LEAPS
demonstrates safety of liposuction, established study protocol
From
Plastic Surgery News, October/November 2001
A recent
released, comprehensive study has found liposuction procedures
both safe and effective.
The
final report for the Lipoplasty Effectiveness and Patient
Safety (LEAPS) outcomes research study was recently presented
by Bruce Cunningham, MD, LEAPS principal investigator.
This
study was funded by Association of Plastic Surgeons (ASPS),
Plastic Surgeons Education Foundations (PSEF), and the Aesthetic
Surgery Education and Research Foundation.
LEAPS
was designed and developed by the Outcomes Research Subcommittee
of the Joint Outcomes Task Force. The primary objective
of LEAPS was to determine if liposuction, as performed by
American Board of Plastic Surgery (ABPS) certified plastic
surgeons, is safe and effective. The specific hypotheses:
- Liposuction
as currently practiced by ABPS diplomats is a safe and
effective operation.
- Patient
satisfaction with the procedures is high.
- Complications
rates with the surgery can be defined, and are predictable
and acceptable.
- Outcomes-based
guidelines of the procedure can be derived.
- A
standardized instrument can determine safety and effectiveness
of this procedure.
Developed
to address scientific deficiencies in previous research
on the outcomes of liposuction surgery, the protocol employed
a multi-center prospective design with validated and standardized
instruments developed for measuring outcomes.
There
were 231 patients initially enrolled at baseline, and 55
percent completed the study. Baseline and follow-up patients
self-administered questionnaires were provided from these
126 patients by 29 surgeons from 16 centers. Surgeries were
performed in office surgical centers (46 percent), freestanding
surgical centers (31 percent), and hospitals (23 percent).
General anesthesia was used in 71 percent of operations
with 73 percent of these administered by MD Anesthesiologist
and 27 percent administered by RN Anesthetists.
Fifteen
complications (9 percent) were reported. These included
seven minor complications requiring no treatment, seven
moderate complications requiring minimal treatment and one
severe complication. There were no deaths.
Concurrent
operations were performed in 35 percent of cases, with abdominoplasty
the most common (14 percent). When concurrent procedures
were performed, the complications rate remained relatively
unchanged (11 percent versus 9 percent).
The
median estimated fat removal was 1,625 cc (range 300 - 6,725
cc).
Liposuction was found to be both safe and effective for patients included
in this prospective, multi-center study.
|
