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

June 25, 2025 updated by: Dr.Maryum Naveed, Quaid-e-Azam Medical College

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Bahawalpur, Punjab, Pakistan, 63100
        • Quaid-e-Azam Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Electrocautery Dissection Group
Axillary dissection was performed as per standard hospital protocol.
Device: Electrocautery
Axillary dissection was done through bipolar electrocautery
Other Names:
  • Bipolar electrocautery
Experimental: Ultrasonic Dissection Group
Axillary dissection was performed using ultrasonic dissector.
Device: Ultrasonic dissector
Axillary dissection was done through ultrasonic dissector.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgery Time
Time Frame: Intraoperative
Duration (minutes) of surgery was noted from skin incision to skin closure using stopwatch.
Intraoperative
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.
30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quaid-e-Azam Medical College

Investigators

  • Study Chair: Tariq I Professor, FCPS, Quaid-e-Azam Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2024

Primary Completion (Actual)

December 3, 2024

Study Completion (Actual)

December 3, 2024

Study Registration Dates

First Submitted

June 25, 2025

First Submitted That Met QC Criteria

June 25, 2025

First Posted (Actual)

July 3, 2025

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1324-5017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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