Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage in Prevention of Seroma Formation After Mastectomy for Breast Cancer : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 8
- 主要终点
- Wound seroma requiring aspiration or surgical intervention
研究概览
简要总结
The objective of this study is to compare quilting suture of the "dead space" without drainage of the pectoral area to conventional closure with drainage to prevent post-operative seroma requiring intervention (aspiration or surgical intervention) within 21 days after mastectomy for breast cancer.
详细描述
Eligible patients are patients with operable breast cancer (invasive carcinoma and/or carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either alone or in association with sentinel lymph node biopsy or standard level I/II axillary node dissection
Randomization will be stratified by center and by type of surgery (mastectomy alone/ mastectomy with sentinel node biopsy / mastectomy with axillary lymph node dissection).
Two follow-up visits will be performed: at 21 days and 9 months after surgery, these appointments are conventional, thus our trial will not modify usual follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 18 years and ≤ 85 years
- •Women with operable breast cancer (invasive carcinoma and/or carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either alone or in association with sentinel lymph node biopsy or standard level I/II axillary node dissection
- •Women that give her informed written consent
- •French social security affiliation
排除标准
- •Any physical or psychiatric condition that could impair with patient's ability to cooperate with postoperative data collection.
- •Women with indication of bilateral mastectomy or immediate reconstruction.
- •Degenerative neuromuscular disease with thoracic muscular damage
- •Planned ambulatory surgery
研究组 & 干预措施
Closure with conventional technique with drainage
The skin flaps are not fixed subcutaneously but sutured at the edges, a closed suction drain is inserted under the flaps in the dead space created by the dissection at the pectoral area. The drain is stitched to the skin.
干预措施: Conventional closure with drainage (Procedure)
Quilting suture without drainage
In an attempt to obliterate the dead space, the skin flaps are sutured to the underlying pectoralis major with multiple parallel rows of 0/0 vicryl (or equivalent). Running sutures at periodic intervals (<2cm) are placed from the skin flaps to the underlying muscle.
干预措施: Quilting suture without drainage (Procedure)
结局指标
主要结局
Wound seroma requiring aspiration or surgical intervention
时间窗: Within 21 days following mastectomy
A seroma is defined as a postoperative fluid collection via palpation on clinical examination. The Common Terminology Criteria for Adverse Events (CTCAE) which is a descriptive terminology that can be used for adverse event reporting provide a grading scale for seromas (lymphoceles). Only grade 2 and 3 seromas i.e. seromas requiring one or more aspirations or a surgical intervention will be considered as primary outcome.
次要结局
- Wound seroma requiring aspiration or surgical intervention(Within 9 months following mastectomy)
- Homolateral shoulder movement(Before surgery, 21 days and 9 months following mastectomy)
- Wound seroma whatever their type (requiring or not intervention)(Within 9 months following mastectomy)
- Other wound complications(Within 9 months following mastectomy)
- Surgical morbidity(During surgical intervention)
- Pain(Before surgery, day 1, 21 days and 9 months following mastectomy)
- Cosmesis results(21 days, 9 months following mastectomy)
- Health related quality of life : EQ-5D-5L(Before surgery, day 1, 21 days and 9 months following mastectomy)
- Cost-effectiveness assessment(During the whole follow-up period i.e. 9 months following mastectomy)