NCT07866274

Brief Summary

Functional endoscopic sinus surgery (FESS), or sinusoscopy, is a standard surgical procedure used to treat chronic rhinosinusitis and other conditions of the nasal sinuses. However, bleeding during surgery is a frequent challenge that can obstruct the surgeon's view, lengthen operative time, and increase the risk of complications. Vitamin C (ascorbic acid) supports collagen synthesis, capillary wall strength, and blood vessel integrity, which may help minimize mucosal bleeding during surgical procedures. The purpose of this randomized clinical trial is to evaluate whether administering preoperative Vitamin C reduces intraoperative bleeding, enhances surgical field visibility, and shortens operative duration in adult patients undergoing elective sinusoscopy. Participants will be randomly assigned to one of two groups:

  • Vitamin C Group: Receives a standardized 500 mg dose of Vitamin C before surgery.
  • Control Group: Receives standard perioperative care/placebo before surgery. Total blood loss will be recorded during surgery, surgical field clarity will be evaluated every 15 minutes using the Boezaart scale, and participants will be monitored for postoperative bleeding and potential side effects for up to 48 hours.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
13mo left

Started Nov 2026

Shorter than P25 for phase_2

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 8, 2026

Status Verified

October 1, 2026

Enrollment Period

1 year

First QC Date

October 4, 2026

Last Update Submit

October 4, 2026

Conditions

Keywords

Vitamin CAscorbic AcidFunctional Endoscopic Sinus SurgeryFESSSinusoscopySurgical Field VisibilityBoezaart ScaleEpistaxis

Outcome Measures

Primary Outcomes (1)

  • Total Intraoperative Blood Loss

    Total intraoperative blood loss measured in milliliters (mL). Calculated as the total fluid collected in the suction canisters minus the volume of surgical irrigation fluid used, added to the volume calculated from blood-soaked gauzes (determined gravimetrically: wet gauze weight minus dry gauze weight, where 1 g = 1 mL).

    Through completion of surgery, up to 2 hours

Study Arms (2)

Vitamin C Group

EXPERIMENTAL

Patients scheduled for elective functional endoscopic sinus surgery (FESS) receiving a standardized dose of 500 mg Vitamin C (ascorbic acid) preoperatively in addition to standard general anesthesia and monitoring.

Drug: Ascorbic acid

Control Group

PLACEBO COMPARATOR

Patients scheduled for elective functional endoscopic sinus surgery (FESS) receiving matching placebo or standard perioperative care preoperatively in addition to standard general anesthesia and monitoring.

Other: Placebo

Interventions

Administration of a standardized dose of 500 mg Vitamin C (ascorbic acid) preoperatively prior to functional endoscopic sinus surgery (FESS).

Also known as: Vitamin C
Vitamin C Group
PlaceboOTHER

Administration of matching placebo or standard perioperative care preoperatively prior to functional endoscopic sinus surgery (FESS).

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective functional endoscopic sinus surgery (FESS / sinusoscopy)
  • Age between 18 and 65 years
  • American Society of Anesthesiologists (ASA) physical status I or II

You may not qualify if:

  • Pre-existing bleeding disorders, coagulopathy, or concurrent anticoagulant/antiplatelet therapy
  • History of renal stones (nephrolithiasis) or severe renal impairment
  • Pregnant or lactating females
  • Current smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Blood Loss, SurgicalEpistaxis

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative ComplicationsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

October 4, 2026

First Posted

October 8, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

October 8, 2026

Record last verified: 2026-10