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

NCT07050329 | Completed

• 1 other identifier: U1111-1324-5017
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

Breast carcinoma; electrocautery; modified radical mastectomy; ultrasonic dissector; axillary dissection; post-mastectomy seroma; Bipolar electrocautery

Outcome Measures

Primary Outcomes (1)

• Seroma Formation

  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 Outcomes (2)

• Surgery Time

  Intraoperative

• Drains Duration

  30 days postoperatively

Study Arms (2)

Electrocautery Dissection Group

ACTIVE COMPARATOR

Axillary dissection was performed as per standard hospital protocol.

Device: Electrocautery

Ultrasonic Dissection Group

EXPERIMENTAL

Axillary dissection was performed using ultrasonic dissector.

Device: Ultrasonic dissector

Interventions

Electrocautery DEVICE

Axillary dissection was done through bipolar electrocautery

Also known as: Bipolar electrocautery

Electrocautery Dissection Group

Ultrasonic dissector DEVICE

Axillary dissection was done through ultrasonic dissector.

Ultrasonic Dissection Group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with breast cancer and
• Planned for modified radical mastectomy

You may not qualify if:

• Planned with immediate reconstruction
• Women with recurrent breast cancer and
• Women with previous radiation over chest wall

Sponsors & Collaborators

• Quaid-e-Azam Medical College: lead

Study Sites (1)

Quaid-e-Azam Medical College

Bahawalpur, Punjab Province, 63100, Pakistan

Location

Related Publications (2)

• 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.

  PMID: 6976748 BACKGROUND

• 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.

  PMID: 33679225 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Electrocoagulation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cautery; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Tariq I Professor, FCPS

  Quaid-e-Azam Medical College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: June 4, 2024
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)