跳至主要内容
临床试验/NCT02292407
NCT02292407Unknown3 期

AND Precise! : Axillary Lymph Node Dissection and No Drain With the PRECISE Instrument

The Netherlands Cancer Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年6月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
20
试验地点
1
主要终点
Number of seroma evacuations per patient

研究概览

简要总结

This study aims at providing first evidence that axillary clearance by using an operation technique including the precise LigaSure instrument and closure of dead space of the axilla will result in an operation were a drain is not necessary and the need for seroma evacuation after surgery is very limited.

详细描述

Axillary clearance in breast cancer is usually performed by using a drain to prevent seroma formation and to support obliteration of the dead space in the axillary carry out. The hypothesis made in this protocol is that axillary clearance by using an operation technique including the use of the precise LigaSure instrument and closure of dead space can be done without using a postoperative drain.

The AND PRECISE PROTOCOL aims at providing first evidence that axillary clearance by using an operation technique including the precise LigaSure instrument and closure of dead space of the axilla will result in an operation were a drain is not necessary and the need for seroma evacuation after surgery is very limited Patients undergoing axillary clearance necessary for achieving reasonable control in invasive breast cancer and participating in the AND PRECISE protocol will undergo the operation by using a technique including the use of the precise LigaSure instrument and closure of dead space. Postoperatively, the numbers of seroma punctions and the amount of seroma will be recorded prospectively. Patients will be asked to record on a daily basis their experience of pain by a visual analog scale of pain.

The main study parameter is the percent of cases which successfully did not need seroma punctions after the intervention.

Potential disadvantages for the patient are risk for more seroma formation and discomfort. Patients will be asked to record on a daily basis their experience of pain by a visual analog scale of pain.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Indications for axillary clearance can be a tumor positive sentinel node or tumor positive lymph nodes proven by ultrasound or fine needle aspiration cytology.
  • •For this pilot, only patients undergoing breast conserving surgery are eligible.
  • •Axillary clearance can be performed after previous sentinel node procedure, at the same operation, and after neo-adjuvant chemo therapy, and as secondary procedure in case of axillary relapse after previous treatment for breast cancer.

排除标准

  • •Patients undergoing a modified radical mastectomy including an axillary clearance.
  • •Preoperative preexisting seroma.

研究组 & 干预措施

LigaSure Precise instrument

Experimental

ALND with use of LigaSure Precise instrument, closure of dead space, omission of a postoperative drain.

干预措施: LigaSure Precise instrument (Device)

结局指标

主要结局

Number of seroma evacuations per patient

时间窗: within 3 months after surgery

次要结局

  • Number of hematomas per patient(within 3 months after surgery)
  • Number of wound infections per patient(within 3 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验