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临床试验/NCT07177222
NCT07177222已完成不适用

Quality of Life in Patients With Achalasia Cardia Before and After Esophagocardiomyotomy

Osh State University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2017年12月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
Significant and long-lasting reduction in symptom severity according to the Eckardt scale

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Significant and long-lasting reduction in symptom severity according to the Eckardt scale

时间窗: from 6 to 60 months

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.

次要结局

未报告次要终点

研究者

发起方
Osh State University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhypargul Abdullaeva

PhD

Osh State University

研究点 (1)

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