An observational study in Tongue Carcinoma, Tongue Neoplasms and Quality of Life, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Al-Azhar University · Observational
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This study evaluates and compares the postoperative surgical outcomes and quality of life (QoL) in patients undergoing tongue reconstruction after tongue cancer resection, comparing two reconstructive options: the Submental Island Pedicled Flap (SIPF) and the Radial Forearm Free Flap (RFFF). Quality of life was assessed using the University of Washington Quality of Life questionnaire (UW-QOL v4) to evaluate functional, cosmetic, and psychological recovery.
Surgical reconstruction following tongue cancer resection is essential for restoring oral function, speech, swallowing, and facial aesthetics. The Radial Forearm Free Flap (RFFF) is widely considered a gold standard for soft tissue oral reconstruction; however, it requires microvascular expertise and carries donor-site morbidity. The Submental Island Pedicled Flap (SIPF) serves as an alternative, offering a reliable regional pedicled flap with local color match and simplified surgical execution without requiring microvascular anastomoses.
This retrospective observational cohort study aims to compare patients who received SIPF versus RFFF for tongue reconstruction. The primary objective is to evaluate health-related quality of life outcomes using the validated University of Washington Quality of Life Questionnaire version 4 (UW-QOL v4), alongside evaluating postoperative surgical outcomes and donor site morbidity.
121 studies on the registry are indexed under Tongue Neoplasms; 12 are open to participants now.
This study's enrollment of 28 is below the median of 97 across 16 observational studies indexed under Tongue Neoplasms.
Browse Tongue Neoplasms studies →Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Patients undergoing hemiglossectomy for oral tongue squamous cell carcinoma with immediate reconstruction using either a radial forearm free flap (RFFF) or a submental island pedicled flap (SIPF).
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who underwent tongue reconstruction using Submental Island Pedicled Flap following tongue cancer resection.
Procedure: Submental Island Pedicled Flap (SIPF)
Patients who underwent tongue reconstruction using Radial Forearm Free Flap following tongue cancer resection.
Procedure: Radial Forearm Free Flap (RFFF)
Surgical reconstruction of tongue defect following oncological resection using a pedicled submental island flap.
Surgical reconstruction of tongue defect following oncological resection using a microvascular radial forearm free flap.
12-Month Baseline-Adjusted Composite Quality of Life (UW-QOL v4)
Unweighted composite score calculated as the mean of all 12 domains of the University of Washington Quality of Life Questionnaire version 4 (UW-QOL v4), evaluated at 12 months postoperatively and adjusted for baseline composite score using analysis of covariance (ANCOVA). Scores range from 0 to 100, where higher scores indicate better quality of life.
Time frame: 12 months post operatively
6-Month Baseline-Adjusted Composite Quality of Life (UW-QOL v4)
Unweighted composite score of the 12 UW-QOL v4 domains evaluated at 6 months postoperatively and adjusted for baseline composite score using ANCOVA. Scores range from 0 to 100.
Time frame: 6 months post operatively
Operative time
Total duration of surgery measured in hours from initial skin incision to final closure.
Time frame: Day of surgery (intraoperative)
Length of hospital stay
Total duration of inpatient hospital admission measured in days from surgery until discharge.
Time frame: From date of surgery to hospital discharge. Up to 30 days
Plan to share: No — Individual participant data will not be shared to protect patient privacy and confidentiality, in accordance with the institutional ethics review board guidelines.
No publications or documents are linked to this record.
Ran from Sep 2024 to primary completion in Apr 2026, 19 months.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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