CClinicalTrials.gg
CompletedNCT07177222GERD-HRQLUpdated Sep 16, 2025

Compare the Quality of Life of Patients With Achalasia Cardia (AC) After Laparoscopic and Open Esophagocardiomyotomy.

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 type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
38
Sex
All
01

Study summary

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:

  • Clinically and instrumentally confirmed diagnosis of grade II-III AС, established on the basis of esophagogastroduodenoscopy, fluoroscopy with a contrast agent.
  • No previous surgical operations on the esophagus and cardia;
  • Availability of written informed consent for participation in the study and subsequent observation.

Exclusion criteria: Patients were excluded from the study if they had:

  • Severe concomitant diseases (cardiovascular, respiratory, endocrine and others) that could limit the possibility of safe surgery and/or long-term observation;
  • Detected malignant neoplasms of the esophagus, cardia or stomach;
  • Refusal to participate in the study or inability to comply with the observation protocol. Preoperative preparation: All patients underwent a preoperative examination, which included: - Clinical history collection with a detailed description of complaints, duration and dynamics of the disease, presence of complications and concomitant diseases;
  • General clinical and biochemical tests, electrocardiography;
  • Esophagogastroduodenoscopy (EGDS) to assess the degree of expansion of the esophagus, the condition of the mucous membrane and to exclude tumor processes;
  • X-ray examination of the esophagus with barium contrast to assess the degree of esophageal dilation, the functional state of the cardia and the identification of associated changes (diverticula, gastroesophageal reflux).

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.

02

Conditions studied

  • Achalasia Cardia
  • GERD-HRQL Scale
  • Eckardt Scale

Browse trials for

03

In context

Esophageal Achalasia

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

  • Clinically and instrumentally confirmed diagnosis of grade II-III AС, established based on esophagogastroduodenoscopy, fluoroscopy with a contrast agent;
  • No previous surgical operations on the esophagus and cardia;
  • Availability of written informed consent for participation in the study and subsequent observation.

Exclusion criteria

Exclusion Criteria:

  • Severe concomitant diseases (cardiovascular, respiratory, endocrine and others) that could limit the possibility of safe surgery and/or long-term observation;
  • Detected malignant neoplasms of the esophagus, cardia or stomach;
  • Refusal to participate in the study or inability to comply with the observation protocol.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
38 participants (actual)
Patient registry
No

Groups and cohorts

  • 18 patients

    underwent laparoscopic esophagocardiomyotomy

    Procedure: laparoscopic esophagocardiomyotomy

  • 20 patients

    underwent open surgery

    Procedure: open surgery

Interventions

  • Procedurelaparoscopic esophagocardiomyotomy

    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.

  • Procedureopen surgery

    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.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Laparoscopic esophagocardiomyotomy
    Bishkek, 720020, Kyrgyzstan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07177222
Lead sponsor
Osh State University
Collaborators
Kyrgyz State Medical Academy
Responsible party
Zhypargul Abdullaeva (PhD, Osh State University) — Principal investigator
First posted
Sep 16, 2025
Start date
Dec 1, 2017
Primary completion
Jul 30, 2025
Completion
Jul 30, 2025
Last update
Sep 16, 2025

Study contacts

Bakytbek Osmonaliev, PhD
principal investigator · Kyrgyz State Medical Academy

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion