Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Proportion in percentage of patients treated successfully
研究概览
简要总结
Lymphocele secondary to a mastectomy whether or not associated with a lymph node procedure (sentinel lymph node or axillary dissection) is an almost systematic consequence observed in the postoperative situation in this type of surgery.
This can be the source of pain, skin complications, and infection with a significant impact on the length of hospitalization for patients treated for breast cancer.
There is no consensus regarding the management of lymphocele. The placement of a compression bandage after mastectomy and / or axillary dissection would allow a more efficient and rapid reduction of the lymphocele and a reduction in recurrences.
This would make it possible to reduce the duration of the wearing of the drain, which determines the length of hospitalization and reduce the recurrence of lymphoceles, the punctures of which can be one of the risk factors for secondary lymphedema.
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
- None
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
- •Patients over 18 years old,
- •Undergoing mastectomy-type surgery with or without axillary dissection for breast cancer
- •Affiliated with a health insurance plan
排除标准
- •Recurrence of breast cancer,
- •Mastectomy with RMI (immediate breast reconstruction) at the same time of operation
- •Anticoagulant treatment at curative dose
- •Arteritis obliterans of the upper limbs,
- •Other cancer during treatment,
- •Decompensated heart failure,
- •Acute infectious episode (cellulitis, erysipelas, lymphangitis)
- •Acute deep vein thrombosis upper limb ipsilateral to mastectomy,
- •Cutaneous atrophy of the upper limb,
- •Bullous dermatoses,
- •Hyperalgesia of the shoulder
- •Inability to submit to the constraints of the protocol,
- •Impossibility for the patient to achieve self-restraint at the thoracic level
- •Pregnancy,
- •Feeding with milk
- •Adult protected by law (guardianship, curatorship and safeguard of justice).
- •Anyone who is not in a position to give their consent in writing
研究组 & 干预措施
drain without compression bandage
干预措施: No bandage (Device)
drain + compression bandage
干预措施: Bandage (Device)
结局指标
主要结局
Proportion in percentage of patients treated successfully
时间窗: 6 months
Provide an estimate of the proportion of patients treated successfully (success rate defined by the absence of lymphocele on D4 post mastectomy) in two groups of patients (drain + compression bandage vs drain without compression bandage).
次要结局
- Lymphocele volume in milliliter(6 months)
- Number of lymphocele punctures(6 months)
- Frequency of adverse events(6 months)
- Clinical signs associated with lymphocele(8 days)
- Changes in quality of life(6 months)