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Comparison of robotic-assisted vs conventional laparoscopy for extraperitoneal paraaortic lymphadenectomy
Gynecologic Oncology 132 (2014) 98–101
Contents lists available at ScienceDirect
Gynecologic Oncology journal homepage: www.elsevier.com/locate/ygyno
Comparison of robotic-assisted vs conventional laparoscopy for extraperitoneal paraaortic lymphadenectomy B. Díaz-Feijoo a,1, B. Gil-Ibáñez a,1, A. Pérez-Benavente a, X. Martínez-Gómez c, E. Colás a, J.L. Sánchez-Iglesias a, S. Cabrera-Díaz a, O. Puig-Puig a, J.F. Magrina b, A. Gil-Moreno a,⁎ a b c
Unit of Gynecologic Oncology, Department of Obstetrics and Gynecology, Hospital Materno-Infantil Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain Department of Gynecology, Mayo Clinic in Arizona, USA Service of Epidemiology and Preventive Medicine, General Hospital Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain
a r t i c l e
i n f o
Article history: Received 20 July 2013 Accepted 1 November 2013 Available online 11 November 2013 Keywords: Robotic-assisted laparoscopy Extraperitoneal paraaortic lymphadenectomy Cervical cancer
a b s t r a c t Objective. To evaluate the perioperative outcomes of robotic-assisted extraperitoneal paraaortic lymphadenectomy for locally advanced cervical cancer and to compare to a previous series of patients from our institution undergoing the same procedure by conventional laparoscopy. Methods. 17 patients with locally advanced cervical cancer (FIGO stages IB2, IIA2 and IIB–IVA) underwent pretherapeutic extraperitoneal paraaortic lymphadenectomy by robotic-assisted laparoscopy. Perioperative outcomes including age, BMI, FIGO stage, operating time, blood loss, complications and length of hospital stay were compared to a series of 83 patients from our institution undergoing the same procedure by conventional laparoscopy. Results. The median values for operating time and hospital days for the robotic-assisted and conventional laparoscopy groups were 150 vs. 150 min and 2 vs 2 days, respectively. In the robotic group, blood loss was lower (90 vs 20 ml, p b 0.05) and more aortic nodes were removed (14 vs 17 nodes, p b 0.05). Docking time was 7 min (range 3–15). There were no intraoperative complications. There were no differences for postoperative complications (17.6% vs 8.4%). Conclusion. Robotic-assisted and conventional laparoscopy provide similar perioperative outcomes other than lower blood loss and higher number of aortic nodes removed (both without clinical impact) in robotic patients for the performance of extraperitoneal paraaortic lymphadenectomy in patients with locally advanced cervical cancer. We believe that robotic surgery is an additional tool to perform the same surgical procedure. Highlights. Robotic-assisted and conventional laparoscopic extraperitoneal paraaortic lymphadenectomy provide similar perioperative outcomes. © 2013 Elsevier Inc. All rights reserved.
Introduction The value of pretherapeutic extraperitoneal laparoscopic aortic lymphadenectomy in patients with locally advanced cervical cancer has recently become a possible option in the care of these patients [1]. Lymph node metastasis, particularly in the paraaortic area, and local tumor extent, are the most important prognostic factors in cervical cancer [1–3]. Although Positron Emission Tomography (PET-scan) has shown improved detection of aortic nodal metastases as compared to computed tomography (CT) and magnetic resonance imaging (MRI) [4–6], 18–32% of patients classified as aortic node-negative by PET-scan have
⁎ Corresponding author at: Unit of Gynecologic Oncology, Department of Obstetrics and Gynecology, Hospital Materno-Infantil Vall d'Hebron, Passeig Vall d'Hebron 119-129, E-08035 Barcelona, Spain. Fax: +34 93 4893039. E-mail address: [email protected] (A. Gil-Moreno). 1 Equal contributors. 0090-8258/$ – see front matter © 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ygyno.2013.11.004
aortic nodal metastases at lymphadenectomy [7]. A prospective randomized trial evaluating the impact of surgical staging on disease-free interval and overall survival is currently being developed (www. clinicaltrials.gov, NCT01365156). The implementation of appropriate treatment following identification and removal of histologically positive aortic nodes results in a respectable 5-year survival of 50%, as compared to a dismal or no survival if undetected and untreated [8, 9]. Resection of micrometastases (b 5 mm) and enlarged positive nodes has also been shown to provide a therapeutic benefit [1, 10–12]. The laparoscopic approach has replaced laparotomy for the evaluation of aortic nodal metastases in locally advanced cervical cancer patients due to improved perioperative outcomes [13] and decreased intestinal complications from irradiation. The extraperitoneal laparoscopic approach, while providing a similar number of aortic nodes, has been shown to have some advantages over the transperitoneal route due to decreased risk of bowel injury, avoidance of pre-existing abdominal adhesions, and reduced adhesion formation [14].
