Oncological Outcome of Contralateral Submental Artery Island Flap Versus Primary Closure in Tongue Squamous Cell Carcinoma

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

Tongue Squamous Cell Carcinoma

Treatments

Procedure: primary closure for tongue cancer defect
Procedure: contralateral submental flap for tongue cancer defect

Study type

Interventional

Funder types

Other

Identifiers

NCT03440151
513

Details and patient eligibility

About

The purpose of this study is to compare the oncological and functional results of the contralateral submental flap with primary closure for reconstruction of tongue squamous cell carcinoma.

Full description

Resection of tongue malignancies remains one of most surgical challenges because of its adverse effects on speech articulation, swallowing, and eventual quality of life. A variety of local flaps such as infrahyoid flap and the Platysma flap, and free flaps like the radial forearm and anterolateral thigh (ALT) flap have been available for reconstruction of tongue. However, all these options have their shortcomings. When reconstructing particular oral cavity defect the tissue used should be reliable; functional and cosmetically acceptable with minimum donor site morbidity and match the recipient site in terms of color, texture and thickness. The submental island flap (SMI-flap) which has been first introduced by Martin et al in 1990, meets all these requirements and due to its optimal location, ease of harvest, and favorable arc of rotation, the SMI-flap has gained acceptance as a simple, reliable and convenient to repair defects of tongue and oral cavity cancer. The oncological safety of submental flap in oral cancer patient still debate, this is due to its proximity to the main nodal basins of levels 1A and 1B and the possibility of transfer of occult metastatic lymph node to the recipient site during reconstruction. in addition some authors has not been recommended submental flap for cases with clinically or radiologically established nodal disease as it might compromise the oncological resection and continuity of neck dissection and so alternative options should be considered. The contralateral submental island flap (CSMI-flap) is believed to offer such alternate option for patient with contralateral negative node. our a priori-hypothesis is that utilization of the CSMI-flap is not related to an altered prognosis in tongue squamous cell carcinoma patients. In order to test this hypothesis, we will compare the oncological outcome of group of patients receive CSMI-flap with the results of another group of patients not receive CSMI-flap and close tongue defect by primary closure, which is another well-established concept of management tongue cancer defect.

Enrollment

64 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with T1&T2 tongue squamous cell carcinoma.

Exclusion criteria

  • Patients with contralateral N positive.
  • Patients with previous neck surgery that interrupt contralateral facial artery or vein.
  • Patients with prior radiotherapy to the neck.
  • Patients with lesions crossing the midline, or those reaching the base of tongue requiring total glossectomy.
  • Patients second primary tumors at the time of diagnosis.
  • Patient with recurrent tongue squamous cell carcinoma.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

64 participants in 2 patient groups

contralateral submental flap for tongue cancer defect
Experimental group
Treatment:
Procedure: contralateral submental flap for tongue cancer defect
primary closure for tongue cancer defect
Active Comparator group
Treatment:
Procedure: primary closure for tongue cancer defect

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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