Evidence map›Paper›PMID 39540299›Full record

Trial reportJournal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale

Submandibular Gland-Sparing Technique Versus En-Bloc Level IB Dissection in Oral Cavity Cancers with N0 Neck Status: A Randomized Controlled Trial.

G Vetrivel, Areej Moideen, Bhinyaram Jat, Prashant Durgapal, Amit Kumar, Amit Kumar Tyagi, Sourabha Kumar Patro, Kinjal Shankar Majumdar, Vikramjit Singh, Nivedhan Ravichandran and 5 more

Abstract readRandomized Controlled TrialComparative StudyEquivalence Trial
In one paragraph

Trial report in Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

G VetrivelDepartment of Otorhinolaryngology-Head & Neck Surgery, AIIMS Rishikesh, Rishikesh, India.ORCID 0000-0003-3979-7742
Areej MoideenDepartment of Otorhinolaryngology-Head & Neck Surgery, AIIMS Rishikesh, Rishikesh, India.
Bhinyaram JatDepartment of Otorhinolaryngology-Head & Neck Surgery, AIIMS Rishikesh, Rishikesh, India.ORCID 0000-0002-5360-0865
Prashant DurgapalDepartment of Pathology, AIIMS Rishikesh, Rishikesh, India.
Amit KumarDepartment of Otorhinolaryngology-Head & Neck Surgery, AIIMS Rishikesh, Rishikesh, India.ORCID 0000-0002-6491-5010
Amit Kumar TyagiDepartment of Otorhinolaryngology-Head & Neck Surgery, AIIMS Rishikesh, Rishikesh, India.
Sourabha Kumar PatroDepartment of ENT-HNS, PGI, Chandigarh, India.ORCID 0000-0002-4819-7928
Kinjal Shankar MajumdarDepartment of Otorhinolaryngology-Head & Neck Surgery, AIIMS Rishikesh, Rishikesh, India.ORCID 0000-0003-4696-3139
Vikramjit SinghDepartment of Otorhinolaryngology-Head & Neck Surgery, AIIMS Rishikesh, Rishikesh, India.
Nivedhan RavichandranDepartment of Otorhinolaryngology-Head & Neck Surgery, AIIMS Rishikesh, Rishikesh, India.
Ankita SemwalDepartment of Otorhinolaryngology-Head & Neck Surgery, AIIMS Rishikesh, Rishikesh, India.
Rachit SoodDepartment of Otorhinolaryngology-Head & Neck Surgery, AIIMS Rishikesh, Rishikesh, India.ORCID 0000-0002-4644-1296
Ashutosh HotaDepartment of Head and Neck Oncology, Acharya Harihar Post Graduate Institute of Cancer, Cuttack, India.
Akhilesh Chandra YadavDepartment of Otorhinolaryngology-Head & Neck Surgery, AIIMS Rishikesh, Rishikesh, India.
M Ramesh PrasathDepartment of Otorhinolaryngology-Head & Neck Surgery, AIIMS Rishikesh, Rishikesh, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

importanceMetastases to the submandibular gland (SMG) from oral cavity primaries are very rare. Hence, a gland-preserving level IB dissection technique is a feasible option without compromising the lymph node yield (LNY).

objectiveTo assess the feasibility and noninferiority of the SMG-preserving dissection technique to the conventional en bloc removal of level IB in terms of LNY in patients with cN0 oral squamous cell carcinoma (OSCC) undergoing elective neck dissection.

designParallel-design, single-center, open-label, randomized controlled trial.

settingTertiary care health care center-Department of Otorhinolaryngology-Head & Neck Surgery, AIIMS Rishikesh.

participantsThirty-eight (n = 38) participants with 46 (n = 46) neck dissection specimens of OSCC were randomly allocated (1:1) into gland-preserving (n

interventionElective neck dissection comparing SMG-sparing level IB dissection technique versus en bloc level IB dissection.

main outcome measuresLNY, lymph node density, and level IB operative time in both groups were compared between groups (α < .05).

resultsMedian LNY ( CONCLUSIONS AND RELEVANCE: None of the examined SMGs were involved by the tumor. SMG-preserving technique is noninferior to the traditional technique of level IB clearance and can be used in elective neck dissections without compromising the LNY. Functional neck dissection has greatly evolved to decrease patient morbidity, and this method can be adopted in case-specific situations.

trial registrationThe trial was registered in the Clinical Trials Registry-India (CTRI/2022/05/042344) on May 2, 2023, https://ctri.nic.in/.

Indexed as

Carcinoma, Squamous CellMouth NeoplasmsNeck DissectionOrgan Sparing TreatmentsSubmandibular GlandAdultAgedFeasibility StudiesFemaleHumansLymphatic MetastasisMaleMiddle AgedNeoplasm Stagingmetastasesneck dissectionoral cancerorgan preservationsquamous cell carcinomasubmandibular gland

Identifiers

PMID39540299
PMCPMC11561978

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.