1. ABSTRACT
Background. No studies have compared Robot assisted transaxillary thyroidectomy (RATT)
and Minimally Invasive Videoassisted Thyroidectomy (MIVAT) regarding cosmetic outcome and satisfaction
Methods
Patients matching the inclusion criteria (benign nodule less than 6 cm and thyroid volume less than 30 mL) were randomly allotted to undergo MIVAT (group A) or RATT (group B).
Cosmetic result, overall satisfaction, operative time and complications were evaluated.
Results
62 patients underwent hemithyroidectomy (30 in group A and 32 in group B). All patients were females except one male in each group. Mean age was 36.9 years (group A) and 33.8 years (group B). Nodule diameter was larger in group B (33.9 mm) than in group A (15.2 mm). Surgical time was comparable: 46.5 minutes in group A and 54.9 minutes in group B.
Total time (intubation-extubation) was shorter in group A (71.6 minutes) than in group B (122.6 minutes). Complications were one transient laryngeal nerve injury in both groups and one subcutaneous hematoma in group B. Postoperative stay was longer in group B (1.92 days) than in group A (1.15 days).
On the PASQ questionnaire, “scar appearance” and “satisfaction with appearance” scores resulted better in group A than in group B. In the SF-36 questionnaire, domains of “social activity” and “general health” were better in group B than in group A, while “bodily pain”
resulted higher in group B than in group A.
Conclusions
RATT seems not to overcome MIVAT when comparing two groups of patients undergoing thyroidectomy for benign disease, although nodule diameter was significantly larger in the RATT group.
2. INTRODUCTION
The da Vinci Surgical System is a robotic surgical system made by the American company
Intuitive Surgical. Approved by the Food and Drug Administration (FDA) in 2000, it is designed to facilitate complex surgery using a minimally invasive approach, and is controlled by a surgeon from a console. The system is commonly used for prostatectomies, and increasingly for cardiac valve repair and gynecologic surgical procedures. According to the manufacturer, the da Vinci
System is called "da Vinci" in part "because Leonardo da Vinci invented the first robot". Da Vinci also used anatomical accuracy and three-dimensional details in his works.
Da Vinci robots operate in hospitals worldwide, with an estimated 200,000 surgeries conducted in 2012, most commonly for hysterectomies and prostate removals. By January 2013, more than 2,000 units had been sold worldwide. The "Si" version of the system costs on average slightly under US$2 million, in addition to several hundred thousand dollars of annual maintenance fees. The da Vinci system has been criticised for its cost and for a number of issues with its surgical performance.The da Vinci System consists of a surgeon’s console that is typically in the same room as the patient, and a patient-side cart with four interactive robotic arms controlled from the console. Three of the arms are for tools that hold objects, and can also act as scalpels, scissors, bovies, or unipolar or hi, the surgeon must first use the system's weight to judge how hard it should work. Then he/she uses the console’s master controls to maneuver the patient-side cart’s three or four robotic arms (depending on the model). The instruments’ jointed-wrist design exceeds the natural range of motion of the human hand; motion scaling and tremor reduction further interpret and refine the surgeon’s hand movements. The da Vinci System always requires a human operator, and incorporates multiple redundant safety features designed to minimize opportunities for human error when compared with traditional approaches.
The da Vinci System has been designed to improve upon conventional laparoscopy, in which the surgeon operates while standing, using hand-held, long-shafted instruments, which have no wrists. With conventional laparoscopy, the surgeon must look up and away from the instruments, to a nearby 2D video monitor to see an image of the target anatomy. The surgeon must also rely on his/her patient-side assistant to position the camera correctly. In
contrast, the da Vinci System’s ergonomic design allows the surgeon to operate from a seated position at the console, with eyes and hands positioned in line with the instruments.
To move the instruments or to reposition the camera, the surgeon simply moves his/her hands.
By providing surgeons with superior visualization, enhanced dexterity, greater precision and ergonomic comfort, the da Vinci Surgical System makes it possible for more surgeons to perform minimally invasive procedures involving complex dissection or reconstruction. For the patient, a da Vinci procedure can offer all the potential benefits of a minimally invasive procedure, including less pain, less blood loss and less need for blood transfusions.
