Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06502197
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Comparative Analysis of Silastic Stenting in Sinus Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Analysis of Short-term 4 Weeks vs Long-term 12 Weeks Silastic Stenting in Frontal Sinus Surgery A Prospective Study of Clinical Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Silastic stenting is a measure taken to support tissue healing following sinus surgery Silastic stents are inserted into the sinus cavities and provide structural support while facilitating healing in the critical period of recovery following surgery There is controversy over the optimal duration for which silastic stents should be left in place Having them in place for shorter periods may reduce the likelihood of stent-related reactions while leaving them for longer periods could promote more tissue healing The aim of this study is to compare the impact of stent duration on clinical outcomes of patients following sinus surgery
Detailed Description:
Patients will be recruited consecutively from the PIs frontal sinus surgery list The research assistant will approach the patient to obtain informed consent before the day of the operation A written patient information leaflet explaining the study will be provided
Eligible patients will be categorized into two groups
Group A Short-term stent retention 4 weeks
Group B Long-term stent retention 12 weeks We aim for a sequence of 50 4 week-stent and 50 12 week-stent The patients will be told whether they are receiving the stent for 4 or 12 weeks at the day of surgery
Standard of care
1 Preoperative visit assessment including nasal endoscopy and completion of SNOT-22 baseline questionnaire
2 Surgery with frontal sinus drill out Draf IIa IIb III are done as a standard of care in these centers Dressing of the raw drilled out surface area of the beak with silastic stents is the standard of care for all drill outs
3 Post-operative follow-ups at 4 weeks and 12 weeks with 4 weeks vs 12 weeks of stent removal time scale
Study will require
1 Categorization of patients into two groups one group who will have a silastic stent for 4 weeks and the other group will have stent in place for 12 weeks
2 Saving a copy of the endoscopic image intra-operative and at 6 months and one-year post-op To compare the size of a frontal drainage pathway measuring anterior-posterior medial-lateral diameters
Study Process
At the first pre-operative appointment for drill out the procedure is discussed At this point the study will be introduced by the principal and sub investigators and explained in detail by the research coordinator who would also obtain informed consent If the patient consents to the study a SNOT22 sino-nasal outcome measure 22 pre-operative questionnaire will be completed thereafter they will be categorized to one of the two groups
At time of surgery frontal stent placement is placed to minimize contracture and to aid with re-mucolisation of the raw surface area due to the drill out allowing for creation of optimal frontal sinus opening Therefore after the maximal desired sinus drill out has been achieved and the surgeon feels that the surgery proceeded routinely with no circumstances that would indicate the use of silastic stents for other reasons such as injury to posterior plate mucosa or 360 mucosal disruption an envelope that indicates which arm of the study the patient will be opened and the choice for placement of the stent for what time interval would be revealed to the surgeon In the event of a non-routine surgery the surgeon will complete the surgery as required by the circumstance and the patient will be withdrawn from the study The information about withdrawal will be communicated to the participant immediately post-operative and during their first routine follow-up appointment
For all participants that provide informed consent a routine follow-up endoscopic assessment will be performed as per standard of care at 4 weeks 12 weeks 6 months and 1 year During these examinations an endonasal photograph will be taken for measurement and analyzing Photographs will be evaluated by two independent surgeons to reduce bias
At the second and final 1-year postoperative follow-ups the patients will be asked to complete two brief questionnaires of the patient-reported experience related to healing Questionnaires on symptoms one is the validated SNOT22 scoring system and the other was adopted from SNOT22 both address health related issues concerning the quality of life as pertain to sinus disease1 The second questionnaire includes the following items that relate to the study aims
A During the post-operative process
Nasal obstruction none-mild-moderate-severe
Crusting none-mild-moderate-severe
Cacosmia none-mild-moderate-severe
Halitosis none-mild-moderate-severe
Nasal discomfort none-mild-moderate-severe
Acute sinus infection when duration antibiotic requirement
B Experience of the post-operative appointment
Pain association with debridement andor stent removal graded on a visual analogue scale where 0 is no pain none and 10 is the worst severe pain ever experienced
Did the patients adhere to taken analgesia Tylenol Paracetamol 30 mins pre-procedure
Eligible patients will be categorized into two groups
Group A Short-term stent retention 4 weeks
Group B Long-term stent retention 12 weeks We aim for a sequence of 50 4 week-stent and 50 12 week-stent The patients will be told whether they are receiving the stent for 4 or 12 weeks at the day of surgery
Standard of care
1 Preoperative visit assessment including nasal endoscopy and completion of SNOT-22 baseline questionnaire
2 Surgery with frontal sinus drill out Draf IIa IIb III are done as a standard of care in these centers Dressing of the raw drilled out surface area of the beak with silastic stents is the standard of care for all drill outs
3 Post-operative follow-ups at 4 weeks and 12 weeks with 4 weeks vs 12 weeks of stent removal time scale
Study will require
1 Categorization of patients into two groups one group who will have a silastic stent for 4 weeks and the other group will have stent in place for 12 weeks
2 Saving a copy of the endoscopic image intra-operative and at 6 months and one-year post-op To compare the size of a frontal drainage pathway measuring anterior-posterior medial-lateral diameters
Study Process
At the first pre-operative appointment for drill out the procedure is discussed At this point the study will be introduced by the principal and sub investigators and explained in detail by the research coordinator who would also obtain informed consent If the patient consents to the study a SNOT22 sino-nasal outcome measure 22 pre-operative questionnaire will be completed thereafter they will be categorized to one of the two groups
At time of surgery frontal stent placement is placed to minimize contracture and to aid with re-mucolisation of the raw surface area due to the drill out allowing for creation of optimal frontal sinus opening Therefore after the maximal desired sinus drill out has been achieved and the surgeon feels that the surgery proceeded routinely with no circumstances that would indicate the use of silastic stents for other reasons such as injury to posterior plate mucosa or 360 mucosal disruption an envelope that indicates which arm of the study the patient will be opened and the choice for placement of the stent for what time interval would be revealed to the surgeon In the event of a non-routine surgery the surgeon will complete the surgery as required by the circumstance and the patient will be withdrawn from the study The information about withdrawal will be communicated to the participant immediately post-operative and during their first routine follow-up appointment
For all participants that provide informed consent a routine follow-up endoscopic assessment will be performed as per standard of care at 4 weeks 12 weeks 6 months and 1 year During these examinations an endonasal photograph will be taken for measurement and analyzing Photographs will be evaluated by two independent surgeons to reduce bias
At the second and final 1-year postoperative follow-ups the patients will be asked to complete two brief questionnaires of the patient-reported experience related to healing Questionnaires on symptoms one is the validated SNOT22 scoring system and the other was adopted from SNOT22 both address health related issues concerning the quality of life as pertain to sinus disease1 The second questionnaire includes the following items that relate to the study aims
A During the post-operative process
Nasal obstruction none-mild-moderate-severe
Crusting none-mild-moderate-severe
Cacosmia none-mild-moderate-severe
Halitosis none-mild-moderate-severe
Nasal discomfort none-mild-moderate-severe
Acute sinus infection when duration antibiotic requirement
B Experience of the post-operative appointment
Pain association with debridement andor stent removal graded on a visual analogue scale where 0 is no pain none and 10 is the worst severe pain ever experienced
Did the patients adhere to taken analgesia Tylenol Paracetamol 30 mins pre-procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None