Laparoscopic myotomy versus pneumatic dilatation for achalasia
| ISRCTN | ISRCTN05714772 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05714772 |
| ClinicalTrials.gov number | NCT00188344 |
| Secondary identifying numbers | 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
Scientific
Toronto General Hospital
200 Elizabeth Street
Eaton Wing 9EN-236A
Toronto, Ontario
M5G 2C4
Canada
| Phone | +1 416 340 4284 |
|---|---|
| david.urbach@uhn.on.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/08/2005 |
| Completion date | 31/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
M5G 2C4
Canada
Sponsor information
University Health Network, Toronto (Canada)
University/education
University/education
200 Elizabeth Street
Toronto, Ontario
M5G 2C4
Canada
| Phone | +1 416 340 4800 |
|---|---|
| carolynm@uhnresearch.ca | |
| Website | http://www.uhnresearch.ca |
"ROR" |
https://ror.org/026pg9j08 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-76449)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
15/02/2019: Publication reference added.
