NCT01717274

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2016

Enrollment Period

2.3 years

First QC Date

October 26, 2012

Last Update Submit

April 13, 2016

Conditions

Sinusitis

Keywords

Functional Endoscopic Sinus SurgeryHot water irrigation

Outcome Measures

Primary Outcomes (1)

  • 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..

Secondary Outcomes (1)

  • Total Estimated Blood Loss

    Duration of surgery

Study Arms (2)

Hot saline irrigation

EXPERIMENTAL

Hot saline is prepared by first placing 2 litres of sterile normal saline (0.9%) into a basin (IntraTemp Therma BasinTM) that is wrapped in a sterile disposable drape (IntraTemp Therma Basin DrapeTM). The basin is then placed in a medical grade warmer (IntraTemp Fluid Warming SystemTM). The warmer is set to heat the saline up to a temperature of 50 degrees Celsius. An external digital thermometer is placed in the saline at all times to ensure that the temperature is between 45-50 degrees.

Procedure: Hot saline irrigation

Room temperature saline irrigation

NO INTERVENTION

Room temperature saline is prepared in the same manner as the experimental arm except that the warmer is switched off and the temperature of the saline in the basin is left to equilibrate to the temperature of the operating room.

Interventions

Hot saline irrigationPROCEDURE

The surgical field is flushed with 20 cc of hot saline (45-50 degrees Celsius) at five minutes intervals. This is in contrast to the standard of care, room temperature (20-25 degrees Celsius) saline irrigation.

Also known as: HSI
Hot saline irrigation

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E.N.T. Clinic, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (8)

  • 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. doi: 10.1288/00005537-199207000-00012.

    PMID: 1614253BACKGROUND

  • 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.

    PMID: 16686395BACKGROUND

  • 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.

    PMID: 15584584BACKGROUND

  • 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.

    PMID: 21271600BACKGROUND

  • 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. doi: 10.1001/archotol.125.6.686.

    PMID: 10367928BACKGROUND

  • 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.

    PMID: 21888749BACKGROUND

  • 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.

    PMID: 19671263BACKGROUND

  • Gan EC, Alsaleh S, Manji J, Habib AR, Amanian A, Javer AR. Hemostatic effect of hot saline irrigation during functional endoscopic sinus surgery: a randomized controlled trial. Int Forum Allergy Rhinol. 2014 Nov;4(11):877-84. doi: 10.1002/alr.21376. Epub 2014 Aug 18.

    PMID: 25137523DERIVED

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Amin R Javer, MD, FRCSC, FARS

    St Pauls Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 26, 2012

First Posted

October 30, 2012

Study Start

November 1, 2012

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

April 14, 2016

Record last verified: 2016-04

Locations

CA(1)