Abstract
Robot assisted laparoscopic radical hysterectomy and pelvic lymphadenectomy with short and long term morbidity data.
Persson, Jan; Reynisson, Petur; Borgfeldt, Christer; Päivi, Kannisto; Lindahl, Bengt; Bossmar, Thomas Link to publication Citation for published version (APA): Persson, J., Reynisson, P., Borgfeldt, C., Kannisto, P., Lindahl, B., & Bossmar, T. (2009). Robot assisted laparoscopic radical hysterectomy and pelvic lymphadenectomy with short and long term morbidity data. Gynecologic Oncology, 113, 185-190. DOI: 10.1016/j.ygyno.2009 General rights Copyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights.
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Introduction

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Robot assisted surgery was introduced in October 2005 following a training programme 72 for surgeons and operating room teams. From the start, detailed protocols for prospective 73 retrieval of perioperative and follow up data were used. All data were consecutively entered to 74 a computerized quality registry instituted for all robot assisted gynecological procedures on 75 demand of, and approved by, the hospital administration. For the present study, we retrieved 76 the data from women planned for robot assisted laparoscopic radical hysterectomy and pelvic 77 lymphadenectomy with the aim of assessing feasibility, short and long term morbidity of the 78 procedure. The study was approved by the regional Institutional Review Board. cancer or stage 2 endometrial cancer were considered for a modified Piver II-III robot assisted 99 laparoscopic radical hysterectomy and pelvic lymphadenectomy. We excluded women with a 100 compromising cardiovascular/respiratory comorbidity (n=5), a uterine size not allowing 101 vaginal retrieval (n=4) and known intraabdominal adhesions or multiple midline incision 102 (n=6). Five women had open surgery due to limited access to the robot. 103
The remaining 90 women were offered robot assisted laparoscopy after an information 104 including their option of alternative surgical approaches. All eligible women approved. 105
In 55 of 70 women with cervical cancer, 120 MBq 99m Technetium was injected superficially 106 at four points in the cervix the day before surgery followed by a lymphoscintigram to identify 107 sentinel lymph nodes as a part of a parallel study. During surgery, the sentinel lymph nodes 108 were detected by a laparoscopic gamma probe (Neo2000® laparoscopic probe, Neoprobe 109
Corporation, Dublin OHIO) and sent for frozen section. The hysterectomy was aborted in 110 favour of radiation therapy if a sentinel node was metastatic. 111
We used a four arm da Vinci or da Vinci-S robot. To facilitate an optimal exposure for the 112 gamma-probe scanning, first and foremost in the common iliac area, two assistants' trocars 113 were used (Excel ®12 millimetre Ethicon Inc, Somerville, NJ and Versaseal® Plus15 114 millimetre, Auto Suture/ Tyco Health care, Oriscany Falls, NY). The probe was used in 115 either of the trocars to achieve an optimal angle for the sidemounted gamma-element. The 15 116 millimetre trocar was also used for compartmentwize retrieval of lymph nodes in a 117 reinsertable retrieval bag (LINA Medical, Glostrup, Denmark). The port placements and 118 instruments are illustrated in Figure 1 . The grasper was used to present the specimen in an 119 appropriate position and to apply adequate tension of the tissue for monopolar dissection. 120
Posterior dissection was finished first to avoid impaired visibility by bleeding from anterior 121 6 dissection. A folded swab on a forceps was placed vaginally to help to decide the level for the 122 vaginal transsection and to prevent gas-leakage after opening of the vagina. No vaginal dilator 123 or uterine manipulator was used. Monopolar diathermia was set a 30-40 Watts using the 124 coagulating mode for electrodissection and the cutting mode for opening of the vagina. 125
Initially, the paravesical and pararectal spaces were developed and sentinel nodes 126 identified. Full uterine blood supply was preserved until the sentinel nodes were found 127 negative. The full lymphadenectomy was performed en bloc compartmentwize starting with 128 the common iliac nodes (boundary five centimetres cranial of the bifurcation of the iliac 129 artery), followed by the external iliac nodes (distal boundary the Cloquet's node, lateral 130 boundary the genitofemoral nerve), and the obturator nodes (distal boundary the pubic bone, 131 dorsal boundary the obturator nerve). 132
