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NCT number NCT03438838
Study type Interventional
Source Govind Ballabh Pant Hospital
Contact Hirdaya H Nag, MS
Phone 91 11 2323 4242
Email hirdayanag@gmail.com
Status Recruiting
Phase N/A
Start date January 24, 2018
Completion date January 2019

Clinical Trial Summary

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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Not yet recruiting NCT03186248 - Randomized Clinical Trial Comparing Short Versus Long Oesophageal Myotomy in POEM for Achalasia Cardia. N/A
Recruiting NCT02025790 - POEM Versus Pneumatic Dilatation in Achalasia Cardia N/A