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

Quaid-e-Azam Medical College

Status: Completed

Conditions: Mastectomy Plus Axillary Lymph Node Dissection; Breast Cancer; Mastectomy, Modified Radical; Seroma Following Procedure

Treatments: Device: Electrocautery; Device: Ultrasonic dissector

Study type: Interventional

Funder types: Other

Identifiers

NCT07050329

U1111-1324-5017

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: Female

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups

Electrocautery Dissection Group

Active Comparator group

Description:

Axillary dissection was performed as per standard hospital protocol.

Treatment:

Device: Electrocautery

Ultrasonic Dissection Group

Experimental group

Description:

Axillary dissection was performed using ultrasonic dissector.

Treatment:

Device: Ultrasonic dissector