Comparison of Outcome With Ultrasonic Dissector Versus Electrocautery in Modified Radical Mastectomy
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:
- Does the ultrasonic dissector reduce the duration of surgery compared to electrocautery?
- Do patients operated with an ultrasonic dissector require surgical drains for fewer days?
- 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
- 否
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
Dr.Maryum Naveed
Principal Investigator
Quaid-e-Azam Medical College
