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临床试验/NCT06427759
NCT06427759尚未招募不适用

Optimizing Aesthetic Outcome for Arm Contouring Surgery by Utilizing Anthropometric Measurements

Abdelrahman Mostafa Shehata Mohammed2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
45
试验地点
2
主要终点
Group(A) anthropometric measures of arm length , arm circumference and forearm circumference . Group (B) compare postoperative measures of arm length , arm circumference and forearm circumference with anthropometric measures of Group A

研究概览

简要总结

Brachioplasty is a popular plastic surgery procedure. Current and common various techniques are based on either surgeon 's sense preoperatively. A method is needed to define how much skin and soft tissue should be excised precisely, or what can be a reference point to design a brachioplasty mathematically.(1)

Anthropometric reference measurements can be applied in designing arm aesthetic surgery.

Classically, anthropometry binds the upper arm length with forearm circumference and upper arm circumference to make postoperative results more harmonious and natural . (2)a 2020).

详细描述

2.4.1- Type of the study: 2.4. 2- Study Setting: Plastic and Reconstructive Surgery Department, Assuit University Hospital 2.4. 3- Study subjects:

a. Inclusion criteria:

  • Group (A) this group will be available for measurements only with no interventions needed.
  • Group (B) Include patients asking for arm aesthetic surgery .
  • Group B1: patients will be submitted for liposuction only. liposuction is the preferred approach, particularly in young patients after massive weight loss.
  • Group B2: patients will be submitted for liposuction and brachioplasty in same setting. When skin laxity is excessive, even in young patients, an extensive arm-long operation that extends across the axilla and onto the lateral chest is indicated.
  • Group B3: patients will be submitted for liposuction then brachioplasty after 3 months.

in borderline cases to take chance for skin retraction .

c. Sample Size Calculation: sample size was calculated using g power program version 3.1.9.7 in order to detect anthropometric measures of arm and compare these measures with post operative cases, assumed effect size 0.8 based on clinical assumption (novel study) , α error 0.2 power 0.8 and allocation 1:1:1 the sample size will be 40 patients for each group. 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ...): Group (A) will be subjected to these measures

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • group A : Anthropometric databases and studies done on females with normal BMI, In reproductive period , No history of pregnancy or weight fluctuation , No medical comorbidities .
  • group B :Include patients asking for arm aesthetic surgery .
  • Group B1: patients will be submitted for liposuction only.
  • Group B2: patients will be submitted for liposuction and brachioplasty in same setting.
  • Group B3: patients will be submitted for liposuction then brachioplasty after 3 months.

排除标准

  • Males 2) Athletes 3) Current morbidities

结局指标

主要结局

Group(A) anthropometric measures of arm length , arm circumference and forearm circumference . Group (B) compare postoperative measures of arm length , arm circumference and forearm circumference with anthropometric measures of Group A

时间窗: 3 years

Group(A) anthropometric measures of arm length , arm circumference and forearm circumference . Group (B) compare postoperative measures of arm length , arm circumference and forearm circumference with anthropometric measures of Group A

次要结局

未报告次要终点

研究者

发起方
Abdelrahman Mostafa Shehata Mohammed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Abdelrahman Mostafa Shehata Mohammed

assistant lecturer

Assiut University

研究点 (2)

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