Comparing two procedures to prevent reflux in patients who undergo hellers cardiomyotomy for achalasia cardia

Prospective randomized control trial comparing Angle of his accentuation v/s toupet fundoplication as a anti reflux procedure in patients of Achalasia Cardia undergoing Hellers Cardiomyotomy - AOH V/S Toupet

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/04/013036

Enrollment

Registered

2018-04-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- ACHALASIA CARDIA

Interventions

Intervention1: Angle of His accentuation: In this arm patients who undergo hellers cardiomyotomy will undergo Angle of His Accentuation Control Intervention1: Toupet Fundoplication: In this arm patien

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of achalasia cardia consenting for Laparoscopic Hellerâ??s cardiomyotomy and along with antireflux procedure based on randomization. 2. Age 16-65years 3. Fit for general anesthesia

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Patient not willing to participate in the study. 2. Patients unfit for GA 3. Prior esophageal/Gastric surgeries 4. Sigmoid esophagus 5. Dilation related complications 6. Previously operated for achalasia cardia 7. Hiatal hernia >5cm

Design outcomes

Primary

Measure	Time frame
Primary outcome-Incidence of symptomatic reflux estimated in terms of heart burn and regurgitation in patients undergoing Hellers cardiomyotomy as well as incidence of objective GERD by endoscopy at 3-6months and a repeat endoscopy at 12-18months with or without pH study Secondary outcome-Relief of dysphagia Quality of life assessment after Hellers CardiomyotomyTimepoint: Primary outcome-Incidence of symptomatic reflux estimated in terms of heart burn and regurgitation in patients undergoing Hellers cardiomyotomy as well as incidence of objective GERD by endoscopy at 3-6months and a repeat endoscopy at 12-18months with or without pH study Secondary outcome-Relief of dysphagia Quality of life assessment after Hellers Cardiomyotomy	—

Measure

Time frame

Primary outcome-Incidence of symptomatic reflux estimated in terms of heart burn and regurgitation in patients undergoing Hellers cardiomyotomy as well as incidence of objective GERD by endoscopy at 3-6months and a repeat endoscopy at 12-18months with or without pH study Secondary outcome-Relief of dysphagia Quality of life assessment after Hellers CardiomyotomyTimepoint: Primary outcome-Incidence of symptomatic reflux estimated in terms of heart burn and regurgitation in patients undergoing Hellers cardiomyotomy as well as incidence of objective GERD by endoscopy at 3-6months and a repeat endoscopy at 12-18months with or without pH study Secondary outcome-Relief of dysphagia Quality of life assessment after Hellers Cardiomyotomy

—

Secondary

Measure	Time frame
Secondary outcome-Relief of dysphagia Quality of life assessment after Hellers CardiomyotomyTimepoint: 1year from the time of surgery	—

Countries

India

Contacts

Public ContactManjunath Bale

AIIMS New Delhi

rajinderparshad@aiims.edu01126594607

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026