NCT06262724已完成不适用
Reliability of Chest Wall Perforator Flaps for Breast Reshaping Following Massive Weight Loss
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
- 是
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
研究点 (2)
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