Randomised Trial Between LHM Alone Vs LHM With Anterior Fundoplication In Achalasia Cardia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Achalasia Cardia

Intervention / Treatment
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* Procedure: Laparoscopic Heller's myotomy
* Procedure: Anterior Fundoplication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients (18 years or more) with Achalasia cardia Exclusion Criteria: Patients of achalasia with axis deviation Patients with history of pneumatic dilatation Patient with other associated motility or non motility disorders Patients with pseudoachalasia Prior gastric or esophageal surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic Heller's Myotomy (LHM)alone<br>A minimum 10 patients undergo Laparoscopic Heller's myotomy alone | Procedure: Laparoscopic Heller's myotomy<br>* 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<br>|
| Active Comparator: LHM with Anterior Fundoplication<br>A Minimum 10 patients undergo Laparoscopic Heller's myotomy along with fundoplication | Procedure: Laparoscopic Heller's myotomy<br>* 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<br>Procedure: Anterior Fundoplication<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Dysphagia | None- 0 Occasional-1 Daily-2 Each meal-3 | Minimum one month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manometry pressure | Using High resolution Manometry | Minimum one month after surgery | 
| Gastro esophageal reflux | GERD symptoms | 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 | Minimum after one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Achalasia, LHM, Anterior fundoplication