Oral CancerNCT07143058
Different Modalities Flaps of Head and Neck Reconstructions in Oral Cancer Patients
An observational study of Oral Cancer, run by Ahmed Mohamed Abdelhafiz at 1 site in Egypt.
Trial summary
Different Modalities of Flaps used in Head and Neck Reconstructions in oral cancer Patients, retrospective study Study design: This study will be conducted in a Retrospective study with prospective collective data. At General Surgery Department of Sohag University Hospital in the period between June 2020 to June 2025. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Flaps reconstruction in head and neck in oral cance and Flap of head and neck
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jun 2025to 12 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients with oral cancer done flap reconstruction
Who may be able to join
- All patients with head and neck Reconstruction on oral cancer patients ,Cooperative and mentally healthy
- Exclusion Criteria:Patients with associated with Severe chronic illness such as chronic renal failure, chronic liver disease, etc.
- Mentally or psychologically disordered patients
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flaps of Head and Neck in Oral Cancer
Different Modalities of Flaps used in Head and Neck Reconstructions in oral cancer Patients, retrospective study
Study design:
Read more
This study will be conducted in a Retrospective study with prospective collective data. At General Surgery Department of Sohag University Hospital in the period between June 2020 to June 2025. Data base will be gathered, reviewed, and consequently will be analyzed.
Study population:
The study will include patients presented post operative Head and Neck cancer Resection and Reconstruction with flap during the period of the study, analysis of the clinical presentation, follow up size, color, regeneration skin, early and late complication and a defect appear
Inclusion criteria:
All patients with head and neck Reconstruction on oral cancer patients
- Age: any age.
- Sex: males and females.
- Cooperative, mentally healthy.
Exclusion criteria :
Patients with associated with
1 -Severe chronic illness such as chronic renal failure, chronic liver disease, etc.
2- Mentally or psychologically disordered patients.
Read the detailed description
Follow up:
The following diameters of patients will be entered into a dedicated database:
Quality of life Questionnaire survey Washington University
2- Clinical: Age. Gender. Comorbidity disease Type , size and site of Tumor Pathology of Tumor Resected part and Method of Resection Size and color of flap Cosmeses Early and late complication Revision of Reconstruction 3 -Investigation: Lab Cbc, Esr, Crp, d-dimer
Radiological:
Ultrasonography laser intervention Statistical method of study Statistical analysis will be done by SPSS v26 (IBM Inc., Chicago, IL, USA). Shapiro-Wilks test and histograms will be used to evaluate the normality of the distribution of data. Quantitative parametric data will be presented as mean and standard deviation (SD). Quantitative non-parametric data will be presented as median and interquartile range (IQR). Qualitative variables will be presented as frequency (%).
Ethical consideration:
Anoralandwrittenconsent willbetakenfromthepatientsincludedinthestudyand willbeintroducedtoethicsscientificcommitteeatSohagUniversityhospitalforapproval.
- Conditions
- Oral Cancer
- Being tested
- Flaps reconstruction in head and neck in oral cance, Flap of head and neck
- Keywords
- Different Modalities of Flaps used in Head and Neck Reconstructions in oral cancer Patients, retrospective study
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flaps reconstruction in head and neck in oral canceProcedure or surgery
Follow up and quality of life of reconstruction flaps in head and neck
Flap of head and neckProcedure or surgery
All types of flaps in oral cancer reconstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital stay
how many days staying in hospital post sugery of reconstrucion of head and neck
Measured: Up to 1 week
incidence of infection
incidence of wound infection , discharge pus ,edema ,how many days to releved by antibiotic
Measured: Up to 1 week
incidence of Bleeding
incidence of bleeding and hematoma under flap which cause compromise of local flap vascularity by inducing vasospasm, stretching the sub dermal plexus, or separating the flap from the surface of the recipient site
Measured: Up to 1 week
incidence of Ischemia
incidence of ischemia of flap as dark skin , Pale, cold, delayed capillary refill, no bleeding on needle prick.
Measured: Up to 1 week
Wound Dehiscence
: The surgical wound may separate, exposing the flap
Measured: Up to 4 weeks
Fistula Formation
An abnormal connection can form between the flap and other structures, like the oral cavity or pharynx , clinically leakage and ct neck e iv contrast or mri show track of fistula
Measured: Up to 4 weeks
Number of participants with fibrosis
may occur fibrosis between flap and beside structures of oral cavity ,make limitation of movement of mandible , mri image show fibrosis
Measured: Up to 8 weeks
questionnaire quality of life of Washington university : Health-related quality of life (HRQOL) is an important outcome parameter following treatment for head and neck cancer.
