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

NCT07050329 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2025-07-03

No results posted yet for this study

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

DEVICE

Electrocautery

Axillary dissection was done through bipolar electrocautery

DEVICE

Ultrasonic dissector

Axillary dissection was done through ultrasonic dissector.

Sponsors & Collaborators

  • Quaid-e-Azam Medical College

    lead OTHER

Principal Investigators

  • Tariq I Professor, FCPS · Quaid-e-Azam Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-04
Primary Completion
2024-12-03
Completion
2024-12-03

Countries

  • Pakistan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07050329 on ClinicalTrials.gov