Oral CancerNCT05296811
Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects.
A study testing Lateral Arm Free Flap in people with Oral Cancer, run by hassan harby mohamed at 1 site in Egypt.
Trial summary
The excision of oral cancers causes extensive impairment of the oral cavity soft tissue. Complete excision of the tumors is vital, and the reconstruction of the resected area influences not only the postoperative recovery period of patients but also physiological functions such as swallowing, phonation function ,daily… Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Lateral Arm Free Flap
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Jun 2024
- Phase
- Interventional
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients post glossectomy.
- Patients post maxillectomy with malignant maxillary swelling with no distant metastases.
- All patients which defect after surgery for head and neck neoplasia.
Who cannot join
- 1. Small defect post excision can be closed directly 2. medically unfit patients
Trial locations and contacts
1 site in 1 country.
About this study
The excision of oral cancers causes extensive impairment of the oral cavity soft tissue. Complete excision of the tumors is vital, and the reconstruction of the resected area influences not only the postoperative recovery period of patients but also physiological functions such as swallowing, phonation function ,daily activities and psychosocial impact.
Oral and maxillofacial surgeons are faced with the task of reconstructing the affected area to reduce these problems as much as possible.
Read more
In 1982, Song introduced the lateral arm flap (LAF). Since this time, its used in surgical repairs of oral defects, But the specific subject of publications generally restricted to a small number of cases.
LAF is a thin and pliable flap with consistent anatomy and a high success rate. It is also claimed that there is no risk of vascular compromise to the arm
Read the detailed description
reconstruction of oral , head and neck defects with Lateral Arm Free Flap
- Conditions
- Oral Cancer
- Being tested
- Lateral Arm Free Flap
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Arm Free FlapProcedure or surgery
Primary Reconstruction of intraoral defects by use of Lateral Arm Free Flap.
What is being measured
The primary outcome is the main question the study is designed to answer.
Early detection of recurrence
reconstruction of defects in head and neck post surgical excision by lateral arm free flap and early detection of recurrence by CT neck.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- hassan harby mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, hassan harby mohamed, Assiut University
- Investigators
- hassan harby, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296811
- Sponsor's protocol ID
- Lateral Arm Free Flap
- Status last verified
- Mar 2022
- First submitted
- 6 Mar 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nahabedian MY, Deune EG, Manson PN. Utility of the lateral arm flap in head and neck reconstruction. Ann Plast Surg. 2001 May;46(5):501-5. doi: 10.1097/00000637-200105000-00008.
PubMed 11352423
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects.
- ClinicalTrials.gov ID
- NCT05296811
- Acronym / sponsor ID
- Lateral Arm Free Flap
- Conditions
- Oral Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- hassan harby mohamedUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 25 Mar 2022 (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.
The excision of oral cancers causes extensive impairment of the oral cavity soft tissue. Complete excision of the tumors is vital, and the reconstruction of the resected area influences not only the postoperative recovery period of patients but also physiological functions such as swallowing, phonation function ,daily activities and psychosocial impact.
Oral and maxillofacial surgeons are faced with the task of reconstructing the affected area to reduce these problems as much as possible.
In 1982, Song introduced the lateral arm flap (LAF). Since this time, its used in surgical repairs of oral defects, But the specific subject of publications generally restricted to a small number of cases.
LAF is a thin and pliable flap with consistent anatomy and a high success rate. It is also claimed that there is no risk of vascular compromise to the arm
Detailed description
reconstruction of oral , head and neck defects with Lateral Arm Free Flap
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All patients post glossectomy.
- Patients post maxillectomy with malignant maxillary swelling with no distant metastases.
- All patients which defect after surgery for head and neck neoplasia.
Key exclusion criteria (1 listed)
- 1. Small defect post excision can be closed directly 2. medically unfit patients
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 |
|---|---|---|
| Lateral Arm Free FlapPrimary Reconstruction of intraoral defects by use of Lateral Arm Free Flap. | Procedure or surgery | – |
Primary outcome
Early detection of recurrence
Time frame: 3 month
reconstruction of defects in head and neck post surgical excision by lateral arm free flap and early detection of recurrence by CT neck.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Background: PubMed 11352423Nahabedian MY, Deune EG, Manson PN. Utility of the lateral arm flap in head and neck reconstruction. Ann Plast Surg. 2001 May;46(5):501-5. doi: 10.1097/00000637-200105000-00008.
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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.
hassan harby principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral Arm Free Flap in people with Oral Cancer, run by hassan harby mohamed 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hassan harby (0101261001, harby1990hassan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early detection of recurrence (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05296811, which also lists 1 linked publication.
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 25 Mar 2022.