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

NCT ID: NCT07177222

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2025-07-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

18 patients

underwent laparoscopic esophagocardiomyotomy

laparoscopic esophagocardiomyotomy

Intervention Type: 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.

20 patients

underwent open surgery

open surgery

Intervention Type: 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.

Interventions

laparoscopic 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.

Intervention Type: PROCEDURE

open 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyrgyz State Medical Academy

OTHER

Sponsor Role: collaborator

Osh State University

OTHER

Sponsor Role: lead

Responsible Party

Zhypargul Abdullaeva

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bakytbek Osmonaliev, PhD

Role: PRINCIPAL_INVESTIGATOR

Kyrgyz State Medical Academy

Locations

Laparoscopic esophagocardiomyotomy

Bishkek, , Kyrgyzstan

Countries

Kyrgyzstan

Other Identifiers

Quality of life in patients

Identifier Type: -

Identifier Source: org_study_id