Comparison of Operation Time, Drain Duration, and Seroma Formation After Modified Radical Mastectomy Using Ultrasonic Dissector Versus Electrocautery in Women With Breast Cancer
NCT ID: NCT07050329
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
138 participants
INTERVENTIONAL
2024-06-04
2024-12-03
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Electrocautery Dissection Group
Axillary dissection was performed as per standard hospital protocol.
Electrocautery
Axillary dissection was done through bipolar electrocautery
Ultrasonic Dissection Group
Axillary dissection was performed using ultrasonic dissector.
Ultrasonic dissector
Axillary dissection was done through ultrasonic dissector.
Interventions
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Electrocautery
Axillary dissection was done through bipolar electrocautery
Ultrasonic dissector
Axillary dissection was done through ultrasonic dissector.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned for modified radical mastectomy
Exclusion Criteria
* Women with recurrent breast cancer and
* Women with previous radiation over chest wall
35 Years
65 Years
FEMALE
No
Sponsors
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Quaid-e-Azam Medical College
OTHER
Responsible Party
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Dr.Maryum Naveed
Principal Investigator
Principal Investigators
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Tariq I Professor, FCPS
Role: STUDY_CHAIR
Quaid-e-Azam Medical College
Locations
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Quaid-e-Azam Medical College
Bahawalpur, Punjab Province, Pakistan
Countries
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References
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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.
Other Identifiers
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U1111-1324-5017
Identifier Type: -
Identifier Source: org_study_id
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