Achalasia Cardia Clinical Trial
Randomised Clinical Trial Comparing Relief of Dysphagia Between Laparoscopic Heller's Myotomy Alone Versus Laparoscopic Heller's Myotomy With Anterior Fundoplication In Achalasia Cardia-A Pilot Study
Back ground: Achalasia Cardia (AC) manifests with major symptom dysphagia. Surgery as the
treatment modality relieves dysphagia in most of the patients. Laparoscopic Heller's
myotomy(LHM) 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.
Hypothesis:The hypothesis of present study is that "Frequency of dysphagia following Laparoscopic Heller's myotomy with Dor fundoplication is more than that compared to Laparoscopic Heller's 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 Heller's myotomy (LHM) alone or LHM with Dor fundoplication. Symptomatic outcomes would be assessed using frequency of dysphagia and Eckardt's 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 < 0.05 is considered significant.
|Source||Govind Ballabh Pant Hospital|
|Contact||Hirdaya H Nag, MS|
|Phone||91 11 2323 4242|
|Start date||January 24, 2018|
|Completion date||January 2019|