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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03440151
Recruitment Status : Active, not recruiting
First Posted : February 20, 2018
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Omer mohammed jamali, Cairo University

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.

Condition or disease Intervention/treatment Phase
Tongue Squamous Cell Carcinoma Procedure: contralateral submental flap for tongue cancer defect Procedure: primary closure for tongue cancer defect Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Oncological Outcome of Contralateral Submental Artery Island Flap Versus Primary Closure in Tongue Squamous Cell Carcinoma (Randomize Noninferiority Clinical Trial)
Actual Study Start Date : February 21, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: contralateral submental flap for tongue cancer defect Procedure: contralateral submental flap for tongue cancer defect

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.


Active Comparator: primary closure for tongue cancer defect Procedure: primary closure for tongue cancer defect
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 Outcome Measures :
  1. local recurrence [ Time Frame: at least one year post operative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440151


Locations
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Egypt
Omer M Jamali
Cairo, Faculty Of Dentistry-Cairo University, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Omer M Jamali, phd student Cairo University
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Responsible Party: Omer mohammed jamali, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03440151    
Other Study ID Numbers: 513
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Omer mohammed jamali, Cairo University:
Tongue Squamous Cell Carcinoma,
Contralateral Submental Flap
Submental Flap
oncological safety
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell