Chronic Rhinosinusitis (Diagnosis)NCT04093193
Debridement and Functional Endoscopic Sinus Surgery
A study testing Debridement in people with Chronic Rhinosinusitis (Diagnosis), run by St. Paul's Hospital, Canada at 1 site in Canada.
Trial summary
Functional endoscopic sinus surgery (FESS) is the gold standard surgical intervention for management of patients with chronic rhinosinusitis (CRS). Synechiae formation in the middle meatus is the most common complication of endoscopic sinus surgery after FESS. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jun 2018to 1 Sep 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 19;
- Have chronic sinus disease (CRS) and are scheduled to undergo sinus surgery on both sides of your nose for the first time.
Who cannot join
- Unable to speak English;
- Are having surgery for the removal of a nasal tumor;
- Have a disorder of your immune system in which your body's immune system attacks itself (autoimmune disorder)
- Diagnosed with cystic fibrosis
- Have had sinus surgery in the past
- Are scheduled to have a procedure known as nasal septal reconstruction, without additional sinus surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
E.N.T Clinic, St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
India Dhillon, BSc, 604-806-9926, idhillon3@providencehealth.bc.ca
Amin R Javer, MD FRCSCFARS
About this study
Official title: The Efficacy of Debridement of the Sinus Cavity Following Primary Functional Endoscopic Sinus Surgery (FESS): A Randomized Controlled Trial.
Functional endoscopic sinus surgery (FESS) is the gold standard surgical intervention for management of patients with chronic rhinosinusitis (CRS). Synechiae formation in the middle meatus is the most common complication of endoscopic sinus surgery after FESS. Nasal debridement is a postoperative procedure used in the prevention of synechiae formation. This procedure lacks standardized evidence-based guidelines. The currently existing studies that have been conducted to determine the efficacy of post-operative debridement have shown conflicting results. We hypothesize that there is no difference in short and long term clinical outcomes between patients who had routine post-operative nasal debridement following FESS and patients who did not have post-operative nasal debridement.
Read the detailed description
Purpose The purpose of this study is to assess the efficacy of post-FESS nasal debridements in the prevention of post-operative synechiae formation.
Hypothesis There is no difference in short and long term clinical outcomes between patients who had routine post-operative nasal debridement following FESS and patients who did not have post-operative nasal debridement.
Justification To prevent synechiae formation, many studies have been published evaluating the efficacy of post-operative debridement procedures. Many of these studies have shown conflicting results. There were many inconsistent variables between the studies, such as limited follow-up periods, varying extent of surgery, and variability in pre and post-operative treatment.
With a well designed study, we would like to assess if there is a difference in the incidence of formation of middle meatal synechiae between patients who have debridement and patients who don't.
This will further add much needed evidence to the need for this procedure in the post operative period following FESS.
Surgery The participants in this study will all undergo standard-of-care functional endoscopic sinus surgery (FESS) to treat their sinus disease. No changes will be made to pre-operative or operative protocol on account of this study. All post-operative standard-of-care procedures and medication will be maintained.
Follow up visits After FESS, participant subjects will be asked to return for 4 follow-up visits within the first 90 days and one follow-up visit at 180 days. They will be asked to return at 6, 30, 60, 90 and 180 days following their sinus surgery. At their 6 and 30 day follow-up visits they will either receive or not receive routine post-operative debridement depending on randomization.
Statistical Analysis
Sample size calculations A sample size calculation was performed to determine the appropriate number of patients required to adequately compare the incidence of synechiae between participants with versus without postoperative debridement following FESS. Previous investigations at the St. Paul's Sinus Centre have found that of post-FESS cases, 18% develop synechiae from use of gloved-Merocel middle meatal spacers. Utilizing a type I error of 5%, type II error of 20%, effect difference of 15% and 10% loss to follow-up, a total of 150 patients are required (75 per arm).
Statistical Comparisons The primary objective of this randomized controlled trial will be to compare the incidence of synechiae between subjects receiving debridement versus those receiving saline irrigation (no debridement) up to 180 days post-surgery. Count and absolute percentages of synechia incidence will be reported. The Chi-Squared test will be used to determine statistical significance between incidence rates. Probability values less than 5% (α=0.05) will be considered significant. Corresponding odds ratios and 95% confidence intervals will be reported.
