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| Name | Class |
|---|---|
| Addenbrooke's Hospital, Cambridge University | UNKNOWN |
| NHS Greater Glasgow and Clyde | OTHER |
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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.
Patients will be recruited consecutively from the PI's 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:
Standard of care:
Study will require:
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:
B) Experience of the post-operative appointment:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-term (4 weeks) Silastic Stenting | Experimental |
| |
| Long-term (12 weeks) Silastic Stenting | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silastic Stenting | Procedure | Drill-out frontal sinus procedures, are a well-established surgical intervention in the management of CRS, involves extensive sinus surgery with the creation of a large, surgically exposed area of raw bone. This raw bone, left exposed postoperatively, poses a unique challenge in the context of mucosal healing. Silastic stents, inserted into the sinus cavities, offer a promising solution by providing structural support and facilitating mucosal re-mucolisation in this critical period of postoperative recovery. |
| Measure | Description | Time Frame |
|---|---|---|
| Long-Term Patency | Patency is to be assessed by using the validated scoring system from Lund VJ, Kennedy DW. Quantification for staging sinusitis. In: Kennedy DW, editor. International Conference on Sinus Disease: Terminology, Staging, Therapy. Ann Otol Rhinol Laryngol 1995; 104(Suppl 167):17-21. | 6 and 18 months |
| Incidence of acute sinus infection | The occurrence and frequency of acute sinusitis in both cohorts, requiring rescue course of oral antibiotics. | 2 and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability Assessment | Instrument: Likert Scale | At the respective stent extraction time |
| Symptom Relief Assessment | Instrument: Sinonasal Outcome Test-22 (SNOT-22) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 6 and 18 months post-op |