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

NCT03440151 | Unknown DMC

• 1 other identifier: 513
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tongue Squamous Cell Carcinoma

Keywords

Tongue Squamous Cell Carcinoma,; Contralateral Submental Flap; Submental Flap; oncological safety

Outcome Measures

Primary Outcomes (1)

• local recurrence

  at least one year post operative

Study Arms (2)

contralateral submental flap for tongue cancer defect

EXPERIMENTAL

Procedure: contralateral submental flap for tongue cancer defect

primary closure for tongue cancer defect

ACTIVE COMPARATOR

Procedure: primary closure for tongue cancer defect

Interventions

contralateral submental flap for tongue cancer defect PROCEDURE

Tumor resection will be star first this accomplish with 1- 2 cm safety margin, Simultaneous neck dissection will be performed in all patient. Flap dissection begins from the opposite side of the pedicle in the subplatysmal plane. Then the level 1a is dissected, the distal facial artery and facial vein to the branching point of the submental pedicle are ligated. The anterior belly of the digastric muscle on ipsilateral to the pedicle and strip of mylohyoid muscle will dissected off the mandible and the hyoid bone and included with the flap. This results in complete mobilization of the flap.A tunnel will be created between the defect and the donor site and the skin paddle of the flap will be transported through it intraorally and the flap is insetted.

contralateral submental flap for tongue cancer defect

primary closure for tongue cancer defect PROCEDURE

Under general anesthesia the tumor will be resected with Preserving floor of mouth mucosa as much as possible to avoid restriction of tongue mobility. After Obtaining meticulous hemostasis, the tongue defect will be closed in layers.

primary closure for tongue cancer defect

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with T1\&T2 tongue squamous cell carcinoma.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Omer M Jamali

Cairo, Faculty of Dentistry-Cairo University, Egypt

Location

Study Officials

• Omer M Jamali, phd student

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because the two interventions used in this trial are clearly different and easly recognized by the participants and investigators, neither investigators nor Participants can be blinded. The statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: February 20, 2018
• Study Start: February 21, 2018
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Locations

EG (1)