An interventional study of Laparoscopic Heller's myotomy and Anterior Fundoplication in Achalasia Cardia, sponsored by Govind Ballabh Pant Hospital. Status unknown at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-23.
Sponsored by Govind Ballabh Pant Hospital · Not applicable, Interventional, and Treatment
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.
143 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.
This study's enrollment of 20 is below the median of 56 across 95 interventional studies indexed under Esophageal Achalasia.
Browse Esophageal Achalasia studies →Govind Ballabh Pant Hospital is the lead sponsor of 23 studies on the registry; none are open to participants now.
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Exclusion Criteria:
A minimum 10 patients undergo Laparoscopic Heller's myotomy alone
Procedure: Laparoscopic Heller's myotomy
A Minimum 10 patients undergo Laparoscopic Heller's myotomy along with fundoplication
Procedure: Laparoscopic Heller's myotomy · Procedure: Anterior Fundoplication
Laparoscopic Heller's myotomy: Anterior wall of esophagus is exposed by opening peritoneum and minimal dissection of fat over it. Myotomy is started at 2 cm above the esophago- gastric junction. Initial plane is created using dissector and further muscles are split using pair of dissector or bowel holding forceps for length of 7 to 8 cm with 2 cm over stomach
The Fundus was sutured with 3 stitches on either side of the esophagus to right and left crus of diaphragm using ethibond(1-0) beside intervening stitch over esophagus. Width of fundoplication is kept approximately at 2cm. The proximal short gastric vessels were divided only if the fundus is insufficiently mobile
Frequency of Dysphagia
None- 0 Occasional-1 Daily-2 Each meal-3
Time frame: Minimum one month after surgery
Manometry pressure
Using High resolution Manometry
Time frame: Minimum one month after surgery
Gastro esophageal reflux
GERD symptoms
Time frame: Minimum after one month
Eckardt's score
Dysphagia * 0-None * 1-Occasional * 2-Daily * 3-Each meal Retrosternal pain * 0-None * 1-Occasional * 2-Daily * 3-Each meal Regurgitation * 0-None * 1-Occasional * 2-Daily * 3-Each meal Weight loss * 0-None * 1-less than 5 kg * 2-5 to 10kg * 3-more than 10kg Minimum score: 0 Maximum score: 12
Time frame: Minimum after one month
Plan to share: No
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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Govind Ballabh Pant Hospital