Moreover, the da Vinci System can enable a shorter hospital stay, a quicker recovery and faster return to normal daily activities.
Since the first report of endoscopic parathyroidectomy in 1996 (1) , countless endoscopic and minimally invasive procedures have been developed with the aim of gaining the safest approach with the best cosmetic result and postoperative outcome after thyroidectomy.
Aiming to shift the scar from the neck, several endoscopic approaches, including transaxillary endoscopic thyroidectomy (2,3), breast approach (4), anterior chestwall approach using a flap-lifting system (5), axillobilateral-breast approach (6), bilateralaxillobreast approach (7), and transareola single-site endoscopic thyroidectomy (8) have been proposed, most often by surgeons in Far Eastern countries. Several trials showed that most of these techniques achieved this goal over traditional cervicotomy (9- 12) for benign and malignant disease. However, these endoscopic approaches soon proved to be technically challenging because of two-dimensional vision and inadequate
instrumentation and, above all, they cannot be considered minimally invasive (13-15).
As a consequence, minimally invasive video-assisted thyroidectomy (MIVAT), proposed in 1998 (16), with its central cervical access, gained a larger popularity in Europe and became the most widespread minimally invasive endoscopic technique for thyroidectomy in North America (17). Several studies reported MIVAT has safety, easy reproducibility, and optimal results compared with traditional cervicotomy in cosmetic outcome, postoperative pain, and postoperative course, not only for benign disease but also for low-risk and intermediate-risk papillary carcinoma (18-26).
In recent years, the da Vinci S surgical robotic system was developed to improve the weak points of endoscopic surgery, and recent studies have reported that robotic axillary thyroidectomy (RATT), introduced by Chung in South Korea in 2009 (27,28), is feasible, safe, and has excellent cosmetic results. The robotic approach easily overcomes the endoscopic techniques performed by conventional laparoscopic instruments through the same access due to magnified and enhanced three-dimensional vision, the availability of a fourth arm to retract the thyroid lobe, extended freedom of motion of the robotic instruments, and comfortable surgeon ergonomics. The first aim of this technique is an optimal cosmetic result, and indeed, RATT represents a “scarless in the neck” operation. In fact, several studies that have compared RATT with axillary endoscopic thyroidectomies report the robotic approach provides better cosmetic results and patient satisfaction (29- 33). Not least, an alternative “scarless in the neck” approach taking advantage from the robotic system is represented by “robotic facelift thyroidectomy” proposed by Terris and
collegues in 2011 and performed through a postauricolar and occipital hairline (facelift) incision (34)
The enthusiasm for these new robot-assisted techniques can be seriously reduced by the costs of these procedures, that are much higher than the costs of the traditional and video-assisted thyroidectomy. Broome and coll. report a 217% increased cost of Robotic thyroidectomy compared with traditional thyroidectomy, and this greater expense might be prohibitive in countries with a flat reimbursement schedule (x x x )
In the context of this wide and varied panorama of different approaches aiming to reach the best cosmetic result, at present, to the best of our knowledge, no published studies have compared RATT and MIVAT. We thus initiated a study to prospectively compare two groups of patients undergoing thyroid surgery randomly allotted to MIVAT or RATT and report the results. Study end points were safety and outcomes of these two procedures, particularly focusing on cosmetic result and overall patient satisfaction.
3. PATIENTS AND METHODS
Study design
This prospective, randomized study recruited 62 patients undergoing hemithyroidectomy between January 2012 and February 2013 at the Department of Surgery, University of Pisa. Eligibility criteria were benign disease, nodule diameter of less than 6 cm, and total thyroid volume of less than 30 mL. Excluded were patients with
symptoms attributable to the thyroid nodule (disphagia, dispnea, dysphonia) , so as not to affect the validity of the test SF36, patients with malignant disease, intrathoracic goiter, previous neck operation or neck irradiation, and those who required central or lateral compartment lymphadenectomy, permanent medication for pain, and anticoagulation medication. All patients provided an informed consent for the study.
