A clinical trial to study role of antireflux procedures in patients of Achalasia cardia (motility disorder of food pipe due to which patients have difficulty in swallowing solids and liquids) undergoing surgery

Completed

• Conditions: Achalasia Cardia

• Registration Number: CTRI/2014/04/004563
• Lead Sponsor: Dr Rajinder Parshad

Brief Summary

This study was a continuation of previous thesis, with two groups- retrospective- follow up of patients previously operated and prospectively a randomised parallel group trial comparing two antireflux procedures namely Angle of His accentuation and Dor’s fundoplication in patients of Achalasia Cardia undergoing Laparoscopic Heller’s cardiomyotomy. Primary out come measure was symptomatic relief in terms of dysphagia, regurgitation, heartburn and quality of life. Secondary outcome was new onset  heartburn. As the duration of the study, intervention and outcome measures were same as the previous study, a minimum sample size of 20 was calculated with 95% confidence interval and 80% power. We included all the patients enrolled in within the duration of the study from February 2012 to October 2013.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-02
• Last Update Posted: 2014-04-23

Recruitment & Eligibility

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

Inclusion Criteria

• 1.All diagnosed patients of achalasia cardia planned for laproscopic cardiomyotomy.
• 2.Patients who are willing to give consent for the study.
• 3.Patients fit for General anesthesia.

Exclusion Criteria

• 1.Patient not willing to participate in the study.
• 2.Patient who are not fit for general anesthesia.
• 3.Patients undergoing re operation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
symptomactic relief- Dysphagia, regurgitation and heartburn, Quality of life	1 week, 3 months and every 6 months thereafter

Secondary Outcome Measures

Name	Time	Method
new onset reflux	1 week, 3 months, every 6 months thereafter

Trial Locations

Locations (1)

AIIMS; 🇮🇳 Delhi, DELHI, India

AIIMS

🇮🇳Delhi, DELHI, India

Dr Pavithra B

Principal investigator

9013949630

pavitz86@gmail.com