| CTRI Number |
CTRI/2026/01/101451 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the postoperative outcomes of pectoralis major myocutaneous flap vs pectoralis major myofacial flap used for reconstruction of type iii and iv glossectomy defects in patients with squamous cell carcinoma of tongue -a comparative study. |
|
Scientific Title of Study
|
Comparative evaluation of postoperative outcomes of pectoralis major myocutaneous flap vs pectoralis major myofacial flap used for reconstruction of type iii and iv glossectomy defects in patients with squamous cell carcinoma of tongue -a comparative 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 Karamvir |
| Designation |
MDS 1st Year |
| Affiliation |
Sharad Pawar Dental College and Hospital,Wardha |
| Address |
SPDC, DMIHER WARDHA, MAHARASHTRA- 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9888819055 |
| Fax |
|
| Email |
Karamvir1055@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NITIN BHOLA |
| Designation |
HOD OMFS |
| Affiliation |
Sharad Pawar Dental College and Hospital,Wardha |
| Address |
SPDC, DMIHER WARDHA, MAHARASHTRA- 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9888819055 |
| Fax |
|
| Email |
Karamvir1055@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karamvir |
| Designation |
MDS 1st Year |
| Affiliation |
Sharad Pawar Dental College and Hospital,Wardha |
| Address |
SPDC, DMIHER WARDHA, MAHARASHTRA- 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9888819055 |
| Fax |
|
| Email |
Karamvir1055@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharad Pawar Dental College and Hospital, Wardha Maharastra , India |
|
|
Primary Sponsor
|
| Name |
Sharad Pawar Dental College and Hospital, Wardha |
| Address |
SPDC, DMIHER WARDHA, MAHARASHTRA- 442001 |
| Type of Sponsor |
Research institution and 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 Karamvir |
Sharad Pawar Dental College and Hospital,Wardha |
SPDC, DMIHER WARDHA, MAHARASHTRA- 442001 DEPT OF ORAL AND MAXILLOFACISAL SURGERY
Wardha
MAHARASHTRA |
9888819055
Karamvir1055@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe DMIHERe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group II- RECONSTRUCTION OF SURGICAL DEFECT IN SQUAMOUS CELL CARCINOMA OF TONGUE WITH PECTORALIS MAJOR |
Group II- RECONSTRUCTION OF SURGICAL DEFECT IN SQUAMOUS CELL CARCINOMA OF TONGUE WITH PECTORALIS MAJOR |
| Intervention |
surgical |
This protocol ensures accurate diagnosis and appropriate management for patients presenting with suspected tongue cancer at SGMCH. After diagnosis, patients will be divided into two groups by computer generated randomization and undergo surgery under all aseptic protocols. After surgery, the patient will be monitored, and after 1 week, 3 months, and 6 months, they will be evaluated for functional and aesthetic outcomes, according to which the PMMC and PMMF flap will be judged.
The two groups will be divided based on the type of reconstruction to be done after wide local excision or composite resection of the lesion and suitable neck dissection, which are
Group I – RECONSTRUCTION OF SURGICAL DEFECT IN SQUAMOUS CELL CARCINOMA OF TONGUE WITH PECTORALIS MAJOR MYOCUTANEOUS FLAP.
Group II- RECONSTRUCTION OF SURGICAL DEFECT IN SQUAMOUS CELL CARCINOMA OF TONGUE WITH PECTORALIS MAJOR MYOFASCIAL FLAP
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All the patients age 18 years and above with Biopsy proven case of Squamous Cell Carcinoma of Tongue
Type III and Type IV Tongue defects according to Ansari classification
Patients fit to undergo surgery ASA I
|
|
| ExclusionCriteria |
| Details |
All patients who are not willing to be a part of study
• All patients with uncontrolled systemic diseases.
• Small lesions of tongue for primary closure.
• Poland Syndrome
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Suture line leakage, Fistula, Flap discoloration and Donor site morbidity. |
1MONTH, 3, MONTHS , 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Flap Related Complications like Survival of flap, Flap discoloration, Donor site morbidity & Neck division will be evaluated. |
1 MONTH , 3 MONTHS, 6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2026 |
| 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="6"
Days="1" |
|
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
|
This study compares PMMC and PMMF flaps used to repair tongue defects. The goal is to help surgeons choose the best method to maintain tongue function appearance and recovery.
Aim
To compare the functional and appearance related results of PMMC and PMMF flaps in patients with type three and type four tongue defects caused by squamous cell carcinoma.
Materials and Method
This randomized study will be carried out in the Department of Oral and Maxillofacial Surgery at Siddharth Gupta Memorial Cancer Hospital in Sawangi Wardha from August two thousand twenty five to September two thousand twenty six after approval from the ethics committee. Patients with confirmed oral squamous cell carcinoma will be examined using clinical examination MRI scans and biopsy. Eligible patients will be divided into two groups to receive either PMMC or PMMF flap reconstruction. The outcomes will include tongue movement swallowing speech and overall appearance including tongue shape and size. |