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

Level IB dissection with Intact Submandibular gland versus En bloc Level IB dissection for Oral cavity cancers : A Parallel design, Single centre, Open label, Non-inferiority Randomised Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042344
Enrollment
100
Registered
2022-05-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C021- Malignant neoplasm of border of tongue Health Condition 2: C060- Malignant neoplasm of cheek mucosa Health Condition 3: C020- Malignant neoplasm of dorsal surface of tongue Health Condition 4: C050- Malignant neoplasm of hard palate Health Condition 5: C004- Malignant neoplasm of lower lip, inner aspect Health Condition 6: C062- Malignant neoplasm of retromolar area Health Condition 7: C003- Malignant neoplasm of upper lip, inner aspect Health Condition 8: C022- Maligna

Interventions

Intervention1: Level IB dissection with intact submandibular gland: Fibrofatty tissue around the submandibular gland are dissected seperately. The submandibular gland is dissected seperately to look f

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Age 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

Design outcomes

Primary

MeasureTime frame
Lymph node yieldTimepoint: After surgery (One time)

Secondary

MeasureTime frame
Level IB dissection operative time Marginal mandibular paresisTimepoint: Post surgery (One time)

Countries

India

Contacts

Public ContactDr Vetrivel G

AIIMS Rishikesh

dramit4111@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026