Home | All trials

[RDF data]
Trial NCT00188344

Resource URI: http://static.linkedct.org/resource/trials/NCT00188344
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/18161>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/7785>
linkedct:brief_title A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:condition <http://static.linkedct.org/resource/condition/4557>
linkedct:criteria Inclusion Criteria: - Clinical diagnosis of achalasia by a physician - manometric diagnosis of achalasia including both: Incomplete relaxation of the lower esophageal sphincter during swallowing (<80% of elevation over intragastric pressure and absence of esophageal peristalsis (peristalsis in <20% of initiated contractions) - Facility with English, ability to complete English language questionnaires Exclusion Criteria: - Pseudoachalasia: esophageal carcinoma; esophageal stricture; previous esophageal or gastric surgery; previous instrumentation of the lower esophageal sphincter i.e. suture, polymer injection, silicone band - Previous gastric or esophageal surgery: fundoplication; Heller myotomy; gastric resection; vagotomy with or without gastric drainage - Age 17 year or less - Pregnancy - 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
linkedct:description Achalasia is a rare disease of the esophagus. It can cause difficulty swallowing, regurgitation of swallowed food, and chest pain. In achalasia, there are two problems in the esophagus. First, the esophagus does not properly push swallowed food down towards the stomach. Second, the valve at the lower end of the esophagus, called the lower esophageal sphincter, does not relax to allow food to pass from the esophagus into the stomach. Achalasia cannot be "cured". However, the symptoms of achalasia can be improved by treatment. Treatment is usually directed towards reducing the degree of blockage caused by the lower esophageal sphincter. the muscle of the lower esophageal sphincter can be stretched using a technique called pneumatic dilatation, or it can be divided (cut in half) during a surgical operation. The operation is called laparoscopic Heller myotomy, and is done by laparoscopic ("keyhole") surgery, where small incisions are used and patients usually stay in hospital 1-2 nights. Other treatments for achalasia, such as medications or injection of Botulinum Toxin Type A are not often used because they do not provide effective long-term improvement.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date September 2012
linkedct:enrollment 100 (xsd:int)
linkedct:firstreceived_date September 9, 2005
linkedct:has_dmc Yes
linkedct:id NCT00188344
linkedct:intervention <http://static.linkedct.org/resource/intervention/102519>
linkedct:intervention <http://static.linkedct.org/resource/intervention/92074>
rdfs:label Trial NCT00188344
linkedct:lastchanged_date March 4, 2009
linkedct:lead_sponsor_agency University Health Network, Toronto
linkedct:location <http://static.linkedct.org/resource/location/20312>
linkedct:location <http://static.linkedct.org/resource/location/20465>
linkedct:nct_id NCT00188344
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia
linkedct:org_study_id MCT-76449
linkedct:overall_contact_email stacey.stegienko@uhnres.utoronto.ca
linkedct:overall_contact_last_name Stacey Stegienko
linkedct:overall_contact_phone 416-340-4800
linkedct:overall_contact_phone_ext 2621
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/12806>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/415>
foaf:page <http://clinicaltrials.gov/show/NCT00188344>
linkedct:phase N/A
linkedct:primary_completion_date September 2012
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/58099>
linkedct:secondary_id ISRCTN05714772
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/27754>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/48422>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/48432>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/48655>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/66066>
linkedct:source University Health Network, Toronto
linkedct:start_date September 2005
linkedct:study_design Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to compare pneumatic dilatation and laparoscopic Heller myotomy in patients with achalasia in order to learn which of these two treatments should be recommended to patients in the future.
rdf:type linkedct:trials
linkedct:verification_date March 2009