Esophageal FistulaACDFNCT06536738
Esophageal Fistula After Anterior Cervical Decompression and Fusion
An observational study of Esophageal Fistula, run by Taizhou Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Fistula
- What is being tested?
- esophageal repair
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 Jan 2024
- How long will I take part?
- 24 Months
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients secondary esophageal fistula following anterior cervical decompression and fusion surgery.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Being tested
- esophageal repair
- Medical subject headings
- Esophageal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophageal repairProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Jan 2010
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal FistulaStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 5 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Luo, Taizhou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536738
- Sponsor's protocol ID
- K20230934
- Other IDs
- 2024KY531
- Acronym
- ACDF
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Fistula After Anterior Cervical Decompression and Fusion
- ClinicalTrials.gov ID
- NCT06536738
- Acronym / sponsor ID
- ACDF / K20230934
- Conditions
- Esophageal Fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Taizhou HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 5 Aug 2024 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients secondary esophageal fistula following anterior cervical decompression and fusion surgery.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| esophageal repairThe 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. | Procedure or surgery | – |
Primary outcome
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.
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 6 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Esophageal Fistula
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Not yet recruitingObservational study
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula
Tracheoesophageal Fistula, Esophageal Atresia With Tracheo-esophageal Fistula
Enrolling by invitationObservational study
Luso-Cor Stent Compared to Other Endoscopic Techniques for Management of Fistulas and Anastomotic Dehiscences(ES-LCCE-UDFM)
Obesity, Obesity, Morbid
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Fistula, run by Taizhou Hospital.
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 4 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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The healing rate after the repair of an esophageal fistula (time frame: 2 month). 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 6 Aug 2024.