Breast Cancer, Mastectomy, Modified Radical, Mastectomy Plus Axillary Lymph Node Dissection, Seroma Following Procedure
Conditions
Keywords
Breast carcinoma, electrocautery, modified radical mastectomy, ultrasonic dissector, axillary dissection, post-mastectomy seroma, Bipolar electrocautery
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: 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.
Interventions
DEVICEElectrocautery
Axillary dissection was done through bipolar electrocautery
DEVICEUltrasonic dissector
Axillary dissection was done through ultrasonic dissector.
Sponsors
Quaid-e-Azam Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroma Formation | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Surgery Time | Intraoperative | Duration (minutes) of surgery was noted from skin incision to skin closure using stopwatch. |
| Drains Duration | 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. |
Countries
Pakistan
Outcome results
None listed