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OpenTrials
Completed

NCT Number: NCT07050329

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

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.

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Key information

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Quaid-e-Azam Medical College

Bahawalpur, Punjab Province, 63100, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrocautery

Device

Axillary dissection was done through bipolar electrocautery

Other names: Bipolar electrocautery

Ultrasonic dissector

Device

Axillary dissection was done through ultrasonic dissector.

Primary outcomes

  1. Seroma Formation

    Time frame: 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

Other outcomes

  1. Surgery Time

    Time frame: Intraoperative

    Duration (minutes) of surgery was noted from skin incision to skin closure using stopwatch.

  2. Drains Duration

    Time frame: 30 days postoperatively

    Time in days from placement to removal of drain will be calculated. The drains will be removed when the drainage volume is less than 30 ml over 24 h for 2 successive days.

Sponsors and collaborators

Lead sponsor

Quaid-e-Azam Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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