Effect of Hot Saline Irrigation on the Operative Field During Endoscopic Sinus Surgery: A Randomized Controlled Trial
Phase: NA
Conditions: Rhinosinusitis
Sponsor: Rawalpindi Medical College

 
 
Cover Page for ClinicalTrials.gov 
 
Document: 
Study Protocol and Statistical Analysis Plan 
 
Official Title of the Study  
Effect Of Hot Saline Irrigation on the Operative Field During 
Endoscopic Sinus Surgery: A Randomized Controlled trial 
 
 Date of the Document: 16th May, 2023 
 
 
 
 
 
 
 
                                                                                                    
 

 
 
 
 
 
Dr Jawairia Altaf, Department of ENT, Benazir Bhutto Hospital, Rawalpindi Medical University and 
Allied Hospitals, Rawalpindi  
 
Introduction 
        Chronic rhinosinsusitis is an inflammatory disease of the sinonasal mucosa lasting for more 
than 12 weeks.¹ Endoscopic sinus surgery is the surgical procedure used to treat recalcitrant 
chronic rhinosinusitis. ² It not only helps in the drainage of sinuses and removal of pathology 
but also prevents the disturbance of anatomy and formation of facial scars. ³,⁴ Control of 
bleeding during the procedure is a test for surgeons as well as anesthetists.⁵ 
                 Hot normal saline with a temperature of 50°C causes dilatation of vessels and nasal 
edema without causing mucosal necrosis, it not only helps in control of bleeding via 
compression of vasculature but also promotes the clotting pathways.5         
          A study conducted by Shehata A et al. showed a significant improvement in the operative 
field when hot normal saline at 50° C was used during endoscopic sinus surgery with a mean 
and standard deviation of 1.96±0.67 as compared to the control group (2.64±0.7).5 A study by 
Ranford D et al. concluded that irrigation with heated saline during endoscopic sinus surgery 
reduced bleeding by 20 percent.7 Moreover it also decreased the duration of patient’s surgery 
by 9 minutes. ⁶ 
        The aim of this study is to evaluate the effect of hot saline irrigation during endoscopic 
sinus surgery. The additional advantages provided by irrigation of hot saline will not only 
provide superior post-operative results but will also reduce the duration of surgery. 
 
Objective 
   To determine the effect of hot saline irrigation on the operative field during endoscopic sinus 
surgery. 
 

 
Hypothesis 
Hot saline irrigation provides good control of bleeding during endoscopic sinus surgery. 
 
 
Operational Definitions 
 
Endoscopic Sinus Surgery: An endonasal surgery done via endoscope using instruments for 
drainage of sinuses and removal of sinonasal pathology. 
 
Hot Normal Saline: A solution formed by dissolving 0.9 grams of NaCl in 100ml of water and 
warmed up to 50°C. 
 
Mean Arterial Pressure: It is an average pressure present in the arteries in one cardiac cycle 
calculated by addition of diastolic blood pressure with 1/3rd of the pulse pressure. 
 
Boezaart Score: 5 
Grades Assessment 
0- No bleeding (cadaveric conditions) 
1- Slight bleeding: no suctioning required. 
2- Slight bleeding: occasional suctioning required. 
3- Slight bleeding: frequent suctioning. Bleeding threatens surgical ſ eld a few seconds after 
suction is removed. 
4- Moderate bleeding: frequent suctioning required and bleeding threatens surgical field 
directly after suction is removed. 
5- Severe bleeding: constant suctioning required; bleeding appears faster than can be removed 
by suction; surgical field severely threatened and surgery usually not possible.  
 
 

Methods & Materials 
 
Study Design: Randomized controlled trial 
Study Setting: Department of ENT, Benazir Bhutto Hospital 
Study Duration: After the approval of the topic till completion of sample size 
Sample Size:  
      By using WHO sample size calculator 
      Sample size n = 60 (30 in each group) 
     Level of significance = 5% 
     Power of test = 90% 
    Test value population mean = 1.96⁵ 
    Anticipated population mean = 2.64⁵ 
    Population standard deviation = 0.685⁵ 
Sampling Technique: Simple random sampling 
 
 
Sample Selection 
Inclusion Criteria 
      Patients  bilateral chronic rhinosinusitis refractory to medical treatment and requiring 
surgical intervention. 
Exclusion Criteria 
1. Patients with malignancies. 
2. Patients with unilateral disease  
3. Bleeding diathesis 
4. Uncontrolled hypertension 
5. Long term usage of NSAIDS and anti-coagulants. 
 
 
Data Collection Procedure 

      This research will be carried out after approval from the Ethical Review Board of Rawalpindi 
Medical University. Patients requiring surgical intervention for chronic rhinosinusitis will be 
selected via simple random sampling. They will be divided into 2 groups via randomization (30 
patients in each group) and undergo endoscopic sinus surgery in the operation theatre of 
Benazir Bhutto Hospital. Double blinding will be done. Surgery will be performed by a 
consultant with an experience of more than 5 years. For the intervention, normal saline will be 
warmed in a boiler up to 50°C and temperature will be continuously checked with the help of a 
thermometer. Group A will have irrigation of nasal cavities with hot normal saline (of 50°C) 
during the operation. Group B will have irrigation with saline at room temperature. This is a 
double blinded RCT in which the patient and the operating surgeon will not know about the 
specific intervention. Bleeding score will be checked via Boezaart score. More over, duration of 
the procedure and mean arterial pressure of all patients will also be documented. The 
researcher will collect the data by herself to avoid bais. 
    
 
Data Analysis 
 
   Data will be analysed with help of SPSS version 26. Qualitative variables will be represented as 
frequencies and percentages. Quantitative variables will be represented via mean and standard 
deviation. Chi square test will be applied. Furthermore, logistic regression will be done. Data 
will be documented in tabular form. A P-value of <0.05 will be considered significant. 
 
 
References 
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bacteria and quality of life improvement after sinus surgery. Int Forum Allergy Rhinol. 
2015 Jul;5(7):643-9. Doi: 10.1002/alr.21505. Epub 2015 Mar 12. PMID: 25763837. 
 
2. Senior BA, Kennedy DW, Tanabodee J, Kroger H, Hassab M, Lanza D. Long-term results 
of functional endoscopic sinus surgery. Laryngoscope. 1998 Feb;108(2):151-7. Doi: 
10.1097/00005537-199802000-00001. PMID: 9473061. 
 
 
3. Alkan A, Honca M, Alkan A, Güleç H, Horasanlı E. The efficacy of esmolol, remifentanil 
and nitroglycerin in controlled hypotension for functional endoscopic sinus surgery. Braz 

J Otorhinolaryngol. 2021 May-Jun;87(3):255-259. Doi: 10.1016/j.bjorl.2019.08.008. Epub 
2019 Oct 3. PMID: 31668787; PMCID: PMC9422684. 
 
4. Dalziel K, Stein K, Round A, Garside R, Royle P. Endoscopic sinus surgery for the excision 
of nasal polyps: A systematic review of safety and effectiveness. Am J Rhinol. 2006 Sep-
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5. Shehata A, Ibrahim MS. & Abd-El-Fattah MH. Topical tranexamic acid versus hot saline 
for field quality during endoscopic sinus surgery. The Egyptian Journal of 
Otolaryngology. 2014; 30:327-331. https://doi.org/10.4103/1012-5574.144965. 
 
6. Ranford D, Fu B, Surda P, Rudd J. Hot saline irrigation for haemostasis in functional 
endoscopic sinus surgery: a systematic review and meta-analysis. The Journal of 
Laryngology & Otology. Cambridge University Press; 2022;136(8):676–
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