NCT06816758

Brief Summary

This study aims to evaluate the diagnosis and treatment methods for corrosive esophagitis based on 26 years of clinical experience. It will retrospectively analyze patient records to identify patterns in clinical outcomes, complications, and the effectiveness of treatment strategies. The study focuses on optimizing patient care by proposing a diagnosis and treatment algorithm that can guide future clinical practices. Data will be collected from hospital archives and electronic health records, covering cases of corrosive esophagitis managed at Ondokuz Mayıs University between 1998 and 2024.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

May 21, 2025

Status Verified

January 1, 2025

Enrollment Period

9 days

First QC Date

January 27, 2025

Last Update Submit

May 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of Esophageal Stricture, Perforation, and Other Related Complications

    The number of patients who develop esophageal strictures, perforation, or other complications within 1 month post-admission will be recorded.

    Within 1 month after hospital admission

Interventions

This is an observational study, so participants are not assigned interventions. However, the study investigates the outcomes of patients diagnosed with corrosive esophagitis who received routine clinical care. The exposure of interest includes diagnostic and treatment procedures such as endoscopic evaluation (Zargar classification), proton pump inhibitors, corticosteroid therapy, and surgical interventions for complications like strictures. The outcomes and clinical data collected reflect routine care practices over 26 years.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study focuses on patients diagnosed with corrosive esophagitis due to the ingestion of corrosive substances. The population includes individuals aged over 18 years who were hospitalized and treated at Ondokuz Mayıs University Thoracic Surgery Department between 1998 and 2024. The patients underwent clinical, laboratory, and radiological evaluations, and their outcomes were assessed retrospectively.

You may qualify if:

  • Patients diagnosed with corrosive esophagitis due to corrosive substance ingestion.
  • Hospitalized and treated at Ondokuz Mayıs University Thoracic Surgery Department.
  • Patients who underwent clinical, laboratory, and radiological evaluations to confirm the diagnosis.
  • Patients who were monitored and met follow-up criteria during their treatment.
  • Patients above 18 years of age

You may not qualify if:

  • Patients under 18 years of age.
  • Patients who refused hospitalization or treatment.
  • Patients who ingested non-corrosive or non-toxic substances (verified by the Ministry of Health Poison Information Center).
  • Patients lost to follow-up or did not complete follow-up requirements.
  • Patients with incomplete data during the diagnostic or treatment process.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University Faculty of Medicine

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Esophageal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2025

First Posted

February 10, 2025

Study Start

May 1, 2025

Primary Completion

May 10, 2025

Study Completion

May 15, 2025

Last Updated

May 21, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Locations