Chronic Sinus DiseasePhase 2/3NCT05095961
Pre-operative Steroids in CRSsP
A Phase 2/3 study testing Prednisone in people with Chronic Sinus Disease and Chronic Sinusitis, Ethmoidal, run by Loma Linda University.
Trial summary
Randomized controlled trial to determine the effectiveness of a five-day course of pre-operative oral steroids on decreasing intra-operative blood loss during endoscopic sinus surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Sinus Disease, Chronic Sinusitis, Ethmoidal, Chronic Sinusitis, Sphenoidal
- What is being tested?
- Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Aug 2024
- Phase
- Phase 2/3
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients between the ages of 18 and 99 years of age with a diagnosis of chronic rhinosinusitis without polyps who are being scheduled for functional endoscopic sinus surgery
Who cannot join
- Patients under 18 years old, patients with a condition in which the use of systemic corticosteroids is contraindicated (poorly controlled diabetes mellitus, poorly controlled hypertension, active or untreated tuberculosis, active viral or fungal infection, acute angle glaucoma, osteoporosis, or acute congestive heart failure) patients allergic to corticosteroids, or, patients unwilling or unable to take the prescribed course of pre-operative steroids.
About this study
Official title: Effect of Pre-operative Oral Steroids on Blood Loss in Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Polyps
Randomized controlled trial to determine the effectiveness of a five-day course of pre-operative oral steroids on decreasing intra-operative blood loss during endoscopic sinus surgery.
Read the detailed description
The study will be a randomized cohort study, and patients will be recruited before surgery. Following randomization, patients will be given either a course of Prednisone (30 milligrams per day for 5 days, to be started five days prior to surgery) or no additional pre-operative prescriptions besides what is clinically determined by their treating physician. Patients will be scheduled for surgery and undergo functional endoscopic sinus surgery with timing as clinically indicated.
During endoscopic sinus surgery, surgical video will be recorded and stored on encrypted, flash drives with unique, non PHI, indicators to identify drives. Subsequently, each video will be graded by two, blinded surgeons for field visualization and thoroughness of dissection. Intra-operative blood loss will also be recorded. Post-operative data through 30 days post-operatively will be collected including: post-operative complications, resolution of symptoms, and nasal crusting during post-operative follow up. Following completion of data collection, these data will be analyzed by a separate, blinded investigator.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
5 day course of oral prednisone pre-operatively. 30mg per day.
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative oral steroids | Experimental | Patients will be given a course of oral prednisone (30mg daily) for 5 days. Receives: Drug: Prednisone |
| Control | No intervention | No pre-operative medication will be prescribed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative blood loss - 1
Measured intra-operative blood loss (in milliliters) as assessed by standard measure (total of blood in the suction canister [less the irrigation used])
Measured: Intra-operative
Intra-operative blood loss - 2
Blinded assessors grading of blood loss (in milliliters) as assessed by standard measure (total of blood in the suction canister [less the irrigation used])
Measured: Intra-operative
Surgical field visibility
Blinded assessor's grading of surgical field visualization
Measured: Intra-operative
Secondary outcomes (1)
Patient intolerance of steroids
Patient report of intolerable adverse effects of pre-operative steroids
Measured: Pre-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study startMar 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionAug 2024 (estimated)
Why it stopped: Technical difficulties encountered with recording intraoperative blood loss; unable to proceed with study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Sinus DiseaseStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient's will be randomized to one of two groups: pre-operative oral steroids or no control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Chan, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095961
- Sponsor's protocol ID
- 5210327
- Status last verified
- Aug 2023
- First submitted
- 29 Sep 2021
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Govindaraj S, Adappa ND, Kennedy DW. Endoscopic sinus surgery: evolution and technical innovations. J Laryngol Otol. 2010 Mar;124(3):242-50. doi: 10.1017/S0022215109991368. Epub 2009 Nov 23.
