Achalasia Digestive System Achalasia
Conditions
Interventions
Intervention Arm #1 (primary achalasia) will receive pneumatic dilatation
Intervention Arm #2 (primary achalasia) will receive Heller myotomy with partial fundoplication
Sponsors
University Health Network, Toronto (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Persons of either sex age groups 18 and up 2. Clinical diagnosis of achalasia by a physician 3. Manometric diagnosis of achalasia including both: incomplete relaxation of the lower oesophageal sphincter during swallowing (<80% of elevation over intragastric pressure) and absence of oesophageal peristalsis (peristalsis in <20% of initiated contractions) 4. Facility with English, ability to complete English-language questionnaires
Exclusion criteria
Exclusion criteria: 1. Pseudoachalasia: oesophageal carcinoma; oesophageal stricture; previous oesophageal or gastric surgery; previous instrumentation of the lower oesophageal sphincter i.e. suture, polymer injection, silicone band 2. Previous gastric or oesophageal surgery: fundoplication; Heller myotomy; gastric resection; vagotomy with or without gastric drainage 3. Age 17 years or less 4. Pregnancy 5. Presence of severe comorbid illness: unstable angina; recent myocardial infarction (<6 months), cancer (except integumentary), unless free of disease for more than 5 years; end stage renal disease; previous stroke with cognitive, motor, speech, or swallowing deficit persisting longer than one month; severe respiratory disease; cognitive impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The achalasia severity questionnaire score at 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Generic health related quality of life (SF-36) 2. Gastrointestinal disease-specific quality of life (GIQLI) 3. Measures of oesophageal physiology (lower oesophageal sphincter pressure, mean amplitude of oesophageal contractions, presence of any contractions after intervention) 4. Gastroesophageal reflux as measured by ambulatory 24-hour oesophageal pH measurement 5. Oesophageal emptying, as quantified by times barium oesophagram 6. Clinical outcomes of care including short term outcomes (i.e. death within 30 days of treatment); major complications (i.e. oesophageal perforation, prolonged hospitalisation, myocardial infarction etc.) and long-term clinical outcomes (i.e. survival after randomisation, incidence of oesophageal cancer, reintervention, clinical gastroesophageal reflux disease, use of antisecretory medications) | — |
Countries
Canada
Outcome results
None listed