B. Díaz-Feijoo et al. / Gynecologic Oncology 132 (2014) 98–101
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Robotic technology has advantages over conventional laparoscopic instrumentation [15], and specially for limited surgical fields such as the extraperitoneal approach to aortic nodes. Robotic-assisted laparoscopic extraperitoneal paraaortic node dissection has been shown to be safe and feasible for patients with locally advanced cervical cancer [16–18]. The purpose of this study was to provide a comparison of the robotic assisted vs conventional laparoscopic approaches for extraperitoneal paraaortic lymphadenectomy in patients with locally advanced cervical cancer. Patients and methods Between July 2009 and January 2013, 17 non-consecutive patients with locally advanced cervical cancer (FIGO stages IB2, IIA2 and IIB– IVA) {Figo 2009 [19]} were diagnosed and treated at the Unit of Gynecologic Oncology of Hospital Vall d'Hebron in Barcelona, Spain. All patients underwent robotic-assisted laparoscopic extraperitoneal paraaortic and common iliac lymphadenectomy with the da Vinci S surgical system (Intuitive Inc., Sunnyvale, CA®) and constitute our robotic learning curve for this technique. There were no specific selection criteria to perform the lymphadenectomy with robotic technique besides da Vinci robot availability. Exclusion criteria were as follows: severe cardiorespiratory disease, age 80 years old or older, prior radiotherapy or retroperitoneal surgery and evidence of metastatic disease outside of the pelvis in preoperative imaging study. Patients with metastatic paraaortic lymph nodes received extended field radiation therapy concurrent with chemotherapy. Pretherapeutic MRI/PET scan studies were performed in all patients. Lymph nodes were interpreted as suspected following the European Association of Nuclear Medicine (EANM) procedure guidelines for tumor PET imaging, version 1.0.[20]. The study was approved by the ethics committee and the institutional review board. The operating time was measured from skin incision to completion of skin closure. Early postoperative complications include any adverse event in the first 42 postoperative days. Any subsequent adverse event was considered a late postoperative complication. These 17 patients were compared to a series of 83 patients from our institution undergoing the same procedure by conventional laparoscopy. The technique and results have been previously published [21].
Fig. 1. Port placement for robotic-assisted laparoscopic extraperitoneal paraaortic lymphadenectomy.
though the middle 12-mm trocar and the right robotic arm is docked to the 8-mm robotic trocar behind de 11th rib (Fig. 2). Care is taken to maintain a 7–8 cm distance between the ports to avoid arm collision. A bipolar grasper (fenestrated bipolar forceps endowrist instrument, Intuitive Surgical, Sunnyvale, CA®) and a monopolar curved scissors (endowrist instrument, Intuitive Surgical, Sunnyvale, CA®) are used through the left and right robotic trocars, respectively. One monitor and the tower containing the electrosurgical generators are positioned at the end of the operating table.
Robotic surgical technique The robotic surgical technique is similar to that previously reported for laparoscopy [22] which was modified from Querleu et al. [23]. A left approach is chosen because the majority of lymph nodes are on the left paraaortic region [24] and the right aortic nodes can also be removed [21, 25]. The patient is in a supine position on the left side of the operating table with the surgeon and the assistant to the patient's left side. The patient's right arm is tucked to her side and the left arm is extended at 90°. A diagnostic transperitoneal laparoscopy by means of a transumbilical 12-mm trocar is performed to rule out peritoneal disease. In the absence of peritoneal metastases a 2 cm incision is made above and medial to the left iliac spine with direct laparoscopic intra-abdominal visualization and a 12-mm trocar is inserted under direct laparoscopic visualization. Finger dissection as described in the original technique is no longer used since the space is developed when the extraperitoneal CO2 insufflation reaches a maximal pressure of 12 mm Hg. A 30° laparoscope is introduced through the extraperitoneal 12-mm trocar and the following trocars are introduced under direct visualization: an 8-mm robotic trocar behind the 11th rib, a 12-mm optical robotic trocar equidistant between the 11th rib and the iliac spine, and a one 5-mm assistant trocar in the midaxillary line for ventral peritoneal retraction, suction and irrigation (Fig. 1). The robotic column is positioned at the level of the patient's right shoulder. The left robotic arm is docked to an 8-mm robotic trocar introduced though the 12-mm trocar near the left iliac spine (telescoping). The 30° da Vinci laparoscope is introduced
Fig. 2. Position of robotic column and the patient in robotic-assisted laparoscopic extraperitoneal para-aortic lymphadenectomy.
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B. Díaz-Feijoo et al. / Gynecologic Oncology 132 (2014) 98–101
The surgical field boundaries are identified first by exposing the surgical field. They include the left renal vein, the common iliac arteries bilaterally, the left psoas muscle and the right margin of the vena cava. The superior hypogastric plexus is preserved. The left ureter and left ovarian vessels are identified and mobilized ventrally. The fatty-lymph node bearing tissue from the left infra- and supramesenteric areas, aortocaval space, ventral to the vena cava and the common iliac arteries is removed and placed in endobags to avoid port-site metastasis. The location of each group of aortic nodes, is noted. Once completed, a peritoneal window is made over the dissected area to prevent lymphocyst formation. A pelvic node dissection was not performed routinely unless they were noted to be enlarged in the preoperative imaging studies. The trocar sites were irrigated with a 10% povidone-iodine solution and the fascia at the 12-mm trocar sites cutaneous was closed with 0polyglactin suture (Vicryl®). The skin at all sites was closed with staples. Statistical analysis Data are expressed as median and range for variables whose distribution departed from normality. We compared both groups using Chisquare test and the Mann–Whitney U test. Statistical significance was set at p b 0.05. All relevant data concerning the characteristics of the patients, length of hospital stay, adjuvant therapy, histological findings and follow-up were prospectively registered using an Excel database. Statistical analysis was performed using IBM SPSS Statistics 19.0 software for Windows (SPSS Inc., Chicago, IL).
