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Comparative outcomes of re-boot surgery versus Traditional Functional Endoscopic Sinus Surgery (non-reboot)in chronic rhinosinusitis with nasal polyposis

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 - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097949
Enrollment
60
Registered
2025-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 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

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All adult patients of either gender and age 18 years- 60 years with a confirmed diagnosis of CRSwNP (including extensive polyposis) 2. Persistent symptoms despite a minimum of 12 weeks of maximal medical therapy, including intranasal corticosteroids. 3. Patients willing to provide informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of previous sinus surgery within the last five years. 2. Presence of severe co-morbid conditions such as uncontrolled asthma or immunodeficiency. 3. Patients using biologic therapy within the last 12 months. 4. History of sinonasal malignancy or conditions other than CRSwNP causing nasal obstruction.

Design outcomes

Primary

MeasureTime frame
To compare the postoperative sinonasal outcomes, measured by SNOT-22 scores, between patients undergoing Re-boot surgery and those undergoing FESS (non Re-boot) (traditional mucosa-sparing) surgery for chronic rhinosinusitis with nasal polyps (CRSwNP).Timepoint: Preop and 3 months postop

Secondary

MeasureTime frame
1. To assess the impact of the surgeries on olfactory function (measured by subjective smell scores). 2. To evaluate polyp recurrence rates at 3 months post-surgery.Timepoint: Pre-op and 3 months postop

Countries

India

Contacts

Public ContactDr Neelam Chittiappa

Jawaharlal Institute of Postgraduate Medical Education and Research

gsivram@gmail.com9442355292

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026