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

Not Applicable

Completed

• Conditions: Achalasia
• Interventions: Procedure: Toupet; Procedure: Dor

• Registration Number: NCT01933373
• Lead Sponsor: Karolinska University Hospital

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.

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Study First Submitted: 2013-06-19
• Status Verified: 2013-08
• Study First Submitted QC: 2013-08-30
• Last Update Submitted: 2013-08-30
• Study First Posted: 2013-09-02
• Last Update Posted: 2013-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Toupet	Toupet	Laparoscopic Myotomy + Toupet 180 degree partial posterior fundoplication.
Dor	Dor	Laparoscopic Myotomy + Dor anterior partial fundoplication. 90 degree partial fundoplication being the standard of care.

Primary Outcome Measures

Name	Time	Method
Dysphagia symptoms according to Eckhardt	up to five years follow up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden