Comparison of piezosurgery and conventional osteotomy post rhinoplasty morbidities
: A double-blind randomized controlled trial
Abstract
Background:
Several approaches have been introduced to reduce soft tissue injury during rhinoplasty. Piezoelectric ultrasonic could be used to perform bone surgeries more precise and avoid soft tissue perforation.
Aim:
To compare post-operative pain, edema and ecchymosis in internal lateral osteotomiesperformed by the piezosurgery device to that using conventional method.
Materials and methods:
In this double-blind randomized controlled trial (RCT) patients who needed osteotomy of lateral nasalwalls were randomly assigned to the group A and B. Patients in group A received conventional intra nasal lateral osteotomy method using osteotome and for patients in group B internal lateral osteotomy was performed by the piezosurgery device. Post-operative pain was assessed 1, 2 and 3 days after surgery using the visual analogue scale, edema graded based on a 4-grade visual scale and ecchymosis was also assessed by a 3-grade visual scale, 2 and 7 days after surgery. Data were analyzed by Mann-Whitney U test with a significant level of 0.05.
Results:
Overall 20 patients with 10 in each group were included in this study. Post-operative painand ecchymosis were significantly lower in group B patients at all time points (P<0.05). Edema was significantly lower in group B after 2 days (P=0.043) while the difference was not significant after 7 days (P=0.280).
Conclusion:
Performing internal lateral osteotomy using the piezosurgery device isassociated with lower post-operative pain, edema and ecchymosis when compared to conventional osteotomy.
Keywords:
Rhinoplasty, Piezosurgery, Osteotomy, Pain, Edema, Ecchymosis
Introduction
Several approaches and methods have been developed to reduce soft tissue damage during rhinoplasty (1). A precise and consistent lateral osteotomy is the key to successful rhinoplasty. Power assisted instruments designed for rhinoplasty resulted in favorable outcomes (21, 3). However, soft tissue damage and post-operation morbidities have been reported using this approach (4). Previously, piezoelectric ultrasonic devices have been used for lateral osteotomies during rhinoplasty (5, 6). These instruments could be more precise to avoid perforating soft tissue (7, 8). Application of piezoelectric devices in bone surgeries have been reported in the past two decades (9). This method is considered a relatively new alternative for bony procedures in craniofacial surgeries.
The first report on the use of piezosurgery instruments in rhinoplasty was published in 2007 by Robiony et al. (5). Later, they said an application of piezoelectric devices for lateral osteotomies (6). Since then, some studies have been reported using piezosurgery instruments with fewer morbidities of both external and internal lateral osteotomies (5, 6, 10-12). To our knowledge, no previous study evaluated post-treatment morbidities following application of piezoelectric devices for internal lateral osteotomy. Therefore, randomized clinical trials (RCTs) would provide the additional information needed for evidence-based clinical decision making for the use of piezoelectric devices.
The purpose of the current study was to compare the performance of the piezosurgery device to that of the conventional methods of performing internal lateral nasal osteotomies. The null hypothesis was that there is no difference in early postoperative complications of two techniques. The specific aims were to compare the severities of pain, ecchymosis and edema in the early postoperative period between to techniques.
Materials and methods
Patients
This double-blind, parallel randomized controlled trial (RCT) was conducted in Jundishapour University of Medical Sciences in Ahvaz, Iran in 2015-2016. The study protocol was reviewed and approved by ethical committee of Jundishapour University of Medical Sciences (IR.AJUMS.REC.1395.531) For this study, informed consent was obtained from 20 patients who needed rhinoplasty by internal lateral osteotomy method and met the inclusion and exclusion criteria outlined in the study protocol. The inclusion criteria were the indication of internal lateral osteotomy, no anesthesia contraindication (ASA I and II), no serious airway malformation (septal deviation, breathing dysfunction). Patients were excluded as study subjects if pregnant, on antidepressants, or appeared non-compliant or were unwilling to participate in the study These patients were randomly assigned to two groups using block randomization method with the following sequences: AABB, ABAB, ABBA, BAAB, BABA. Group A received conventional method during internal lateral osteotomy and in the group, B piezosurgery was used for internal lateral osteotomy. The patients were blind to the group they were assigned to.