Table 2 Comparison of perioperative outcomes between robotic-assisted and conventional laparoscopic extraperitoneal para-aortic lymphadenectomy in patients with cervical cancer. Median (range)
Conventional laparoscopy (n = 83)
Robot-assisted laparoscopy (n = 17)
p values
Operating time (min) Blood loss (ml) Hospital stay (days) Lymph node removal (n) Post-operative complication rate (%)
150 (80–255) 90 (10–260) 2 [1–4] 14 (4–62) 7 (8.4%)
150 (85–270) 20 (5–350) 2 [1–5] 17 (10–31) 3 (17.6%)
0.59 b0.05 0.22 b0.05 0.23
operative complications. A significant difference was observed for a lower blood loss and higher number of nodes removed in the robotic group (Table 2). The median length of follow-up was 13.4 months (range 1–40.5). At follow-up, recurrence was observed in one patient eight months later (node recurrence in the interaortocaval region). This patient with node relapse underwent a second robotic-assisted transperitoneal node debulking with 12 nodes being removed, 5 of them positive. She received adjuvant extended chemoradiation. Three patients had progression of pelvic disease during chemoradiation. One of them underwent a pelvic exenteration and two were treated with chemotherapy alone. All died of their disease. Two additional patients were subsequently diagnosed with gastric and lung cancer, respectively, histologically different than their original cervical cancer. They were free of cervical cancer at the time of their death.
Results
Discussion
Clinical and pathologic characteristics of the study population as well as those from patients treated by are depicted in Table 1. Perioperative outcomes are summarized in Table 2. The docking time was 7 min (range 3–15). Positive aortic nodes were observed only in 1 patient (5.9%). Pelvic lymphadenectomy was performed in 9 patients (52.9%) with enlarged nodes on preoperative study (MRI or PET) according with our protocol and one of them had positive pelvic nodes. There were no intraoperative complications or conversions, and none of the patients required a blood transfusion. Early postoperative complications occurred in three patients (17.6%): two lymphocysts and one chylous ascites. Successful treatment of the lymphocysts was achieved by a single percutaneous TC-guided needle aspiration. Complete resolution of the chylous ascites occurred with operative drainage and 15 days of medium-chain fatty acid diet. There were no late postoperative complications. No differences between robotic-assisted and conventional laparoscopy were seen in terms of operating time, hospital stay and post-
Robotic-assisted laparoscopy provides a 3D imaging of the operative field, instrumentation with seven degrees of articulation, and tremor filtration resulting in increased precision [26]. The advantages of robotic technology over conventional laparoscopy for the performance of extraperitoneal aortic lymphadenectomy as a single operation have not been demonstrated [21]. Different authors have reported variations in patient positioning as well as trocar placement to avoid arm collision, which may occur due to the reduced surgical field. We and others [16] have found that 10–15 degree rotation of the table to the right is useful in some patients to avoid arm collision during the infrarenal dissection. Others have found useful a slight degree of Trendelenburg and table rotation [27]. Others have placed the optical trocar in the anterior superior iliac spine [17]. Comparison of the perioperative data of the present series with our previous series of conventional laparoscopy patients, showed no significant differences except for a lower blood loss in robotic patients (20 vs 90 ml, p b 0.05), which is not clinically significant. Our docking time of 7 min (range 3–15) did not prolong operating time unnecessarily. The number of nodes removed was statistically significantly higher in the robotic group probably because the surgical team had a lot of laparoscopic experience and because of the improved robotic technology which makes it more comfortable for the surgeon. A comparison of the robotic perioperative data with other robotic series is shown in Table 3. In our series we had no intraoperative complications or
Table 1 Clinical and pathologic characteristics of patients undergoing conventional laparoscopy and robotic-assisted laparoscopy.
Median age (years) (range) Median BMI (kg/m2) (range) Prior surgery (%) FIGO stage (%) IB2 IIA2 IIB IIIA IIIB IVA Histology (%) Squamous cell Adenocarcinoma Other
Conventional laparoscopy (n = 83)
Robotic-assisted laparoscopy (n = 17)
p values
51 (24–74) 26.5 (18–44) 32 (38.5%)
49 (29–66) 23 (16–32) 6 (35.3%)
0.38 0.04 0.9
30 (36.1%) 14 (16.8%) 28 (33.7%) 2 (2.4%) 8 (9.6%) 1 (1.2%)
5 (29.4%) 1 (5.9%) 8 (47.1%) – 3 (17.6%) –
66 (79.5%) 15 (18%) 2 (2.4%)
15 (88.2%) 2 (11.8%) –
0.5
Table 3 Literature review of perioperative outcomes of robotic-assisted laparoscopic extraperitoneal paraaortic lymphadenectomy. Authors
N
Operation Blood Lymph Hospital Complications time (min) loss (ml) nodes stay
Vergote [18]a Magrina [16] Lambaudie [27] Present series (2013)
5 1 15 17
128 262 202 150
a
b50 30 71 20
Does not include infrarenal nodes.
