Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation : Feasibility, Complications, Evaluation of Aesthetic Result and Quality of Life.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Describe the complications that occurs after a prepectoral placed implant with lipo-preparation
研究概览
简要总结
Breast implants associated with the installation of a complementary matrix (of dermal or synthetic origin), showed satisfactory results in term of post-operative follow-up but also aesthetic outcomes.
The objective of the subcutaneous positioning of this implant, is to reduce the muscular pain related to the stretching of the muscular muscle, the deformations related to the muscular contraction with an animation of the prothesis, but also the risk of hull when associated with a matrix. It also pursues the objective, of obtaining a better aesthetic result, by systematically coupling at least one lipo-modelling session.
For a long time, patients with a history of mastectomy and radiotherapy benefited from secondary breast flap reconstruction, in order to reduce the risk of complications and achieve a satisfying aesthetic outcome. But the lipo-filling technique allowed to reconsider the management of these patients.
The benefits of fat tissue transplants are know to improve tissue trophicity (flexibility, thickness, vascularization).
The objective of this study, is to evaluate the feasibility of secondary breast reconstructions by prepectoral positioned implant after lipo-preparation of the wall.
详细描述
60 women who have had a mastectomy and want a secondary breast reconstruction by implant at Institut de Cancérologie de l'Ouest well be included in this study.
Patients will be recruited in consultation before the start of reconstruction and up to 18 months after radiation therapy.
They will be followed for 24 months from the end of the breast reconstruction.
The following data will be collected indirectly from the clinical medical record (letters, reports of examinations, consultations, surgical report, hospitalization) of the patient, supplemented if necessary by specific records (radiotherapy records, chemotherapy, physiotherapy management) :
- Clinical data
- Technique-related data
- Complication-related data : adverse events will be evaluated at 15 days, 3 months, 6 months, 12 months and 24 months after reconstruction
- Aesthetic results data : aesthetic result will be evaluated by patients and surgeons at 6 months, 12 months and 24 months after reconstruction
- Quality of life data : a questionnaire will be submitted prior to the intervention, at 12 months and 24 months after reconstruction
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman aged over 18
- •Medical history of mastectomy +/- radiotherapy
- •Woman requesting breast reconstruction by implant
- •Patient treated for non-metastatic cancer
排除标准
- •Locally uncontrolled disease
- •Metastatic disease
- •Patient with major cutaneous atrophy allowing only flap reconstruction
- •Patients under guardianship or trusteeship
- •Patients who objected to the research
研究组 & 干预措施
Breast reconstruction
Women who have had a mastectomy and want a secondary breast reconstruction by implant.
干预措施: Breast reconstruction (Procedure)
结局指标
主要结局
Describe the complications that occurs after a prepectoral placed implant with lipo-preparation
时间窗: 12 months
Pre-surgical implant positioning failure at 12 months. A failure will be defined by the occurence of at least one of the following complications : documented infection ; red breast syndrome ; hematoma ; lymphocele ; delayed healing ; prothesis removal ; stage 1 hull (Baker classification) ; prothesis rotation ; waves / folds ; muscle contractions with prothesis animation ; pain (EVA 4 or 5)
次要结局
- Evaluate the aesthetic result(6 months, 12 months and 24 months)
- Evaluate the quality of life(24 months)