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OpenTrials
Completed

NCT Number: NCT06536738

Esophageal Fistula After Anterior Cervical Decompression and Fusion

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.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

esophageal repair

Procedure

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.

Primary outcomes

  1. The healing rate after the repair of an esophageal fistula

    Time frame: 2 month

    Successful repair of an esophageal fistula can result in a high healing rate, with many patients experiencing complete recovery. However, complications such as infection, poor blood supply to the repaired area, or underlying health conditions can affect the healing process. Close postoperative monitoring and appropriate care are crucial to ensure optimal healing and to address any potential complications promptly.

Sponsors and collaborators

Lead sponsor

Taizhou Hospital

Other

Registry information

Acronym: ACDF

Important dates

Study start
2010
Primary completion
2024
Study completion
2024
First posted
Aug 5, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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