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ISRCTN
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ISRCTN05714772
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ClinicalTrials.gov identifier
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NCT00188344
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Public title
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Laparoscopic myotomy versus pneumatic dilatation for achalasia
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Scientific title
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A randomised comparison of laparoscopic myotomy and pneumatic dilatation for
achalasia
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Acronym
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N/A
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Serial number at source
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MCT-76449
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Study hypothesis
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In patients with achalasia, is symptom relief at one year better with laparoscopic Heller myotomy with partial fundoplication, or pneumatic dilatation?
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Lay summary
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Ethics approval
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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).
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Achalasia
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/08/2005
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Anticipated end date
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31/08/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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100
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Interventions
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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
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Primary outcome measure(s)
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The achalasia severity questionnaire score at 1 year.
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Secondary outcome measure(s)
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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)
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-76449)
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Trial website
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Publications
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Contact name
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Dr
David Robert
Urbach
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Address
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Toronto General Hospital
200 Elizabeth Street
Eaton Wing 9EN-236A
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City/town
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Toronto, Ontario
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Zip/Postcode
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M5G 2C4
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Country
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Canada
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Tel
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+1 416 340 4284
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Fax
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+1 416 340 4211
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Email
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david.urbach@uhn.on.ca
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Sponsor
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University Health Network, Toronto (Canada)
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Address
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200 Elizabeth Street
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City/town
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Toronto, Ontario
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Zip/Postcode
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M5G 2C4
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Country
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Canada
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Tel
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+1 416 340 4800
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Email
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carolynm@uhnresearch.ca
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Sponsor website:
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http://www.uhnresearch.ca
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Date applied
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28/07/2005
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Last edited
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24/02/2009
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Date ISRCTN assigned
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28/07/2005
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