up.

Conditions

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Achalasia

Keywords

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Randomized Toupet Dor Achalasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Toupet

Laparoscopic Myotomy + Toupet 180 degree partial posterior fundoplication.

Group Type ACTIVE_COMPARATOR

Toupet

Intervention Type PROCEDURE

Laparoscopic posterior partial fundoplication plus myotomy.

Dor

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

Group Type EXPERIMENTAL

Dor

Intervention Type PROCEDURE

Anterior partial fundoplication plus myotomy.

Interventions

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Toupet

Laparoscopic posterior partial fundoplication plus myotomy.

Intervention Type PROCEDURE

Dor

Anterior partial fundoplication plus myotomy.

Intervention Type PROCEDURE

Other Intervention Names

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Laparascopic posterior partial fundoplication plus myotomy. Anterior partial fundoplication plus myotomy.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ersta Hospital, Sweden

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lars Lundell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars R Lundell, Professor

Role: PRINCIPAL_INVESTIGATOR

Gastrocentrum Karolinska University Hospital, Stockholm Sweden

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 24892729 (View on PubMed)

Other Identifiers

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2007/595-32

Identifier Type: -

Identifier Source: org_study_id