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CTRI Number  CTRI/2025/11/097949 [Registered on: 24/11/2025] Trial Registered Prospectively
Last Modified On: 27/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative outcomes of re-boot surgery versus Traditional Functional Endoscopic Sinus Surgery (non-reboot)in chronic rhinosinusitis with nasal polyposis 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neelam Chittiappa 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  ENT office, 1st floor, In Patient Department building, Jawaharlal Institue of Postgraduate Medical Education and Research,Gorimedu, Dhanvantari nagar, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7899256982  
Fax    
Email  drneelamc3008@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sivaraman G 
Designation  Additional Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  ENT office, 1st floor, In Patient Department building, Jawaharlal Institue of Postgraduate Medical Education and Research,Gorimedu, Dhanvantari nagar, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9442355292  
Fax    
Email  gsivram@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neelam Chittiappa 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  ENT office, 1st floor, In patient department building, Jawaharlal Institue of Postgraduate Medical Education and Research,Gorimedu, Dhanvantari nagar, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7899256982  
Fax    
Email  drneelamc3008@gmail.com  
 
Source of Monetary or Material Support  
Intramural Research Fund, JIPMER, Pondicherry- 605005 India. 
 
Primary Sponsor  
Name  JIPMER 
Address  Dhanvantri Road, Jawaharlal Institute of Post Graduate Medical Education and Research Campus, Puducherry 605006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neelam Chittiappa  Jawaharlal Institute of Postgraduate Medical Education and Research  ENT office, 1st floor, IPD Building, JIPMER campus, Dhanvantri Road, Puducherry 605006
Pondicherry
PONDICHERRY 
7899256982

drneelamc3008@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Non reboot surgery  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 diseases course.This procedure takes around 1 hour to perform. Patients are reviewed at 3 month follow up period. 
Intervention  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. The surgery tajes around 1-1.5 hours to perform. Patients are reviewed at 3 month follow up period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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.  
 
ExclusionCriteria 
Details  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.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
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).  
Preop and 3 months postop 
 
Secondary Outcome  
Outcome  TimePoints 
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. 
Pre-op and 3 months postop 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   03/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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. 
2. 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. 
 
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