Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique
18 Years
N/A
Female
Breast Cancer, Pain, Perioperative/Postoperative Complications
Trial Information
Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique
OBJECTIVES:
Primary
- To compare post-operative pain after tumescent vs standard mastectomy in women with
stage I-III breast cancer.
Secondary
- To compare the total time of operation from incision to completion of wound closure.
- To compare the time of operation from first incision to completion of skin flaps.
- To compare the total estimated blood loss.
- To compare the number of days the Jackson-Pratt drain is left in place under skin flaps
with wound drainage > 30 mL/24 hours.
- To compare the incidence of wound complications such as skin necrosis, hematoma,
cellulitis, abscess, and seroma between groups.
OUTLINE: Patients are grouped according to which surgeon provided their evaluation and
treatment recommendations.
- Group 1: Patients undergo standard mastectomy.
- Group 2: Patients undergo tumescent mastectomy. All patients receive standardized
post-operative pain management comprising morphine sulfate for analgesia or an
equivalent dose of hydromorphone hydrochloride for 24 hours following surgery. Patients
then receive 1-2 oral acetaminophen/oxycodone hydrochloride combination tablets (or a
comparable amount of another narcotic/acetaminophen combination) every 6 hours as
needed. Pain is assessed using the Short-form McGill Pain Questionnaire (SF-MPQ).
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- Invasive (ductal or lobular) breast cancer
- In situ (ductal) breast cancer
- Stage 0-III disease
- Localized disease
- Candidate for curative mastectomy and selected mastectomy or modified radical
mastectomy for surgical option of treatment at the University of California Davis
Medical Center
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- WBC ≥ 1,500/mm^3
- Platelet count ≥ 90,000/mm^3
- PT/PTT ≤ upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- No NYHA cardiac disease class III-IV
- Cancer survivors must have undergone potentially curative therapy for all prior
malignancies with no evidence of prior malignancy within the last 5 years, except for
effectively treated basal cell or squamous cell carcinoma of the skin, carcinoma in
situ of the cervix treated by surgery alone, or lobular carcinoma in situ of the
breast treated by surgery alone
- Body Mass Index ≤ 40
PRIOR CONCURRENT THERAPY:
- No prior major breast surgery, including breast augmentation or reduction surgery
- No preoperative chemotherapy or radiotherapy
- No concurrent immediate breast reconstruction
- No concurrent bilateral mastectomy
- No concurrent narcotic pain medication
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
Post-operative pain at 1 and at 7-10 days after mastectomy
Outcome Time Frame:
7-10 days
Safety Issue:
No
Principal Investigator
Steve R. Martinez, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, Davis
Authority:
United States: Institutional Review Board
Study ID:
CDR0000633754
NCT ID:
NCT00859157
Start Date:
October 2008
Completion Date:
December 2013
Related Keywords:
- Breast Cancer
- Pain
- Perioperative/Postoperative Complications
- perioperative/postoperative complications
- pain
- ductal breast carcinoma in situ
- invasive ductal breast carcinoma
- invasive lobular breast carcinoma
- stage IA breast cancer
- stage IB breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- Breast Neoplasms
- Postoperative Complications
Name | Location |
|---|---|
| University of California Davis Cancer Center | Sacramento, California 95817 |
