Bilateral Prophylactic Mastectomy; Should we Preserve the Pectoral Fascia?: Protocol of a Dutch Double Blinded, Prospective, Randomized Controlled Pilot Study With a Within-subject Design
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Drainproduction in milliliters
研究概览
简要总结
Many surgical guidelines promote the removal of the pectoral fascia in mastectomies for invasive breast cancer, but there is no evidence to support this statement in (bilateral) prophylactic mastectomies. Reported wound-related local complications following mastectomy include seroma, flap necrosis, infection, hematoma, and nerve injury. Seroma causes discomfort and may delay the reconstructive procedures. Whether the removal or preservation of the pectoral fascia influences seroma formation following mastectomy remains unclear to our knowledge.
详细描述
The primary objective of this pilot study is to investigate the impact of removal versus preservation of the pectoral fascia on drain policy and needle aspirations in women who undergo a bilateral prophylactic mastectomy. The secondary objective is to investigate the impact of removal versus preservation of the pectoral fascia on postoperative (surgical) complications.
The study design includes a double-blinded, prospective, randomized controlled pilot study with a within-subject design. All patients will undergo a bilateral prophylactic mastectomy and randomization will occur within the patient. Preservation of the PF will be performed in one breast (intervention), while removal of the PF will be performed in the contralateral breast of the same patient (control). Consequently, the operation involves a total bilateral prophylactic mastectomy, with unilateral preservation of the PF
The follow-up time of each patient will be 6 weeks. The patients' files will be viewed after the removal of the drain for additional recorded variables.
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, Care Provider)
盲法说明
The patient and the observer for drain volume are both blinded for their assigned breast randomization. The surgeon(s) and coordinating researcher will not be blinded, and are therefore not allowed to measure the drain production.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient
- •Scheduled for a bilateral prophylactic mastectomy in the Erasmus MC Academic Breast Cancer Centre in Rotterdam
- •Ability to give written consent
- •Adequate understanding of Dutch language
排除标准
- •History of diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS)
- •Other malignancies
结局指标
主要结局
Drainproduction in milliliters
时间窗: Until drain removal, maximum 1 week
The total drainage volume of the left and right breast in milliliters
Time to drain removal in days
时间窗: Until drain removal, maximum 1 week
Number of days until drain removed
次要结局
- Postoperative bleeding (yes/no)(Up to 6 weeks)
- Needle aspirations (number)(Up to 6 weeks)
- Postoperative pain (score 1-10)(Up to 6 weeks)
- Seroma (yes/no)(Up to 6 weeks)
- Wound related issues (yes/no)(Up to 6 weeks)
- Hospitalization duration (in days)(Up to 6 weeks)
研究者
Linetta Koppert
Principal Investigator
Erasmus Medical Center