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CTRI Number  CTRI/2019/07/020084 [Registered on: 08/07/2019] Trial Registered Prospectively
Last Modified On: 05/07/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   use of nerve monitoring during neck surgery for marginal mandibular nerve-a branch of facial nerve 
Scientific Title of Study   Intraoperative nerve monitoring of marginal mandibular nerve during neck dissection 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
3284  Protocol Number 
version 1.1 dated 28th may 2019  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prathamesh Pai 
Designation  Professor and Head of Unit, Dept. of Head and Neck Oncology, Tata Memorial Hospital 
Affiliation  Tata Memorial Hospital 
Address  Room no. 1229, 12th floor, Homi Bhabha block, Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai - 400 012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177000  
Fax  022-24146937  
Email  drpspai@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prathamesh Pai 
Designation  Professor and Head of Unit, Dept. of Head and Neck Oncology, Tata Memorial Hospital 
Affiliation  Tata Memorial Hospital 
Address  Room no. 1229, 12th floor, Homi Bhabha block, Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai - 400 012 India


MAHARASHTRA
400012
India 
Phone  022-24177000  
Fax  022-24146937  
Email  drpspai@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prathamesh Pai 
Designation  Professor and Head of Unit, Dept. of Head and Neck Oncology, Tata Memorial Hospital 
Affiliation  Tata Memorial Hospital 
Address  Room no. 1229, 12th floor, Homi Bhabha block, Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai - 400 012 India


MAHARASHTRA
400012
India 
Phone  022-24177000  
Fax  022-24146937  
Email  drpspai@gmail.com  
 
Source of Monetary or Material Support  
Tata memorial hospital, Dr. E Borges Road, Parel, Mumbai - 400 012 India  
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prathamesh Pai  Tata Memorial Hospital  operation theatre, 2nd floor, main building, tata memorial hospital, Dr. E Borges Road, Parel, Mumbai - 400 012 India
Mumbai
MAHARASHTRA 
9819068268
022-24146937
drpspai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee-II, Tata Memorial Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  INTRAOPERATIVE NERVE MONITORING -   marginal mandibular nerve has a highly variable anatomy that cannot ensure reliable anatomic landmarks. Nerve integrity monitoring (NIM) is a technique that monitors muscle activity as a reflection of nerve function during surgery In this trial, we will use intraoperative nerve monitoring of marginal mandibular nerve during neck dissection in the experimental arm 
Comparator Agent  STANDARD NECK DISSECTION  STANDARD PROCEDURE OF UNILATERAL NECK DISSECTION 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1) stage T1/T2/T3 per primum tongue carcinoma patients

2) primary defect can be closed with primary closure
 
 
ExclusionCriteria 
Details  1) patients received prior chemotherapy or radiotherapy
2) prior neck surgeries
3) requiring bilateral neck dissection
4) pre-operative facial weakness
5) patients requiring lower cheek flap/angle split incision
6) requiring mandibular resection or mandibulotomy for approach
7) patients requiring free flap/pedicled flap reconstruction
8) requiring nerve sacrifice for oncological margins
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
PRESENCE OF MARGINAL MANDIBULAR NERVE PARESIS  post operative day 1/2  
 
Secondary Outcome  
Outcome  TimePoints 
PRESENCE OF MARGINAL MANDIBULAR NERVE PARESIS  AT 3 MONTHS, 6 MONTHS AND A YEAR OF FOLLOW-UP 
OVERALL SURGICAL COST  IMMEDIATE POST SURGERY 
OVERALL SURGICAL TIME  IMMEDIATE POST NECK DISSECTION 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   15/07/2019 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NOT YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Marginal mandibular nerve injury is a complication that causes an aesthetic deficit that has a great impact on the patient’s perception of appearance, inevitably influencing quality of life.1,2The reason for this deficit is loss of innervation of depressor angulioris, depressor labii inferioris, mentalis, and orbicularis oris muscles, causing inability to move the lower lip downward or laterally.3 The consequent cosmetic deficit, manifesting lower lip asymmetry and imbalance, is especially noticeable when opening the mouth and is most obvious when the patient cries.2,4Because the condition of the neck lymph nodes is the single most important prognostic factor in carcinoma of the upper digestive airways, neck dissection has become ordinary clinical practice in head and neck oncologic surgery.5

The main cause of nerve injury is that the marginal mandibular nerve has a highly variable anatomy that cannot ensure reliable anatomic landmarks.

Nerve integrity monitoring (NIM) is a technique that monitors muscle activity as a reflection of nerve function during surgery. The benefits of electromyographic monitoring for nerve preservation have been well established in many ear, nose, and throat (ENT) surgeries; however, its use is still debated in other procedures. The purpose of this study will be to assess the usefulness of NIM as an aid to reduce the incidence of marginal mandibular nerve paralysis after neck dissection, also to consider its possible impact on costs and surgical time.

In our institution , among 74 patients with stage T1/T2 per primum carcinoma tongue operated for per-oral wide local excision of tongue with unilateral neck dissection within January 2017 to June 2018, there is an incidence of around 58 % patients having temporary marginal paresis in the post operative period and on follow up of minimum 3 months and more, around 32 % are still having marginal nerve paresis i.e permanent nerve paresis

 
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