For the secondary outcome measures (e.g. Sinonasal Outcomes Test 22 SNOT-22, PJESS/MLK), results will be summated and considered as continuous, numerical variables. Descriptive statistics using mean, median, standard deviation and inter-quartile ranges will be reported. The unpaired two sample student t-tests will be applied to investigate the difference between the means of the various outcome measures. Probability values less than 5% (α =0.05) will also be considered statistically significant.
Baseline demographics and clinical factors will be compared between each treatment group to determine whether randomization yielded comparable groups. Multivariable logistic and linear regression will be used to investigate the relationship between postoperative debridement and the primary (incidence of synechiae) or secondary outcomes (PJESS/MLK).
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- Debridement
- Keywords
- Functional Endoscopic Sinus Surgery
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DebridementProcedure or surgery
Debridement or cleaning of the sinuses post-operatively has been described as a regular post-surgery procedure .
| Study group | Role | What they receive |
|---|---|---|
| Debridement group | Experimental | Patients receive routine post-operative debridement at their Day 6, 30 and 60 follow up appointments. Receives: Procedure: Debridement |
| Non Debridement Group | No intervention | Patients will not receive debridement at any follow up visit after surgery. They will continue with saline irrigation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Postoperative Synechiae
The existence of postoperative synechiae will be considered as a categorical, dichotomous outcome variable (presence or absence).
Measured: Day 30, 60, 90, and 180 follow-up visits.
Secondary outcomes (3)
Sinonasal Outcomes Test - 22 (SNOT-22)
The SNOT-22 is a sinus-specific questionnaire that evaluates subjective symptoms for patients suffering from chronic rhinosinusitis.
SNOT-22 is scored out of 110 (22 questions, up to 5-points each) has demonstrated internal consistency, reliability, discriminate and concurrent validity and responsiveness to change. Responses will be summated and considered as a continuous, numerical variable.
Measured: Day 30, 60, 90, and 180 follow-up visits.
Philpott-Javer (PJ) and Modified Lund-Kennedy (MLK) Endoscopic Staging System (ESS)
Sinonasal mucosal inflammation is an objective measure assessed endoscopically and graded on both the PJ and MLK ESS for CRS.
Measured: Day 30, 60, 90, and 180 follow-up visits.
Visual Analog Score (VAS) for pain and discomfort
The visual analog score describes subjective pain and discomfort levels experienced by the participant following the procedures in both arms of the study.
Measured: Day 6, 30, 60, 90, and 180 follow-up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start22 Jun 2018
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two possible scenarios resulting from randomization: 1. The patient is randomized to the arm that receives routine post-operative debridement (treatment group). 2. The patient is randomized to the arm that will not receive post-operative debridement (control group).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Paul's Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Javer, St. Paul's Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093193
- Sponsor's protocol ID
- H15-02071
- Status last verified
- Sep 2019
- First submitted
- 7 Jun 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be available to other researchers.
Publications
Bachert C, Pawankar R, Zhang L, Bunnag C, Fokkens WJ, Hamilos DL, Jirapongsananuruk O, Kern R, Meltzer EO, Mullol J, Naclerio R, Pilan R, Rhee CS, Suzaki H, Voegels R, Blaiss M. ICON: chronic rhinosinusitis. World Allergy Organ J. 2014 Oct 27;7(1):25. doi: 10.1186/1939-4551-7-25. eCollection 2014.
PubMed 25379119Fernandes SV. Postoperative care in functional endoscopic sinus surgery? Laryngoscope. 1999 Jun;109(6):945-8. doi: 10.1097/00005537-199906000-00020.
PubMed 10369288Green R, Banigo A, Hathorn I. Postoperative nasal debridement following functional endoscopic sinus surgery, a systematic review of the literature. Clin Otolaryngol. 2015 Feb;40(1):2-8. doi: 10.1111/coa.12330.
PubMed 25314101Bednarski KA, Kuhn FA. Stents and drug-eluting stents. Otolaryngol Clin North Am. 2009 Oct;42(5):857-66, x. doi: 10.1016/j.otc.2009.07.001.
