Redefining Limits: A Clinical Trial on the Safety of Combining Liposuction With Undermining During Abdominoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Aesthetic outcome
研究概览
简要总结
This study evaluates the safety and outcomes of combining liposuction with varying degrees of abdominal flap undermining during abdominoplasty. Patients were randomly anssigned into three groups based on the extent of undermining and use of liposuction. Outcomes assessed included complication rates, horizontal laxity, and aesthetic results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult patients undergoing
- •Patients fit for elective surgery
- •BMI less than 35 kg/m2
排除标准
- •Significant uncontrolled comorbidities
- •Previous major abdominal surgery affecting flap vascularity
研究组 & 干预措施
Group C: Wide undermining + liposuction
干预措施: Liposuction (Procedure)
Group A: limited undermining + liposuction
干预措施: Liposuction (Procedure)
Group A: limited undermining + liposuction
干预措施: Limited undermining (Procedure)
Group B: Wide undermining without liposuction
干预措施: Wide undermining (Procedure)
Group C: Wide undermining + liposuction
干预措施: Wide undermining (Procedure)
结局指标
主要结局
Aesthetic outcome
时间窗: 6 months postoperatively
The postoperative aesthetic outcome was assessed using four predefined criteria by three independent surgeons in a double-blinded fashion. Each patient was assigned a postoperative score, with 1 representing the poorest outcome and 5 the best outcome. The mean score of all reviewers was then calculated for each case. These criteria included waist contour, residual adiposity (central), skin flaccidity, and the overall aesthetic appearance.
Postoperative complication rate (e.g., seroma, necrosis, infection)
时间窗: Within 6 months postoperatively
次要结局
- Horizontal laxity(6 months postoperatively)
- Change in BMI(6 months postoperatively)
- Epigastric pinch(6 months postoperatively)
研究者
Youssef Rafik Rizkalla
Assistant lecturer of plastic surgery
Cairo University