9.2 10 16.7 17
2 2 2.6 2
1 ureteral injury No 1 aortic hematoma 1 chylous ascites 2 lymphocysts
B. Díaz-Feijoo et al. / Gynecologic Oncology 132 (2014) 98–101
conversions. Our postoperative complications were similar to other series [28]. They all resolved with conservative treatment and no delay to the initiation of chemoradiation. The infrarenal group of aortic nodes in patients with cervical cancer were thought to be absent for metastases in the presence of negative ipsilateral inframesenteric nodes [18]. We demonstrated positive infrarenal nodes in 31% of patients with cervical cancer stages IB2–IVa with negative ipsilateral inframesenteric aortic nodes [21]. Lymphatic spread in some patients with advanced cervical cancer appears to be through the ovarian vessels directly to the infrarenal nodes, bypassing the inframesenteric nodes. Although we had been performing robotic surgery for 3.5 years (with more than 180 different procedures in this period of time), the present series looks at our first 17 cervical cancer patients who underwent extraperitoneal lymphadenectomies using robotic technology. Perioperative outcomes of our learning curve with robotic technology are most encouraging since they were similar except for a lower blood loss and higher number of aortic nodes removed in the robotic group. We elected to evaluate our initial results and compare with laparoscopy due to our extensive laparoscopic experience with this operation. The increased experience could result in improved robotic perioperative outcomes in the future. In conclusion, the perioperative outcomes of robotic-assisted extraperitoneal laparoscopic paraaortic lymphadenectomy are similar to the conventional laparoscopic route other than a lower blood loss and higher number of aortic nodes removed in the robotic group, both of which are not clinically significant. We believe that robotic surgery is an additional tool to perform the same surgical procedure. Conflict of interest statement The authors have neither commercial, proprietary, nor financial interests in the products and companies described in this article. The authors did not disclose any financial support or potential conflicts of interest.
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[7] Ramirez PT, Jhingran A, Macapinlac HA, Euscher ED, Munsell MF, Coleman RL, et al. Laparoscopic extraperitoneal para-aortic lymphadenectomy in locally advanced cervical cancer: a prospective correlation of surgical findings with positron emission tomography/computed tomography findings. Cancer 2011;117(9):1928–34. [8] Goff BA, Muntz HG, Paley PJ, Tamimi HK, Koh WJ, Greer BE. Impact of surgical staging in women with locally advanced cervical cancer. Gynecol Oncol 1999;74(3):436–42. [9] Varia MA, Bundy BN, Deppe G, Mannel R, Averette HE, Rose PG, et al. Cervical carcinoma metastatic to para-aortic nodes: extended field radiation therapy with concomitant 5-fluorouracil and cisplatin chemotherapy: a Gynecologic Oncology Group study. Int J Radiat Oncol Biol Phys 1998;42(5):1015–23. [10] Loft A, Berthelsen AK, Roed H, Ottosen C, Lundvall L, Knudsen J, et al. The diagnostic value of PET/CT scanning in patients with cervical cancer: a prospective study. Gynecol Oncol 2007;106(1):29–34. [11] Cosin JA, Fowler JM, Chen MD, Paley PJ, Carson LF, Twiggs LB. Pretreatment surgical staging of patients with cervical carcinoma: the case for lymph node debulking. Cancer 1998;82(11):2241–8. [12] Marnitz S, Kohler C, Roth C, Fuller J, Hinkelbein W, Schneider A. Is there a benefit of pretreatment laparoscopic transperitoneal surgical staging in patients with advanced cervical cancer? Gynecol Oncol 2005;99(3):536–44. [13] Sonoda Y, Leblanc E, Querleu D, Castelain B, Papageorgiou TH, Lambaudie E, et al. Prospective evaluation of surgical staging of advanced cervical cancer via a laparoscopic extraperitoneal approach. Gynecol Oncol 2003;91(2):326–31. [14] Potish RA, Twiggs LB, Prem KA, Levitt SH, Adcock LL. The impact of extraperitoneal surgical staging on morbidity and tumor recurrence following radiotherapy for cervical carcinoma. Am J Clin Oncol 1984;7(3):245–51. [15] Magrina JF. Robotic surgery in gynecology. Eur J Gynaecol Oncol 2007;28(2):77–82. [16] Magrina JF, Kho R, Montero RP, Magtibay PM, Pawlina W. Robotic extraperitoneal aortic lymphadenectomy: development of a technique. Gynecol Oncol 2009;113(1): 32–5. [17] Narducci F, Lambaudie E, Houvenaeghel G, Collinet P, Leblanc E. Early experience of robotic-assisted laparoscopy for extraperitoneal para-aortic lymphadenectomy up to the left renal vein. Gynecol Oncol 2009;115(1):172–4. [18] Vergote I, Pouseele B, Van Gorp T, Vanacker B, Leunen K, Cadron I, et al. Robotic retroperitoneal lower para-aortic lymphadenectomy in cervical carcinoma: first report on the technique used in 5 patients. Acta