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NCT Number: NCT07143058

Different Modalities Flaps of Head and Neck Reconstructions in Oral Cancer Patients

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

1. Age: any age. 2. Sex: males and females. 3. 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Oral Cancer Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag university faculty of medicine

Sohag, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

-

Treatment and study plan

Flaps reconstruction in head and neck in oral cance

Procedure

Follow up and quality of life of reconstruction flaps in head and neck

Flap of head and neck

Procedure

All types of flaps in oral cancer reconstruction

Primary outcomes

  1. Hospital stay

    Time frame: Up to 1 week

    how many days staying in hospital post sugery of reconstrucion of head and neck

  2. incidence of infection

    Time frame: Up to 1 week

    incidence of wound infection , discharge pus ,edema ,how many days to releved by antibiotic

  3. 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

  4. 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.

  5. Wound Dehiscence

    Time frame: Up to 4 weeks

    : The surgical wound may separate, exposing the flap

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Ahmed Mohamed Abdelhafiz

Other

Collaborators

  • Sohag University

Registry information

Official study title

Flaps of Head and Neck in Oral Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

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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