| CTRI Number |
CTRI/2025/07/091718 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two different types of neck incisions used during surgery for oral cancer patients, to see which one gives better results |
|
Scientific Title of Study
|
Evaluation and comparision of outcomes of apron incision ( Freund and latyshevsky ) and transverse cervical incision when used for selective neck dissection in patients with oral sqamous cell carcinoma : A Randomised Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sindhoora N |
| Designation |
Fellow In Oral Oncology |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department Of Oral and Maxillofacial Surgery , ground Floor, SPDC Building
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9591386197 |
| Fax |
|
| Email |
sindhooranellikar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitin Bhola |
| Designation |
HOD and Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department Of Oral and Maxillofacial Surgery , ground Floor, SPDC Building
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9970070607 |
| Fax |
|
| Email |
drnitinbhola@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitin Bhola |
| Designation |
HOD and Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department Of Oral and Maxillofacial Surgery , ground Floor, SPDC Building
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9970070607 |
| Fax |
|
| Email |
drnitinbhola@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education and Research
Sawangi Meghe,Wardha , Maharashtra, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Sawangi Meghe,Wardha , Maharashtra, India 442001 |
| 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 Sindhoora N |
Siddharth Gupta Memorial Cancer Hospital |
Department of oral Oncology,SGMCH ground floor,Sawangi Meghe
Wardha
MAHARASHTRA |
9591386197
sindhooranellikar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute Of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Apron incision of Freund and Latyshevsky in selective neck dissection |
In case of oral squamous cell carcinoma patients undergoing neck dissection at the beginning of surgery apron incision of Freund and latyshevsky will be given and duration of such intervention will be 4 weeks |
| Comparator Agent |
Transverse Cervial Incision |
In oral squamous cell carcinoma patients undergoing neck dissection, at the beginning of surgery transverse cervical incision will be givenand duration of it will be 4weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients underdoing selective neck dissection for squamous cell carcinoma of oral cavity |
|
| ExclusionCriteria |
| Details |
Patients who has undergone preoperative radiotherapy
Patients who exhibit tumors with clinical or radiological skin involvement
Patients who refuse to provide written consent
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Surgical accessibility to all the levels of neck maybe better with apron incision than with transverse cervical incision. |
Surgical accessibility to neck will be assessed intraoperatively on the day of surgery that is baseline Day 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Wound healing & post operative scar maybe better with transverse cervical incision than with apron incision |
Wound healing will be assessed by the end of 1 week & 2nd week posoperatively
Scar assessment will be done on 4th week postopertively |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
01/09/2025 |
| 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="1"
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
|
Oral squamous cell carcinoma (OSCC) accounts for the majority of oral cancer cases worldwide, and effective treatment often requires surgical removal of both the primary tumor and affected cervical lymph nodes through neck dissection. The choice of surgical incision plays a crucial role in ensuring adequate exposure, minimizing complications, and achieving satisfactory aesthetic outcomes. While both the apron flap incision (Freund and Latyshevsky) and the transverse cervical incision are commonly used for selective neck dissection, there is limited comparative evidence on their effectiveness. The aim of this study is to systematically evaluate and compare the clinical outcomes of these two incisions in terms of surgical exposure, wound healing, complication rates, and cosmetic results in patients undergoing neck dissection for OSCC.This is a randomised controlled trial which will be conducted in Siddharth Gupta memorial Cancer Hospital, Sawangi, Maharashtra. |