| CTRI Number |
CTRI/2025/08/092709 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparative Study of various Reconstruction Procedures following surgery of For Carcinoma Tongue with respect to post operative Speech And Swallowing assessment |
|
Scientific Title of Study
|
Assessment Of Speech And Swallowing In Post-Operative Cases For Carcinoma Tongue Following Reconstruction Procedures |
| 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 Anuja Kulkarni |
| Designation |
Sr DMO SG Consultant |
| Affiliation |
JRH Mumbai |
| Address |
Room no 5 Department of ENT, Jagjivan Ram Railway Hospital, Maratha Mandir Marg ,Mumbai Central , Mumbai
Room no 5 Department of ENT, Jagjivan Ram Railway Hospital, Maratha Mandir Marg ,Mumbai Central , Mumbai Ram Railway Hospital, Maratha Mandir Marg ,Mumbai Central , Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9819464115 |
| Fax |
|
| Email |
dr.anujakulkarni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisma Loknath |
| Designation |
PG Tainee |
| Affiliation |
JRH Mumbai |
| Address |
Jagjivan Ram Railway Hospital, Maratha Mandir Marg ,Mumbai Central , Mumbai
Jagjivan Ram Railway Hospital, Maratha Mandir Marg ,Mumbai Central , Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9819464115 |
| Fax |
|
| Email |
pbsjrh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuja Kulkarni |
| Designation |
Sr DMO SG Consultant |
| Affiliation |
JRH Mumbai |
| Address |
Room No 5, Department of ENT Jagjivan Ram Railway Hospital, Maratha Mandir Marg ,Mumbai Central , Mumbai
India
Room No 5, Department of ENT Jagjivan Ram Railway Hospital, Maratha Mandir Marg ,Mumbai Central , Mumbai
India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9819464115 |
| Fax |
|
| Email |
dr.anujakulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jagjivan Ram Railway Hospital |
| Address |
Jagjivan Ram Railway Hospital
Maratha Mandir Marg Mumbai Central Mumbai 400008 |
| Type of Sponsor |
Other [Govt 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 A S Kulkarni |
Jagjivan Ram Railway Hospital |
Room No 5 Jagjivan Ram Railway HospitalMaratha mandir marg Mumbai Central Mumbai 400008
Mumbai
MAHARASHTRA |
9819464115
dr.anujakulkarni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC/JRH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
primary closure |
Post operative sppech and swallowing |
| Comparator Agent |
Flap closure |
Post operative speech and swallowing |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
diagnosed with tongue cancer requiring surgical treatment |
|
| ExclusionCriteria |
| Details |
Children less than18 years old
Pregnant women
Unconscious patients, mentally challenged patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Locoregional control of disease |
AT 3months 6 months and at 2 years follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disease specific mortality |
at 3 months 6 months 1 year |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
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)
|
22/08/2025 |
| 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="3"
Days="15" |
|
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
|
The tongue cancer has posed
the challenge to clinicians with respect to preservation of form and function
post cancer surgery and So far there is no consensus with regards to the best
possible reconstruction amongst the various options available , with regards to
preservation of form and function i.e speech and swallowing which adds to
quality of life in case of tongue
cancer.
In order to attempt to
answer this question, this observational study is being undertaken pertaining to the
prevailing practices in our cohort. |