Options of Breast Reconstruction Timing and Method After Removing of Polyacrylamide Hydrogel: a Propensity Score-matched Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The probability of reoperations
研究概览
简要总结
Since polyacrylamide hydrogel (PAAG) was used in cosmetic surgery in 1997, about 30 million women have received PAAG injection for breast augmentation. Although the use of PAAG has been prohibited in most countries due to its myriad complications, a large number of symptomatic patients and asymptomatic patients have continued to seek medical advice. The strategy of repairing secondary breast deformities after PAAG removal has increasingly become a concern for both doctors and patients, but there is no standardized algorithm yet. The purpose of the present study was to perform a retrospective study to compare the safety and effectiveness of different reconstruction timing and method after removing the gel.
详细描述
The primary purposes of this study are to:
- Compare the safety and effectiveness of IBR vs DBR after PAAG removal;
- Compare the safety and effectiveness of breast implants with silicone gel prosthesis vs autologous fat transplantation after PAAG removal;
- Evaluate the clinical characteristics associated with and rates of complications based on reconstruction timing and type.
The secondary purposes of this study are to：
- Explore and summarize the characteristics of long-term complications of PAAG injection for breast augmentation;
- Compare the rate of postoperative complications and reoperations between the patients who had breast reconstruction with implants and patients who had primary breast augmentation with implants.
- Further refine the algorithm for breast reconstruction in patients with PAAG injections.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •history of PAAG breast injection;
- •appeal to remove the gel;
- •availability of complete medical records;
- •accepting the potential complications of the operation and breast deformity after gel removal.
- •agreeing with medical history data collection, clinical follow-up investigation, and independent Complete the questionnaire.
排除标准
- •Patients who had other breast diseases;
- •Patients who failed to follow the standard diagnosis, treatment and follow-up;
- •Lost to follow-up due to various reasons or incomplete medical records;
- •Patients with cognitive disorders such as mental illness, understanding, memory, or orientation, and other serious diseases.
结局指标
主要结局
The probability of reoperations
时间窗: until 10 years post operation
Reoperation was defined as a surgical event performed after PAAG removal alone or stage I and II reconstruction. An anticipated operation of delayed breast implantation in patients with two-stage surgery was not classified as reoperation.
the occurrence of a postoperative complication
时间窗: until 10 years post operation
Complications are defined as any adverse postoperative events directly related to gel removal or breast reconstruction surgery that require further treatment. According to the patient's main complaint, physical examination, chest radiography, breast ultrasound, breast mammography or MRI, pathological biopsy and other methods to evaluate the complications. According to the degree of complications, they were further divided into: (1) Mild complications: conservative treatment without surgical treatment. (2) Severe complications: the incidence of complications requiring reoperations or implant removal/replacement operations.
次要结局
- Patient-reported quality of life, QOL(until 1 year post operation)
- change in patient satisfaction(until 1 year post operation)
- Aesthetic evaluation(until 1 year post operation)