All consecutive patients referring to our Department with uninodular thyroid benign disease and matching the inclusion criteria were randomly allotted to undergo hemithyroidectomy by the MIVAT technique (group A) or hemithyroidectomy by the RATT procedure (group B). Patients, previously informed about the chance to undergo one of these two different techniques, were randomized the day before surgery by draw, with a sealed envelope containing “MIVAT” or “RATT.” Because nodules sized between 4 and 6 cm were considered too challenging for a MIVAT and could constitute a bias, the study excluded patients with a nodule diameter exceeding 4 cm who were allotted to MIVAT.
This happened in only two patients.
Primary study end points were to analyze the cosmetic result and overall satisfaction. Secondary end points were to evaluate operative time and complications.
Surgical treatment
MIVAT
MIVAT was performed with the patient supine, without neck extension, through a central, transversal 1.5-cm incision placed two fingers above the sternal notch. Operative
space was maintained by external use of small retractors. A 30º 5-mm endoscope was used during the endoscopic step. Under endoscopic vision, the upper pedicle was dissected and divided by means of Harmonic Scalpel®. The recurrent nerve and parathyroid glands were identified and isolated. After extraction of the lobe, hemithyroidectomy was achieved. Hemostasis was obtained by Harmonic Scalpel® and titanium clips (5 mm). Subcuticular stitches and glue were used to close the wound. Drains were never used.
RATT
The da Vinci Si system (© 2013 Intuitive Surgical Inc.) was used in all procedures.
The patient was placed supine with one arm extended over the shoulder. The working space was created using the standard technique through a 5-cm to 7-cm skin incision along the anterior border of pectoralis major muscle. A Chung’s retractor was used to maintain the operative space. Only three arms were used in all operations. During the docking of the robot, the dual-channel endoscope was positioned on the central arm, the Harmonic curved shears was positioned on the upper side arm, and the Maryland dissector (Intuitive Surgical) was positioned on the lower side arm.
The operation started with the dissection of the upper pedicle. Under endoscopic view, the upper pole was dragged downward with the Maryland dissector. The upper thyroid vessels were exposed then sealed and interrupted with the Harmonic shears, very close to the thyroid capsule to avoid any damage to the external branch of the upper
laryngeal nerve. The Maryland dissector was hence used to retract the thyroid lobe medially, and the surgeon started the identification of the recurrent laryngeal nerve, dissecting the tracheoesophageal groove with the Harmonic shears, both bluntly and cutting, with the same instrument. In the same manner, the parathyroid glands were identified and preserved. Once the critical structures were identified, the thyroid lobe was dissected with the Harmonic scalpel, and the specimen was removed. A drain was left in the operative space, and skin was closed by intradermal reabsorbable suture.
Assessment of surgical complications
Direct fiberoptic laryngoscopy was performed in all patients immediately before and 3 months after thyroidectomy to assess cord motility. Patients with cord palsy were sent to a voice therapist. Recurrent laryngeal nerve injury was considered permanent if persistent 6 months after surgery. Hypoparathyroidism assessment was not considered necessary because all procedures were simple hemithyroidectomies.
Analysis of epidemiological data, follow-up and cosmetic and satisfaction outcome assessment
Data were collected on age, sex, Body Mass Index (BMI) , compressive symptoms attributable to the thyroid nodule (disphagia, dispnea, disfonia), thyroid volume, nodule diameter, skin-to-skin operative time, total time from intubation to extubation, final histology report, complications, and postoperative stay length. Cosmetic result was evaluated after 2 months by the by the Patient Scar Assessment Questionnaire (PSAQ).
Overall satisfaction was evaluated after 1 month by the Short Form 36-item (SF-36) questionnaire.
