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

Karolinska University Hospital

Status: Completed

Conditions: Achalasia

Treatments: Procedure: Dor; Procedure: Toupet

Study type: Interventional

Funder types: Other

Identifiers

NCT01933373

2007/595-32

Details and patient eligibility

About

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.

Full description

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

Enrollment: 25 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Toupet

Active Comparator group

Description:

Laparoscopic Myotomy + Toupet 180 degree partial posterior fundoplication.

Treatment:

Procedure: Toupet

Dor

Experimental group

Description:

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

Treatment:

Procedure: Dor