A modified Piver II (stage 1A 2 and stage 1b1 <1 centimetres) or Piver III (stage 1b1>=1 133 centimetres) radical hysterectomy was performed. For the modified Piver II and Piver III we 134 aimed at a shorter vaginal specimen length (minimum two and four centimetres respectively) 135 and a less extended dissection of the sacrouterine ligaments (minimum two and four 136 centimetres from the cervix respectively) compared with the original Piver classification. 137
Technically, we followed a uniform plan for the radical hysterectomy. The uterine vessels 138 were divided at their origin (all tumor stages). The parametria and the ureters were dissected 139 as far distally as possible. The uterus was lifted, the rectovaginal space was opened and the 140 sacrouterine ligaments isolated at appropriate distance. After a dissection of the bladder in the 141 midline, the bladder pillar was isolated followed by division of the lower parametria and 142 paracolpia before the vagina was transsected. To ensure the desired level for the vaginal 143 transsection, the vaginal swab was pushed inwards and then slowly moved back to visualize 144 the level of the distal cervix. We first incised the vagina anteriorly and the following 145 transsection was performed under visual control from the inside of the vagina. The specimen 146 was removed vaginally using either a tenaculum or a retrieval bag. The vagina was closed 147 from inside using a continuous Vicryl 0 (Ethicon Inc, Somerville, NJ) suture secured with 148 laparoscopic knots. Surgeon A used a figure-of-eight inverting suture whereas surgeon B and 149 C used plain sutures for vaginal closure. The fascia was closed at the site of the 150 supraumbilical optics port and the 15 millimetre assistants' port. 151
In case of small tumours (<1 centimetre) we usually identified the ileohypogastric nerves 152 by further developing the pararectal space. Vessel loops were used to facilitate nerve sparing 153 dissection to the bladder by pulling the nerves and ureters laterally together. 154
Bladder catheterization was interrupted when residual urine was less than 100mL once or less 155 than 150mL twice provided that the voided volume was at least 200 mL. Women with 156 persistent inadequate voiding after seven postoperative days were prescribed self 157 catheterization monitored by telephone controls until approved residual urine. All women 158 received antibiotic prophylaxis and low molecular weight heparin according to local treatment 159 protocol. In median, women were discharged on the third postoperative day (range1-9 days). 160
According to protocol, surgical data, short and long term postoperative complications and 161 time to spontaneous voiding were prospectively registered. During follow-ups, including a 162 vaginal ultrasonography for identification of lymphoceles, women were actively asked and 163 investigated for defined adverse events in particular from the urogenital, neural and lymphatic 164 systems and the abdominal wall. procedure. The four women staged as 1A1 cervical cancer after final histology had a radical 179 hysterectomy due to difficulties in the preoperative staging (adenocarcinoma and/or 180 multifocality and/or intracervical lesions proximal to cone specimens). The procedures were 181 performed by either of three surgeons (surgeon A, n=38, surgeon B, n=22, surgeon C, n=20). No patient received intraoperative blood transfusion and no intraoperative complications 197 occured apart from the neural complications described in Table 2. Time for surgery and blood  198 loss differed significantly between surgeons (Table 1) Times for surgery and bleeding differed significantly between surgeons ( Table 1 ). The 254 surgeon with the longest times for surgery and the largest median bleeding had the least 255 experience with traditional laparoscopic surgery. All surgeons intended to follow the defined 256 steps of the surgical procedure. Discrepancies in surgical technique/skill are difficult to define 257 but we believe that the extent of previous experience with advanced traditional laparoscopy 258 affects the performance of robot surgery at least during an introductory phase. 259
The separate times for the sentinel node procedures were not recorded in our protocol and 260 would have been difficult to define as we finished at least the common iliac node dissection 261 bilaterally while waiting for the frozen section results. Overall, mean surgical time with the 262 sentinel procedure included was 21 minutes longer than for operations without the sentinel 263 node procedure. However, this difference diminished over time as we became more efficient 264 in identifying the sentinel nodes. Seven of the 10 fastest operations included the sentinel node 265 procedure. We intend to publish the details of the sentinel node study separately. 266
