Breast CancerNCT07050329
Comparison of Operation Time, Drain Duration, and Seroma Formation After Modified Radical Mastectomy Using Ultrasonic Dissector Versus Electrocautery in Women With Breast Cancer
A study testing Electrocautery and Ultrasonic dissector in people with Breast Cancer and Mastectomy, Modified Radical, run by Quaid-e-Azam Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Mastectomy, Modified Radical, Mastectomy Plus Axillary Lymph Node Dissection
- What is being tested?
- Electrocautery and Ultrasonic dissector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Jun 2024to 3 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with breast cancer and
- Planned for modified radical mastectomy
Who cannot join
- Planned with immediate reconstruction
- Women with recurrent breast cancer and
- Women with previous radiation over chest wall
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Quaid-e-Azam Medical College
Bahawalpur, Punjab Province, 63100
About this study
Official title: Comparison of Outcome With Ultrasonic Dissector Versus Electrocautery in Modified Radical Mastectomy
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:
Read more
- Does the ultrasonic dissector reduce the duration of surgery compared to electrocautery?
- Do patients operated with an ultrasonic dissector require surgical drains for fewer days?
- 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
- Breast Cancer, Mastectomy, Modified Radical, Mastectomy Plus Axillary Lymph Node Dissection, Seroma Following Procedure
- Being tested
- Electrocautery, Ultrasonic dissector
- Keywords
- Breast carcinoma, electrocautery, modified radical mastectomy, ultrasonic dissector, axillary dissection, post-mastectomy seroma, Bipolar electrocautery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocauteryDevice
Also called Bipolar electrocautery
Axillary dissection was done through bipolar electrocautery
Ultrasonic dissectorDevice
Axillary dissection was done through ultrasonic dissector.
| Study group | Role | What they receive |
|---|---|---|
| Electrocautery Dissection Group | Active comparator | Axillary dissection was performed as per standard hospital protocol. Receives: Device: Electrocautery |
| Ultrasonic Dissection Group | Experimental | Axillary dissection was performed using ultrasonic dissector. Receives: Device: Ultrasonic dissector |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start4 Jun 2024
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quaid-e-Azam Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Maryum Naveed, Quaid-e-Azam Medical College
- Investigators
- Tariq I Professor, FCPS, Study chair, Quaid-e-Azam Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050329
- Sponsor's protocol ID
- U1111-1324-5017
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee 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.
PubMed 31964119Deori 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.
PubMed 33679225
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome With Ultrasonic Dissector Versus Electrocautery in Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT07050329
- Acronym / sponsor ID
- U1111-1324-5017
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Quaid-e-Azam Medical CollegeUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the ultrasonic dissector reduce the duration of surgery compared to electrocautery?
- Do patients operated with an ultrasonic dissector require surgical drains for fewer days?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrocautery Dissection Group | Active comparator | Device: ElectrocauteryAxillary dissection was performed as per standard hospital protocol. |
| Ultrasonic Dissection Group | Experimental | Device: Ultrasonic dissectorAxillary dissection was performed using ultrasonic dissector. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with breast cancer and
- Planned for modified radical mastectomy
Key exclusion criteria (3 listed)
- Planned with immediate reconstruction
- Women with recurrent breast cancer and
- Women with previous radiation over chest wall
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrocauteryAlso: Bipolar electrocauteryAxillary dissection was done through bipolar electrocautery | Device | Electrocautery Dissection Group |
| Ultrasonic dissectorAxillary dissection was done through ultrasonic dissector. | Device | Ultrasonic Dissection Group |
Primary outcome
Seroma Formation
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Background: PubMed 31964119Lee 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.
- Background: PubMed 33679225Deori 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tariq I Professor, FCPS study chair
Quaid-e-Azam Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocautery and Ultrasonic dissector in people with Breast Cancer and Mastectomy, Modified Radical, run by Quaid-e-Azam Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroma Formation (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07050329, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.