| 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
|
|
|
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
|
|
|
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. |