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Clinical trial

Effect of Hot Saline Irrigation on the Operative Field During Endoscopic Sinus Surgery: A Randomized Controlled Trial

ID
Name
JALTAF
Description
Control of bleeding is very important during endoscopic sinus surgery. Saline heated up to 50°C causes dilatation of vessels and edema without nasal mucosa necrosis. It also promotes the clotting cascade so helps in having a bloodless procedure. This randomized controlled trial was conducted on 60 patients divided into two groups (30 each). Group A was the interventional group in which patients were irrigated with saline of 50°C during surgery. Group B was the control group where room temperature saline was used. Operative field was assessed using the Boezaart score, duration of surgery and bleeding in ml. KEY WORDS: * Chronic rhinosinusitis (CRS) * Endoscopic sinus surgery * Boezaart score
Trial arms
Trial start
2023-06-16
Estimated PCD
2023-12-15
Trial end
2023-12-31
Status
Completed
Treatment
Normal saline heated up to 50 °C
Saline heated up to 50 °C used for irrigation
Arms:
Group A (Interventional Group)
Other names:
NaCl 0.9%
Size
60
Primary endpoint
Boezaart Score
Per operative
Eligibility criteria
Inclusion Criteria: * All patients with chronic rhinosinusitis requiring surgery Exclusion Criteria: * Unilateral disease * Suspicion of malignancy * CSF leak * Bleeding diathesis * Significant comorbidities
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-04-02

1 organization

1 product

1 indication

Organization
Rawalpindi Medical College
Product
Normal saline
Indication
Rhinosinusitis