Obstet Gynecol Scand 2008;87(7):783–7. [19] Pecorelli S. Revised FIGO staging for carcinoma of the vulva, cervix, and endometrium. Int J Gynaecol Obstet 2009;105(2):103–4. [20] Boellaard R, O'Doherty MJ, Weber WA, Mottaghy FM, Lonsdale MN, Stroobants SG, et al. FDG PET and PET/CT: EANM procedure guidelines for tumour PET imaging: version 1.0. Eur J Nucl Med Mol Imaging 2010;37(1):181–200. [21] Gil-Moreno A, Magrina JF, Perez-Benavente A, Diaz-Feijoo B, Sanchez-Iglesias JL, Garcia A, et al. Location of aortic node metastases in locally advanced cervical cancer. Gynecol Oncol 2012;125(2):312–4. [22] Gil-Moreno A, Maffuz A, Diaz-Feijoo B, Puig O, Martinez-Palones JM, Perez A, et al. Modified approach for extraperitoneal laparoscopic staging for locally advanced cervical cancer. J Exp Clin Cancer Res 2007;26(4):451–8. [23] Querleu D, Dargent D, Ansquer Y, Leblanc E, Narducci F. Extraperitoneal endosurgical aortic and common iliac dissection in the staging of bulky or advanced cervical carcinomas. Cancer 2000;88(8):1883–91. [24] Michel G, Morice P, Castaigne D, Leblanc M, Rey A, Duvillard P. Lymphatic spread in stage Ib and II cervical carcinoma: anatomy and surgical implications. Obstet Gynecol 1998;91(3):360–3. [25] Dargent D, Ansquer Y, Mathevet P. Technical development and results of left extraperitoneal laparoscopic paraaortic lymphadenectomy for cervical cancer. Gynecol Oncol 2000;77(1):87–92. [26] Kho RM, Hilger WS, Hentz JG, Magtibay PM, Magrina JF. Robotic hysterectomy: technique and initial outcomes. Am J Obstet Gynecol 2007;197(1):113 [e1-4]. [27] Lambaudie E, Narducci F, Leblanc E, Bannier M, Jauffret C, Cannone F, et al. Robotically assisted laparoscopy for paraaortic lymphadenectomy: technical description and results of an initial experience. Surg Endosc 2012;26(9):2430–5. [28] Fastrez M, Goffin F, Vergote I, Vandromme J, Petit P, Leunen K, et al. Multi-center experience of robot-assisted laparoscopic para-aortic lymphadenectomy for staging of locally advanced cervical carcinoma. Acta Obstet Gynecol Scand Aug 2013;92(8):895–901.
Contents lists available at ScienceDirect
Gynecologic Oncology journal homepage: www.elsevier.com/locate/ygyno
Comparison of robotic-assisted vs conventional laparoscopy for extraperitoneal paraaortic lymphadenectomy B. Díaz-Feijoo a,1, B. Gil-Ibáñez a,1, A. Pérez-Benavente a, X. Martínez-Gómez c, E. Colás a, J.L. Sánchez-Iglesias a, S. Cabrera-Díaz a, O. Puig-Puig a, J.F. Magrina b, A. Gil-Moreno a,⁎ a b c
Unit of Gynecologic Oncology, Department of Obstetrics and Gynecology, Hospital Materno-Infantil Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain Department of Gynecology, Mayo Clinic in Arizona, USA Service of Epidemiology and Preventive Medicine, General Hospital Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain
a r t i c l e
i n f o
Article history: Received 20 July 2013 Accepted 1 November 2013 Available online 11 November 2013 Keywords: Robotic-assisted laparoscopy Extraperitoneal paraaortic lymphadenectomy Cervical cancer
a b s t r a c t Objective. To evaluate the perioperative outcomes of robotic-assisted extraperitoneal paraaortic lymphadenectomy for locally advanced cervical cancer and to compare to a previous series of patients from our institution undergoing the same procedure by conventional laparoscopy. Methods. 17 patients with locally advanced cervical cancer (FIGO stages IB2, IIA2 and IIB–IVA) underwent pretherapeutic extraperitoneal paraaortic lymphadenectomy by robotic-assisted laparoscopy. Perioperative outcomes including age, BMI, FIGO stage, operating time, blood loss, complications and length of hospital stay were compared to a series of 83 patients from our institution undergoing the same procedure by conventional laparoscopy. Results. The median values for operating time and hospital days for the robotic-assisted and conventional laparoscopy groups were 150 vs. 150 min and 2 vs 2 days, respectively. In the robotic group, blood loss was lower (90 vs 20 ml, p b 0.05) and more aortic nodes were removed (14 vs 17 nodes, p b 0.05). Docking time was 7 min (range 3–15). There were no intraoperative complications. There were no differences for postoperative complications (17.6% vs 8.4%). Conclusion. Robotic-assisted and conventional laparoscopy provide similar perioperative outcomes other than lower blood loss and higher number of aortic nodes removed (both without clinical impact) in robotic patients for the performance of extraperitoneal paraaortic lymphadenectomy in patients with locally advanced cervical cancer. We believe that robotic surgery is an additional tool to perform the same surgical procedure. Highlights. Robotic-assisted and conventional laparoscopic extraperitoneal paraaortic lymphadenectomy provide similar perioperative outcomes. © 2013 Elsevier Inc. All rights reserved.