Surgery
All operations were performed by a single experienced surgeon under general anesthesia. Surgeries began as a regular open rhinoplasty by means of a transcolumellar stair-step incision with bilateral standard marginal extensions. Then, the cutaneous flap was carefully elevated in a supraperichondrial plane by sharp dissection with scissors and retracted with an Aufricht retractor. Posteriorly, the critical point was to continue the dissection laterally by raising the periosteum. All the periosteum retracted with all the soft tissues, from the midline to the lateral aspect beyond the nasomaxillary suture line. Once the entire nasal dorsum—both bone and cartilage— was exposed, the upper lateral cartilages were detached from the nasal septum in order to prevent damage to the nasal mucosa. cartilaginous hump was reduced with the use of a scalpel while the bony hump was removed with the use of an osteotome. This was performed in a similar manner for both groups.
During internal lateral osteotomy in group A, a double-guarded straight osteotome was used and then a subperiosteal tunnel was created before performing the osteotomy. The guard of the osteotome was placed internally, a submucosal tunnel was created along the nasal surface of the ascending process of the maxilla. The guard was placed beneath the mucosa, which was preserved, and the osteotomy was performed. As the sharp part of osteotome is behind the guards, it is not possible for the osteotome to slip away laterally or medially from the nasal bone. By tunneling precisely at the base of the nasal bones, arteries, veins, and lymphatics were preserved while the superior part of the external periosteum and the internal mucoperichondrium maintained the bones in a stable position with firm support to both sides. In group B, principal micro-saw OT7 tip (Mectron, Carasco, Italy) was used to perform the osteotomy. Irrigation with internal cooling and a flow of 40 ml/min was used to avoid heating the bone. The mucosa was incised along the lower edge of the pyriform aperture for about 3mm to access the bony lateral wall creating a tunnel. The piezo scalpel was inserted into this tunnel and the osteotomy was performed along the osteotomy path under digital control. The soft tissue envelope was removed after infracting to evaluate the condition of the osteotomy line and the size, shape, and amount of the bony fragments.
After surgery, all patients were prescribed to use the antibiotic (cephalexin/500 mg/every 6 hours) and painkiller (acetaminophen/codeine 325/10 mg every 6 hours) for seven days.
Measurement of morbidities
Assessments were performed during the first week post-operative by an examiner who was blind to the type of osteotomy.
Pain:
Patients pain was assessed by visual analogue scale (VAS) 1, 2 and 3 days post-surgery.A ten-point ruler was given to patients in which zero showed least pain and 10 represented the most severe pain.
Edema:
Eyelid edema was evaluated by a 4-grade visual scale 2 and 7 days post-surgery as described by Kara and Gökalan. (13). In thisscale, grade 1 showed no coverage of iris with eyelids, grade 2, slight coverage of iris with swollen eyelids, grade 3, full coverage of iris with swollen eyelids, and grade 4, full coverage of the eye.
Ecchymosis
: Eyelid ecchymosis was also assessed by a 3-grade visual scale 2 and 7 days post-surgery as described by Kara and Gökalan. (13). In this scale, grade 1 represented ecchymosis up to the medial one-third part of lower and /or upper eyelid, grade 2, ecchymosis up to the medial two-third part of the lower and/or upper eyelid and grade 3, ecchymosis up to the full length and /or upper eyelid.
Statistical analysis
Pain score was not distributed normally. Independent samples t-test was used to compare mean age between two groups and Mann-Whitney U test was applied to compare morbidities between two groups. To evaluate the correlation between age and morbidities Spearman test was used and a regression model was applied to control the effect of age and gender on differences between morbidities of two groups. Statistical analysis was performed with a significant level of 0.05 using SPSS software v.21 (SPSS Inc, Chicago, Illinois, USA).
Results
Overall 20 patients were included in this trial and all of them attended follow-ups. Distribution of males and females were equal in both groups (4 males and 6 females in each group) (Table 1). The mean age of patients was 24.00±1.63 and 24.90±2.38 years old in group A and B, respectively (P=0.481). Therefore, there was no significant difference between two groups regarding their confounding variables.
Post-operative pain was significantly lower in group B patients at every time-point (Table 2). After 2 days, half of the patients in group A had grade 2 eyelid edema while grade 1 edema was more common in group B (P=0.043). After 7 days, all patients in group B and 70% of patients in group A had grade 1 edema (P=0.280). Regarding post-operative ecchymosis,patients in group B had the significantly lower grade at both time points compared to group A (P<0.05).
