Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical improvement reported on SNOT-22 questionnaire
研究概览
简要总结
To assess the efficacy of intra-sinus installation of a poloxamer gel that releases antibiotics and corticosteroids topically after balloon sinuplasty in chronic sinusitis patients with or without polyps. This is a single-blinded Randomized Control Trial study, in which every patient receives active gel on one side and placebo on the other (L or R to be randomly selected).
详细描述
STUDY DESIGN This is a single-blinded Randomized Control Trial study, in which every patient receives active gel on one side and placebo on the other (L or R to be randomly selected). Sixty patients will be included in this study. These are patients undergoing balloon sinuplasty for Chronic sinusitis with and without polyps.
As the patients will enter the study- they will be divided into Chronic sinusitis with Polyps (CRSwNP) and Chronic rhinosinusitis without polyps (CRSsNP). Each patient will be assigned in chronological order as they will join the study.
For each group, all even numbered patients will receive the active gel application on right side and all odd number patients will receive the active gel on left side.
Then patient selection for CRSwNP and CRSsNP will be as such Each group will have 3 subgroups. Subgroup 1- gel will be loaded with steroids only Subgroup 2- gel will be loaded with antibiotic (Levaquin) only Subgroup 3- gel will be loaded with both steroids and antibiotic CRSwNP group with right side gel application Subgroup 1- patient number- 1,7,13,19,25 Subgroup 2- patient number- 3,9,15,21,27 Subgroup 3- patient number- 5,11,17,23,29 CRSwNP group with left side gel application Subgroup 1- patient number- 2,8,14,20,26 Subgroup 2- patient number- 4,10,16,22,28 Subgroup 3- patient number- 6,12,18,24,30
A similar patient randomization will be done with the CRSsNP group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Principle investigator will be non blinded and all others will be blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic sinusitis symptoms with or without polyps
- •Trial of at least 2 courses of oral antimicrobial treatment without significant improvement
- •CAT scan showing evidence of bilateral symmetric chronic sinusitis with or without polypss
- •Endoscopic confirmation of CRS
排除标准
- •Minor (Less than <18 years of age).
- •Pregnant and breastfeeding women.
- •Allergy to specific antibiotics
- •Patient currently taking oral corticosteroids.
- •Patient currently taking oral antibiotics.
研究组 & 干预措施
CRSwNP - Subgrp 1(Momentasone - Right)
Patients undergoing balloon sinuplasty will receive a gel loaded with steroids (Momentasone) only on right side and placebo on left side
干预措施: gel loaded with steroids (momentasone) (Drug)
CRSwNP-Subgrp 2(Levofloxacin - Right)
Patients undergoing balloon sinuplasty with receive a gel loaded with antibiotic (Levofloxacin) only on right side and placebo on left side
干预措施: gel loaded with antibiotic (Levofloxacin) (Drug)
CRSwNP-Subgrp 3(Steroid/Antibotic Right)
Patients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on right side and placebo on left side
干预措施: gel loaded with both steroids and antibiotic (Drug)
CRSsNP - Subgrp 1 (Momentasone Right)
Patients undergoing ballon sinuplasty will receive a gel loaded with steroids (Momentasone) only on right side and placebo on left side
干预措施: gel loaded with steroids (momentasone) (Drug)
CRSsNP - Subgrp 2 (Levofloxacin Right)
Patients undergoing balloon sinuplasty will receive a gel loaded with antibiotic (Levofloxacin) only on right side and placebo on left side
干预措施: gel loaded with antibiotic (Levofloxacin) (Drug)
CRSsNP-Subgrp 3(Steroid/Antibiotic Right
Patients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on right side and placebo on left side
干预措施: gel loaded with both steroids and antibiotic (Drug)
CRSwNP - Subgrp 1 (Momentasone Left)
Patients undergoing balloon sinuplasty will receive a gel loaded with steroids (Momentasone) only on left side and placebo on right side
干预措施: gel loaded with steroids (momentasone) (Drug)
CRSwNP - Subgrp 2 (Levofloxacin Left)
Patients undergoing balloon sinuplasty will receive a gel loaded with antibiotic (Levofloxacin) only left side and placebo on right side
干预措施: gel loaded with antibiotic (Levofloxacin) (Drug)
CRSwNP-Subgrp 3(Steroid/Antibiotic Left)
Patients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on left side and placebo on right side
干预措施: gel loaded with both steroids and antibiotic (Drug)
CRSsNP - Subgrp 1 (Momentasone Left)
Patients undergoing balloon sinuplasty will receive a gel loaded with steroids (Momentasone) only left side and placebo on right side
干预措施: gel loaded with steroids (momentasone) (Drug)
CRSsNP - Subgrp 2 (Levofloxacin Left)
Patients undergoing balloon sinuplasty will receive a gel loaded with antibiotic (Levofloxacin) only left side and placebo on right side
干预措施: gel loaded with antibiotic (Levofloxacin) (Drug)
CRSsNP-Subgrp 3(Steroid/Antibiotic Left)
Patients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on left side and placebo on right side
干预措施: gel loaded with both steroids and antibiotic (Drug)
结局指标
主要结局
Clinical improvement reported on SNOT-22 questionnaire
时间窗: The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.
Assessment of the healing process will be done at the end of one month then at two, three and six months. Total number of visits would be 8 including the operation day.
Improvement in the Lund-Kennedy endoscopic appearance scores. Improvement in the Lund-Kennedy endoscopic appearance scores
时间窗: The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.
Assessment of the healing process will be done at the end of one month then at two, three and six months. Total number of visits would be 8 including the operation day. Polyps (left, right) Edema (left, right) Discharge (left, right) Scarring (left, right) Crusting (left, right) Scoring: Polyps on left side - (0 absent, 1 polyps in middle meatus, 2 polyps beyond middle meatus) Polyps on right side - (0 absent, 1 polyps in middle meatus, 2 polyps beyond middle meatus) Edema, scarring and crusting on left side (0 absent, 1 mild, 2 severe) Edema, scarring and crusting on right side (0 absent, 1 mild, 2 severe) Discharge on left side (0, no discharge, 1 clear, thin discharge, 2 thick purulent discharge) Discharge on right side (0, no discharge, 1 clear, thin discharge, 2 thick purulent discharge)
次要结局
- Radiological improvement of the Lund-Mackay score(The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.)