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

NCT07177222 | Completed FDA Drug FDA Device

• 1 other identifier: Quality of life in patients
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Achalasia Cardia; GERD-HRQL Scale; Eckardt Scale

Outcome Measures

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.

  from 6 to 60 months

Study Arms (2)

18 patients

underwent laparoscopic esophagocardiomyotomy

Procedure: laparoscopic esophagocardiomyotomy

20 patients

underwent open surgery

Procedure: open surgery

Interventions

laparoscopic esophagocardiomyotomy PROCEDURE

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.

18 patients

open surgery PROCEDURE

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.

20 patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Osh State University: lead
• Kyrgyz State Medical Academy: collaborator

Study Sites (1)

Laparoscopic esophagocardiomyotomy

Bishkek, 720020, Kyrgyzstan

Location

MeSH Terms

Conditions

Esophageal Achalasia

Interventions

Conversion to Open Surgery

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Bakytbek Osmonaliev, PhD

  Kyrgyz State Medical Academy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 16, 2025
• Study Start: December 1, 2017
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-07

Locations

KY (1)