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
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:
- Does the ultrasonic dissector reduce the duration of surgery compared to electrocautery?
- Do patients operated with an ultrasonic dissector require surgical drains for fewer days?
- 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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Bahawalpur, Punjab, Pakistan, 63100
- Quaid-e-Azam Medical College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.
|
Axillary dissection was done through bipolar electrocautery
Other Names:
|
|
Experimental: Ultrasonic Dissection Group
Axillary dissection was performed using 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
Sponsor
Investigators
- Study Chair: Tariq I Professor, FCPS, Quaid-e-Azam Medical College
Publications and helpful links
General Publications
- Mayer JH. Slide reproduction of radiographs: improved results with color film. AJR Am J Roentgenol. 1982 Feb;138(2):361-2. doi: 10.2214/ajr.138.2.361. No abstract available.
- Deori A, Gupta N, Gupta AK, Yelamanchi R, Agrawal H, Durga CK. A Prospective Randomised Controlled Study Comparing Ultrasonic Dissector with Electrocautery for Axillary Dissection in Patients of Carcinoma Breast. Malays J Med Sci. 2021 Feb;28(1):97-104. doi: 10.21315/mjms2021.28.1.12. Epub 2021 Feb 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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