跳至主要内容
临床试验/NCT06262724
NCT06262724已完成不适用

Reliability of Chest Wall Perforator Flaps for Breast Reshaping Following Massive Weight Loss

Ain Shams University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Measurement of breast volume by sono-mammography

研究概览

简要总结

Reliability of Chest Wall Perforator Flaps for Breast Reshaping following Massive Weight Loss

详细描述

Conditions for inclusion in the study:

  • Ptotic and deflated breasts following massive weight loss (MWL) with Pittsburgh Rating Scale (PRS) score of 2-3 as described by Songet al. (Song AY, Jean RD, Hurwitz D, Fernstrom MH, Scott JA, Rubin JP. A Classification of Contour Deformities after Bariatric Weight Loss: The Pittsburgh Rating Scale. Plast Reconstr Surg. 2005;116:1535-1544).
  • MWL is defined as loss of 50% or greater of excess weight, following surgical or non-surgical interventions.
  • Stable weight for at least 6 months, to achieve metabolic and nutritional homeostasis and decrease the risk of surgical complications.
  • Body mass index (BMI): 18.5 - 30 kg/m2.
  • Patients seeking autologous augmentation or refusing implants.
  • Patients requiring simultaneous contouring of lateral chest wall redundancy.

Exclusion Criteria:

  • Weight fluctuations in the previous 6 months.
  • Medical co-morbidities (e.g., uncontrolled diabetes, uncontrolled hypertension, thyroid diseases, hormonal disturbances, cardiopulmonary diseases).
  • Hereditary conditions that affect wound healing (e.g., Ehler Danlos Syndrome, Progeria).
  • Active smokers (Smokers are required to stop smoking 1 month before surgery).
  • Nutritional deficiencies (e.g., iron, vitamin B12, protein, folate).
  • Previous breast surgery.
  • Congenital breast deformity (e.g., tuberous breasts).
  • Breast masses.
  • Pregnant or lactating patients.

Local breast examination:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: 18-45 years old.
  • Loss of 50% or greater of excess weight, following surgical or non-surgical interventions (MWL).
  • Stable weight for at least 6 months, to achieve metabolic and nutritional homeostasis and decrease the risk of surgical complications (Rubin et al., 2004).
  • BMI: 18.5 - 30 kg/m
  • Ptotic and deflated breasts with Pittsburgh Rating Scale (PRS) score 2-3 (Song, et al., 2005).
  • Patients seeking autologous augmentation or refusing implants.
  • Patients requiring simultaneous contouring of lateral chest wall redundancy.

排除标准

  • Weight fluctuations in the previous 6 months.
  • Medical co-morbidities (e.g., uncontrolled diabetes, uncontrolled hypertension, thyroid diseases, hormonal disturbances, cardiopulmonary diseases).
  • Hereditary conditions that affect wound healing (e.g., Ehler Danlos Syndrome, Progeria).
  • Active smokers (Smokers are required to stop smoking 1 month before surgery).
  • Nutritional deficiencies (e.g., iron, vitamin B12, protein, folate).
  • Previous breast surgery.
  • Congenital breast deformity (e.g., tuberous breasts).
  • Breast masses.
  • Pregnant or lactating patients.
  • PRS score 1.

结局指标

主要结局

Measurement of breast volume by sono-mammography

时间窗: One year follow-up

Use of sono-mammography to measure the breast volume in cubic centimetres preoperatively, after 6 months and after one year following surgery. The equation used to measure the breast volume was as follows: Breast volume = π/4 × (W × H × C) where W = breast width, H = breast height, and C=compression thickness in craniocaudal mammography)

次要结局

  • Sternal notch to nipple distance(One-year follow-up)
  • Nipple to inframammary fold distance(One-year follow-up)
  • Measure of nipple-to-nipple distance(One-year follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Breast Reshaping Following Massive Weight Loss | 临床试验