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

Govind Ballabh Pant Hospital

Status: Unknown

Conditions: Achalasia Cardia

Treatments: Procedure: Laparoscopic Heller's myotomy; Procedure: Anterior Fundoplication

Study type: Interventional

Funder types: Other

Identifiers

NCT03438838

GIPMER

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Laparoscopic Heller's Myotomy (LHM)alone

Active Comparator group

Description:

A minimum 10 patients undergo Laparoscopic Heller's myotomy alone

Treatment:

Procedure: Laparoscopic Heller's myotomy

LHM with Anterior Fundoplication

Active Comparator group

Description:

A Minimum 10 patients undergo Laparoscopic Heller's myotomy along with fundoplication

Treatment:

Procedure: Laparoscopic Heller's myotomy

Procedure: Anterior Fundoplication