Introduction The value of pretherapeutic extraperitoneal laparoscopic aortic lymphadenectomy in patients with locally advanced cervical cancer has recently become a possible option in the care of these patients [1]. Lymph node metastasis, particularly in the paraaortic area, and local tumor extent, are the most important prognostic factors in cervical cancer [1–3]. Although Positron Emission Tomography (PET-scan) has shown improved detection of aortic nodal metastases as compared to computed tomography (CT) and magnetic resonance imaging (MRI) [4–6], 18–32% of patients classified as aortic node-negative by PET-scan have
⁎ Corresponding author at: Unit of Gynecologic Oncology, Department of Obstetrics and Gynecology, Hospital Materno-Infantil Vall d'Hebron, Passeig Vall d'Hebron 119-129, E-08035 Barcelona, Spain. Fax: +34 93 4893039. E-mail address: [email protected] (A. Gil-Moreno). 1 Equal contributors. 0090-8258/$ – see front matter © 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ygyno.2013.11.004
aortic nodal metastases at lymphadenectomy [7]. A prospective randomized trial evaluating the impact of surgical staging on disease-free interval and overall survival is currently being developed (www. clinicaltrials.gov, NCT01365156). The implementation of appropriate treatment following identification and removal of histologically positive aortic nodes results in a respectable 5-year survival of 50%, as compared to a dismal or no survival if undetected and untreated [8, 9]. Resection of micrometastases (b 5 mm) and enlarged positive nodes has also been shown to provide a therapeutic benefit [1, 10–12]. The laparoscopic approach has replaced laparotomy for the evaluation of aortic nodal metastases in locally advanced cervical cancer patients due to improved perioperative outcomes [13] and decreased intestinal complications from irradiation. The extraperitoneal laparoscopic approach, while providing a similar number of aortic nodes, has been shown to have some advantages over the transperitoneal route due to decreased risk of bowel injury, avoidance of pre-existing abdominal adhesions, and reduced adhesion formation [14].
B. Díaz-Feijoo et al. / Gynecologic Oncology 132 (2014) 98–101
99
Robotic technology has advantages over conventional laparoscopic instrumentation [15], and specially for limited surgical fields such as the extraperitoneal approach to aortic nodes. Robotic-assisted laparoscopic extraperitoneal paraaortic node dissection has been shown to be safe and feasible for patients with locally advanced cervical cancer [16–18]. The purpose of this study was to provide a comparison of the robotic assisted vs conventional laparoscopic approaches for extraperitoneal paraaortic lymphadenectomy in patients with locally advanced cervical cancer. Patients and methods Between July 2009 and January 2013, 17 non-consecutive patients with locally advanced cervical cancer (FIGO stages IB2, IIA2 and IIB– IVA) {Figo 2009 [19]} were diagnosed and treated at the Unit of Gynecologic Oncology of Hospital Vall d'Hebron in Barcelona, Spain. All patients underwent robotic-assisted laparoscopic extraperitoneal paraaortic and common iliac lymphadenectomy with the da Vinci S surgical system (Intuitive Inc., Sunnyvale, CA®) and constitute our robotic learning curve for this technique. There were no specific selection criteria to perform the lymphadenectomy with robotic technique besides da Vinci robot availability. Exclusion criteria were as follows: severe cardiorespiratory disease, age 80 years old or older, prior radiotherapy or retroperitoneal surgery and evidence of metastatic disease outside of the pelvis in preoperative imaging study. Patients with metastatic paraaortic lymph nodes received extended field radiation therapy concurrent with chemotherapy. Pretherapeutic MRI/PET scan studies were performed in all patients. Lymph nodes were interpreted as suspected following the European Association of Nuclear Medicine (EANM) procedure guidelines for tumor PET imaging, version 1.0.[20]. The study was approved by the ethics committee and the institutional review board. The operating time was measured from skin incision to completion of skin closure. Early postoperative complications include any adverse event in the first 42 postoperative days. Any subsequent adverse event was considered a late postoperative complication. These 17 patients were compared to a series of 83 patients from our institution undergoing the same procedure by conventional laparoscopy. The technique and results have been previously published [21].
