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

A Prospective Randomized Trial Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia. Comparing Toupet Versus DOR.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01933373

Enrollment

Registered

2013-09-02

Start date

2007-05-31

Completion date

2012-12-31

Last updated

2013-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achalasia

Keywords

Randomized, Toupet, Dor, Achalasia

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.

Interventions

PROCEDUREToupet

Laparoscopic posterior partial fundoplication plus myotomy.

PROCEDUREDor

Anterior partial fundoplication plus myotomy.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Dysphagia symptoms according to Eckhardt	up to five years follow up

Secondary

Measure	Time frame
Ambulatory esophageal PH	One and five years follow up
Health-related quality of life according to Velanovich	One and five years follow up
Timed barium esophagogram at 1, 2 and 5 minutes	One and five years follow up

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026