| CTRI Number |
CTRI/2024/07/070222 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Reconstruction of oral cancer with hand muscle graft. |
|
Scientific Title of Study
|
Comparative evaluation of functional and esthetic outcomes in reconstruction of Commissure of Mouth with radial forearm free flap with and without Palmaris Longus Tendon in patients being operated for squamous cell carcinoma of Buccal Mucosa and lip |
| 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 Imran Solanki |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, Wardha |
| Address |
Department of Oral and Maxillofacial Surgery,Ground floor SPDC Building,Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9399931411 |
| Fax |
|
| Email |
solankiimran012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajanikanth Kambala |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, Wardha |
| Address |
Department of Oral and Maxillofacial Surgery,Ground floor SPDC Building,Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
8888839380 |
| Fax |
|
| Email |
rajanikanthmalaviya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajanikanth Kambala |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, Wardha |
| Address |
Department of Oral and Maxillofacial Surgery,Ground floor SPDC Building,Sawangi
MAHARASHTRA
442001
India |
| Phone |
8888839380 |
| Fax |
|
| Email |
rajanikanthmalaviya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Wardha,India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi,Wardha 445001 |
| Type of Sponsor |
Private medical college |
|
|
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 Imran Solanki |
Sharad Pawar Dental College |
Department of Oral & Maxillofacial Surgery,Ground Floor ,SPDC Building Sawangi Meghe 442001
Wardha
MAHARASHTRA |
939993411
solankiimran012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research, Wardha. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Radial Forearm Free Flap with Palmaris Longus Tendon |
Cases of oral cancer will be reconstruct with tha radial forearm free flap |
| Comparator Agent |
Radial Forearm Free Flap without Palmaris Longus Tendon |
Oral Cancer cases will be recontruct with Radial forearm free flap |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
• Biopsy proven case of Squamous Cell Carcinoma of buccal mucosa and lip.
• All patient with carcinoma of commissure of mouth.
• All patient with carcinoma of Buccal Mucosa and lip.
• All patients who have shown positive test on Allen test , as a pre-requisite to Radial Forearm Free Flap with or without Palmaris Longus Tendon.
|
|
| ExclusionCriteria |
| Details |
• Any carcinoma ( verrucous carcinoma, basal cell carcinoma ,etc) other than squamous cell carcinoma.
• Patient who have undergone surgery, or chemotherapy.
• Patient who has undergone radiotherapy.
• Patient who are lost to follow up.
• Patient who are not fit for surgery.
• All patient not willing for RADIAL FOREARM FREE FLAP
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reconstruction with radial forearm free flap will help in better functional and esthetics outcomes |
Assesment will be done 7 days,1 month,3 month after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Introduction-: Our experience demonstrates the
effectiveness of radial forearm flap (RFF) in lip deformity and buccal mucosa
restorations, both with and without Palmaris Longus Tendon. The best therapy
after large oncologic resections is with microvascular free flaps. The tissue
produced by the Radial Forearm Free Flap is thin, malleable, and
well-vascularized. It guarantees less morbidity at the donor site because it is
harvested pedicled on the radial artery. Successful vascularization is
facilitated by microvascular anastomosis. With a high success rate, RFFF
provides good functional and cosmetic results for a range of intraoral
reconstructions.
Need of
the study This study will help evaluate the functional
and aesthetic results of reconstructing the lip and buccal mucosa in cases with
squamous cell carcinoma. Long-term preservation of the vertical lip height and
lip supports is carried out by the Palmaris Longus Tendon, which functions as a
sling over which the flap is elevated.
Aim: The study is design to compare & evaluate functional & esthetic outcomes in
reconstruction of Commissure of Mouth with radial forearm free flap with &
without Palmaris Longus Tendon in patients being operated for squamous cell
carcinoma of Buccal Mucosa and lip.
Materials and Method : Prospective
Observational study. The clinical study will be performed at the
Department of Oral and Maxillofacial Surgery, Siddharth Gupta Memorial Cancer
Hospital, Sawangi, Wardha, Maharashtra. After taking approval from the IEC,
DMIHER (DU) and explaining detailed treatment protocol to the patients.
Procedure will be performed in patients which are histopathological proven. Detailed Case History,Clinical
Examination,Past medical, dental history, general personal information, and
then biopsy will be performed. In patient with biopsy proven of Squamous Cell Carcinoma,
further be subjected to Radiographic Examination (CT SCAN) for knowing the
extent of lesion, metastasis of lymph node. Patients with Biopsy proven and those who are meeting the inclusion
criteria will be included in the study after obtaining detailed informed
consent.
2 group in which 8
patients with Radial forearm free flap with Palmaris Longus Tendon
& 8 without Palmaris Longus Tendon in which functional outcomes like Drooling,
Swallowing, Speech & Esthetics outcomes Smile, Lip Competence &
Commissural ends will be assessed. |