use of nerve monitoring during neck surgery for marginal mandibular nerve-a branch of facial nerve

Phase 3

Not yet recruiting

Conditions: Malignant neoplasm of tongue, unspecified,

Registration Number: CTRI/2019/07/020084

Lead Sponsor: NA

Brief Summary: Marginal mandibular nerve injury is a complication that causes anaesthetic deficit that has a great impact on the patient’s perception ofappearance, inevitably influencing quality of life.1,2The reason forthis deficit is loss of innervation of depressor angulioris, depressor labii inferioris,mentalis, and orbicularis oris muscles, causing inability to move the lower lipdownward or laterally.3 The consequent cosmetic deficit, manifestinglower lip asymmetry and imbalance, is especially noticeable when opening themouth and is most obvious when the patient cries.2,4Because thecondition of the neck lymph nodes is the single most important prognosticfactor in carcinoma of the upper digestive airways, neck dissection has becomeordinary clinical practice in head and neck oncologic surgery.5

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

Nerve integrity monitoring (NIM) is a technique that monitors muscleactivity as a reflection of nerve function during surgery. The benefits ofelectromyographic monitoring for nerve preservation have been well establishedin many ear, nose, and throat (ENT) surgeries; however, its use is stilldebated in other procedures. The purpose of this study will be to assess theusefulness of NIM as an aid to reduce the incidence of marginal mandibularnerve paralysis after neck dissection, also to consider its possible impact oncosts and surgical time.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 44

Inclusion Criteria

stage T1/T2/T3 per primum tongue carcinoma patients 2) primary defect can be closed with primary closure.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PRESENCE OF MARGINAL MANDIBULAR NERVE PARESIS	post operative day 1/2

Secondary Outcome Measures

Name	Time	Method
OVERALL SURGICAL COST	IMMEDIATE POST SURGERY
OVERALL SURGICAL TIME	IMMEDIATE POST NECK DISSECTION
PRESENCE OF MARGINAL MANDIBULAR NERVE PARESIS	AT 3 MONTHS, 6 MONTHS AND A YEAR OF FOLLOW-UP

Trial Locations

Locations (1): Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Prathamesh Pai
Principal investigator
9819068268
drpspai@gmail.com