Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00925158 |
| Other study ID # |
CEP-UNIFESP 1515/07 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
June 18, 2009 |
| Last updated |
July 23, 2012 |
| Start date |
December 2007 |
| Est. completion date |
December 2013 |
Study information
| Verified date |
July 2012 |
| Source |
Federal University of São Paulo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Brazil: Ethics Committee |
| Study type |
Interventional
|
Clinical Trial Summary
BACKGROUND: Endoscopy was first used in plastic surgery for the treatment of frontal
rhytides. This minimally invasive approach allows the treatment of frontal wrinkles using a
practical procedure that does not directly interfere with the frontalis muscle, acting only
on its antagonists.
It is also possible to treat the middle third of the face, but these evolutions depends on
special surgical instruments. Videoendoscopic approach in rhytidoplasty have been improved
by new devices and surgical instruments.
The mid third of the face can be treated in different ways. Zygomatic projection can be
achieved by the use of the Dissector Assisted Malar Elevation (DAME) procedure.
AIM: Evaluate the zygomatic projection achieved by DAME in videoendoscopic rhytidoplasties.
METHODS: 30 non-white female patients, 30 to 59 years old, will be submitted to
videoendoscopic rhytidoplasty with malar elevation by the DAME. Pre- and post-operative
facial appearance will be evaluated by digital photogrammetry.
Description:
THE NEW SURGICAL INSTRUMENT:
The dissector developed by the authors is a stainless steel instrument, 20 cm in length, 1
cm in diameter, with a cylindrical handle, and an articulated section 3 cm in length and 1cm
in diameter at the distal end. When the most proximal end of the handle is rotated, the
articulated section provides for angulation or articulation of the distal end portion with
respect to the longitudinal axis of the instrument that is similar to the movements of a
distal phalanx of a finger.
SURGICAL TECHNIQUE:
1. Frontal Region: An incision line, 2 cm long, in the median sagittal plane and 1 cm from
the hairline; an incision line, 2 cm long, parallel and 4 cm from the sagittal line, to
the right and left sides;
2. Temporal Region: An incision line, 3 cm long, 3 cm from the hairline, perpendicular to
and bisected by a line traced from the margin of the nasal wing, passing by the lateral
palpebral commissure and extending in the posterior direction, bilaterally.
Following, the hair was gathered into bundles to allow access to the skin markings, and held
by latex rings, which were obtained by cross-sectional cuts through fingers of sterile latex
surgical gloves.
Skin antisepsis was performed with 0.2% aqueous chlorhexidine, followed by the placement of
sterile surgical drapes, and retracing of the sagittal, parasagittal and temporal incision
lines (described above) with methylene blue.
The right temporal incision was performed on the marked area, cutting through the skin and
superficial temporal fascia, and exposing the deep temporal fascia. Following, the
undermining of the temporal region surrounding the incision was carried out in the
interfascial plane, under direct vision, to prepare the optical cavity. The dissection
proceeded to the orbital and zygomatic regions, under endoscopic vision, using a rigid
endoscope (Karl Storz, model 7230 BWA) 18cm in length, 4mm in diameter and with a 30-degree
angle. The dissection continued until the medial zygomatic-temporal vein (also known as
sentinel vein) was reached; a xenon light source (Karl Storz, model 20131501) was used to
illuminate the optical cavity.
The zygomatic-temporal vein was previously cauterized with an endoscopic grasper (Karl
Storz, model 50232 GG) and incised with scissors (Karl Storz, model 50231 GW) to allow
dissection toward the lateral orbital rim. In this region, after passing the lateral
palpebral ligament, the undermining ?) deepened, becoming subperiosteal on the zygomatic
bone. The subperiosteal undermining ?) progressed along the whole inferior orbital rim up to
its most medial portion, superior to the infraorbital nerve, to completely release the
inferior orbital rim under endoscopic vision with the aid of an elevator (Karl Storz, model
50205s).
Using the same surgical instrumentation, a subcutaneous tunnel was created from the temporal
incision towards the middle third of the face until the inferolateral limit of the
orbicularis oculi muscle was reached. From this point, a blunt dissection of the malar fat
pad was performed with the use of a dissector instrument, which had been developed for this
purpose, as described by the author in 2004 and published in 2006. After blunt dissection,
the malar fat pad was projected in the antero-superior direction by means of a suture in the
zygomatic projection to restore the zygomatic contour and the anterior projection of the
middle third of the face. The above procedures were then repeated on the contralateral
hemiface.
