Chronic RhinosinusitisPhase 2NCT07866274
Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
A Phase 2 study testing Ascorbic acid in people with Chronic Rhinosinusitis and Intraoperative Bleeding, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Rhinosinusitis, Intraoperative Bleeding, Blood Loss, Surgical
- What is being tested?
- Ascorbic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy: A Randomized Clinical Trial
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.
Read more
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.
- Being tested
- Ascorbic acid, Placebo
- Keywords
- Vitamin C, Ascorbic Acid, Functional Endoscopic Sinus Surgery, FESS, Sinusoscopy, Surgical Field Visibility, Boezaart Scale, Epistaxis
- Medical subject headings
- Blood Loss, Surgical, Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic acidDrug
Also called Vitamin C
Administration of a standardized dose of 500 mg Vitamin C (ascorbic acid) preoperatively prior to functional endoscopic sinus surgery (FESS).
PlaceboOther
Administration of matching placebo or standard perioperative care preoperatively prior to functional endoscopic sinus surgery (FESS).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through completion of surgery, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Ahmed Mahmoud Sanad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866274
- Sponsor's protocol ID
- Vitamin C for Sinusoscopy
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07866274
- Acronym / sponsor ID
- Vitamin C for Sinusoscopy
- Keywords
- Vitamin C, Ascorbic Acid, Functional Endoscopic Sinus Surgery, FESS, Sinusoscopy, Surgical Field Visibility, Boezaart Scale, Epistaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C Group | Experimental | Drug: Ascorbic acidPatients 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. |
| Control Group | Placebo comparator | Other: PlaceboPatients scheduled for elective functional endoscopic sinus surgery (FESS) receiving matching placebo or standard perioperative care preoperatively in addition to standard general anesthesia and monitoring. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic acidAlso: Vitamin CAdministration of a standardized dose of 500 mg Vitamin C (ascorbic acid) preoperatively prior to functional endoscopic sinus surgery (FESS). | Drug | Vitamin C Group |
| PlaceboAdministration of matching placebo or standard perioperative care preoperatively prior to functional endoscopic sinus surgery (FESS). | Other | Control Group |
Primary outcome
Total Intraoperative Blood Loss
Time frame: Through completion of surgery, up to 2 hours
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ascorbic acid in people with Chronic Rhinosinusitis and Intraoperative Bleeding, run by Assiut University.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Total Intraoperative Blood Loss (time frame: Through completion of surgery, up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.