PubMed 19930748Linder TE, Simmen D, Stool SE. Revolutionary inventions in the 20th century. The history of endoscopy. Arch Otolaryngol Head Neck Surg. 1997 Nov;123(11):1161-3. doi: 10.1001/archotol.1997.01900110011001.
PubMed 9366694Moffatt DC, McQuitty RA, Wright AE, Kamucheka TS, Haider AL, Chaaban MR. Evaluating the Role of Anesthesia on Intraoperative Blood Loss and Visibility during Endoscopic Sinus Surgery: A Meta-analysis. Am J Rhinol Allergy. 2021 Sep;35(5):674-684. doi: 10.1177/1945892421989155. Epub 2021 Jan 21.
PubMed 33478255Wawrzyniak K, Burduk PK, Cywinski JB, Kusza K, Kazmierczak W. Improved quality of surgical field during endoscopic sinus surgery after clonidine premedication--a pilot study. Int Forum Allergy Rhinol. 2014 Jul;4(7):542-7. doi: 10.1002/alr.21308. Epub 2014 Mar 3.
PubMed 24591266Sieskiewicz A, Olszewska E, Rogowski M, Grycz E. Preoperative corticosteroid oral therapy and intraoperative bleeding during functional endoscopic sinus surgery in patients with severe nasal polyposis: a preliminary investigation. Ann Otol Rhinol Laryngol. 2006 Jul;115(7):490-4. doi: 10.1177/000348940611500702.
PubMed 16900802Gunel C, Basak HS, Bleier BS. Oral steroids and intraoperative bleeding during endoscopic sinus surgery. B-ENT. 2015;11(2):123-8.
PubMed 26563012Hwang SH, Seo JH, Joo YH, Kang JM. Does the Preoperative Administration of Steroids Reduce Intraoperative Bleeding during Endoscopic Surgery of Nasal Polyps? Otolaryngol Head Neck Surg. 2016 Dec;155(6):949-955. doi: 10.1177/0194599816663455. Epub 2016 Aug 23.
PubMed 27554509
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-operative Oral Steroids on Blood Loss in Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Polyps
- ClinicalTrials.gov ID
- NCT05095961
- Acronym / sponsor ID
- 5210327
- Conditions
- Chronic Sinus Disease, Chronic Sinusitis, Ethmoidal, Chronic Sinusitis, Sphenoidal, Chronic Sinusitis - Maxillary Bilateral, Chronic Sinusitis - Frontoethmoidal
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technical difficulties encountered with recording intraoperative blood loss; unable to proceed with study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 27 Oct 2021 (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.
Randomized controlled trial to determine the effectiveness of a five-day course of pre-operative oral steroids on decreasing intra-operative blood loss during endoscopic sinus surgery.
Detailed description
The study will be a randomized cohort study, and patients will be recruited before surgery. Following randomization, patients will be given either a course of Prednisone (30 milligrams per day for 5 days, to be started five days prior to surgery) or no additional pre-operative prescriptions besides what is clinically determined by their treating physician. Patients will be scheduled for surgery and undergo functional endoscopic sinus surgery with timing as clinically indicated.
During endoscopic sinus surgery, surgical video will be recorded and stored on encrypted, flash drives with unique, non PHI, indicators to identify drives. Subsequently, each video will be graded by two, blinded surgeons for field visualization and thoroughness of dissection. Intra-operative blood loss will also be recorded. Post-operative data through 30 days post-operatively will be collected including: post-operative complications, resolution of symptoms, and nasal crusting during post-operative follow up. Following completion of data collection, these data will be analyzed by a separate, blinded investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patient's will be randomized to one of two groups: pre-operative oral steroids or no control
| Arm | Type | Receives |
|---|---|---|
| Pre-operative oral steroids | Experimental | Drug: PrednisonePatients will be given a course of oral prednisone (30mg daily) for 5 days. |
| Control | No intervention | –No pre-operative medication will be prescribed |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients between the ages of 18 and 99 years of age with a diagnosis of chronic rhinosinusitis without polyps who are being scheduled for functional endoscopic sinus surgery
Key exclusion criteria (1 listed)
- Patients under 18 years old, patients with a condition in which the use of systemic corticosteroids is contraindicated (poorly controlled diabetes mellitus, poorly controlled hypertension, active or untreated tuberculosis, active viral or fungal infection, acute angle glaucoma, osteoporosis, or acute congestive heart failure) patients allergic to corticosteroids, or, patients unwilling or unable to take the prescribed course of pre-operative steroids.
