| CTRI Number |
CTRI/2020/03/023994 [Registered on: 16/03/2020] Trial Registered Prospectively |
| Last Modified On: |
13/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the outcomes of Infrahyoid flap & Radial Forearm Flap used for reconstruction of carcinoma of tongue cases. |
|
Scientific Title of Study
|
A randomized single blind multi centre parallel group phase III clinical study to evaluate treatment outcome between infrahyoid myocutaneous and radial forearm flap used for reconstruction of carcinoma of tongue patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harish Saluja |
| Designation |
Associate Professor |
| Affiliation |
Rural Dental College Pravara insitute of medical sciences,Loni |
| Address |
Department of Oral and Maxillofacial Surgery Rural Dental College Loni tehsil Rahata Ahmednagar
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9766921178 |
| Fax |
|
| Email |
harry_saluja@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Harish Saluja |
| Designation |
Associate Professor |
| Affiliation |
Rural Dental College Pravara insitute of medical sciences,Loni |
| Address |
Department of Oral and Maxillofacial Surgery Rural Dental College Loni tehsil Rahata Ahmednagar
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9766921178 |
| Fax |
|
| Email |
harry_saluja@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Harish Saluja |
| Designation |
Associate Professor |
| Affiliation |
Rural Dental College Pravara insitute of medical sciences,Loni |
| Address |
Department of Oral and Maxillofacial Surgery Rural Dental College Loni tehsil Rahata Ahmednagar
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9766921178 |
| Fax |
|
| Email |
harry_saluja@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Pravara Rural Hospital, Loni & Apex Hospital Aurangabad, all cases included in study will be under Mahatama Phule Jeevandayi Aroygya Yojna (state government health policy) |
|
|
Primary Sponsor
|
| Name |
Harish Saluja |
| Address |
Department of Oral and Maxillofacial Surgery Rural Dental College Loni tehsil Rahata Ahmednagar Maharashtra 413736 |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harish Saluja |
APEX HOSPITAL |
APEX HOSPITAL, 5-8 Bassaye nagar,opposite sfs school,jalana road sanjay nagar Aurangabad 431001
Aurangabad
MAHARASHTRA |
9766921178
harry_saluja@yahoo.co.in |
| Dr Harish Saluja |
Pravara Rural Hospital/Rural Dental College |
Rural Dental College Department of Oral & Maxillofacial Surgery room number 307 pravara insitute of medical sciences Loni 413736- Tehsil-Rahata
Ahmadnagar
MAHARASHTRA |
9766921178
harry_saluja@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Pravara institute of medical sciences (IEC-PIMS DU). Loni 413736 |
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 |
Infrahyoid myocutaneous flap |
infrahoid myocutaneous flap will be taken from neck region and will be used for reconstruction of tongue and clinical findings will be noted at 10th post operative day,3 month,6 month interval. |
| Comparator Agent |
Radial Forearm Free Flap |
Radial Forearm Free flap will be used to comapre it with interventional group at 10th post operative day, 3rd month & 6 month . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Disease related:
1 Newly diagnosed or known cases
2 Histological confirmed SCC of tongue cases (Stage I to Stage IV)
3 Lesion of any size and location
4 Irrespective of type of glossectomy
Demography related:
A Patients in between 18 -70 years of age and of any gender.
B Subject/s with reproductive potential with negative pregnancy test
C Patients willing to give written and informed consent before any study specific procedure.
Laboratory:
D Hamodynamically stable patients
Rational for inclusion criteria’s:
These criteria’s are included to ensure enrollment of representative subjects for the planned indication.
|
|
| ExclusionCriteria |
| Details |
Disease related:
1 Prior or current evidence of any metastatic involvement of distant site
2 Patients with local recurrences.
3 Patient with previous history of any thyroid surgery.
4 Patients whose necks are previously irradiated.
Medical related:
5 Active Hepatitis B virus or Hepatitis C virus, HIV/AIDS
6 Known case of tuberculosis/AKT therapy, patients on long term steroid therapy, immune compromised patients, patients having chronic diseases, uncontrolled diabetes.
7 Subjects who having psychiatry morbidity
8 Subjects who declared unfit for general anaesthesia by anaesthetics as SOP
General:
9 Subject who are planning to become pregnant within five months of surgery, lactating mother
10 Subjects having any kind of disorder that compromises the ability of subject to think rationally and/or prevent from completing the study as per protocol.
Rational of exclusion criteria’s
These criteria’s are included to ensure enrolment of representative subjects for the planned indication and to exclude potential confounding effects if any.
|
|
|
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 |
1. Diet type intake
2. speech outcome
3. tongue movement
4. aspiration on swallowing
|
10 days, 3 months , 6 months postoperatively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Complications at Donar site
Complications at recipient site
Time taken for harvesting and insetting of flap
Effect of post operative radiotherapy on flap
Cost factor related to both flap surgeries
Post operative stay
Need of skin graft
|
intraoperative,10 days,3 months, 6 months postoperatively |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
16/03/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This will be a randomized single blind multicentre parellel group phase III clinical study to evaluate treatment outcome of 2 flaps, Infrahyoid myocutaneous flap and Radial forearm flap for reconstruction of carcinoma of tongue cases.The study will be done at Pravara Rural Hospital,Loni & Apex Hospital Aurangabad , Mahashtra. 2 different reconstruction groups will be evaluated & comapared for their clinical outcomes like speech,diet intake, swallowing,tongue movements, donor & recipient site morbidity, duration of surgery,need of skin graft for donor site etc. |