Clinical trial NCT01933373: 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
Overall status: COMPLETED
Phase: NA
Conditions: Achalasia
Keywords: Randomized
Toupet
Dor
Achalasia
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Ersta Hospital, Sweden
First posted: 2013-09-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dysphagia symptoms according to Eckhardt
timeFrame: up to five years follow up
Secondary outcomes:
measure: Ambulatory esophageal PH
timeFrame: One and five years follow up
measure: Health-related quality of life according to Velanovich
timeFrame: One and five years follow up
measure: Timed barium esophagogram at 1, 2 and 5 minutes
timeFrame: One and five years follow up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Gastrocentrum Karolinska University Hospital, Stockholm Sweden
name: Lars R Lundell, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.