Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT07143058
Brief 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. 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.
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:
NCT07143058
Study Brief:
Protocol Section:
NCT07143058