Strengths of this study are the prospective retrieval of data, the relatively large number of 267 included women and the few women lost for follow up. A weakness of this study is the lack 268 of comparison with established surgical techniques. However, this prospective study describes 269 a surgical approach during an introductory phase and a retrospective comparison with 270 previous open radical hysterectomies at our institution would inevitably be biased in favour of 271 the established technique. Moreover, the differences between surgeons in surgical time and 272 bleeding would further bias such a comparison. 273
Our complication rate was higher than rates reported by most other authors, in particular 274 complications from the vaginal cuff and lymphatic system (Table 2 and The incarcerations of the small bowel both occured trough the peritoneal opening at the place 306 for the 15 millimetre assitants trocar despite an intact sutured fascia. To avoid this 307 complication we included a peritoneal suture during the second half of the procedures. No 308 hernias occurred at the da Vinci trocar sites. 309
In our series, in-patient times were longer than reported by other authors (5-10). There are 310 several explanations: First, as we were pioneers from a European perspective, we initially 311 wanted to gain experience with the procedure and to ensure the women were perfectly fit to 312 go home, in particular the majority of women living in distant parts of the hospital recruitment 313 area. Second, nine women were older than 70 years and were kept longer for socio-medical 314 reasons. Third, initially we often kept women for repeated assessment of voiding if the criteria 315 for approved residual urine were close to be met. Later we abstained from the initial second 316 postoperative day control of voiding. Instead, women were discharged with an indwelling 317 catheter and a scheduled outpatient control of voiding seven days after surgery. Altogether, 318
during the last year, 55% of unselected women were discharged within 48 hours after the 319 surgical procedure. 320 14 Apart from the high cost for investment and maintenance of the da Vinci system, we 321 believe the major disadvantage with robot assisted surgery is the relatively long time for 322 nurses preparation affecting the total time for patient in the operating room as well as time for 323 change in between procedures (Table 1) . In our series, the median time from patients entry in 324 the operating room (including anesthesia) until onset of surgery was 68 minutes (range 35-123 325 minutes). So far, we have not been able to significantly diminish that time, probably since we 326 still introduce new nurses into robotics and since we suffer from a constant turnover of 327 anesthesia teams. Considering the times for nurses preparation and cost for the robot it is 328 unclear whether the robot concept is cost efficient compared with laparoscopy or open 329
surgery. 330
We believe that the implementation of laparoscopic radical hysterectomies at our 331 institution was facilitated by the da Vinci system and that further shortening of surgical time 332 and nurses preparation time is possible. Moreover, once familiar with the da Vinci system we 333 have managed to apply laparoscopic surgery also for rare advanced oncological procedures 334 such as laparoscopic radical trachelectomy, surgery for vaginal cuff recurrencies and removal 335 of bulky nodes and pelvic side wall tumors (15). We do not believe that those procedures 336 would have been laparoscopic at our institution without the robot. 337
However, it is unclear to which extent the robot facilitates laparoscopic radical 338 hysterectomies at an institution with a previous large experience of traditional laparoscopic 339 radical hysterectomies. 340
In conclusion, we found robot assisted laparoscopic radical hysterectomy to be associated 341 with a steep learning curve and a diminishing number of complications over time. Complications following robot assisted radical hysterectomy and pelvic lymphadenectomy. * nd = not defined ** Proportion of uneventful cases unknown *** sd = specifically denied, nsd = not specifically denied
Type of complication


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