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临床试验/NCT07143058
NCT07143058进行中(未招募)不适用

Flaps of Head and Neck in Oral Cancer

Ahmed Mohamed Abdelhafiz1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
1
主要终点
Hospital stay

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Patients with associated with Severe chronic illness such as chronic renal failure, chronic liver disease, etc.
  • Mentally or psychologically disordered patients

结局指标

主要结局

Hospital stay

时间窗: Up to 1 week

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

incidence of infection

时间窗: Up to 1 week

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

incidence of Bleeding

时间窗: 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

时间窗: Up to 1 week

incidence of ischemia of flap as dark skin , Pale, cold, delayed capillary refill, no bleeding on needle prick.

Wound Dehiscence

时间窗: Up to 4 weeks

: The surgical wound may separate, exposing the flap

Fistula Formation

时间窗: 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

时间窗: 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.

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Ahmed Mohamed Abdelhafiz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmed Mohamed Abdelhafiz

Resident in general surgery department

Sohag University

研究点 (1)

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