Esophageal Fistula After Anterior Cervical Decompression and Fusion

NCT ID: NCT06536738

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2024-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to evaluate the incidence, risk factors, and preventive measures of esophageal fistula following anterior cervical decompression and fusion. By understanding the mechanisms and clinical manifestations of this complication, the study seeks to provide clinicians with better guidelines for treatment and improve postoperative outcomes for patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Fistula

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

esophageal repair

The surgery confirmed a secondary esophageal fistula following the anterior cervical surgery. The procedure involved trimming the esophageal tissue around the fistula and repairing the fistula.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients aged 18 and older. Diagnosed with a secondary esophageal fistula following anterior cervical decompression and fusion surgery.

Postoperative confirmation of the esophageal fistula via imaging studies or endoscopy.

Presence of clinical symptoms such as dysphagia, coughing, or signs of infection.

Patients or their legal representatives must provide informed consent.

Exclusion Criteria

Preexisting esophageal diseases such as esophageal cancer, severe esophagitis, or congenital anomalies.

Other types of fistulas not related to the surgery. Severe comorbid conditions, including: Uncontrolled diabetes, severe cardiovascular diseases, immunosuppression, pregnant women.

Individuals unable or unwilling to comply with study protocols. Life expectancy of less than six months due to other underlying health conditions.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taizhou Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hua Luo

Department of Orthopedic

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024KY531

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

K20230934

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.