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Completed

NCT Number: NCT07819617

Submental Island Flap vs Radial Forearm Free Flap in Tongue Reconstruction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Dental Medicine, Al-Azhar University (Assiut Branch)

Asyut, Assuit, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (aged 18 years or older) diagnosed with squamous cell carcinoma of the tongue requiring partial or total glossectomy.
  • Indication for immediate soft tissue reconstruction using either Submental Island Pedicled Flap (SIPF) or Radial Forearm Free Flap (RFFF).
  • Patients eligible and cleared for major surgical resection and flap reconstruction under general anesthesia.
  • Patient's informed consent to participate in the study and complete follow-up evaluations.

Exclusion criteria

  • History of previous radiation therapy or surgical intervention in the head and neck region.
  • Clinical or radiological evidence of nodal metastasis in level I submental lymph nodes (for SIPF candidates).
  • Severe systemic comorbidities precluding major surgery or prolonged general anesthesia (ASA class IV or higher).
  • Distance or inability to commit to the 12-month postoperative follow-up schedule and quality of life assessments.

Treatment and study plan

Submental Island Pedicled Flap (SIPF)

Procedure

Surgical reconstruction of tongue defect following oncological resection using a pedicled submental island flap.

Radial Forearm Free Flap (RFFF)

Procedure

Surgical reconstruction of tongue defect following oncological resection using a microvascular radial forearm free flap.

Primary outcomes

  1. 12-Month Baseline-Adjusted Composite Quality of Life (UW-QOL v4)

    Time frame: 12 months post operatively

    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.

Secondary outcomes

  1. 6-Month Baseline-Adjusted Composite Quality of Life (UW-QOL v4)

    Time frame: 6 months post operatively

    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.

  2. Operative time

    Time frame: Day of surgery (intraoperative)

    Total duration of surgery measured in hours from initial skin incision to final closure.

  3. Length of hospital stay

    Time frame: From date of surgery to hospital discharge. Up to 30 days

    Total duration of inpatient hospital admission measured in days from surgery until discharge.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Evaluation of Quality of Life Post Tongue Cancer Resection and Reconstruction Using Submental Island Pedicled Flap Versus Radial Forearm Free Flap

Acronym: SIPF-RFFF

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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