Correlation of Preoperative Indices (serum Vit D, Calcium, Phosphorus, FAR, PLR, SII) on Intraoperative Bleeding in CRS

The purpose of this observational study was to examine whether preoperative indicators correlate with intraoperative bleeding to facilitate control of intraoperative bleeding.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Rhinosinusitis (CRS) with and Without Nasal Polyps
• Intervention / Treatment: Other: without interventios.

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Diagnosed with chronic sinusitis

Description

Inclusion Criteria:

Clinical diagnosis of chronic rhinosinusitis

Exclusion Criteria:

Sinus cyst Upper respiratory tract infection in the last 1 week Use of antiepileptic drugs Use of aspirin Use of anticoagulant or antiplatelet drugs

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
chronic rhinosinusitis; chronic rhinosinusitis with/without nasal polys.	Other: without interventios.; without interventios.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2024/11/1-2025/7/31

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	2024/11/1-2025/7/31

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: chronic rhinosinusitis; Intraoperative haemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Hemorrhage; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Sinusitis; Paranasal Sinus Diseases; Polyps; Intraoperative Complications; Rhinosinusitis; Nasal Polyps; Blood Loss, Surgical
• Other Study ID Numbers: KY20241112-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No