Esophageal Fistula After Anterior Cervical Decompression and Fusion

NCT06536738 | Completed DMC

• 2 other identifiers: K202309342024KY531
• Study Type: observational
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Esophageal Fistula

Outcome Measures

Primary Outcomes (1)

• The healing rate after the repair of an esophageal fistula

  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.

  2 month

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients secondary esophageal fistula following anterior cervical decompression and fusion surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taizhou Hospital: lead

MeSH Terms

Conditions

Esophageal Fistula

Interventions

Esophagoplasty

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Orthopedic

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: January 1, 2010
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share