PSAQ
The PSAQ was used with the aim of providing a valid measure of the patient's perception of scarring. This scale, designed specifically for the assessment of linear scars, is composed of four subscales: scar appearance, consciousness, satisfaction with scar appearance, and satisfaction with scar symptoms. The symptoms subscale was omitted due to its poor reliability in this kind of scar. For each subscale, a higher score reflects a poorer outcome of the scar. The reliability of this scale has been demonstrated in several studies, in particular, to evaluate scars after thyroid and parathyroid surgery (35,36)
SF-36 2 TM Health Ssurvey (version 2.0)
SF-36 2TM questionnaire was used to evaluate the burden of surgery. The SF-36 is a multipurpose, short-form health survey that has proven to be useful in the assessment of a patient's quality of life (QoL). It is composed of eight subscales, each highlighting a different aspect of a patient's QoL: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. For this tool, a lower score indicates a poorer QoL (37).
Statistical analysis
We used the Kolmogorov-Smirnov test to check normality of data distribution. The introductory phase was concluded with a statistical power analysis (ex post) to estimate
the sample size required for the
specific tests. The 1-β value of the significant variables was >0.8, assuring a low risk of type II error and an appropriate sample size. We used the Mann-Whitney test and the t test to assess continuous variables and the χ2 test for categoric variables. The analysis was performed with SPSS 17.0.1 software (SPSS Inc, Chicago, IL, USA).
4. RESULTS
A total of 62 patients underwent hemithyroidectomy, of whom 30 were allotted to group A (MIVAT) and 32 to group B (RATT). The groups were well matched in age, sex ratio and BMI (Table 1). There were 29 women and 1 man in group A and 31 women and 1 man in group B. Patients were a mean age of 36.9 ± 9.6 years (range, 21-62 years) in group A and 33.8 ± 12.26 years (range, 18-73 years) group B. There were 16 right lobectomies and 14 left lobectomies in group A, and 14 right lobectomies and 18 left lobectomies in group B.
No conversions to open cervicotomy were required.
The preoperative diagnosis was 21 nodular goiters and 9 microfollicular nodules in group A and 22 nodular goiters, 3 toxic adenomas, and 7 microfollicular nodules in group B. The final histology report showed benign disease in all patients except two microfoci of papillary carcinoma (0.3 and 0.5 mm) in two patients in group A and three microfoci of
papillary carcinoma (0.1, 0.2, and 0.6 mm) in group B. (table 1)
Mean nodule diameter was significantly larger in group B (33.9 ± 14.7; range, 10-60 mm) than in group A (15.2 ± 5.6; range, 7-31 mm; P < 0.0001).
Operative times (skin-to-skin time in MIVAT group and console time plus closure of the wound in RATT) were comparable, at 46.5 ± 10.5 minutes (range, 30-70 minutes) in group A and 54.9 ± 38.47 minutes (range, 19-220 minutes) minutes in group B. Total surgical time (intubation-extubation time, including preparation of the operative space and docking time in group B) was significantly shorter in group A (71.6 ± 13.3; range, 50-95 minutes) than in group B (122.6 ± 47.7; range, 75-325 minutes; P < 0.0001). (table 1)
Complications consisted of one transient recurrent laryngeal nerve injury in both groups and one subcutaneous hematoma over the major pectoralis fascia diagnosed by ultrasound on the first postoperative day and conservatively treated by ultrasound guided evacuation of the blood and antibiotics administration in group B.
There were non definitive complications, since recurrent nerve injury in both groups recovered completely in two months.
Postoperative stay was 1.92 days in group B, which was significantly longer than the 1.15 days in group A (P < 0.0001).
Assessment of cosmetic result and overall satisfaction
significantly higher in group B than in group A, respectively, at 17.87 ± 3.86 vs 13.62 ± 2.94 (P < 0.0001) and 14.74 ± 4.82 vs 12.03 ± 3.65 (P < 0.018), and the remaining variables (consciousness and satisfaction with symptoms) were comparable. These results mean that patients who underwent MIVAT (group A) were more satisfied with their scar than those who underwent RATT (group B).
