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Two ways to rebuild a tongue: which one leaves patients better off?

NCT ID NCT07819617

Symptom relief Sponsor: Al-Azhar University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers compare two surgical techniques for rebuilding the tongue after cancer removal: the submental island pedicled flap, taken from under the chin, and the radial forearm free flap, taken from the arm. Twenty-eight adults with tongue cancer that requires partial or total removal of the tongue join the study. Everyone answers a quality-of-life questionnaire before surgery and again at 6 and 12 months, covering speech, swallowing, appearance, and mood. The goal is to see whether one flap leads to better daily life after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
surgical reconstruction of the tongue using either a submental island pedicled flap or a radial forearm free flap
What this could lead to
If one flap clearly gives better quality of life, surgeons could favor it for rebuilding the tongue after cancer removal, helping patients speak, swallow, and feel more like themselves.
What could go wrong
The study is small, with 28 patients at one center, so its results may not apply to everyone. Both operations carry risks of bleeding, infection, flap failure, and scarring, and quality-of-life scores can be swayed by factors outside the surgery itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

28 people

The number who actually took part.

Started

Sep 2024

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult patients (aged 18 years or older) diagnosed with squamous cell carcinoma of the tongue requiring partial or total glossectomy. 2. Indication for immediate soft tissue reconstruction using either Submental Island Pedicled Flap (SIPF) or Radial Forearm Free Flap (RFFF). 3. Patients eligible and cleared for major surgical resection and flap reconstruction under general anesthesia. 4. Patient's informed consent to participate in the study and complete follow-up evaluations. Exclusion Criteria: 1. History of previous radiation therapy or surgical intervention in the head and neck region. 2. Clinical or radiological evidence of nodal metastasis in level I submental lymph nodes (for SIPF candidates). 3. Severe systemic comorbidities precluding major surgery or prolonged general anesthesia (ASA class IV or higher). 4. Distance or inability to commit to the 12-month postoperative follow-up schedule and quality of life assessments.

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Conditions

The condition(s) this trial relates to.

tongue cancer tongue carcinoma tongue neoplasm tongue squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Quality of life Tongue carcinoma Tongue neoplasms

Contacts and locations

Locations

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

    Asyut, Assuit, Egypt

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