Tongue CarcinomaSIPF-RFFFNCT07819617
Submental Island Flap vs Radial Forearm Free Flap in Tongue Reconstruction
An observational study of Tongue Carcinoma and Tongue Neoplasms, run by Al-Azhar University at 1 site in Egypt.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tongue Carcinoma, Tongue Neoplasms, Quality of Life
- What is being tested?
- Submental Island Pedicled Flap (SIPF) and Radial Forearm Free Flap (RFFF)
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dental Medicine, Al-Azhar University (Assiut Branch)
Asyut, Assuit
About this study
Official title: Evaluation of Quality of Life Post Tongue Cancer Resection and Reconstruction Using Submental Island Pedicled Flap Versus Radial Forearm Free Flap
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.
Read the detailed description
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.
- Conditions
- Tongue Carcinoma, Tongue Neoplasms, Quality of Life
- Being tested
- Submental Island Pedicled Flap (SIPF), Radial Forearm Free Flap (RFFF)
- Keywords
- Submental flap, Radial fore arm flap, Quality of life, Partial tongue resection, Tongue reconstruction
- Medical subject headings
- Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submental Island Pedicled Flap (SIPF)Procedure or surgery
Surgical reconstruction of tongue defect following oncological resection using a pedicled submental island flap.
Radial Forearm Free Flap (RFFF)Procedure or surgery
Surgical reconstruction of tongue defect following oncological resection using a microvascular radial forearm free flap.
| Study group | Role | What they receive |
|---|---|---|
| SIPF Group | Patients who underwent tongue reconstruction using Submental Island Pedicled Flap following tongue cancer resection. Receives: Procedure: Submental Island Pedicled Flap (SIPF) | |
| RFFF group | Patients who underwent tongue reconstruction using Radial Forearm Free Flap following tongue cancer resection. Receives: Procedure: Radial Forearm Free Flap (RFFF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post operatively
Secondary outcomes (3)
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.
Measured: 6 months post operatively
Operative time
Total duration of surgery measured in hours from initial skin incision to final closure.
Measured: Day of surgery (intraoperative)
Length of hospital stay
Total duration of inpatient hospital admission measured in days from surgery until discharge.
Measured: From date of surgery to hospital discharge. Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Sep 2024
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tongue CarcinomaStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Serag Eldin Attia, Al-Azhar University
- Investigators
- Mohamed Serag Attia, MSc, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819617
- Sponsor's protocol ID
- AUAREC20240007-3
- Acronym
- SIPF-RFFF
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient privacy and confidentiality, in accordance with the institutional ethics review board guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quality of Life Post Tongue Cancer Resection and Reconstruction Using Submental Island Pedicled Flap Versus Radial Forearm Free Flap
- ClinicalTrials.gov ID
- NCT07819617
- Acronym / sponsor ID
- SIPF-RFFF / AUAREC20240007-3
- Conditions
- Tongue Carcinoma, Tongue Neoplasms, Quality of Life
- Keywords
- Submental flap, Radial fore arm flap, Quality of life, Partial tongue resection, Tongue reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIPF Group | – | Procedure: Submental Island Pedicled Flap (SIPF)Patients who underwent tongue reconstruction using Submental Island Pedicled Flap following tongue cancer resection. |
| RFFF group | – | Procedure: Radial Forearm Free Flap (RFFF)Patients who underwent tongue reconstruction using Radial Forearm Free Flap following tongue cancer resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Submental Island Pedicled Flap (SIPF)Surgical reconstruction of tongue defect following oncological resection using a pedicled submental island flap. | Procedure or surgery | SIPF Group |
| Radial Forearm Free Flap (RFFF)Surgical reconstruction of tongue defect following oncological resection using a microvascular radial forearm free flap. | Procedure or surgery | RFFF group |
Primary outcome
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.
3 secondary outcomes
6-Month Baseline-Adjusted Composite Quality of Life (UW-QOL v4)
Time frame: 6 months post operatively
Operative time
Time frame: Day of surgery (intraoperative)
Length of hospital stay
Time frame: From date of surgery to hospital discharge. Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient privacy and confidentiality, in accordance with the institutional ethics review board guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Serag Attia, MSc principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tongue Carcinoma and Tongue Neoplasms, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-Month Baseline-Adjusted Composite Quality of Life (UW-QOL v4) (time frame: 12 months post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.