Scores for the SF-36 domains of social activity and general health were significantly higher in group B than in group A (respectively, 89.03 ± 24.42 vs 74.03 ± 27.34 [P < 0.006]
and 90.90 ± 12.19 vs 78.51 ± 17.71 [P < 0.0001]), showing that patients undergoing RATT have a better perception of their general state of health and are more prone to social activities than patients undergoing MIVAT. Scores for bodily pain were significantly higher in group A than in group B (97.55 ± 8.14 vs 81.67 ± 21.43; P < 0.0005), indicating that patients undergoing MIVAT experienced less tenderness than patients undergoing RATT.
Scores for the remaining domains (physical functioning, role-physical, vitality, role- emotional, and mental health) were comparable in the two groups. Results are summarized in Table 2.
5. DISCUSSION
To our knowledge, this is the first prospective randomized study comparing cosmetic and overall satisfaction after MIVAT and RATT for benign disease. Concerning this primary end point of the study, RATT seems not to overcome MIVAT when comparing two groups of patients undergoing thyroidectomy for benign disease, although nodule
diameter was significantly larger in the RATT group.
In particular, the PSAQ questionnaire, which specifically evaluates the scar, highlighted that the axillary scar, even if hidden in a remote site, is less appreciated than the scar produced by MIVAT, although the latter is more evident. The appearance and satisfaction with scar appearance scores (Table 2) were significantly in favor of MIVAT. This might be due mainly to the length of the scar after RATT, which is necessarily longer, and less obviously because the axillary skin incision, which is placed in the border of the pectoralis major muscle and does not follow the natural skin folds, might result in worse healing.
For the SF-36 questionnaire, we found that patients undergoing RATT experienced a better perception of their general state of health and were more prone to social activities after surgery but scored higher on the bodily pain domain at prolonged follow-up.
Since its introduction, RATT has yielded in published studies better patients outcomes compared with open thyroidectomy, including lower postoperative pain and increased cosmetic satisfaction (32-33). If the increased cosmetic satisfaction provided by RATT and reported by these papers might be reasonable when comparing RATT with traditional cervicotomy due to the hidden localtion of the skin incision, the lower postoperative pain after RATT is difficult to understand, when comparing patients undergoing a “maximally invasive” operation (dissection of large flap over the major pectoralis fascia since axilla to the neck) and patients undergoing cervicotomy, most of the times, in expert hands, not larger than 6-8 centimeters, without large dissection of the
cutaneous flaps and strap muscles division.
Likewise MIVAT, which is performed through a 1.5-cm incision without any dissection of the subcutaneous tissue, allows a superior cosmetic result and a better postoperative outcome for patients with small thyroid lesions compared with traditional thyroidectomy, although the operation is performed through an incision placed in a well visible part of the body (22,24,25). For these reasons, it seemed reasonable to try a comparison between two endoscopic procedures, both of them considered cosmetic, rather than comparing them with traditional thyroidectomy.
The first important observation is that RATT allows treatment of larger lesions than MIVAT. In our series, the nodule diameter in group B was significantly larger (33.9 ± 12.2;
range, 10-60 mm) than in group A (15.2 ± 5.6; range, 7-31 mm; P < 0.0001), and that is undoubtedly an advantage provided by RATT because it allows recruiting a larger number of patients. In fact, one of the major limits of MIVAT is the strict indication criteria in thyroid volume (3 cm maximum diameter) and nodule diameter (25 mL maximum gland volume), which limits to 10% to 15% the maximum rate of patients who can benefit from this cosmetic operation (18). Conversely, because the dimensional limit for RATT is 5 to 6 cm, a larger number of patients will benefit from a cosmetic operation while complaining of larger goiters (27). This aspect must not be definitively neglected as a consistent advantage of the robotic technique compared with MIVAT, especially in Europe, where goiter is endemic and mean thyroid volumes are higher than in Eastern countries.
There were no differences regarding complications, thus confirming safety of both
techniques. Both approaches benefit from the magnification provided by the endoscope (and a 3D image for the robotic approach). Several reports showed a complication rate similar to traditional thyroidectomy for endoscopic operations (38-40).
