Laparoscopic myotomy versus pneumatic dilatation for achalasia

ISRCTN	ISRCTN05714772
DOI	https://doi.org/10.1186/ISRCTN05714772
ClinicalTrials.gov (NCT)	NCT00188344
Protocol serial number	MCT-76449
Sponsor	University Health Network, Toronto (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-76449)

Submission date: 28/07/2005
Registration date: 28/07/2005
Last edited: 15/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Robert Urbach
Scientific

Toronto General Hospital
200 Elizabeth Street
Eaton Wing 9EN-236A
Toronto, Ontario
M5G 2C4
Canada

Phone	+1 416 340 4284
Email	david.urbach@uhn.on.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised comparison of laparoscopic myotomy and pneumatic dilatation for achalasia
Study objectives	In patients with achalasia, is symptom relief at one year better with laparoscopic Heller myotomy with partial fundoplication, or pneumatic dilatation?
Ethics approval(s)	University Health Network Research Ethics Board, approval gained initially on May 19, 2005; renewed and continued approval until May 19, 2007 (reference number: 05-0065-A).
Health condition(s) or problem(s) studied	Achalasia
Intervention	Intervention Arm #1 (primary achalasia) will receive pneumatic dilatation Intervention Arm #2 (primary achalasia) will receive Heller myotomy with partial fundoplication Intervention Arm #3 (recurrent achalasia) will receive pneumatic dilatation Intervention Arm #4 (recurrent achalasia) will receive Heller myotomy with partial fundoplication
Intervention type	Other
Primary outcome measure(s)	The achalasia severity questionnaire score at 1 year.
Key secondary outcome measure(s)	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)
Completion date	31/08/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	01/08/2005
Date of final enrolment	31/08/2012

Locations

Countries of recruitment

Canada

Study participating centre

Toronto General Hospital

Toronto, Ontario
M5G 2C4
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

15/02/2019: Publication reference added.