Breast CancerPhase 3HMRMNCT01587248
Use of Harmonic in Breast Surgery
A Phase 3 study testing Harmonic and electrocautery in people with Breast Cancer and Modified Radical Mastectomy, run by Aga Khan University at 1 site in Pakistan.
Trial summary
To compare harmonic scalpel with electrocautery for outcomes i.e. estimated blood loss (EBL), operating time, drain Volume and drain Days, seroma formation, surgical site infection and postoperative pain in adult females undergoing MRM at a tertiary care hospital. Read more about this study
- Who is it for?
- Ages 16 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Modified Radical Mastectomy
- What is being tested?
- Harmonic and electrocautery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 sitePakistan
- Study dates
- Mar 2010to Aug 2011
- Phase
- Phase 3
- 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 16 to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult females with biopsy proven breast cancer underwent MRM
Who cannot join
- Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Harmonic Scalpel vs. Electrocautery Dissection in Modified Radical Mastectomy: A Randomized Controlled Trial
To compare harmonic scalpel with electrocautery for outcomes i.e. estimated blood loss (EBL), operating time, drain Volume and drain Days, seroma formation, surgical site infection and postoperative pain in adult females undergoing MRM at a tertiary care hospital. We hypothesized that harmonic yields better outcome than electrocautery dissection.
Read the detailed description
In this randomized controlled trial, adult females who underwent MRM between April 2010 and July 2011 were randomized to receive either intervention A (harmonic scalpel) or B (electrocautery). The procedure was standardized except elevation of flaps and axillary dissection, that was performed as per randomization. Patients were followed up in clinic for four weeks. The outcomes were estimated blood loss (EBL), operating time, drain Volume and drain Days, complications (seroma, surgical site infection, hematoma and flap necrosis) and postoperative pain.
- Conditions
- Breast Cancer, Modified Radical Mastectomy
- Being tested
- Harmonic, electrocautery
- Keywords
- Breast cancer,, Harmonic scalpel,, Electrocautery,, Modified Radical Mastectomy,, Randomized Controlled Trial
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HarmonicDevice
Dissection with harmonic scalpel
electrocauteryProcedure or surgery
Dissection in modified radical mastectomy
| Study group | Role | What they receive |
|---|---|---|
| Electrocautery | Active comparator | Raising of the flaps with electrocautery Receives: Procedure: electrocautery |
| Harmonic | Experimental | Dissection with harmonic scalpel in modified radical mastectomy Receives: Device: Harmonic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of drains (days)
Durations of drains in place after MRM: Patients were followed in clinic every 3rd day and drains were removed once the volume was <30ml a day.
Measured: 30 days
Secondary outcomes (4)
Operative time
Time taken in minutes from incision to skin closure
Measured: 3-4 hours
Drain Volume
Daily charting of drain volume at a specified time with regular recording in routine clinic follow ups till the drains were is place.
Measured: 30 days
Overall complications
Patients were followed up till 3o days. If any of the following were found, the patient was labelled to have complication:
Seroma- fluctuant swelling under the flaps; SSI- as per CDC criteria; Hematoma- swelling under flaps with characteristic bruising; Flap necrosis- partial or complete necrosis of flaps.
Measured: 30 days
Pain
Pain was measured by Visual Analogue score (1-10) by a registered nurse at 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startMar 2010
- Primary completionJul 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghulam Murtaza, Aga Khan University
- Investigators
- Shaista M Khan, FRCS, Study chair, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587248
- Sponsor's protocol ID
- 1519-Sur-ERC-10
- Acronym
- HMRM
- Status last verified
- Apr 2012
- First submitted
- 19 Apr 2012
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Khan S, Khan S, Chawla T, Murtaza G. Harmonic scalpel versus electrocautery dissection in modified radical mastectomy: a randomized controlled trial. Ann Surg Oncol. 2014 Mar;21(3):808-14. doi: 10.1245/s10434-013-3369-8.
PubMed 24232511
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmonic Scalpel vs. Electrocautery Dissection in Modified Radical Mastectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01587248
- Acronym / sponsor ID
- HMRM / 1519-Sur-ERC-10
- Conditions
- Breast Cancer, Modified Radical Mastectomy
- Keywords
- Breast cancer,, Harmonic scalpel,, Electrocautery,, Modified Radical Mastectomy,, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 30 Apr 2012 (estimated)
- 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.
To compare harmonic scalpel with electrocautery for outcomes i.e. estimated blood loss (EBL), operating time, drain Volume and drain Days, seroma formation, surgical site infection and postoperative pain in adult females undergoing MRM at a tertiary care hospital. We hypothesized that harmonic yields better outcome than electrocautery dissection.
Detailed description
In this randomized controlled trial, adult females who underwent MRM between April 2010 and July 2011 were randomized to receive either intervention A (harmonic scalpel) or B (electrocautery). The procedure was standardized except elevation of flaps and axillary dissection, that was performed as per randomization. Patients were followed up in clinic for four weeks. The outcomes were estimated blood loss (EBL), operating time, drain Volume and drain Days, complications (seroma, surgical site infection, hematoma and flap necrosis) and postoperative pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrocautery | Active comparator | Procedure: electrocauteryRaising of the flaps with electrocautery |
| Harmonic | Experimental | Device: HarmonicDissection with harmonic scalpel in modified radical mastectomy |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult females with biopsy proven breast cancer underwent MRM
Key exclusion criteria (1 listed)
- Simultaneous procedure (Reconstruction, Sentinel lymph node biopsy)
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 |
|---|---|---|
| HarmonicDissection with harmonic scalpel | Device | Harmonic |
| electrocauteryDissection in modified radical mastectomy | Procedure or surgery | Electrocautery |
Primary outcome
Duration of drains (days)
Time frame: 30 days
Durations of drains in place after MRM: Patients were followed in clinic every 3rd day and drains were removed once the volume was <30ml a day.
4 secondary outcomes
Operative time
Time frame: 3-4 hours
Drain Volume
Time frame: 30 days
Overall complications
Time frame: 30 days
Pain
Time frame: 24 hours
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 30 Apr 2012.
- Derived from this study: PubMed 24232511Khan S, Khan S, Chawla T, Murtaza G. Harmonic scalpel versus electrocautery dissection in modified radical mastectomy: a randomized controlled trial. Ann Surg Oncol. 2014 Mar;21(3):808-14. doi: 10.1245/s10434-013-3369-8.
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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.
Shaista M Khan, FRCS study chair
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Harmonic and electrocautery in people with Breast Cancer and Modified Radical Mastectomy, run by Aga Khan University 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 1 inclusion and 1 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 30 Apr 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Duration of drains (days) (time frame: 30 days). 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 NCT01587248, which also lists 1 linked publication.
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 30 Apr 2012.