PubMed 19909864Miller RS, Steward DL, Tami TA, Sillars MJ, Seiden AM, Shete M, Paskowski C, Welge J. The clinical effects of hyaluronic acid ester nasal dressing (Merogel) on intranasal wound healing after functional endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2003 Jun;128(6):862-9. doi: 10.1016/S0194-59980300460-1.
PubMed 12825038Saafan ME, Ragab SM, Albirmawy OA, Elsherif HS. Powered versus conventional endoscopic sinus surgery instruments in management of sinonasal polyposis. Eur Arch Otorhinolaryngol. 2013 Jan;270(1):149-55. doi: 10.1007/s00405-012-1969-8. Epub 2012 Apr 10.
PubMed 22487908Catalano PJ, Roffman EJ. Evaluation of middle meatal stenting after minimally invasive sinus techniques (MIST). Otolaryngol Head Neck Surg. 2003 Jun;128(6):875-81. doi: 10.1016/S0194-59980300469-8.
PubMed 12825040Jorissen M. Postoperative care following endoscopic sinus surgery. Rhinology. 2004 Sep;42(3):114-20.
PubMed 15521662Lund VJ, MacKay IS. Outcome assessment of endoscopic sinus surgery. J R Soc Med. 1994 Feb;87(2):70-2. doi: 10.1177/014107689408700204. No abstract available.
PubMed 8196032Stammberger H. Endoscopic endonasal surgery--concepts in treatment of recurring rhinosinusitis. Part I. Anatomic and pathophysiologic considerations. Otolaryngol Head Neck Surg. 1986 Feb;94(2):143-7. doi: 10.1177/019459988609400202.
PubMed 3083326Kennedy DW. Prognostic factors, outcomes and staging in ethmoid sinus surgery. Laryngoscope. 1992 Dec;102(12 Pt 2 Suppl 57):1-18.
PubMed 1453856Bugten V, Nordgard S, Steinsvag S. The effects of debridement after endoscopic sinus surgery. Laryngoscope. 2006 Nov;116(11):2037-43. doi: 10.1097/01.mlg.0000241362.06072.83.
PubMed 17075402Bugten V, Nordgard S, Steinsvag S. Long-term effects of postoperative measures after sinus surgery. Eur Arch Otorhinolaryngol. 2008 May;265(5):531-7. doi: 10.1007/s00405-007-0501-z. Epub 2007 Oct 25.
PubMed 17960410Alsaffar H, Sowerby L, Rotenberg BW. Postoperative nasal debridement after endoscopic sinus surgery: a randomized controlled trial. Ann Otol Rhinol Laryngol. 2013 Oct;122(10):642-7.
PubMed 24294687Nilssen EL, Wardrop P, El-Hakim H, White PS, Gardiner Q, Ogston S. A randomized control trial of post-operative care following endoscopic sinus surgery: debridement versus no debridement. J Laryngol Otol. 2002 Feb;116(2):108-11. doi: 10.1258/0022215021910041.
PubMed 11827582
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Debridement of the Sinus Cavity Following Primary Functional Endoscopic Sinus Surgery (FESS): A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04093193
- Acronym / sponsor ID
- H15-02071
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Keywords
- Functional Endoscopic Sinus Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- St. Paul's Hospital, CanadaUniversity, hospital or other
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 17 Sep 2019 (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) is the gold standard surgical intervention for management of patients with chronic rhinosinusitis (CRS). Synechiae formation in the middle meatus is the most common complication of endoscopic sinus surgery after FESS. Nasal debridement is a postoperative procedure used in the prevention of synechiae formation. This procedure lacks standardized evidence-based guidelines. The currently existing studies that have been conducted to determine the efficacy of post-operative debridement have shown conflicting results. We hypothesize that there is no difference in short and long term clinical outcomes between patients who had routine post-operative nasal debridement following FESS and patients who did not have post-operative nasal debridement.
Detailed description
Purpose The purpose of this study is to assess the efficacy of post-FESS nasal debridements in the prevention of post-operative synechiae formation.
Hypothesis There is no difference in short and long term clinical outcomes between patients who had routine post-operative nasal debridement following FESS and patients who did not have post-operative nasal debridement.
