Hyperplasia
Conditions
Keywords
Mammaplasty, Electrocoagulation, Breast
Brief summary
Purpose: The aims of this randomized clinical trial are to assess and compare 3 different outcomes in women undergoing breast reduction surgery using two different surgical devices: the Harmonic Scalpel and electrocautery. The three metrics are: 1. the time taken to complete the operation 2. drainage volume in the days immediately following surgery, 3. patient pain in the days immediately following surgery.
Interventions
DEVICEHarmonic Scalpel
harmonic scalpel used to reduce breast on this side
DEVICEElectrocautery
Electrocautery used to reduce breast on this side
Sponsors
Ethicon Endo-Surgery
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients are eligible for enrollment if they agree to provide informed consent, can read and speak English, are at least 18 years of age, and are in generally good health.
Exclusion criteria
* under 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time for Operation | day of surgery | Time to complete the breast reduction per breast. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Drainage in Surgical Drains | within one week of surgery | An index was created to allow comparison between patients whose drain indwell times were different. This was created by taking total volume of drainage per breast drain and dividing it by the number of hours the drain was in place. The units are milliliters per hour. |
| Pain Level in Surgical Sites | first week after surgery | An 11-point visual analog scale was used to obtain subjective pain levels from patients. 0 being no pain and 10 being worst pain imaginable. |
| Hematoma | first day after surgery | A collection of blood or uncontrolled bleeding that necessitates a return to the operating room in the first day after surgery. |
Countries
United States
Participant flow
Recruitment details
Recruitment ran from January 2008 to January 2010. All patients were recruited in one surgical clinic at Dartmouth Hitchcock Medical Center.
Pre-assignment details
Forty-three women were identified as potential study participants from May to December 2009. Three were excluded, because two were unable to consent and one was under 18 years old. Nine women declined to participate. Of the remaining 31 patients (72.1% of those identified), all completed the informed consent, the surgery, and the follow-up process.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants randomized to have one breast reduced with harmonic scalpel and the other breast reduced with electrocautery. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age Continuous | 44 years FULL_RANGE 0 |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 31 |
| serious Total, serious adverse events | 1 / 31 | 0 / 31 |
Outcome results
Primary
Time for Operation
Time to complete the breast reduction per breast.
Time frame: day of surgery
Population: Women over the age of 18 who are not pregnant with symptomatic breast hypertrophy who underwent breast reduction surgery.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Harmonic Reduced Breast | Time for Operation | 32.9 minutes | Standard Deviation 14.7 |
| Electrocautery Reduced Breast | Time for Operation | 31 minutes | Standard Deviation 8.1 |
Secondary
Hematoma
A collection of blood or uncontrolled bleeding that necessitates a return to the operating room in the first day after surgery.
Time frame: first day after surgery
Population: entire study population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Harmonic Reduced Breast | Hematoma | 0 participants |
| Electrocautery Reduced Breast | Hematoma | 0 participants |
Secondary
Pain Level in Surgical Sites
An 11-point visual analog scale was used to obtain subjective pain levels from patients. 0 being no pain and 10 being worst pain imaginable.
Time frame: first week after surgery
Population: all study participants
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Harmonic Reduced Breast | Pain Level in Surgical Sites | 4 units on a scale | Standard Deviation 3.2 |
| Electrocautery Reduced Breast | Pain Level in Surgical Sites | 4 units on a scale | Standard Deviation 3 |
Secondary
Volume of Drainage in Surgical Drains
An index was created to allow comparison between patients whose drain indwell times were different. This was created by taking total volume of drainage per breast drain and dividing it by the number of hours the drain was in place. The units are milliliters per hour.
Time frame: within one week of surgery
Population: All participants in the study.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Harmonic Reduced Breast | Volume of Drainage in Surgical Drains | 2.1 mL/hour | Standard Deviation 1.4 |
| Electrocautery Reduced Breast | Volume of Drainage in Surgical Drains | 2.8 mL/hour | Standard Deviation 1.3 |