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临床试验/NCT03283475
NCT03283475Unknown不适用

Surgical Management of Thigh Lipodystrophy

Assiut University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年5月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
90
试验地点
2
主要终点
regarding patient satisfaction and achievement of symmetry.

研究概览

简要总结

The sample will be divided into two groups:- - Control group which will include 60 adult individuals between 18 and 35 years old who have BMI between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females.

The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences.

  • Patient group which will include 40 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment.

After assessment, one of the following techniques will be selected:-

  • Liposuction only.
  • thigh lift.
  • Liposuction assisted thigh lift.

详细描述

Preoperative assessment:- Patients will be assessed regarding skin redundancy, history of weight loss and site of lipodystrophy whether deformity is proximal, distal or diffuse.

The same measurements mentioned above will be recorded for the patient group before surgery.

Preoperative photographs in anteroposterior, lateral and oblique positions will be taken.

Informed consent will be signed by the patient before surgery illustrating possible risks and complications of the surgery.

Postoperative assessment:- The outcomes will be evaluated 3 months after surgery regarding patient satisfaction and achievement of symmetry.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals between18 and 35 years for control group and more than 18 years for patient group .
  • Patients with BMI between 19 and 25 for control group and less than 35 for patient group.

排除标准

  • Individuals less than 18 years.
  • Patients undergoing bariatric surgery within a period of less than one year.
  • Patients with BMI more than
  • Patients with systemic illness as cancer or mental disorders & hepatic patients (generally debilitating diseases) or any contraindication for anesthesia.

研究组 & 干预措施

control group

No Intervention
  • Control group will include 60 adult individuals between 18 and 35 years old who have body mass index (BMI) between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females.

The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences.

patient group

Active Comparator
  • Patient group will include 30 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment.

After assessment, one of the following techniques will be selected:-

  • Liposuction only.
  • thigh lift.
  • Liposuction assisted thigh lift.

干预措施: thigh lift (Procedure)

结局指标

主要结局

regarding patient satisfaction and achievement of symmetry.

时间窗: 3 months

questionnaire will be performed for the patient group to estimate degree of patient satisfaction with assessment of postoperative symmetry

次要结局

  • complication rates of different surgical techniques(1 week and 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohammed Gamal

plastic surgery department, Assiut University Hospital, Assiut, Egypt

Assiut University

研究点 (2)

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