Comparison of postoperative morbidities between males and female showed no significant difference (P>0.05) (Table 4). However, there was a significant association between patient’s age and postoperative pain on the second day (p=0.011) (Table 5). Therefore, a regression model was applied to control the effect of age on postoperative pain on the second day. The model showed that controlling the age and gender, the difference between postoperative pain on the second day between two groups was still significant (P=0.002, β=0.578).
Discussion
Several approaches have been introduced to reduce morbidities of rhinoplasty and achieve better aesthetic results (1). The internal lateral osteotomy is a rhinoplasty surgical technique whose main objective is to narrow the nose and create a harmonious aesthetic effect. The current study was performed to compare post-operative morbidities of internal lateral osteotomy performed by the piezosurgery and osteotome. The results demonstrated that all morbidities were less in degree in the piezosurgery group.
Studies comparing internal and external approached for nasal wall osteotomy, arrived at different conclusions and recommendations. While some recommend external osteotomy as it reduces edema and ecchymosis (7, 13, 14), others prefer and recommend internal osteotomy (15, 16). In this study, all surgeries were performed internally.
the Piezosurgery seems to be a step forward compared to conventional methods for lateral osteotomy. The Piezosurgery device converts electric current to ultrasonic waves and transmits them to the chisel insert located at the tip of the handpiece. The device has a control unit which allows the operator to adjust the cutting features. The cutting characteristics of the piezosurgery device should be adjusted based on the degree of bone mineralization, the design of the insert being used, the pressure being applied to the handpiece and the speed of movement during usage.
One major advantage of the piezosurgery device is the ability to select the target tissue. This means that the surgeon could cut bone while preserving soft tissue and the critical structures, such as nerves, vessels, and mucosa (7). Ghassemi et al. (8) reported no nasal mucosa perforation following performing 20 lateral osteotomies on the human cadaver. The current study also confirmed that the piezosurgery device could lower the potential damage to surrounding soft tissues.
Histologic studies reported that bone cuts performed by the piezosurgery device show no coagulation and tissue necrosis while preserving osteocytes (17, 18). In addition, the piezosurgery does not cause hemorrhage or soft tissue injury (8). These features could explain The lower occurrence of post-operative morbidities in the piezosurgery group, Taskin et al. (10) concluded that main reason for edema and ecchymosis after rhinoplasty is soft tissue injury during osteotomy.
One of the reported disadvantages of the piezosurgery is that bone cuts are greenstick fractures rather than complete osteotomy (5, 6). However, the experience from the current study and that reported by Tirelli et al. (7), reveals that the piezosurgery device provides direct visualization of the field while allowing a higher degree of precision than that achieved using the traditional osteotome technique.
The results of this RCT was consistent with previous studies showing fewer morbidities of lateral osteotomies performed by the piezosurgery compared to osteotome (5, 6, 10, 11). In 2016, Ilhan et al. (12) compared internal lateral osteotomies performed by the piezosurgery device with those done following conventional method in 56 patients. They concluded that during the first 7 days, ecchymosis was significantly lower in the ultrasonic group. They also revealed that edema was lower in the piezosurgery group after 3 days but there was no significant difference between two groups after 7 days. Similarly, the results of the current study showed that ecchymosis was lower in the piezosurgery group during first 7 days while edema was lower after 2 days with no difference after 7 days.
It should be noted that the aim of this RCT was to help evidence-based clinical decision making, as it relates to short time morbidities and patient discomfort. However, the currentstudy did not compare the aesthetic and functional outcomes of these two osteotomy techniques, nor did it take into consideration other parameters such as individual surgeon’s preferences and how those could impact the surgical outcomes.
Conclusion
Although the surgeons prefer to use techniques with which they are most comfortable, the results of this study show some of the advantages of the piezosurgery compared to conventional osteotomy techniques in lowering post-operative pain, edema, and ecchymosis thereby enhancing patients’ comfort and most likely reducing the duration of the recovery period. These findings are consistent with the results of other studies conducted by other authors in which piezosurgery has been utilized in performing rhinoplasty. The present study assessed pain, edema and ecchymosis at 1, 2, 3 and 7 days postoperatively. Subsequent studies are needed to evaluate long-term aesthetic results and patient satisfaction with the piezosurgery device.
