NCT06343493

Brief 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. 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

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 Jun 2023

Shorter than P25 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

Study Start

First participant enrolled

June 16, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

March 17, 2024

Last Update Submit

March 29, 2024

Conditions

Rhinosinusitis

Keywords

Endoscopic sinus surgeryOperative fieldSaline

Outcome Measures

Primary Outcomes (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.

    Per operative

Secondary Outcomes (2)

  • Bleeding in ml

    Per operative

  • Duration of Surgery

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

Study Arms (2)

Group A (Interventional Group)

EXPERIMENTAL

Hot 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.

Drug: Normal saline heated up to 50 °C

Group B (Control Group)

NO INTERVENTION

Saline at room temperature used for irrigation during endoscopic sinus surgery. Frequency according to the operative field and surgeon's need.

Interventions

Normal saline heated up to 50 °CDRUG

Saline heated up to 50 °C used for irrigation

Also known as: NaCl 0.9%
Group A (Interventional Group)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with chronic rhinosinusitis requiring surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benazir Bhutto Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 34819186RESULT

  • 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.

    PMID: 17063747RESULT

  • 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: 9473061RESULT

MeSH Terms

Conditions

Rhinosinusitis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

RhinitisRespiratory Tract InfectionsInfectionsSinusitisParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jawairia Altaf PGR

    Rawalpindi Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate trainee ENT

Study Record Dates

First Submitted

March 17, 2024

First Posted

April 2, 2024

Study Start

June 16, 2023

Primary Completion

December 15, 2023

Study Completion

December 31, 2023

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)