Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Mastectomy, Modified Radical | — | UNRESOLVED | — |
| Mastectomy Plus Axillary Lymph Node Dissection | — | UNRESOLVED | — |
| Seroma Following Procedure | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electrocautery | Device | — | UNRESOLVED |
| Ultrasonic dissector | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Electrocautery Dissection Group
- description
- Axillary dissection was performed as per standard hospital protocol.
- interventionNames
- Device: Electrocautery
- type
- EXPERIMENTAL
- label
- Ultrasonic Dissection Group
- description
- Axillary dissection was performed using ultrasonic dissector.
- interventionNames
- Device: Ultrasonic dissector
Primary outcomes (1)
- measure
- Seroma Formation
- timeFrame
- 30 days postoperatively
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDLee D, Jung BK, Roh TS, Kim YS. Ultrasonic dissection versus electrocautery for immediate prosthetic breast reconstruction. Arch Plast Surg. 2020 Jan;47(1):20-25. doi: 10.5999/aps.2019.00759. Epub 2020 Jan 15. PMID 31964119
- BACKGROUNDDeori 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