Justification To prevent synechiae formation, many studies have been published evaluating the efficacy of post-operative debridement procedures. Many of these studies have shown conflicting results. There were many inconsistent variables between the studies, such as limited follow-up periods, varying extent of surgery, and variability in pre and post-operative treatment.
With a well designed study, we would like to assess if there is a difference in the incidence of formation of middle meatal synechiae between patients who have debridement and patients who don't.
This will further add much needed evidence to the need for this procedure in the post operative period following FESS.
Surgery The participants in this study will all undergo standard-of-care functional endoscopic sinus surgery (FESS) to treat their sinus disease. No changes will be made to pre-operative or operative protocol on account of this study. All post-operative standard-of-care procedures and medication will be maintained.
Follow up visits After FESS, participant subjects will be asked to return for 4 follow-up visits within the first 90 days and one follow-up visit at 180 days. They will be asked to return at 6, 30, 60, 90 and 180 days following their sinus surgery. At their 6 and 30 day follow-up visits they will either receive or not receive routine post-operative debridement depending on randomization.
Statistical Analysis
Sample size calculations A sample size calculation was performed to determine the appropriate number of patients required to adequately compare the incidence of synechiae between participants with versus without postoperative debridement following FESS. Previous investigations at the St. Paul's Sinus Centre have found that of post-FESS cases, 18% develop synechiae from use of gloved-Merocel middle meatal spacers. Utilizing a type I error of 5%, type II error of 20%, effect difference of 15% and 10% loss to follow-up, a total of 150 patients are required (75 per arm).
Statistical Comparisons The primary objective of this randomized controlled trial will be to compare the incidence of synechiae between subjects receiving debridement versus those receiving saline irrigation (no debridement) up to 180 days post-surgery. Count and absolute percentages of synechia incidence will be reported. The Chi-Squared test will be used to determine statistical significance between incidence rates. Probability values less than 5% (α=0.05) will be considered significant. Corresponding odds ratios and 95% confidence intervals will be reported.
For the secondary outcome measures (e.g. Sinonasal Outcomes Test 22 SNOT-22, PJESS/MLK), results will be summated and considered as continuous, numerical variables. Descriptive statistics using mean, median, standard deviation and inter-quartile ranges will be reported. The unpaired two sample student t-tests will be applied to investigate the difference between the means of the various outcome measures. Probability values less than 5% (α =0.05) will also be considered statistically significant.
Baseline demographics and clinical factors will be compared between each treatment group to determine whether randomization yielded comparable groups. Multivariable logistic and linear regression will be used to investigate the relationship between postoperative debridement and the primary (incidence of synechiae) or secondary outcomes (PJESS/MLK).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- There will be two possible scenarios resulting from randomization: 1. The patient is randomized to the arm that receives routine post-operative debridement (treatment group). 2. The patient is randomized to the arm that will not receive post-operative debridement (control group).
| Arm | Type | Receives |
|---|---|---|
| Debridement group | Experimental | Procedure: DebridementPatients receive routine post-operative debridement at their Day 6, 30 and 60 follow up appointments. |
| Non Debridement Group | No intervention | –Patients will not receive debridement at any follow up visit after surgery. They will continue with saline irrigation. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over the age of 19;
- Have chronic sinus disease (CRS) and are scheduled to undergo sinus surgery on both sides of your nose for the first time.
Key exclusion criteria (6 listed)
- Unable to speak English;
- Are having surgery for the removal of a nasal tumor;
- Have a disorder of your immune system in which your body's immune system attacks itself (autoimmune disorder)
- Diagnosed with cystic fibrosis
- Have had sinus surgery in the past
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 |
|---|---|---|
| DebridementDebridement or cleaning of the sinuses post-operatively has been described as a regular post-surgery procedure . | Procedure or surgery | Debridement group |
Primary outcome
Change in Postoperative Synechiae
Time frame: Day 30, 60, 90, and 180 follow-up visits.
The existence of postoperative synechiae will be considered as a categorical, dichotomous outcome variable (presence or absence).
3 secondary outcomes
Sinonasal Outcomes Test - 22 (SNOT-22)
Time frame: Day 30, 60, 90, and 180 follow-up visits.
