evel IB dissection with Intact Submandibular gland versus En bloc Level IB dissection for Oral cavity cancers

Phase 2

Completed

• Registration Number: CTRI/2022/05/042344
• Lead Sponsor: AIIMS Rishikesh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-02-20
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 46

Inclusion Criteria

Age > 18 years

Biopsy proven Oral cavity Squamous cell cancer

TNM staging : Any T, N0(Clinico-radiological), M0 according to AJCC, 8th ed.

Planned for upfront surgery

Willing to participate in the study

Exclusion Criteria

Age < 18 years

Presence of contiguous tumour extension into Level IB or Involvement of Submandibular gland by the tumour

Paramandibular spread of the disease

Node positivity (Clinico-radiological)

Distant metastasis on presentation

Presence of major co-morbidities making the patient unfit for surgery

Recurrent Oral cavity cancer or Second primar Oral cavity tumour

Any history of prior radiation therapy to Head and Neck region

Any history of Neoadjuvant therapy for Oral cavity malignancy

Any past history of extensive surgery in Oral cavity or Neck, that might have resulted in disruption of lymphatics

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ymph node yieldTimepoint: After surgery (One time)

Secondary Outcome Measures

Name	Time	Method
evel IB dissection operative time <br/ ><br>Marginal mandibular paresisTimepoint: Post surgery (One time)