Endoscopic versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A Randomized Controlled Trial

Endoscopic versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A Randomized Controlled Trial - ELMA Trial (Endoscopic versus Laparoscopic Myotomy in Achalasia)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47726

Enrollment

Registered

2014-01-20

Start date

2014-02-04

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Achalasia Oesophageal Motility disorder

Interventions

Study subjects undergo a Laparoscopic Heller Myotomy or a POEM. Laparoscopic Heller Myotomy (LHM): The LHM is a laparoscopic procedure performed by a surgeon. A five trocar technique is used, a midl

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Patients with symptomatic achalasia with: - an Eckardt score of >3. - pre-operative barium swallow, manometry and esophago-gastro-duodenoscopy which are consistent with the diagnosis. * Patients are classified as achalasia type I-III according to the Chicago classification. * Age > 18 years. * Signed written informed consent.

Exclusion criteria

Exclusion criteria: * Patients with previous surgery of the stomach or oesophagus. * Patients with known coagulopathy. * Previous surgical achalasia treatment (like POEM or Heller myotomy). * Patients with liver cirrhosis and/or oesophageal varices. * Eosinophilic oesophagitis. * Barrett*s oesophagus. * Pregnancy. * Stricture of the oesophagus. * Malignant or premalignant oesophageal lesion * Severe candida oesophagitis. * Hiatal hernia > 1cm. * Extensive, tortuous dilatation (>7cm luminal diameter, S shape) of the oesophagus. * Advanced malignant tumor with prognosis

Design outcomes

Primary

Measure	Time frame
Treatment succes defined as an Eckardt score of 3 or less at two years after treatment. The primary endpoint is measured after two years, but follow-up is continued up to 5 years.	—

Secondary

Measure	Time frame
- Manometry data 3 month after treatment. - Reflux scores (clinical DeMeester score) 3 and 6 months, 1, 2, 3 and 5 years post-treatment. - pH-impedance data at 3 month after treatment. - Adverse events. - Quality of life assessment (gastrointestinal LQ index by Eypasch, Wood- Dauphinee and Troidl) 3 months, 2 and 5 years after treatment. - EGD findings at 3 months and - optional * at 2 and 5 years after treatment.	—

Measure

Time frame

- Manometry data 3 month after treatment. - Reflux scores (clinical DeMeester score) 3 and 6 months, 1, 2, 3 and 5 years post-treatment. - pH-impedance data at 3 month after treatment. - Adverse events. - Quality of life assessment (gastrointestinal LQ index by Eypasch, Wood- Dauphinee and Troidl) 3 months, 2 and 5 years after treatment. - EGD findings at 3 months and - optional * at 2 and 5 years after treatment.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)