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临床试验/NCT07050329
NCT07050329已完成不适用

Comparison of Outcome With Ultrasonic Dissector Versus Electrocautery in Modified Radical Mastectomy

Quaid-e-Azam Medical College2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2024年6月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
138
试验地点
2
主要终点
Seroma Formation

研究概览

简要总结

The goal of this clinical trial was to compare two surgical techniques-ultrasonic dissector and electrocautery-for performing axillary dissection in women undergoing modified radical mastectomy (MRM) for breast cancer. The study aimed to determine whether using an ultrasonic dissector reduces operation time, the number of days surgical drains remain in place, and the frequency of seroma formation compared to conventional electrocautery.

The main questions the study aims to answer are:

  1. Does the ultrasonic dissector reduce the duration of surgery compared to electrocautery?
  2. Do patients operated with an ultrasonic dissector require surgical drains for fewer days?
  3. Is the frequency of postoperative seroma formation lower in the ultrasonic dissector group?

Researchers randomly (1:1) assigned 138 women with breast cancer (aged 35-65 years) undergoing MRM to either the ultrasonic dissector group or the electrocautery group. All surgeries were performed by experienced consultant surgeons using standardized protocols.

Participants:

  • Underwent MRM with either electrocautery or ultrasonic dissector for axillary dissection
  • Were discharged 24 hours after surgery with two drains in place
  • Measured and reported daily drain output at home
  • Returned for weekly follow-up for 30 days postoperatively

Outcomes were measured by recording the operation time, the number of days drains remained in place, and the occurrence of seroma. The results would help guide surgical practice by identifying the safer and more efficient dissection method during MRM.

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, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosed with breast cancer and
  • Planned for modified radical mastectomy

排除标准

  • Planned with immediate reconstruction
  • Women with recurrent breast cancer and
  • Women with previous radiation over chest wall

结局指标

主要结局

Seroma Formation

时间窗: 30 days postoperatively

Presence of fluid collection beneath the skin flaps after the removal of the drains of sufficient quantity to cause the patient discomfort and was measured by subcutaneous aspiration \& through ultrasonography during the postoperative follow up

次要结局

未报告次要终点

研究者

发起方
Quaid-e-Azam Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr.Maryum Naveed

Principal Investigator

Quaid-e-Azam Medical College

研究点 (2)

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