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CTRI Number  CTRI/2026/03/105593 [Registered on: 09/03/2026] Trial Registered Prospectively
Last Modified On: 06/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Airway Space Changes in Kids: Surgery vs Medicine for Adenotonsillar Enlargement 
Scientific Title of Study   A Comparative Cephalometric Evaluation of Upper Airway Space Changes Following Medical Versus Surgical Management in Pediatric Patients with Adenotonsillar Hypertrophy: A Quasi Experimental Study. 
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 SWAPNIL 
Designation  JUNIOR RESIDENT 
Affiliation  UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES, SAIFAI 
Address  ROOM NO.445 4TH FLOOR OLD BUILDING DEPT OF OTORHINOLARYNGOLOGY HEAD NECK UPUMS SAIFAI ETAWAH

Etawah
UTTAR PRADESH
206130
India 
Phone  8885418594  
Fax    
Email  swapnilsw3096@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  PROF DR JITENDRA PRATAP SINGH CHAUHAN 
Designation  HEAD OF DEPARTMENT 
Affiliation  UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES, SAIFAI 
Address  ROOM NO.447 4TH FLOOR OLD BUILDING DEPT OF OTORHINOLARYNGOLOGY HEAD NECK UPUMS SAIFAI ETAWAH

Etawah
UTTAR PRADESH
206130
India 
Phone  9997634222  
Fax    
Email  chauhanbhavya36@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Jitendra Pratap Singh Chauhan 
Designation  Head of Department 
Affiliation  UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES, SAIFAI 
Address  ROOM NO.447 4TH FLOOR OLD BUILDING DEPT OF OTORHINOLARYNGOLOGY HEAD NECK UPUMS SAIFAI ETAWAH

Etawah
UTTAR PRADESH
206130
India 
Phone  9997634222  
Fax    
Email  chauhanbhavya36@gmail.com  
 
Source of Monetary or Material Support  
Uttar Pradesh university of Medical Sciences Saifai 
 
Primary Sponsor  
Name  Uttar Pradesh University of Medical Sciences Saifai 
Address  Etawah Uttar Pradesh 206130  
Type of Sponsor  Government medical college 
 
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 Swapnil  Uttar Pradesh University of Medical Sciences Saifai  Room No 6 New OPD Building UPUMS SAIFAI Hospital Campus
Etawah
UTTAR PRADESH 		 08885418594

swapnilsw3096@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J353||Hypertrophy of tonsils with hypertrophy of adenoids, (2) ICD-10 Condition: J352||Hypertrophy of adenoids, (3) ICD-10 Condition: J351||Hypertrophy of tonsils, (4) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis, (5) ICD-10 Condition: J358||Other chronic diseases of tonsilsand adenoids, (6) ICD-10 Condition: J359||Chronic disease of tonsils and adenoids, unspecified, (7) ICD-10 Condition: J399||Disease of upper respiratory tract, unspecified, (8) ICD-10 Condition: H669||Otitis media, unspecified, (9) ICD-10 Condition: H653||Chronic mucoid otitis media, (10) ICD-10 Condition: G473||Sleep apnea, (11) ICD-10 Condition: H659||Unspecified nonsuppurative otitismedia, (12) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, (13) ICD-10 Condition: H660||Acute suppurative otitis media,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  medical management of adenotonsillar hypertrophy  according to AAOHNS guidelines, it will be decided that medical management of the adenotonsillar hypertrophy in pediatric patients will be done 
Intervention  surgical management of adenotonsillar hypertrophy  according to AAOHNS guidelines, it will be decided that surgical management of the adenotonsillar hypertrophy in pediatric patients will be done. the duration of the procedure will be maximum 2 hrs 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  History of URTI, AOM, OSA.
Able to undergo lateral cephalometric radiography 
 
ExclusionCriteria 
Details  Refusal to give consent or lost to follow up Craniofacial anomalies such as cleft palate, down syndrome, Pierre Robin sequence.
Airway surgery such as prior adenoidectomy, tonsillectomy, or retrognathic surgery.
Chronic cardio respiratory illness, such as uncontrolled asthma, and congenital heart disease. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the anatomical changes in upper airway dimensions in pediatric patients
aged 4 to 15 years diagnosed with adenotonsillar hypertrophy, and assessing the quantifiable
structural differences in the nasopharyngeal and oropharyngeal airway space, before and after
treatment, to determine the comparative efficacy of medical therapy and surgical intervention in
improving airway patency and craniofacial development using reproducible radiographic markers. 		 Cases shall be assessed in the OPD at first contact and then post intervention after 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess specific anatomical changes in cephalometric parameters, including

Mandibular and palatal plane lengths, Cranial base flexure angle, Nasopharyngeal triangle angle,
Mandibular plane angle, Adenoid–Nasopharyngeal Ratio ANR, Oropharyngeal Ratio OPR.
 		 Cases shall be assessed in the OPD at first contact and then post intervention after six months 
To correlate cephalometric changes with clinical symptom improvement, including:
Snoring, Mouth breathing, Sleep disturbance, Recurrent infections  		 Cases shall be assessed in the OPD at first contact and then post intervention after six months 
To analyse demographic and clinical parameters (age, sex, clinical history) in relation to airway
dimensional changes and treatment outcomes 		 Cases shall be assessed in the OPD at first contact and then post intervention after six months 
 
Target Sample Size   Total Sample Size="136"
Sample Size from India="136" 
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 2 
Date of First Enrollment (India)   20/03/2026 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Upper airway obstruction in pediatric patients, predominantly caused by adenotonsillar hypertrophy, is associated with obstructive sleep apnea , craniofacial growth disturbances, and behavioral and academic impairments. Chronic mouth breathing can exacerbate these issues, potentially leading to persistent anatomical abnormalities into adulthood. Treatment is typically either medical using corticosteroids and leukotriene receptor antagonists or surgical via adenotonsillectomy. While surgery has shown to improve airway patency, comparative radiographic data between medical and surgical interventions is lacking. 
 Novelty This quasi-experimental study, conducted in a rural population of Northern India, is novel in its use of standardized cephalometric analysis to evaluate anatomical changes post treatment. Previous studies have focused on clinical outcomes or used retrospective designs. By employing baseline and 6-month follow-up lateral cephalograms, this study aims to offer objective, reproducible evidence of treatment efficacy 
 Objective The primary objective is to evaluate and compare nasopharyngeal and oropharyngeal structural changes in children aged 4 to15 years treated either medically or surgically for adenotonsillar hypertrophy. Secondary objectives include assessing cephalometric markers and correlating these with symptom resolution. Methodology- Methodologically, the study will include 136 participants, 4-15 years of age divided into two groups based on AAOHNS criteria, undergo radiographic and clinical evaluation, and be tracked over 6 months. Expected outcomes include quantifiable data on airway dimensional improvement, guiding future clinical decision-making and fostering interdisciplinary care among otorhinolaryngology, radiology, and orthodontics.
 
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