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 |
|---|---|---|
| Prednisone5 day course of oral prednisone pre-operatively. 30mg per day. | Drug | Pre-operative oral steroids |
Primary outcome
Intra-operative blood loss - 1
Time frame: Intra-operative
Measured intra-operative blood loss (in milliliters) as assessed by standard measure (total of blood in the suction canister [less the irrigation used])
Intra-operative blood loss - 2
Time frame: Intra-operative
Blinded assessors grading of blood loss (in milliliters) as assessed by standard measure (total of blood in the suction canister [less the irrigation used])
Surgical field visibility
Time frame: Intra-operative
Blinded assessor's grading of surgical field visualization
1 secondary outcome
Patient intolerance of steroids
Time frame: Pre-operative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Background: PubMed 19930748Govindaraj S, Adappa ND, Kennedy DW. Endoscopic sinus surgery: evolution and technical innovations. J Laryngol Otol. 2010 Mar;124(3):242-50. doi: 10.1017/S0022215109991368. Epub 2009 Nov 23.
- Background: PubMed 9366694Linder TE, Simmen D, Stool SE. Revolutionary inventions in the 20th century. The history of endoscopy. Arch Otolaryngol Head Neck Surg. 1997 Nov;123(11):1161-3. doi: 10.1001/archotol.1997.01900110011001.
- Background: PubMed 33478255Moffatt DC, McQuitty RA, Wright AE, Kamucheka TS, Haider AL, Chaaban MR. Evaluating the Role of Anesthesia on Intraoperative Blood Loss and Visibility during Endoscopic Sinus Surgery: A Meta-analysis. Am J Rhinol Allergy. 2021 Sep;35(5):674-684. doi: 10.1177/1945892421989155. Epub 2021 Jan 21.
- Background: PubMed 24591266Wawrzyniak K, Burduk PK, Cywinski JB, Kusza K, Kazmierczak W. Improved quality of surgical field during endoscopic sinus surgery after clonidine premedication--a pilot study. Int Forum Allergy Rhinol. 2014 Jul;4(7):542-7. doi: 10.1002/alr.21308. Epub 2014 Mar 3.
- Background: PubMed 16900802Sieskiewicz A, Olszewska E, Rogowski M, Grycz E. Preoperative corticosteroid oral therapy and intraoperative bleeding during functional endoscopic sinus surgery in patients with severe nasal polyposis: a preliminary investigation. Ann Otol Rhinol Laryngol. 2006 Jul;115(7):490-4. doi: 10.1177/000348940611500702.
- Background: PubMed 26563012Gunel C, Basak HS, Bleier BS. Oral steroids and intraoperative bleeding during endoscopic sinus surgery. B-ENT. 2015;11(2):123-8.
- Background: PubMed 27554509Hwang SH, Seo JH, Joo YH, Kang JM. Does the Preoperative Administration of Steroids Reduce Intraoperative Bleeding during Endoscopic Surgery of Nasal Polyps? Otolaryngol Head Neck Surg. 2016 Dec;155(6):949-955. doi: 10.1177/0194599816663455. Epub 2016 Aug 23.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nadia Chan, MD principal investigator
Loma Linda University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Prednisone in people with Chronic Sinus Disease and Chronic Sinusitis, Ethmoidal, run by Loma Linda 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 9 Aug 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Intra-operative blood loss - 1 (time frame: Intra-operative). The study lists 3 primary outcomes in all. 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 NCT05095961, which also lists 7 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 9 Aug 2023.