Fig. 1. Port placement for robotic-assisted laparoscopic extraperitoneal paraaortic lymphadenectomy.
though the middle 12-mm trocar and the right robotic arm is docked to the 8-mm robotic trocar behind de 11th rib (Fig. 2). Care is taken to maintain a 7–8 cm distance between the ports to avoid arm collision. A bipolar grasper (fenestrated bipolar forceps endowrist instrument, Intuitive Surgical, Sunnyvale, CA®) and a monopolar curved scissors (endowrist instrument, Intuitive Surgical, Sunnyvale, CA®) are used through the left and right robotic trocars, respectively. One monitor and the tower containing the electrosurgical generators are positioned at the end of the operating table.
Robotic surgical technique The robotic surgical technique is similar to that previously reported for laparoscopy [22] which was modified from Querleu et al. [23]. A left approach is chosen because the majority of lymph nodes are on the left paraaortic region [24] and the right aortic nodes can also be removed [21, 25]. The patient is in a supine position on the left side of the operating table with the surgeon and the assistant to the patient's left side. The patient's right arm is tucked to her side and the left arm is extended at 90°. A diagnostic transperitoneal laparoscopy by means of a transumbilical 12-mm trocar is performed to rule out peritoneal disease. In the absence of peritoneal metastases a 2 cm incision is made above and medial to the left iliac spine with direct laparoscopic intra-abdominal visualization and a 12-mm trocar is inserted under direct laparoscopic visualization. Finger dissection as described in the original technique is no longer used since the space is developed when the extraperitoneal CO2 insufflation reaches a maximal pressure of 12 mm Hg. A 30° laparoscope is introduced through the extraperitoneal 12-mm trocar and the following trocars are introduced under direct visualization: an 8-mm robotic trocar behind the 11th rib, a 12-mm optical robotic trocar equidistant between the 11th rib and the iliac spine, and a one 5-mm assistant trocar in the midaxillary line for ventral peritoneal retraction, suction and irrigation (Fig. 1). The robotic column is positioned at the level of the patient's right shoulder. The left robotic arm is docked to an 8-mm robotic trocar introduced though the 12-mm trocar near the left iliac spine (telescoping). The 30° da Vinci laparoscope is introduced
Fig. 2. Position of robotic column and the patient in robotic-assisted laparoscopic extraperitoneal para-aortic lymphadenectomy.
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The surgical field boundaries are identified first by exposing the surgical field. They include the left renal vein, the common iliac arteries bilaterally, the left psoas muscle and the right margin of the vena cava. The superior hypogastric plexus is preserved. The left ureter and left ovarian vessels are identified and mobilized ventrally. The fatty-lymph node bearing tissue from the left infra- and supramesenteric areas, aortocaval space, ventral to the vena cava and the common iliac arteries is removed and placed in endobags to avoid port-site metastasis. The location of each group of aortic nodes, is noted. Once completed, a peritoneal window is made over the dissected area to prevent lymphocyst formation. A pelvic node dissection was not performed routinely unless they were noted to be enlarged in the preoperative imaging studies. The trocar sites were irrigated with a 10% povidone-iodine solution and the fascia at the 12-mm trocar sites cutaneous was closed with 0polyglactin suture (Vicryl®). The skin at all sites was closed with staples. Statistical analysis Data are expressed as median and range for variables whose distribution departed from normality. We compared both groups using Chisquare test and the Mann–Whitney U test. Statistical significance was set at p b 0.05. All relevant data concerning the characteristics of the patients, length of hospital stay, adjuvant therapy, histological findings and follow-up were prospectively registered using an Excel database. Statistical analysis was performed using IBM SPSS Statistics 19.0 software for Windows (SPSS Inc., Chicago, IL).
Table 2 Comparison of perioperative outcomes between robotic-assisted and conventional laparoscopic extraperitoneal para-aortic lymphadenectomy in patients with cervical cancer. Median (range)
Conventional laparoscopy (n = 83)
Robot-assisted laparoscopy (n = 17)
p values
Operating time (min) Blood loss (ml) Hospital stay (days) Lymph node removal (n) Post-operative complication rate (%)
150 (80–255) 90 (10–260) 2 [1–4] 14 (4–62) 7 (8.4%)
150 (85–270) 20 (5–350) 2 [1–5] 17 (10–31) 3 (17.6%)
0.59 b0.05 0.22 b0.05 0.23
operative complications. A significant difference was observed for a lower blood loss and higher number of nodes removed in the robotic group (Table 2). The median length of follow-up was 13.4 months (range 1–40.5). At follow-up, recurrence was observed in one patient eight months later (node recurrence in the interaortocaval region). This patient with node relapse underwent a second robotic-assisted transperitoneal node debulking with 12 nodes being removed, 5 of them positive. She received adjuvant extended chemoradiation. Three patients had progression of pelvic disease during chemoradiation. One of them underwent a pelvic exenteration and two were treated with chemotherapy alone. All died of their disease. Two additional patients were subsequently diagnosed with gastric and lung cancer, respectively, histologically different than their original cervical cancer. They were free of cervical cancer at the time of their death.
