- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03440151
Oncological Outcome of Contralateral Submental Artery Island Flap Versus Primary Closure in Tongue Squamous Cell Carcinoma
Oncological Outcome of Contralateral Submental Artery Island Flap Versus Primary Closure in Tongue Squamous Cell Carcinoma (Randomize Noninferiority Clinical Trial)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Faculty Of Dentistry-Cairo University
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Cairo, Faculty Of Dentistry-Cairo University, Egypt
- Omer M Jamali
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: contralateral submental flap for tongue cancer defect
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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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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local recurrence
Time Frame: at least one year post operative
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at least one year post operative
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Omer M Jamali, phd student, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 513
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tongue Squamous Cell Carcinoma
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Region Örebro CountyCompletedTongue Cancer | Floor of Mouth Squamous Cell CarcinomaSweden
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Cairo UniversityUnknownCarcinoma | Tongue Neoplasms
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Radiation Therapy Oncology GroupNational Cancer Institute (NCI); NRG OncologyWithdrawnTongue Cancer | Stage III Squamous Cell Carcinoma of the Oropharynx | Stage IVA Squamous Cell Carcinoma of the OropharynxUnited States
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National Institute of Dental and Craniofacial Research...CompletedHead and Neck Neoplasms | Carcinoma, Squamous Cell | Mouth Neoplasms | Tongue NeoplasmsUnited States
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University of ChicagoNational Cancer Institute (NCI)TerminatedTongue Cancer | Stage I Squamous Cell Carcinoma of the Oropharynx | Stage II Squamous Cell Carcinoma of the Oropharynx | Stage III Squamous Cell Carcinoma of the Oropharynx | Stage IVA Squamous Cell Carcinoma of the OropharynxUnited States
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Ohio State University Comprehensive Cancer CenterCompletedTongue Cancer | Lip and Oral Cavity Squamous Cell Carcinoma | Oral Cavity Verrucous Carcinoma | Stage 0 Lip and Oral Cavity CancerUnited States
Clinical Trials on contralateral submental flap for tongue cancer defect
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Cairo UniversityUnknownPatient With Partial Maxillectomy | Submental Island Flap | Maxillary ObturatorEgypt
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Ain Shams UniversityAssiut University; Egyptian Russian UniversityRecruitingPeriodontal Attachment LossEgypt