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CTRI Number  CTRI/2025/04/085761 [Registered on: 28/04/2025] Trial Registered Prospectively
Last Modified On: 27/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of 3 different flaps used in the reconstruction of carcinoma tongue patients.  
Scientific Title of Study   Comprehensive Pre & Post Operative Functional Assessment of Carcinoma Tongue Patients undergoing reconstructive Surgery with free radial forearm flap, anterolateral thigh flap, medial sural artery perforator flap- Descriptive longitudinal 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. Monal Karkar  
Designation  Assistant Professor 
Affiliation  Rural Dental College, PMT PIMS(DU) 
Address  Room no. 307, Department of Oral And Maxillofacial Surgery, Rural Dental College, Pravara Institute of Medical Sciences, Loni.

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9164751113  
Fax    
Email  monalk81290@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Monal Karkar 
Designation  assistant professor 
Affiliation  Rural Dental College, PMT PIMS(DU) 
Address  Room no. 307, Department of Oral And Maxillofacial Surgery, Rural Dental College, Pravara Institute of Medical Sciences, Loni.

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9164751113  
Fax    
Email  monalk81290@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Monal Karkar 
Designation  Assistant Professor 
Affiliation  Rural Dental College, PMT PIMS(DU) 
Address  Room no. 307, Department of Oral And Maxillofacial Surgery, Rural Dental College, Pravara Institute of Medical Sciences, Loni.

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9164751113  
Fax    
Email  monalk81290@gmail.com  
 
Source of Monetary or Material Support  
Department of Oral And Maxillofacial Surgery, Rural Dental College, Pravara Institute of Medical Sciences, Pravara Medical Trust, Loni.  
 
Primary Sponsor  
Name  Dr Monal Karkar 
Address  Room no. 307, Department of Oral And Maxillofacial Surgery, Rural Dental College, Pravara Institute of Medical Sciences, Loni, Tah: Rahata, Dist: Ahmednagar, Maharashtra. 
Type of Sponsor  Other [self] 
 
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 Monal Karkar  Pravara Institute of Medical Sciences  room no. 307, Department of Oral And Maxillofacial Surgery, Rural Dental College, Pravara Institute of Medical Sciences, Loni.
Ahmadnagar
MAHARASHTRA 		 9164751113

monalk81290@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC of Pravara Institute of Medical Sciences,Loni  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C020||Malignant neoplasm of dorsal surface of tongue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with histopathology report of squamous cell carcinoma of the tongue
Patients who requires free flaps for reconstruction 
 
ExclusionCriteria 
Details  Patients with T1 Carcinoma of the tongue, as they will need primary closure after tumor resection.
Patients with free flap failures that are not salvageable will be excluded.
Patients presenting with the recurrence will be excluded.
Patients who had received prior Radiation &/ Or Chemotherapy.
Pregnant patients.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Preoperative and post operative speech,tongue movement,and swallowing reflex  Speech: Baseline reading Pre-operatively, then post-operatively at 1 weeks, 4 weeks, 12 weeks, 24 weeks.
Tongue movement: Baseline reading Pre-operatively, then post-operatively at 1 weeks, 4 weeks, 12 weeks, 24 weeks.
Swallowing reflex: Baseline reading Pre-operatively, then post-operatively at 1 weeks, 4 weeks, 12 weeks, 24 weeks.
 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life,wound healing,donor site  Quality of life at 4 weeks, 8 weeks, 12 weeks.
wound healing at 4 weeks, 8 weeks, 12 weeks.
donor site at 4 weeks, 8 weeks, 12 weeks. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   01/06/2025 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  monalk81290@gmail.com

  6. For how long will this data be available start date provided 01-09-2024 and end date provided 31-12-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
Tongue cancer -most common intraoral malignancy.In most of these cases, radical ablation & immediate surgical reconstruction of tongue defects are performed .While carrying out the reconstruction, it is necessary to rebuild the function & appearance of the tongue. It is also important to reduce the damage of the donor site on both function & appearance.Radical surgical therapy often diminishes oral functions & subsequently speech, swallowing, chewing, oral rehabilitation, nutrition, & appearance being issues of particular importance.The impairment in the functional outcome of the tongue is due to loss of bulk, musculature, damage of innervations, post-operative and post radiotherapeutic fibrosis.Surgeons have endeavored to overcome these unfavorable outcomes with a steadily improving understanding of the concepts underpinning microvascular free flaps.This study will help us to analyze the functional outcome of each flap & its versatility for the reconstruction. 
 
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