Quaid-e-Azam Medical College
Bahawalpur, Punjab Province, 63100, Pakistan
NCT Number: NCT07050329
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.
Looking for future studies?
Notify Me35 year–65 year
Female
Interventional
Not applicable
Bahawalpur, Punjab Province, 63100, Pakistan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Axillary dissection was done through bipolar electrocautery
Other names: Bipolar electrocautery
Axillary dissection was done through ultrasonic dissector.
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
Time frame: Intraoperative
Duration (minutes) of surgery was noted from skin incision to skin closure using stopwatch.
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.
Quaid-e-Azam Medical College
Other
Comparison of Outcome With Ultrasonic Dissector Versus Electrocautery in Modified Radical Mastectomy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00161980
Breast Cancer, Breast Diseases
Sankt Pölten, Lower Austria, Austria
View Trial DetailsNCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsNCT05754658
Breast Cancer, Breast Diseases
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT07040514
Breast Cancer, Breast Diseases
Lebanon, New Hampshire, United States
View Trial Details