| 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
|
|
|
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
|
|
|
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 |