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

Not Applicable

• Conditions: Achalasia Cardia
• Interventions: Procedure: Laparoscopic Heller's myotomy; Procedure: Anterior Fundoplication

• Registration Number: NCT03438838
• Lead Sponsor: Govind Ballabh Pant Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-24
• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-20
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-03-23
• Primary Completion: 2022-08-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic Heller's Myotomy (LHM)alone	Laparoscopic Heller's myotomy	A minimum 10 patients undergo Laparoscopic Heller's myotomy alone
LHM with Anterior Fundoplication	Anterior Fundoplication	A Minimum 10 patients undergo Laparoscopic Heller's myotomy along with fundoplication
LHM with Anterior Fundoplication	Laparoscopic Heller's myotomy	A Minimum 10 patients undergo Laparoscopic Heller's myotomy along with fundoplication

Primary Outcome Measures

Name	Time	Method
Frequency of Dysphagia	Minimum one month after surgery	None- 0 Occasional-1 Daily-2 Each meal-3

Secondary Outcome Measures

Name	Time	Method
Manometry pressure	Minimum one month after surgery	Using High resolution Manometry
Gastro esophageal reflux	Minimum after one month	GERD symptoms
Eckardt's score	Minimum after one month	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

Trial Locations

Locations (1)

GIPMER; 🇮🇳 New Delhi, India