Hypoparathyroidism was not evaluated in this series because all patients underwent hemithyroidectomy, which almost always excludes the risk that this important complication will occur.
When analyzing the length of the surgical procedure, we found similar operative
“open-close” times in MIVAT compared with “console time” in RATT (Table 1). The two groups differed significantly when total procedure time was considered, which in the RATT group includes preparation of the operative space and docking time. Total time was significantly longer in the RATT group (122.6 ± 47.7; range, 75-325 minutes) than in the MIVAT group (71.6 ± 13.3; range 50-95 minutes; P < 0.0001). That must be considered as a partial disadvantage of RATT, which therefore hardly can be added to the group of minimally invasive techniques, considering also the extension of the dissection needed to gain the operative space. In fact, in our series, the bodily pain score on the SF-36 questionnaire was higher in group B than in group A, and the postoperative hospital stay also was significantly longer in group B (Table 1).
In conclusion, the results that we found most surprising were those expressing satisfaction for the scar appearance as assessed by the PSAQ appearance and satisfaction with scar appearance subscales (Table 2): this demonstrates that relocating the wound
from the neck to a less visible area, such as the axilla, is not enough to meet the full expectations from the patients, probably because the axilla scar is still considered to be too long and its appearance is less likely to improve in time because it cannot be placed in a skin crease. Our results appear to be in agreement with the words of QY Duh, “For now…
neck incisions… are here to stay” (41).
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7. TABLES
Table 1 Demographics of Patients Treated by Minimally Invasive Thyroidectomy (Group A) and Robot Assisted Transaxillary Thyroidectomy (Group B)
Variables Group A (MIVAT) Group B (RATT) P
(N = 30) (N = 32) Sex
Females 29 31 0.99
Males 1 1 0.99
Age, years 36.9±9.6 (21-62) 33.8±12.26 (18-73) 0.278
Procedure
Right lobectomy 16 14 0.99
Left Lobectomy 14 18 0.98
Preoperative diagnosis
Nodular goiter 21 22
Microfollicular nodule 9 7
Toxic adenoma 3
Nodule diameter, mm 15.2±5.6 (7-31) 33.9±14.7 (10-60) 0.0001 Operative time,* min 46.5±10.5 (30-70) 54.9±38.47 (19-220) 0.262 Total operative time (intub/ext), min 71.6±13.3 (50-95) 122.6±47.7 (75-325) 0.0001
Docking time, min 9.7±5.4 (5-25) -
Operative space preparation, min 30.3±12.3 (10-75) - Mean postoperative stay, days 1.15 (1-3) 1.92 (1-4) 0.0001
Continuous data are shown as mean ± standard deviation and range; categoric data as numbers of patients.
Table 2 Patient Scar Assessment Questionnaire (PSAQ) and SF-36 questionnaire scores.
Group A (MVAT) Group B (RATT) P
PSAQ A 13.62±2.94 17.87±3.86 <0.0001
PSAQ C 9.75±3.48 8.71±2.13 0.162
PSAQ SA 12.03±3.65 14.74±4.82 <0.018
PSAQ SC 6.55±1.92 7.29±2.20 0.173
SF36 PF 93.96±10.21 94.83±10.2 0.627
SF36 RP 77.58±41.37 63.71±48.23 0.222
SF36 BP 97.55±8.14 81.67±21.43 0.0005
SF36 GH 78.51±17.71 90.90±12.19 0.0001
SF36 VT 62.24±24.18 72.74±22.98 0.090
SF36 SF 74.03±27.34 89.03±24.42 0.006
SF36 RE 58.62±50.12 79.54±40.07 0.100
SF36 MH 70.20±19.84 78.58±19.85 0.108
PF: physical functioning, RP: role physical, BP: bodily pain, GH: general health, VT: vitality, SF: social functioning, RE: role-emotional, MH: mental health
PSAQ A: appearance, PSAQ C: consciousness, PSAQ SA: satisfaction with appearance, PSAQ SC: satisfaction with symptoms
