Achalasia CardiaGERD-HRQLNCT07177222
Compare the Quality of Life of Patients With Achalasia Cardia (AC) After Laparoscopic and Open Esophagocardiomyotomy.
An observational study of Achalasia Cardia and GERD-HRQL Scale, run by Osh State University at 1 site in Kyrgyzstan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Achalasia Cardia, GERD-HRQL Scale, Eckardt Scale
- What is being tested?
- laparoscopic esophagocardiomyotomy and open surgery
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- 1 Dec 2017to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life in Patients With Achalasia Cardia Before and After Esophagocardiomyotomy
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).
Read more
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
- Being tested
- laparoscopic esophagocardiomyotomy, open surgery
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic esophagocardiomyotomyProcedure or 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 surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 18 patients | underwent laparoscopic esophagocardiomyotomy Receives: Procedure: laparoscopic esophagocardiomyotomy | |
| 20 patients | underwent open surgery Receives: Procedure: open surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from 6 to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Dec 2017
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achalasia CardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osh State University
- Sponsor type
- University, hospital or other
- Collaborators
- Kyrgyz State Medical Academy
- Responsible party
- Principal investigator, Zhypargul Abdullaeva, Osh State University
- Investigators
- Bakytbek Osmonaliev, PhD, Principal investigator, Kyrgyz State Medical Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177222
- Sponsor's protocol ID
- Quality of life in patients
- Acronym
- GERD-HRQL
- Status last verified
- Jul 2025
- First submitted
- 29 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Patients With Achalasia Cardia Before and After Esophagocardiomyotomy
- ClinicalTrials.gov ID
- NCT07177222
- Acronym / sponsor ID
- GERD-HRQL / Quality of life in patients
- Conditions
- Achalasia Cardia, GERD-HRQL Scale, Eckardt Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Osh State UniversityUniversity, hospital or other
- Collaborators
- Kyrgyz State Medical Academy
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18 patients | – | Procedure: laparoscopic esophagocardiomyotomyunderwent laparoscopic esophagocardiomyotomy |
| 20 patients | – | Procedure: open surgeryunderwent open surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic esophagocardiomyotomyHeller 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. | Procedure or surgery | 18 patients |
| open surgeryOpen 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. | Procedure or surgery | 20 patients |
Primary outcome
Significant and long-lasting reduction in symptom severity according to the Eckardt scale
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bakytbek Osmonaliev, PhD principal investigator
Kyrgyz State Medical Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achalasia Cardia and GERD-HRQL Scale, run by Osh State University at 1 site in Kyrgyzstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kyrgyzstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant and long-lasting reduction in symptom severity according to the Eckardt scale (time frame: from 6 to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.