Philpott-Javer (PJ) and Modified Lund-Kennedy (MLK) Endoscopic Staging System (ESS)
Time frame: Day 30, 60, 90, and 180 follow-up visits.
Visual Analog Score (VAS) for pain and discomfort
Time frame: Day 6, 30, 60, 90, and 180 follow-up visits.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Background: PubMed 25379119Bachert C, Pawankar R, Zhang L, Bunnag C, Fokkens WJ, Hamilos DL, Jirapongsananuruk O, Kern R, Meltzer EO, Mullol J, Naclerio R, Pilan R, Rhee CS, Suzaki H, Voegels R, Blaiss M. ICON: chronic rhinosinusitis. World Allergy Organ J. 2014 Oct 27;7(1):25. doi: 10.1186/1939-4551-7-25. eCollection 2014.
- Background: PubMed 10369288Fernandes SV. Postoperative care in functional endoscopic sinus surgery? Laryngoscope. 1999 Jun;109(6):945-8. doi: 10.1097/00005537-199906000-00020.
- Background: PubMed 25314101Green R, Banigo A, Hathorn I. Postoperative nasal debridement following functional endoscopic sinus surgery, a systematic review of the literature. Clin Otolaryngol. 2015 Feb;40(1):2-8. doi: 10.1111/coa.12330.
- Background: PubMed 19909864Bednarski KA, Kuhn FA. Stents and drug-eluting stents. Otolaryngol Clin North Am. 2009 Oct;42(5):857-66, x. doi: 10.1016/j.otc.2009.07.001.
- Background: PubMed 12825038Miller RS, Steward DL, Tami TA, Sillars MJ, Seiden AM, Shete M, Paskowski C, Welge J. The clinical effects of hyaluronic acid ester nasal dressing (Merogel) on intranasal wound healing after functional endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2003 Jun;128(6):862-9. doi: 10.1016/S0194-59980300460-1.
- Background: PubMed 22487908Saafan ME, Ragab SM, Albirmawy OA, Elsherif HS. Powered versus conventional endoscopic sinus surgery instruments in management of sinonasal polyposis. Eur Arch Otorhinolaryngol. 2013 Jan;270(1):149-55. doi: 10.1007/s00405-012-1969-8. Epub 2012 Apr 10.
- Background: PubMed 12825040Catalano PJ, Roffman EJ. Evaluation of middle meatal stenting after minimally invasive sinus techniques (MIST). Otolaryngol Head Neck Surg. 2003 Jun;128(6):875-81. doi: 10.1016/S0194-59980300469-8.
- Background: PubMed 15521662Jorissen M. Postoperative care following endoscopic sinus surgery. Rhinology. 2004 Sep;42(3):114-20.
- Background: PubMed 8196032Lund VJ, MacKay IS. Outcome assessment of endoscopic sinus surgery. J R Soc Med. 1994 Feb;87(2):70-2. doi: 10.1177/014107689408700204. No abstract available.
- Background: PubMed 3083326Stammberger H. Endoscopic endonasal surgery--concepts in treatment of recurring rhinosinusitis. Part I. Anatomic and pathophysiologic considerations. Otolaryngol Head Neck Surg. 1986 Feb;94(2):143-7. doi: 10.1177/019459988609400202.
- Background: PubMed 1453856Kennedy DW. Prognostic factors, outcomes and staging in ethmoid sinus surgery. Laryngoscope. 1992 Dec;102(12 Pt 2 Suppl 57):1-18.
- Background: PubMed 17075402Bugten V, Nordgard S, Steinsvag S. The effects of debridement after endoscopic sinus surgery. Laryngoscope. 2006 Nov;116(11):2037-43. doi: 10.1097/01.mlg.0000241362.06072.83.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be available to other researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debridement in people with Chronic Rhinosinusitis (Diagnosis), run by St. Paul's Hospital, Canada at 1 site in Canada.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Sep 2019. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amin Javer, MD FRCSCFARS (6048069926, sinusdoc@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Postoperative Synechiae (time frame: Day 30, 60, 90, and 180 follow-up visits.). 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 NCT04093193, which also lists 16 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 19 Sep 2019; AzTrials last refreshed its copy on 27 Oct 2026.