AzTrials
AzTrials

RhinosinusitisNCT06343493

Effect of Hot Saline Irrigation on the Operative Field During Endoscopic Sinus Surgery

A study testing Normal saline heated up to 50 °C in people with Rhinosinusitis, run by Rawalpindi Medical College at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Rhinosinusitis
What is being tested?
Normal saline heated up to 50 °C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePakistan
Study dates
16 Jun 2023to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • All patients with chronic rhinosinusitis requiring surgery

Who cannot join

  • Unilateral disease
  • Suspicion of malignancy
  • CSF leak
  • Bleeding diathesis
  • Significant comorbidities

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Benazir Bhutto Hospital

    Rawalpindi, Punjab Province, 46000

Other trials in Pakistan

About this study

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

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
Read the detailed description

INTRODUCTION: Chronic rhinosinsusitis is an inflammatory disease of the sinonasal mucosa lasting for more than 12 weeks. Endoscopic sinus surgery is the surgical procedure used to treat recalcitrant chronic rhinosinusitis. 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. Control of bleeding during the procedure is a test for surgeons as well as anesthetists. Capillaries are the commonest vessels to bleed during the surgery so that's why mean arterial pressure is an important determinant of the severity of bleeding. A good control of bleeding gives a good visualization of the anatomy during the procedure.

There are different ways to reduce bleeding but all carry side effects too. Topical vasoconstrictors may also be absorbed systemically so must be used carefully in children and patients with cardiac ischemia. Moreover, there's no accurate way to measure absorption of a vasoconstrictor so it's difficult to recommend a safe dose for a particular patient. Cautery which is used to seal blood vessels is also associated with pain as well as mucosal damage. Anesthesia induced hypotension is also not appropriate for all patients as it results in decreased oxygen supply to various vitals organs of the body.

Normal saline heated up to 50°C causes dilatation of vessels and nasal edema without causing nasal mucosa necrosis. This edema compresses blood vessels and helps in controlling bleeding. It also promotes the clotting cascade. In addition, it provides better visualization of the surgical field by reduction of fog formation. A study conducted by Shehata A et al. showed a significant improvement in the operative field when normal saline at 50° C was used during endoscopic sinus surgery. Not only the operative filed was improved, also the duration of surgery was significantly reduced. According to the results of this study, saline heated up to 50°C used for the irrigation of endoscopic sinus surgery produced a result comparable to usage of tranexamic acid with a significant p value. Another study by Ranford D et al. concluded that irrigation with heated saline during endoscopic sinus surgery reduced bleeding by 20 percent.

This study aims to assess the effect of heated normal saline up to 50°C upon the operative field during endoscopic sinus surgery. The use of hot saline for irrigation during endoscopic sinus surgery can prove to be a cost effective method to have a bloodless field during surgery.

METHODS AND MATERIALS:

This randomized controlled trial was conducted after approval from the ethical board in the setting of department of ENT and head \& neck surgery, Benazir Bhutto Hospital, Rawalpindi over a period of ten months from June 2023 to Dec 2023. The sampling technique was simple random sampling. The patients were divided into two groups (treatment group and control group) via randomization using the lottery method. Sample size came out to be 60, with 30 patients in each group. Proper written consents taken from the patients and the surgery was done in the ENT operation theatre by a surgeon with an experience of more than 5 years.

Patient with bilateral chronic rhinosinusitis and pansinusitis on plain CT scan nose and paranasal sinuses were included in the study. Patients with unilateral disease, uncontrolled hypertension, diabetes or other significant comorbidities were excluded. Moreover, patients with the suspicion of malignancy, CSF leak and bleeding diathesis affecting the results were also not included in the study. Group A was the interventional group in which normal saline heated up to 50°C was irrigated during surgery. Normal saline was heated in a boiler and a temperature of 50°C was continuously maintained and monitored. Mean arterial pressure appropriate for endoscopic sinus surgery was controlled by the anesthetist using different drugs for hypotensive anesthesia and it was recorded after every 15 minutes. Intra-operative blood loss was measured from the glass suction tank after subtraction of the irrigated normal saline.

The patient, operating surgeon and primary investigator were blinded during the study to prevent bias. To assess the operative field, subjective grading was done by the surgeon using the Boezaart score. Wait and watch approach was followed to assess bleeding control. Total duration of surgery was also recorded. At the end of the surgery, bilateral anterior nasal packing was done.

ANALYSIS PLAN:

The data was analysed by SPSS version 26. Quantitative data was expressed as mean and standard deviation. Qualitative data was represented as frequencies and percentages. Independent sample T tests was used for the quantitative data analysis. Moreover different correlations were done via Spearman and Kendall test. A P value of <0.05 was considered as significant and a P value of <0.001 showed a high significance.

Conditions
Rhinosinusitis
Being tested
Normal saline heated up to 50 °C
Keywords
Endoscopic sinus surgery, Operative field, Saline
Medical subject headings
Rhinosinusitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Normal saline heated up to 50 °CDrug

    Also called NaCl 0.9%

    Saline heated up to 50 °C used for irrigation

Study groups in NCT06343493
Study groupRoleWhat they receive
Group A (Interventional Group)ExperimentalHot saline with a temperature of 50°C used for irrigation during endoscopic sinus surgery. Frequency of the drug is according to the operative field and surgeon's need.
Receives: Drug: Normal saline heated up to 50 °C
Group B (Control Group)No interventionSaline at room temperature used for irrigation during endoscopic sinus surgery. Frequency according to the operative field and surgeon's need.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Boezaart Score

    Operative field is assessed based on the Boezaart score which is a subjective score graded from 0 to 5 where 0 shows no bleeding and is the minimum score. 5 is the maximum score which shows severe bleeding. So the outcome worsens as the grade becomes higher from 0 to 5. 5 shows the worst outcome.

    Measured: Per operative

Secondary outcomes (2)
  1. Bleeding in ml

    Operative field assessed on the basis of blood loss in ml measured from the suction tanks after subtracting the irrigated saline volume

    Measured: Per operative

  2. Duration of Surgery

    If the operative field is good, duration of surgery is decreased and vice versa

    Measured: From the start of surgery to the end (per operative)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start16 Jun 2023
  3. Primary completion15 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06343493
Sponsor's protocol ID
JALTAF
Status last verified
Mar 2024
First submitted
17 Mar 2024
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ranford D, Fu B, Surda P, Rudd J. Hot saline irrigation for haemostasis in functional endoscopic sinus surgery: a systematic review and meta-analysis. J Laryngol Otol. 2022 Aug;136(8):676-682. doi: 10.1017/S0022215121003698. Epub 2021 Nov 25.

    PubMed 34819186
  • 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-Oct;20(5):506-19. doi: 10.2500/ajr.2006.20.2923.

    PubMed 17063747
  • 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.

    PubMed 9473061

Questions about this trial

What is this clinical trial studying?

A study testing Normal saline heated up to 50 °C in people with Rhinosinusitis, run by Rawalpindi Medical College at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Boezaart Score (time frame: Per operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06343493, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in