Sinusitis Clinical Trial
— HSIOfficial title:
Hot Saline Irrigation vs Room Temperature Saline Irrigation in the Control of Intraoperative Bleeding During Functional Endoscopic Sinus Surgery (FESS)
Verified date | April 2016 |
Source | St. Paul's Hospital, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Many methods have been used to reduce bleeding during sinus surgery (FESS) in order to allow
for the best surgical view and to reduce risk while in surgery.
Warm irrigation fluid is believed to accelerate the clotting mechanism in the human body.
The investigators would like to determine if hot saline irrigation (HSI) compared to room
temperature saline irrigation (RTSI) can control bleeding during FESS.
The hypothesis is that HSI is more effective than RTSI in reducing intraoperative bleeding
during FESS.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients with American Society of Anesthesiologist (ASA) classification <2 - Patients with chronic or recurrent sinusitis (as defined by the American Academy of Otolaryngology) with or without nasal polyposis refractory to medical treatment Exclusion Criteria: - Patients with a history of coagulation disorders - Patients with severe ischemic heart disease (IHD), pulmonary and renal disease - Patients with tumours or vascular anomalies - Patients with cystic fibrosis, allergic fungal sinusitis and Wegener's granulomatosis - Patients who are unable to speak, read and write English |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Canada | E.N.T. Clinic, St. Paul's Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
St. Paul's Hospital, Canada |
Canada,
Higgins TS, Hwang PH, Kingdom TT, Orlandi RR, Stammberger H, Han JK. Systematic review of topical vasoconstrictors in endoscopic sinus surgery. Laryngoscope. 2011 Feb;121(2):422-32. doi: 10.1002/lary.21286. Epub 2011 Jan 13. Review. — View Citation
Javer AR, Gheriani H, Mechor B, Flamer D, Genoway K, Yunker WK. Effect of intraoperative injection of 0.25% bupivacaine with 1:200,000 epinephrine on intraoperative blood loss in FESS. Am J Rhinol Allergy. 2009 Jul-Aug;23(4):437-41. doi: 10.2500/ajra.2009.23.3339. — View Citation
Novoa E, Schlegel-Wagner C. Hot water irrigation as treatment for intractable posterior epistaxis in an out-patient setting. J Laryngol Otol. 2012 Jan;126(1):58-60. doi: 10.1017/S002221511100243X. Epub 2011 Sep 5. — View Citation
Riegle EV, Gunter JB, Lusk RP, Muntz HR, Weiss KL. Comparison of vasoconstrictors for functional endoscopic sinus surgery in children. Laryngoscope. 1992 Jul;102(7):820-3. — View Citation
Stangerup SE, Dommerby H, Siim C, Kemp L, Stage J. New modification of hot-water irrigation in the treatment of posterior epistaxis. Arch Otolaryngol Head Neck Surg. 1999 Jun;125(6):686-90. — View Citation
Tirelli G, Bigarini S, Russolo M, Lucangelo U, Gullo A. Total intravenous anaesthesia in endoscopic sinus-nasal surgery. Acta Otorhinolaryngol Ital. 2004 Jun;24(3):137-44. — View Citation
Yaniv E, Shvero J, Hadar T. Hemostatic effect of tranexamic acid in elective nasal surgery. Am J Rhinol. 2006 Mar-Apr;20(2):227-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Boezaart and van der Merwe intraoperative surgical field scale | The Boezaart intra-operative surgical field scale will be used to grade the level of bleeding during surgery. This 0 to 5-point scale will be used to outline the amount of suction required to rid the area of blood disrupting vision. A score of 0 is given for an area with no bleeding, 1 for slight bleeding with no suction required, 2 for slight bleeding requiring suction, 3 for moderate bleeding which improves for several seconds once suction has occurred, 4 for moderate bleeding which restarts directly after suctioning and 5 for severe bleeding which occurs faster then can be removed | Every 15 minutes for the duration of surgery.. | No |
Secondary | Total Estimated Blood Loss | Total blood loss will be recorded over the duration of surgery. | Duration of surgery | No |
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