. Version 4 of the UW-QOL questionnaire consists of 12 single question domains, these having between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety. Another question asks patients to choose up to three of these domains that have been the most important to them.There are also three global questions, one about how patients feel relative to before they developed their cancer, one about their health-related QOL and one about their overall QOL..Scoring of UW-QOL domains The UW-QOL has domains based upon discrete ordinal responses. Scoring is scaled to so that a score of 0 represents the worst possible response, and a score of 100 represents the best possible response .http://www.hancsupport.com/professionals/quality-life/qol-questionnaires/uw-hrqol/uw-qol-v4-translations
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start12 Jun 2025
- Primary completion12 Jun 2026 (estimated)
- Study completion12 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Mohamed Abdelhafiz
- Sponsor type
- University, hospital or other
- Collaborators
- Sohag University
- Responsible party
- Sponsor-investigator, Ahmed Mohamed Abdelhafiz, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143058
- Sponsor's protocol ID
- Soh-Med-25-6__15MS
- Status last verified
- Aug 2025
- First submitted
- 29 Jun 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flaps of Head and Neck in Oral Cancer
- ClinicalTrials.gov ID
- NCT07143058
- Acronym / sponsor ID
- Soh-Med-25-6__15MS
- Conditions
- Oral Cancer
- Keywords
- Different Modalities of Flaps used in Head and Neck Reconstructions in oral cancer Patients, retrospective study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ahmed Mohamed AbdelhafizUniversity, hospital or other
- Collaborators
- Sohag University
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 12 Jun 2026 (estimated)
- Study completion
- 12 Jun 2026 (estimated)
- First posted
- 27 Aug 2025 (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.
Different Modalities of Flaps used in Head and Neck Reconstructions in oral cancer Patients, retrospective study
Study design:
This study will be conducted in a Retrospective study with prospective collective data. At General Surgery Department of Sohag University Hospital in the period between June 2020 to June 2025. Data base will be gathered, reviewed, and consequently will be analyzed.
Study population:
The study will include patients presented post operative Head and Neck cancer Resection and Reconstruction with flap during the period of the study, analysis of the clinical presentation, follow up size, color, regeneration skin, early and late complication and a defect appear
Inclusion criteria:
All patients with head and neck Reconstruction on oral cancer patients
- Age: any age.
- Sex: males and females.
- Cooperative, mentally healthy.
Exclusion criteria :
Patients with associated with
1 -Severe chronic illness such as chronic renal failure, chronic liver disease, etc.
2- Mentally or psychologically disordered patients.
Detailed description
Follow up:
The following diameters of patients will be entered into a dedicated database:
Quality of life Questionnaire survey Washington University
2- Clinical: Age. Gender. Comorbidity disease Type , size and site of Tumor Pathology of Tumor Resected part and Method of Resection Size and color of flap Cosmeses Early and late complication Revision of Reconstruction 3 -Investigation: Lab Cbc, Esr, Crp, d-dimer
Radiological:
Ultrasonography laser intervention Statistical method of study Statistical analysis will be done by SPSS v26 (IBM Inc., Chicago, IL, USA). Shapiro-Wilks test and histograms will be used to evaluate the normality of the distribution of data. Quantitative parametric data will be presented as mean and standard deviation (SD). Quantitative non-parametric data will be presented as median and interquartile range (IQR). Qualitative variables will be presented as frequency (%).
Ethical consideration:
Anoralandwrittenconsent willbetakenfromthepatientsincludedinthestudyand willbeintroducedtoethicsscientificcommitteeatSohagUniversityhospitalforapproval.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with oral cancer done flap reconstruction
Key inclusion criteria (4 listed)
- All patients with head and neck Reconstruction on oral cancer patients ,Cooperative and mentally healthy
- Exclusion Criteria:Patients with associated with Severe chronic illness such as chronic renal failure, chronic liver disease, etc.
- Mentally or psychologically disordered patients
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Flaps reconstruction in head and neck in oral canceFollow up and quality of life of reconstruction flaps in head and neck | Procedure or surgery | – |
| Flap of head and neckAll types of flaps in oral cancer reconstruction | Procedure or surgery | – |
Primary outcome
Hospital stay
Time frame: Up to 1 week
how many days staying in hospital post sugery of reconstrucion of head and neck
incidence of infection
Time frame: Up to 1 week
incidence of wound infection , discharge pus ,edema ,how many days to releved by antibiotic
incidence of Bleeding
Time frame: Up to 1 week
incidence of bleeding and hematoma under flap which cause compromise of local flap vascularity by inducing vasospasm, stretching the sub dermal plexus, or separating the flap from the surface of the recipient site
incidence of Ischemia
Time frame: Up to 1 week
incidence of ischemia of flap as dark skin , Pale, cold, delayed capillary refill, no bleeding on needle prick.
Wound Dehiscence
Time frame: Up to 4 weeks
: The surgical wound may separate, exposing the flap
Fistula Formation
Time frame: Up to 4 weeks
An abnormal connection can form between the flap and other structures, like the oral cavity or pharynx , clinically leakage and ct neck e iv contrast or mri show track of fistula
Number of participants with fibrosis
Time frame: Up to 8 weeks
may occur fibrosis between flap and beside structures of oral cavity ,make limitation of movement of mandible , mri image show fibrosis
questionnaire quality of life of Washington university : Health-related quality of life (HRQOL) is an important outcome parameter following treatment for head and neck cancer.
Time frame: 1 year after surgery
. Version 4 of the UW-QOL questionnaire consists of 12 single question domains, these having between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety. Another question asks patients to choose up to three of these domains that have been the most important to them.There are also three global questions, one about how patients feel relative to before they developed their cancer, one about their health-related QOL and one about their overall QOL..Scoring of UW-QOL domains The UW-QOL has domains based upon discrete ordinal responses. Scoring is scaled to so that a score of 0 represents the worst possible response, and a score of 100 represents the best possible response .http://www.hancsupport.com/professionals/quality-life/qol-questionnaires/uw-hrqol/uw-qol-v4-translations
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oral Cancer, run by Ahmed Mohamed Abdelhafiz 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 0 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hospital stay (time frame: Up to 1 week). The study lists 8 primary outcomes in all. 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 27 Aug 2025.