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临床试验/CTRI/2025/11/097949
CTRI/2025/11/097949招募中3 期

Comparative outcomes of re-boot surgery versus traditional functional endoscopic sinus surgery (non-re-boot) in chronic rhinosinusitis with nasal polyps- a randomised controlled trial

JIPMER1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月3日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
JIPMER
入组人数
60
试验地点
1
主要终点
To compare the postoperative sinonasal

研究概览

简要总结

The terms Reboot Surgery and Traditional Functional Endoscopic Sinus Surgery (non Reboot) are used to distinguish between two approaches in sinus surgery for chronic rhinosinusitis with nasal polyps:

  1. Reboot Surgery: This approach involves extensive removal of the diseased mucosa to address the underlying inflammation that drives polyp recurrence. The procedure can vary in extent:

o Total Reboot: All affected sinus mucosa is removed, targeting a complete "reboot" of the sinus environment.

o Partial Reboot: Select areas, such as the frontal sinus, are spared to retain some mucosal tissue, while still aiming to reduce disease recurrence by eliminating other inflamed areas. Disease-Modifying Concept: Reboot surgery aims to achieve long-lasting disease-modifying effects by replacing the inflamed Type 2 sinus mucosa with healthy nasal mucosa, potentially resulting in sustained improvements in smell and reduced polyp recurrence. This effect resembles the disease modifying benefits observed in allergen immunotherapy, which can suppress mucosal inflammation and prevent disease progression long after treatment ends.

  1. Non Reboot Procedures: This includes traditional Functional Endoscopic Sinus Surgery (FESS), polypectomy, and similar techniques that focus on preserving the existing mucosa. These procedures primarily aim to reestablish drainage and ventilation without extensive mucosal resection, targeting symptom relief rather than profound modification of the disease’s course. This distinction emphasizes that Reboot surgery9s aggressive mucosal removal is intended for durable, long-term remission, aligning with a disease-modifying approach, while non Reboot procedures focus on short-term relief and preservation of mucosa.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All adult patients of either gender and age 18 years- 60 years with a confirmed diagnosis of CRSwNP (including extensive polyposis)
  • Persistent symptoms despite a minimum of 12 weeks of maximal medical therapy, including intranasal corticosteroids.
  • Patients willing to provide informed consent to participate in the study.

排除标准

  • Patients with a history of previous sinus surgery within the last five years.
  • Presence of severe co-morbid conditions such as uncontrolled asthma or immunodeficiency.
  • Patients using biologic therapy within the last 12 months.
  • History of sinonasal malignancy or conditions other than CRSwNP causing nasal obstruction.

结局指标

主要结局

To compare the postoperative sinonasal

时间窗: Preop and 3 months postop

outcomes, measured by SNOT-22 scores,

时间窗: Preop and 3 months postop

between patients undergoing Re-boot surgery

时间窗: Preop and 3 months postop

and those undergoing FESS (non Re-boot)

时间窗: Preop and 3 months postop

(traditional mucosa-sparing) surgery for

时间窗: Preop and 3 months postop

chronic rhinosinusitis with nasal polyps

时间窗: Preop and 3 months postop

(CRSwNP).

时间窗: Preop and 3 months postop

次要结局

  • 1. To assess the impact of the surgeries on(olfactory function (measured by subjective)

研究者

发起方
JIPMER
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Neelam Chittiappa

Jawaharlal Institute of Postgraduate Medical Education and Research

研究点 (1)

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