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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Achalasia Cardia
• Intervention / Treatment: Procedure: Laparoscopic Heller's myotomy; Procedure: Anterior Fundoplication

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110002
    • GIPMER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Laparoscopic Heller's Myotomy (LHM)alone; A minimum 10 patients undergo Laparoscopic Heller's myotomy alone	Procedure: Laparoscopic Heller's myotomy; 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
ACTIVE_COMPARATOR: LHM with Anterior Fundoplication; A Minimum 10 patients undergo Laparoscopic Heller's myotomy along with fundoplication	Procedure: Laparoscopic Heller's myotomy; 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; Procedure: Anterior Fundoplication; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Govind Ballabh Pant Hospital
• Investigators: Principal Investigator: Hirdaya H Nag, MS, GIPMER

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 24, 2018
• Primary Completion (ANTICIPATED): August 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (ACTUAL): February 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Achalasia, LHM, Anterior fundoplication
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophageal Achalasia
• Other Study ID Numbers: GIPMER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No