Ignite Creation Date:
2024-05-06 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03438838
Status:
UNKNOWN
Last Update Posted:
2022-03-23
First Post:
2018-02-13
Brief Title:
Randomised Trial Between LHM Alone Vs LHM With Anterior Fundoplication In Achalasia Cardia
Sponsor:
Govind Ballabh Pant Hospital
Organization:
Govind Ballabh Pant Hospital
Study Overview
Official Title:
Randomised Clinical Trial Comparing Relief of Dysphagia Between Laparoscopic Hellers Myotomy Alone Versus Laparoscopic Hellers Myotomy With Anterior Fundoplication In Achalasia Cardia-A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2022-03
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:
Back ground Achalasia Cardia AC manifests with major symptom dysphagia Surgery as the treatment modality relieves dysphagia in most of the patients Laparoscopic Hellers myotomyLHM is the surgery of choice but is associated with gastroesophageal reflux Anterior fundoplication Dor Fundoplication is usually combined with LHM in patients with AC It reduces gastroesophageal reflux following LHM It has been observed that along with reduction of gastroesophageal reflux Dor Fundoplication also affects relief of dysphagia But it has not been prospectively studied
HypothesisThe hypothesis of present study is that Frequency of dysphagia following Laparoscopic Hellers myotomy with Dor fundoplication is more than that compared to Laparoscopic Hellers myotomy alone in patients with Achalasia Cardia
Methods From December2017 to November 2018 minimum of 20 patients with diagnosis of Achalasia cardia will be randomized to receive either Laparoscopic Hellers myotomy LHM alone or LHM with Dor fundoplication Symptomatic outcomes would be assessed using frequency of dysphagia and Eckardts score
Outcomes Primary outcome is Frequency of dysphagia and secondary outcome is manometry pressure assessment Statistical analysis would be done using Statistical Package for the Social Sciences SPSS soft ware P value 005 is considered significant
HypothesisThe hypothesis of present study is that Frequency of dysphagia following Laparoscopic Hellers myotomy with Dor fundoplication is more than that compared to Laparoscopic Hellers myotomy alone in patients with Achalasia Cardia
Methods From December2017 to November 2018 minimum of 20 patients with diagnosis of Achalasia cardia will be randomized to receive either Laparoscopic Hellers myotomy LHM alone or LHM with Dor fundoplication Symptomatic outcomes would be assessed using frequency of dysphagia and Eckardts score
Outcomes Primary outcome is Frequency of dysphagia and secondary outcome is manometry pressure assessment Statistical analysis would be done using Statistical Package for the Social Sciences SPSS soft ware P value 005 is considered significant
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None