Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication
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
- success rate of total mastectomy
研究概览
简要总结
Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume. Current techniques involve partial or total coverage of the implant with the pectoralis major muscle, to prevent exposure or infection. The muscle dissection technique applied has functional and cosmetic consequences. In this study, an endoscopic approach will be evaluated. This new surgical technique, using a single-port endoscopic way, will put the scar is in the axillary area, away from the breast. The hypothesis is that this delocalized scar potentially reduces the risk of exposure and allows placement of the implant in the subcutaneous space, with no manipulation of the pectoralis major muscle.
详细描述
It s a practicability study, evaluating endoscopic approach for prophylactic mastectomy, using an axillary single port. Classic open surgery conversion rate, operative time, infectious rate, esthetical outcomes, and functional outcomes will be evaluated.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient with an indication for prophylactic uni or bilateral mastectomy (Genetic risk factors for breast cancer)
- •Ask an immediate breast reconstruction during the surgery
- •World Heath Organization score <3
- •Glandular volume : french bra cup size A, B ou C
- •Glandular ptosis <=2 (Classification and Algorithm for Treatment of Breast Ptosis)
- •Contraception for woman of childbearing age and no pregnancy
- •Valid Social Security
- •Wrote consent
排除标准
- •History of breast cancer surgery
- •Breast cancer not operated on the side concerned by the prophylactic mastectomy
- •Patient having had irradiant treatment
- •Breast hypertrophy
- •Smoking > 10 cigarette/day
- •Body Mass Index > 30
- •Large breast volume requiring prostheses > 500ml
- •Chronic pulmonary obstructive gold 4
- •ASA (Physical Status score of American Society of Anesthesiologists) > 3
- •Chronic shoulder pain on the side to operate, or both shoulders
- •History of abarticular pathology of the shoulder on the operating side
- •Patient involvment in another clinical research
- •Protected patient or unable to give consent
- •Pregnant or breastfeeding woman
- •Vulnerable person (Article L1121-6 of the Public Health Code)
研究组 & 干预措施
implant for breast reconstruction
20 patients female with genetic risk for breast cancer and who ask for prophylactic mastectomy. They will have a prophylactic mastectomy with immediate breast reconstruction
干预措施: Prophylactic mastectomy with immediate breast reconstruction (Procedure)
结局指标
主要结局
success rate of total mastectomy
时间窗: one day
The total mastectomy is done by a scar in the axillary area, away from the breast, using single port endoscopy, with Implant base reconstruction in pre pectoral position. Complete excision of the gland by means of an incision on the axillary line, Installation of a definitive smooth prosthesis, Absence of conversion to a conventional approach, No skin necrosis
次要结局
- Number of participants with an infection(1 and 3 months after the prophylactic mastectomy)
- Blood loss(one day)
- Post-operative seromas after the prophylactic mastectomy(1, 3, 6 and 12 months after the prophylactic mastectomy)
- Need for cosmetic reoperation(3 and 12 months after the prophylactic mastectomy)
- Operative time(one day)
- Exposure of the prosthesis(1, 3, 6 and 12 months after the prophylactic mastectomy)
- Disunity of the scar(1, 3, 6 and 12 months after the prophylactic mastectomy)
- Skin case necrosis(1, 3, 6 and 12 months after the prophylactic mastectomy)
- Necrosis of areolo-nipple plaque(1, 3, 6 and 12 months after the prophylactic mastectomy)
- Aesthetic result(3 and 12 months after the prophylactic mastectomy)
- Open surgery conversion rate(one day)
- Number of participants with a local haematoma(Between the day of the prophylactic mastectomy and a month later)
- Complication rate of subcutaneous insufflation(3 and 12 months after the prophylactic mastectomy)
- Analogue visual scale (EVA)(1, 3, 6 and 12 months after the prophylactic mastectomy)
- Hospital stay(Through discharge from hospitalization, an average of 7 days)
- Shoulder function(3 months after the prophylactic mastectomy)
- Life quality(3 and 12 months after the prophylactic mastectomy)