Postoperative Sore ThroatNCT07088224
Establishment of Prediction Model for Postoperative Sore Throat
An observational study of Postoperative Sore Throat, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
This observational study aims to identify the risk factors associated with postoperative sore throat (POST) and to develop a clinical prediction model for patients undergoing thyroid surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Sore Throat
- What is being tested?
- Observational studies without intervention
- How many people
- 375 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with postoperative thyroid surgery pain
Who may be able to join
- Age ≥ 18 years； Undergoing thyroid surgery under general anesthesia, including both open and endoscopic procedures； Complete postoperative follow-up records available (minimum 48 hours)； Accessible and complete surgical and anesthesia records； Provision of written informed consent by the patient or their legally authorized representative；
Who cannot join
- Failed tracheal intubation or need for emergency tracheotomy during surgery； Reoperation required due to postoperative complications such as bleeding or nerve injury； Severe cardiopulmonary disease (ASA physical status ≥ IV) or long-term use of corticosteroids； Incomplete clinical data；
About this study
Official title: Analysis of Risk Factors and Establishment of Prediction Model for Postoperative Sore Throat After Thyroid Surgery Under General Anesthesia
This observational study aims to identify the risk factors associated with postoperative sore throat (POST) and to develop a clinical prediction model for patients undergoing thyroid surgery under general anesthesia. Despite improvements in surgical and anesthetic techniques, POST remains one of the most common complications following thyroidectomy, with an incidence of up to 80%. POST can significantly impact patient comfort, swallowing function, nutritional intake, and recovery quality, leading to prolonged hospitalization and increased healthcare costs.
The etiology of POST is multifactorial, involving intubation-related factors (e.g., endotracheal tube size, cuff pressure), surgery-related factors (e.g., duration of surgery, neck hyperextension), and patient-related factors (e.g., age, sex, smoking history, pre-existing throat symptoms). However, large-scale, systematic studies in the Chinese population remain limited.
Read more
With the increasing adoption of Enhanced Recovery After Surgery (ERAS) principles, the accurate identification of modifiable risk factors and early prediction of POST risk are essential for targeted preventive strategies and improved perioperative management. Recent advancements in machine learning and statistical modeling allow for the development of personalized, multifactorial risk assessment tools.
In this study, clinical data from patients undergoing thyroid surgery at Nanjing First Hospital will be collected and analyzed. The primary goal is to identify key preoperative and intraoperative predictors of POST and to establish a multivariable nomogram-based prediction model. Internal validation using bootstrap methods will be performed to evaluate the model's discrimination, calibration, and clinical utility, ultimately supporting evidence-based interventions to improve postoperative outcomes and patient satisfaction.
- Conditions
- Postoperative Sore Throat
- Being tested
- Observational studies without intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studies without interventionOther
Observational studies without intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of Postoperative Sore rate within 24 hours after surgery
Measured: within 24 hours after surgery
Secondary outcomes (2)
incidence of Postoperative Sore Throat rate 1 hour after surgery
Measured: 1 hour after surgery
incidence of Postoperative Sore Throat rate 48 hour after surgery
Measured: 48 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sore ThroatStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XiaoLiang Wang, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088224
- Sponsor's protocol ID
- KY20250624-12
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Risk Factors and Establishment of Prediction Model for Postoperative Sore Throat After Thyroid Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT07088224
- Acronym / sponsor ID
- KY20250624-12
- Conditions
- Postoperative Sore Throat
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 28 Jul 2025 (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 observational study aims to identify the risk factors associated with postoperative sore throat (POST) and to develop a clinical prediction model for patients undergoing thyroid surgery under general anesthesia. Despite improvements in surgical and anesthetic techniques, POST remains one of the most common complications following thyroidectomy, with an incidence of up to 80%. POST can significantly impact patient comfort, swallowing function, nutritional intake, and recovery quality, leading to prolonged hospitalization and increased healthcare costs.
The etiology of POST is multifactorial, involving intubation-related factors (e.g., endotracheal tube size, cuff pressure), surgery-related factors (e.g., duration of surgery, neck hyperextension), and patient-related factors (e.g., age, sex, smoking history, pre-existing throat symptoms). However, large-scale, systematic studies in the Chinese population remain limited.
With the increasing adoption of Enhanced Recovery After Surgery (ERAS) principles, the accurate identification of modifiable risk factors and early prediction of POST risk are essential for targeted preventive strategies and improved perioperative management. Recent advancements in machine learning and statistical modeling allow for the development of personalized, multifactorial risk assessment tools.
In this study, clinical data from patients undergoing thyroid surgery at Nanjing First Hospital will be collected and analyzed. The primary goal is to identify key preoperative and intraoperative predictors of POST and to establish a multivariable nomogram-based prediction model. Internal validation using bootstrap methods will be performed to evaluate the model's discrimination, calibration, and clinical utility, ultimately supporting evidence-based interventions to improve postoperative outcomes and patient satisfaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with postoperative thyroid surgery pain
Key inclusion criteria (1 listed)
- Age ≥ 18 years； Undergoing thyroid surgery under general anesthesia, including both open and endoscopic procedures； Complete postoperative follow-up records available (minimum 48 hours)； Accessible and complete surgical and anesthesia records； Provision of written informed consent by the patient or their legally authorized representative；
Key exclusion criteria (1 listed)
- Failed tracheal intubation or need for emergency tracheotomy during surgery； Reoperation required due to postoperative complications such as bleeding or nerve injury； Severe cardiopulmonary disease (ASA physical status ≥ IV) or long-term use of corticosteroids； Incomplete clinical data；
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 |
|---|---|---|
| Observational studies without interventionObservational studies without intervention | Other | – |
Primary outcome
incidence of Postoperative Sore rate within 24 hours after surgery
Time frame: within 24 hours after surgery
2 secondary outcomes
incidence of Postoperative Sore Throat rate 1 hour after surgery
Time frame: 1 hour after surgery
incidence of Postoperative Sore Throat rate 48 hour after surgery
Time frame: 48 hour after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
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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.
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 Postoperative Sore Throat, run by Nanjing First Hospital, Nanjing Medical University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 28 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
incidence of Postoperative Sore rate within 24 hours after surgery (time frame: within 24 hours after surgery). 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 28 Jul 2025.