Chronic Rhinosinusitis (CRS) with and Without Nasal PolypsNCT06737198
Correlation of Preoperative Indices (serum Vit D, Calcium, Phosphorus, FAR, PLR, SII) on Intraoperative Bleeding in CRS
An observational study of Chronic Rhinosinusitis (CRS) with and Without Nasal Polyps, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The purpose of this observational study was to examine whether preoperative indicators correlate with intraoperative bleeding to facilitate control of intraoperative bleeding. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis (CRS) with and Without Nasal Polyps
- What is being tested?
- without interventios.
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Mar 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diagnosed with chronic sinusitis
Who may be able to join
- Clinical diagnosis of chronic rhinosinusitis
Who cannot join
- Sinus cyst Upper respiratory tract infection in the last 1 week Use of antiepileptic drugs Use of aspirin Use of anticoagulant or antiplatelet drugs
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this observational study was to examine whether preoperative indicators correlate with intraoperative bleeding to facilitate control of intraoperative bleeding.
Read the detailed description
In this study, we analysed the effect of preoperative inflammation on intraoperative haemorrhage at the subjective and objective levels by measuring a number of indicators (including Vit D, Ca, P, and some ratios) in the blood specimens and by three scales.Blood test indicators can be obtained from routine tests.Three scales were obtained by the researcher after interviewing the patients, Symptom Score (0-15), where higher scores indicate more severe symptoms, Lund-Kennedy Score (0-6), where higher scores indicate higher levels of localised inflammation, Lund-Mackay Score (0-12 unilaterally and 24 bilaterally), where higher scores indicate higher levels of inflammation, and Lund-Mackay Score (0-12 unilaterally and 24 bilaterally), where higher scores indicate higher levels of inflammation.Lund-Mackay score (0-12 unilaterally, 24 bilaterally), where higher scores represent higher levels of inflammation.Final correlation of blood test indices and three scale scores with intraoperative.
- Being tested
- without interventios.
- Keywords
- chronic rhinosinusitis, Intraoperative haemorrhage
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
without interventios.Other
without interventios.
| Study group | Role | What they receive |
|---|---|---|
| chronic rhinosinusitis | chronic rhinosinusitis with/without nasal polys. Receives: Other: without interventios. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative haemorrhage
Intraoperative haemorrhage was grouped with a cut-off value of 150 ml and divided into <150 ml (normal haemorrhage group) and ≥150 ml (high haemorrhage group).
Measured: 2024/11/1-2025/7/31
Secondary outcomes (3)
Symptom system
Symptom system (0-15 scores), assessed in five areas: nasal congestion, runny nose, reduced sense of smell, head and face swelling, and sleep disturbances, where higher scores represent more severe symptoms.
Measured: 2024/11/1-2025/7/31
Lund-Kennedy system
Lund-Kennedy system (0-6 scores), assessed under nasal endoscopy in terms of polyps, oedema and nasal secretions, where a higher score represents a higher level of local inflammation.
Measured: 2024/11/1-2025/7/31
Lund-Mackay system
The Lund-Mackay system (0-12 unilaterally, 24 points in total bilaterally) analyses the inflammatory status within each sinus and the assessment of whether the sinonasal complex is obstructed in two major ways, where higher scores represent higher levels of inflammation.
Measured: 2024/11/1-2025/7/31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Nov 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (CRS) with and Without Nasal PolypsStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737198
- Sponsor's protocol ID
- KY20241112-07
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2024
- Last updated
- 17 Dec 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 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Preoperative Indices (serum Vit D, Calcium, Phosphorus, FAR, PLR, SII) on Intraoperative Bleeding in CRS
- ClinicalTrials.gov ID
- NCT06737198
- Acronym / sponsor ID
- KY20241112-07
- Keywords
- chronic rhinosinusitis, Intraoperative haemorrhage
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 17 Dec 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.
The purpose of this observational study was to examine whether preoperative indicators correlate with intraoperative bleeding to facilitate control of intraoperative bleeding.
Detailed description
In this study, we analysed the effect of preoperative inflammation on intraoperative haemorrhage at the subjective and objective levels by measuring a number of indicators (including Vit D, Ca, P, and some ratios) in the blood specimens and by three scales.Blood test indicators can be obtained from routine tests.Three scales were obtained by the researcher after interviewing the patients, Symptom Score (0-15), where higher scores indicate more severe symptoms, Lund-Kennedy Score (0-6), where higher scores indicate higher levels of localised inflammation, Lund-Mackay Score (0-12 unilaterally and 24 bilaterally), where higher scores indicate higher levels of inflammation, and Lund-Mackay Score (0-12 unilaterally and 24 bilaterally), where higher scores indicate higher levels of inflammation.Lund-Mackay score (0-12 unilaterally, 24 bilaterally), where higher scores represent higher levels of inflammation.Final correlation of blood test indices and three scale scores with intraoperative.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic rhinosinusitis | – | Other: without interventios.chronic rhinosinusitis with/without nasal polys. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with chronic sinusitis
Key inclusion criteria (1 listed)
- Clinical diagnosis of chronic rhinosinusitis
Key exclusion criteria (1 listed)
- Sinus cyst Upper respiratory tract infection in the last 1 week Use of antiepileptic drugs Use of aspirin Use of anticoagulant or antiplatelet drugs
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 |
|---|---|---|
| without interventios.without interventios. | Other | chronic rhinosinusitis |
Primary outcome
Intraoperative haemorrhage
Time frame: 2024/11/1-2025/7/31
Intraoperative haemorrhage was grouped with a cut-off value of 150 ml and divided into <150 ml (normal haemorrhage group) and ≥150 ml (high haemorrhage group).
3 secondary outcomes
Symptom system
Time frame: 2024/11/1-2025/7/31
Lund-Kennedy system
Time frame: 2024/11/1-2025/7/31
Lund-Mackay system
Time frame: 2024/11/1-2025/7/31
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 17 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Chronic Rhinosinusitis (CRS) with and Without Nasal Polyps
Recruiting
Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
RecruitingObservational study
CRS Questionnaire Validation Project
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Enrolling by invitation
Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate (MF)
Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Active, not recruitingEarly Phase 1
Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps (FIH)
Chronic Rhinosinusitis
Not yet recruitingObservational study
The German National CRS Registry (GenreCRS): Clinical Evaluation of the New European Academy for Allergy and Clinical Immunology (EAACI) Criteria for CRSwNP Disease Control, Remission and Cure in a Real-World Evidence Study Approach
Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis (CRS) with and Without Nasal Polyps, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Intraoperative haemorrhage (time frame: 2024/11/1-2025/7/31). 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 17 Dec 2024.