Comparative Analysis of Short-term (4 Weeks) vs. Long-term (12 Weeks) Silastic Stenting in Frontal Sinus Surgery: A Prospective Study of Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Long-Term Patency
研究概览
简要总结
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.
详细描述
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:
- 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:
- Preoperative visit, assessment including nasal endoscopy and completion of SNOT-22 baseline questionnaire.
- 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.
- Post-operative follow-ups at 4 weeks and 12 weeks', with 4 weeks vs 12 weeks of stent removal time scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with chronic rhinosinusitis requiring Frontal drill-out.
排除标准
- •Patients unwilling or unable to comply with the study protocol.
- •Previous Radiotherapy to operated area.
研究组 & 干预措施
Short-term (4 weeks) Silastic Stenting
干预措施: Silastic Stenting (Procedure)
Long-term (12 weeks) Silastic Stenting
干预措施: Silastic Stenting (Procedure)
结局指标
主要结局
Long-Term Patency
时间窗: 6 and 18 months
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.
Incidence of acute sinus infection
时间窗: 2 and 4 weeks
The occurrence and frequency of acute sinusitis in both cohorts, requiring rescue course of oral antibiotics.
次要结局
- Tolerability Assessment(At the respective stent extraction time)
- Symptom Relief Assessment(6 and 18 months post-op)
研究者
Arif Janjua
Clinical Professor
University of British Columbia