The procedure was continued with the frontal incisions, which were previously described, by
cutting through the skin to the periosteum (fig. 2). A subperiosteal dissection of the
entire frontal region was performed to a distance of 1 cm above the eyebrow.
Under endoscopic vision, the dissection proceeded to the glabella, where the periosteum was
incised with a sharp dissector to expose the bone insertions of the procerus, corrugator and
depressor supercilii muscles. A thin dissector and an endoscopic grasper with a diathermy
cable (unipolar high-frequency cord, model 26002 M, Karl Storz) were used in the myotomy and
partial myectomy of these muscles. This periosteotomy started at the glabella region, and
continued transversally toward the lateral end of the eyebrow in both sides, passing by the
supratrochlear nerve, and reaching the supraorbital nerve, where it was interrupted to be
continued in a latero-medial direction in the next surgical step.
The frontal and temporal undermining were united by the incision of the temporal ligament
with a sharp dissector, exposing its most inferior portion, where the Hakme ligament is
located. This ligament was incised with endoscopic scissors; this maneuver simultaneously
released the lateral margin of the detached periosteum. At this level, the periosteotomy
continues marginal to the orbital rim in a lateral-medial direction to the supraorbital
nerve, which was identified and isolated. All fibrous adhesions of the body and tail of the
eyebrow found in this path were dissected using a sharp dissector until the fibers of the
palpebral portion of the orbicularis oculi muscle were reached at this level, completing the
horizontal periosteotomy in its entire extension, the treatment of structures, and the
undermining of the periorbital, frontal and temporal regions.
For the patients in the fixation group, the fixation points of the frontal flap were
determined as the intersection point between the parasagittal line that passes through the
transition of the lateral third with the two medial thirds of the eyebrow and the hairline.
This point was called FEP (flap elevation point).
After attaching one end of a 2-0 nylon monofilament thread to the deep temporal fascia, a
Casagrande needle was inserted at the FEP, penetrating the skin and periosteum, and
transfixing the point. Following, the needle was directed to the deep temporal fascia at the
fixation level. At this level, the other end of the nylon thread was passed through the hole
of the Casagrande needle. The needle was pulled back to the FEP and, at this point, the
periosteum was transfixed from depth to surface, up to the deep dermis. Then, the needle was
returned to the depth, to a point located 0.5 cm medially, in order to fix the flap at the
FEP level. The needle was directed to the sagittal incision, where once more it penetrated
in the periosteum from depth to surface, externalizing the nylon thread. The same procedure
was performed on the contralateral side. The two free ends of both nylon threads were tied
together with a surgical knot at their emergence point along the sagittal plane with enough
traction to elevate and fix the eyebrow to a position immediately superior to the superior
orbital rim.
The incisions were closed with 4-0 monofilament nylon suture on a 2cm triangular needle; the
detached site was drained by a closed vacuum system, with a drain tube (size 10) fixed to
the sagittal incision and maintained for 48 hours. The skin was cleansed with 0.9% saline
solution, tincture of benzoin was applied, and self-adhesive microporous tape (Micropore)
was used and maintained for 7 days.
PHOTOGRAPHIC STANDARDIZATION:
Photographs were taken from all patients in a standardized manner, with respect to the
equipment, camera positioning, lighting conditions, and positioning of the cephalic segment
in relation to the Frankfurt plane. Photographs were taken in frontal view preoperatively
and at 12 months postoperatively.
DIGITAL PHOTOGRAMMETRY:
Image analysis was done on a personal computer using the UTHSCSA ImageTool Version 3.0
software for Windows.
Digital photogrammetric measurements were made based on the anthropometric landmarks
Endocathion (EN), which corresponds to the medial palpebral commissure, and Exocathion (EX),
which corresponds to the lateral palpebral commissure.22-24 The distance between the
EN-right and EN-left points (EN-EN distance) was measured. The length of a paramedian
vertical line, connecting the intersection of the lateral extension of the EN-EN line with
the EX point to the intersection of the EN-EN line with the outer margin of the eyebrow,
which was denominated EB (eyebrow) or distance EX-EB, was also measured.
Based on the photographs, the Brow Position Index (BPI) was calculated for both the right
(BPIR) and left (BPIL) sides. The BPI was defined as the ratio between the EN-EN (in pixels)
and EX-EB (in pixels) distances multiplied by 100. Following, the difference (delta), in
absolute value, between the preoperative BPI (BPI-pre) and 12month postoperative BPI
(BPI-post) was calculated for both sides.
