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Effect of Local Injection of Tranexamic Acid on Surgical Field during Functional Endoscopic Sinus Surgery in Patients with Chronic Rhinosinusitis: A Prospective Randomized Controlled Trial

Effect of Local Injection of Tranexamic Acid on Surgical Field during Functional Endoscopic Sinus Surgery in Patients with Chronic Rhinosinusitis: A Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210531005
Enrollment
47
Registered
2021-05-31
Start date
2021-07-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To study the results of local injection of tranexamic acid on surgical field quality during endoscopic sinus surgery in chronic rhinosinusitis patients Endoscopic sinus surgery, FESS, Tranexamic acid, surgical field quality

Interventions

1. A statistician makes 47 sealed envelopes for 47 subjects using block randomization (computerized program by STATA) - each sealed envelope will specify which side of nose will receive intervention o
Active Comparator Drug
Tranexamic acid

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Being candidate for FESS based on EPOS 2020 criteria 2. Age 18 to 60 years 3. Hemoglobin > 10 mg/dl 4. Normal INR, PT, PTT

Exclusion criteria

Exclusion criteria: 1. Having diathesis hemorrhage such as hemophilia 2. Having history of thrombosis 3. Acute or chronic renal failure 4. Using heparin during 48 hours before surgery 5. Using aspirin during 7 days before surgery 6. Allergy to TXA 7. Cirrhosis 8. Pregnancy 9. Having a cardiac stent 10. Having a nasal tumor 11. Patients who are unable to undergo surgery due to the opinion of an internist 12. Refuse to participate in OR withdraw from the research

Design outcomes

Primary

MeasureTime frame
The quality of surgical field at 15, 30 and 45 minutes after the start of surgery Boezaart surgical field grading sysyem, Wormald surgical field grading system

Secondary

MeasureTime frame
Operative blood loss at 15, 30 and 45 minutes after the start of surgery ml,Duration of surgery at the end of the operation of each side of the nose minute,Side effects 24 hours after operation questionnaire

Countries

Thailand

Contacts

Public ContactKshidej Bongsabhikul

Faculty of Medicine, Mahidol University

kshidej@gmail.com0993546456

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026