Tables
Table 1
– Study variable Vs predictor variable
|
|
|
|
|
|
|
6 |
6 |
1 |
|
|
4 |
4 |
|
|
|
24.00±1.63 |
24.90±2.38 |
0.481 |
|
* Chi-square test for gender, independent sample t –test for age |
|||
Table 2-
Comparison of mean outcome variables by type of intervention
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|
|
|
|
|
||
|
|
|
|
||||
|
|
|
|
||||
|
|
|
|
|
|
||
|
|
|
|
|
|
||
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
2.20 |
.63 |
1.20 |
.63 |
.007 |
|
|
|
1.40 |
.52 |
.50 |
.53 |
.007 |
|
|
|
1.00 |
.00 |
.20 |
.42 |
.002 |
|
|
|
1.90 |
.74 |
1.20 |
.42 |
.043 |
|
|
|
1.30 |
.48 |
1.00 |
.00 |
.280 |
|
|
|
1.70 |
.48 |
.90 |
.57 |
.011 |
|
|
|
1.00 |
.47 |
.40 |
.52 |
.043 |
|
|
* Calculated using Mann–Whitney U test |
||||||
Table 3-
Within and between group analyses
|
|
|
|
|
|
|
|
|
|
|
Within groups |
12.633 |
2 |
6.317 |
38.326 |
<0.001 |
0.680 |
|
Between groups |
12.150 |
1 |
12.150 |
28.159 |
<0.001 |
0.610 |
|
|
|
Within groups |
1.600 |
1 |
1.600 |
14.400 |
0.001 |
0.444 |
|
Between groups |
2.500 |
1 |
2.500 |
6.818 |
0.018 |
0.275 |
|
|
|
Within groups |
3.600 |
1 |
3.600 |
19.636 |
<0.001 |
0.522 |
|
Between groups |
4.900 |
1 |
4.900 |
14.459 |
0.001 |
0.445 |
Table 4-
Difference in postoperative morbidities between males and females
|
|
|
|
|
|
|
|
Pain on 1st day |
Female |
12 |
1.8333 |
.71774 |
.473 |
|
Male |
8 |
1.5000 |
.92582 |
||
|
Pain on 2nd day |
Female |
12 |
.9167 |
.66856 |
.851 |
|
Male |
8 |
1.0000 |
.75593 |
||
|
Pain on 3rd day |
Female |
12 |
.5833 |
.51493 |
.910 |
|
Male |
8 |
.6250 |
.51755 |
||
|
Edema on 2nd day |
Female |
12 |
1.5000 |
.67420 |
.734 |
|
Male |
8 |
1.6250 |
.74402 |
||
|
Edema on 7th day |
Female |
12 |
1.1667 |
.38925 |
.910 |
|
Male |
8 |
1.1250 |
.35355 |
||
|
Echymosis on 2nd day |
Female |
12 |
1.4167 |
.66856 |
.384 |
|
Male |
8 |
1.1250 |
.64087 |
||
|
Echymosis on 7th day |
Female |
12 |
.7500 |
.62158 |
.734 |
|
Male |
8 |
.6250 |
.51755 |
||
|
* Calculated using Mann–Whitney U test |
|||||
Table 5-
Comparison of the correlation of postoperative outcomes variables with age (only pain after two days was significant)
|
Age |
|||
|
Spearman’s rho |
Pain on 1st day |
Correlation Coefficient |
-.443 |
|
Sig. (2-tailed) |
.051 |
||
|
N |
20 |
||
|
Pain on 2nd day |
Correlation Coefficient |
-.553* |
|
|
Sig. (2-tailed) |
.011 |
||
|
N |
20 |
||
|
Pain on 3rd day |
Correlation Coefficient |
-.109 |
|
|
Sig. (2-tailed) |
.646 |
||
|
N |
20 |
||
|
Edema on 2nd day |
Correlation Coefficient |
-.431 |
|
|
Sig. (2-tailed) |
.058 |
||
|
N |
20 |
||
|
Edema on 7th day |
Correlation Coefficient |
-.012 |
|
|
Sig. (2-tailed) |
.958 |
||
|
N |
20 |
||
|
Echymosis on 2nd day |
Correlation Coefficient |
-.057 |
|
|
Sig. (2-tailed) |
.812 |
||
|
N |
20 |
||
|
Echymosis on 7th day |
Correlation Coefficient |
.308 |
|
|
Sig. (2-tailed) |
.186 |
||
|
N |
20 |
||
Figure1-insertion of the activated tip to perform internal lateral osteotomy by the peizosurgery device.
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