An observational study in Achalasia Cardia, GERD-HRQL Scale and Eckardt Scale, sponsored by Osh State University. Completed at 1 site in Kyrgyzstan. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Osh State University · Observational
Study design. A randomized, prospective design study with retrospective data addition was conducted at two medical institutions between December 2017 and July 2025. Patients were equally allocated (1:1) between the laparoscopic and open Heller esophagocardiomyotomy groups.
Ethical aspects. All research procedures were carried out in accordance with the principles of the Helsinki Declaration and national ethical standards. The study protocol was approved by the Bioethics Committee of the Kyrgyz State Medical Academy (KSMA) named after I.K. Akhunbaev (protocol No. 6, dated 11.12.2017).
All participants were provided with a full explanation of the study objectives, methods, potential risks and benefits, and provided written informed consent prior to surgery and the processing of their anonymised clinical data for scientific purposes.
The study included 38 patients diagnosed with AC. The patients were divided into two groups: 18 patients underwent laparoscopic esophagocardiomyotomy, and 20 patients underwent open surgery.
A comparative analysis of these groups made it possible to evaluate the effectiveness and safety of both laparoscopic and traditional surgical interventions in the early and late postoperative periods.
All participants were provided with a full explanation of the study objectives, methods, potential risks and benefits, and provided written informed consent prior to surgery and the processing of their anonymised clinical data for scientific purposes.
The study included 38 patients diagnosed with AC. The patients were divided into two groups: 18 patients underwent laparoscopic esophagocardiomyotomy, and 20 patients underwent open surgery.
A comparative analysis of these groups made it possible to evaluate the effectiveness and safety of both laparoscopic and traditional surgical interventions in the early and late postoperative periods.
Inclusion criteria: Patients meeting the following requirements were accepted into the study:
Exclusion criteria: Patients were excluded from the study if they had:
Surgical intervention. Classical esophagocardiomyotomy performed via laparotomy remains the accepted method of treating AC. The operation involves esophagocardiomyotomy using the Heller technique, which improves the passage of food and reduces swallowing difficulties and reflux of gastric contents.
Traditional laparotomy access is associated with high trauma and a long recovery period. Laparoscopic esophagocardiomyotomy in our study was performed using modern minimally invasive technologies.
140 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.
This study's enrollment of 38 is below the median of 111 across 41 observational studies indexed under Esophageal Achalasia.
Browse Esophageal Achalasia studies →Osh State University is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study included 38 patients diagnosed with AC. The patients were divided into two groups: 18 patients underwent laparoscopic esophagocardiomyotomy, and 20 patients underwent open surgery.
Exclusion Criteria:
underwent laparoscopic esophagocardiomyotomy
Procedure: laparoscopic esophagocardiomyotomy
underwent open surgery
Procedure: open surgery
Heller myotomy, is a minimally invasive surgical procedure that involves cutting the muscle at the lower end of the esophagus to treat achalasia, a condition where this muscle (esophageal sphincter) fails to relax and hinders food passage into the stomach.
Open surgery, or traditional surgery, involves a surgeon making one large incision to directly access and view the internal organ or body part being operated on.
Significant and long-lasting reduction in symptom severity according to the Eckardt scale
The patient's Eckardt score drops from a high value (indicating severe achalasia symptoms) to a low value (typically ≤3) and remains low over several years.
Time frame: from 6 to 60 months
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Osh State University