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CTRI Number  CTRI/2025/09/094519 [Registered on: 10/09/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   An indepth assessment of the factors influencing reconstruction decision after oral tongue Cancer surgery. 
Scientific Title of Study   A Qualitative study Exploring the Factors Influencing Reconstruction Decision-Making After Oral Tongue Cancer Resection: Perspectives of Resecting and Reconstructive Surgeons (REFLECTORAL) 
Trial Acronym  REFLECT ORAL 
Secondary IDs if Any  
Secondary ID  Identifier 
REFLECT ORAL Study protocol Version 1.1 dated 21.08.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SHIVAKUMAR THIAGARAJAN 
Designation  Professor, head and neck oncology E, MS (ENT) DNB  
Affiliation  TATA MEMORIAL HOSPITAL 
Address  1209 HOMI BHABA BLOCK TATA MEMORIAL HOSPITAL DR. ERNEST BORGES MARG PAREL MUMBAI

Mumbai
MAHARASHTRA
400012
India 
Phone  9846572399  
Fax    
Email  drshiva78in@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr SHIVAKUMAR THIAGARAJAN 
Designation  Professor, head and neck oncology E, MS (ENT) DNB  
Affiliation  TATA MEMORIAL HOSPITAL 
Address  1209 HOMI BHABA BLOCK TATA MEMORIAL HOSPITAL DR. ERNEST BORGES MARG PAREL MUMBAI

Mumbai
MAHARASHTRA
400012
India 
Phone  9846572399  
Fax    
Email  drshiva78in@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr SHIVAKUMAR THIAGARAJAN 
Designation  Professor, head and neck oncology E, MS (ENT) DNB  
Affiliation  TATA MEMORIAL HOSPITAL 
Address  1209 HOMI BHABA BLOCK TATA MEMORIAL HOSPITAL DR. ERNEST BORGES MARG PAREL MUMBAI

Mumbai
MAHARASHTRA
400012
India 
Phone  9846572399  
Fax    
Email  drshiva78in@gmail.com   
 
Source of Monetary or Material Support  
TATA MEMORIAL HOSPITAL PAREL MUMBAI 400012 MAHARASHTRA  
 
Primary Sponsor  
Name  TATA MEMORIAL HOSPITAL  
Address  Dr. Ernest Borges Marg, Parel,Mumbai 400012,India Phone 9122-24177000, Extn.6656. 
Type of Sponsor  Other [Investigator Initiated Study] 
 
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 SHIVAKUMAR THIAGARAJAN   TATA MEMORIAL HOSPITAL   Dept of Head and Neck surgical Oncology (OPD) (2nd floor Homi bhabha block and 107 golden jublee block) parel mumbai Dr. Ernest Borges Marg Parel, Office 02224177000 EXTN.6656
Mumbai
MAHARASHTRA 		 9846572399

drshiva78in@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 
Healthy Human Volunteers  Qualified surgeons (MS/MCh/DNB or equivalent) in otolaryngology, head and neck surgery, or plastic surgery. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  - Qualified surgeons (MS/MCh/DNB or equivalent) in otolaryngology, head and neck
surgery, or plastic surgery.
- Actively performing resections or reconstructions for oral tongue cancer.
- Minimum of 3 years of post-training clinical experience.
- Involved in at least 10 oral tongue cancer cases over the past year.
- Willing to participate and provide informed consent. 
 
ExclusionCriteria 
Details  - Surgeons not involved in decision-making regarding reconstruction.
- Surgeons unwilling or unable to participate in interviews. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To explore the key factors that resecting and reconstructive surgeons consider when
deciding on the type of reconstruction following oral tongue cancer resection. 		 - One-on-one, semi-structured interviews will be conducted, lasting 30–45 minutes
each.
- Interviews may be conducted in person or via secure video conferencing platforms.
- Interviews will be audio recorded (with consent), transcribed verbatim, and
anonymized. 
 
Secondary Outcome  
Outcome  TimePoints 
- To compare the decision-making perspectives between resecting and reconstructive surgeons.
- To identify perceived barriers and facilitators to collaborative reconstructive planning.
- To assess how patient-specific, tumor-related, and institutional factors influence reconstructive choices. 		 - One-on-one, semi-structured interviews will be conducted, lasting 30–45 minutes
each.
- Interviews may be conducted in person or via secure video conferencing platforms.
- Interviews will be audio recorded (with consent), transcribed verbatim, and
anonymized. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   N/A 
Date of First Enrollment (India)   22/09/2025 
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="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   This qualitative study aims to understand how surgeons decide on reconstruction methods after oral tongue cancer surgery. It will explore the perspectives of both resecting and reconstructive surgeons, focusing on factors such as tumor size and location, patient health, hospital resources, and surgical roles. About 20 experienced surgeons from various hospitals across India will be interviewed. The study will also examine how team dynamics, communication, and training influence decision-making. Interview data will be systematically analyzed to identify key themes and challenges in collaborative surgical planning. 
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