Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188344
Status:
UNKNOWN
Last Update Posted:
2014-05-21
First Post:
2005-09-09
Brief Title:
A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia
Status:
UNKNOWN
Status Verified Date:
2014-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN05714772 | None | None | None |