NCT07050329

Comparison of Operation Time, Drain Duration, and Seroma Formation After Modified Radical Mastectomy Using Ultrasonic Dissector Versus Electrocautery in Women With Breast Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Quaid-e-Azam Medical College · Academic / Other
• Sex: Female
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer
• Mastectomy, Modified Radical
• Mastectomy Plus Axillary Lymph Node Dissection
• Seroma Following Procedure

Interventions

Type	Name	Description
DEVICE	Electrocautery	Axillary dissection was done through bipolar electrocautery
DEVICE	Ultrasonic dissector	Axillary dissection was done through ultrasonic dissector.

Timeline

• Start date: 2024-06-04
• Primary completion: 2024-12-03
• Completion: 2024-12-03
• First posted: 2025-07-03
• Last updated: 2025-07-03

Locations

1 site across 1 country: Pakistan