Results
Discussion
Clinical and pathologic characteristics of the study population as well as those from patients treated by are depicted in Table 1. Perioperative outcomes are summarized in Table 2. The docking time was 7 min (range 3–15). Positive aortic nodes were observed only in 1 patient (5.9%). Pelvic lymphadenectomy was performed in 9 patients (52.9%) with enlarged nodes on preoperative study (MRI or PET) according with our protocol and one of them had positive pelvic nodes. There were no intraoperative complications or conversions, and none of the patients required a blood transfusion. Early postoperative complications occurred in three patients (17.6%): two lymphocysts and one chylous ascites. Successful treatment of the lymphocysts was achieved by a single percutaneous TC-guided needle aspiration. Complete resolution of the chylous ascites occurred with operative drainage and 15 days of medium-chain fatty acid diet. There were no late postoperative complications. No differences between robotic-assisted and conventional laparoscopy were seen in terms of operating time, hospital stay and post-
Robotic-assisted laparoscopy provides a 3D imaging of the operative field, instrumentation with seven degrees of articulation, and tremor filtration resulting in increased precision [26]. The advantages of robotic technology over conventional laparoscopy for the performance of extraperitoneal aortic lymphadenectomy as a single operation have not been demonstrated [21]. Different authors have reported variations in patient positioning as well as trocar placement to avoid arm collision, which may occur due to the reduced surgical field. We and others [16] have found that 10–15 degree rotation of the table to the right is useful in some patients to avoid arm collision during the infrarenal dissection. Others have found useful a slight degree of Trendelenburg and table rotation [27]. Others have placed the optical trocar in the anterior superior iliac spine [17]. Comparison of the perioperative data of the present series with our previous series of conventional laparoscopy patients, showed no significant differences except for a lower blood loss in robotic patients (20 vs 90 ml, p b 0.05), which is not clinically significant. Our docking time of 7 min (range 3–15) did not prolong operating time unnecessarily. The number of nodes removed was statistically significantly higher in the robotic group probably because the surgical team had a lot of laparoscopic experience and because of the improved robotic technology which makes it more comfortable for the surgeon. A comparison of the robotic perioperative data with other robotic series is shown in Table 3. In our series we had no intraoperative complications or
Table 1 Clinical and pathologic characteristics of patients undergoing conventional laparoscopy and robotic-assisted laparoscopy.
Median age (years) (range) Median BMI (kg/m2) (range) Prior surgery (%) FIGO stage (%) IB2 IIA2 IIB IIIA IIIB IVA Histology (%) Squamous cell Adenocarcinoma Other
Conventional laparoscopy (n = 83)
Robotic-assisted laparoscopy (n = 17)
p values
51 (24–74) 26.5 (18–44) 32 (38.5%)
49 (29–66) 23 (16–32) 6 (35.3%)
0.38 0.04 0.9
30 (36.1%) 14 (16.8%) 28 (33.7%) 2 (2.4%) 8 (9.6%) 1 (1.2%)
5 (29.4%) 1 (5.9%) 8 (47.1%) – 3 (17.6%) –
66 (79.5%) 15 (18%) 2 (2.4%)
15 (88.2%) 2 (11.8%) –
0.5
Table 3 Literature review of perioperative outcomes of robotic-assisted laparoscopic extraperitoneal paraaortic lymphadenectomy. Authors
N
Operation Blood Lymph Hospital Complications time (min) loss (ml) nodes stay
Vergote [18]a Magrina [16] Lambaudie [27] Present series (2013)
5 1 15 17
128 262 202 150
a
b50 30 71 20
Does not include infrarenal nodes.
9.2 10 16.7 17
2 2 2.6 2
1 ureteral injury No 1 aortic hematoma 1 chylous ascites 2 lymphocysts
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conversions. Our postoperative complications were similar to other series [28]. They all resolved with conservative treatment and no delay to the initiation of chemoradiation. The infrarenal group of aortic nodes in patients with cervical cancer were thought to be absent for metastases in the presence of negative ipsilateral inframesenteric nodes [18]. We demonstrated positive infrarenal nodes in 31% of patients with cervical cancer stages IB2–IVa with negative ipsilateral inframesenteric aortic nodes [21]. Lymphatic spread in some patients with advanced cervical cancer appears to be through the ovarian vessels directly to the infrarenal nodes, bypassing the inframesenteric nodes. Although we had been performing robotic surgery for 3.5 years (with more than 180 different procedures in this period of time), the present series looks at our first 17 cervical cancer patients who underwent extraperitoneal lymphadenectomies using robotic technology. Perioperative outcomes of our learning curve with robotic technology are most encouraging since they were similar except for a lower blood loss and higher number of aortic nodes removed in the robotic group. We elected to evaluate our initial results and compare with laparoscopy due to our extensive laparoscopic experience with this operation. The increased experience could result in improved robotic perioperative outcomes in the future. In conclusion, the perioperative outcomes of robotic-assisted extraperitoneal laparoscopic paraaortic lymphadenectomy are similar to the conventional laparoscopic route other than a lower blood loss and higher number of aortic nodes removed in the robotic group, both of which are not clinically significant. We believe that robotic surgery is an additional tool to perform the same surgical procedure. Conflict of interest statement The authors have neither commercial, proprietary, nor financial interests in the products and companies described in this article. The authors did not disclose any financial support or potential conflicts of interest.
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