Condition category
Digestive System
Date applied
28/07/2005
Date assigned
28/07/2005
Last edited
24/02/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Robert Urbach

ORCID ID

Contact details

Toronto General Hospital
200 Elizabeth Street
Eaton Wing 9EN-236A
Toronto
Ontario
M5G 2C4
Canada
+1 416 340 4284
david.urbach@uhn.on.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00188344

Protocol/serial number

MCT-76449

Study information

Scientific title

A randomised comparison of laparoscopic myotomy and pneumatic dilatation for
achalasia

Acronym

Study hypothesis

In patients with achalasia, is symptom relief at one year better with laparoscopic Heller myotomy with partial fundoplication, or pneumatic dilatation?

Ethics approval

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).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

The achalasia severity questionnaire score at 1 year.

Secondary outcome measures

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)

Overall trial start date

01/08/2005

Overall trial end date

31/08/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

01/08/2005

Recruitment end date

31/08/2012

Locations

Countries of recruitment

Canada

Trial participating centre

Toronto General Hospital
Toronto, Ontario
M5G 2C4
Canada

Sponsor information

Organisation

University Health Network, Toronto (Canada)

Sponsor details

200 Elizabeth Street
Toronto
Ontario
M5G 2C4
Canada
+1 416 340 4800
carolynm@uhnresearch.ca

Sponsor type

University/education

Website

http://www.uhnresearch.ca

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-76449)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes