Different Techniques for Abdominoplasty After Massive Weight Loss: Safety and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Number of and type of complications within 30 days
研究概览
简要总结
Excess skin on the abdomen is a common problem for many individuals after massive weight loss. The surgical procedure of abdominoplasty is intended to remove excess skin and improve the shape of the torso in abdomen, in order to address issues such as skin fold eczema, difficulties finding clothing, and psychosocial issues.
The investigators will conduct a randomized, controlled trial where individuals with excess skin on the abdomen will be randomized to either standard abdominoplasty or abdominoplasty in combination with liposuction. The investigators will examine the rate of complications, and the functional and aesthetical outcomes of the two methods.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study is open only to individuals who are residents in Sweden and qualify for government-funded, inpatient, non-emergency health care within the Stockholm Region.
- •Inclusion Criteria:
- •BMI < 30
- •Stable BMI for >= 6 months
- •>= 24 months since bariatric surgery, if applicable
- •Skin fold of >= 5 cm
- •Functional and/or psychosocial issues due to abdominal skin excess
排除标准
- •Ongoing infection
结局指标
主要结局
Number of and type of complications within 30 days
时间窗: 30 days
Number of and type of complications occurring within 30 days of surgery
次要结局
- Average score on aesthetic result(At 12 months post-operatively)
- Average days until discharge(Days)
- Average score on BodyQ score(At baseline, at 3 months post-operatively, at 12 months post-operatively)
- Average need for analgesia in morphine equivalents(Post-operative day 1)
研究者
Ebba Lindqvist
Principal Investigator
Karolinska University Hospital