IJG-07929; No of Pages 4 International Journal of Gynecology and Obstetrics xxx (2014) xxx–xxx
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Initial experience of robotic anterior pelvic exenteration at a single institute Shailesh Puntambekar ⁎, Akhil Lawande, Riddhi Desai, Seema Puntambekar, Geetanjali A. Joshi, Saurabh N. Joshi Department of Surgical Oncology and Minimal Access Surgery, Galaxy Care Laparoscopy Institute, Pune, India
a r t i c l e
i n f o
Article history: Received 23 July 2013 Received in revised form 13 December 2013 Accepted 26 March 2014 Keywords: Minimally invasive exenterative surgery Pelvic cancer Pelvic exenteration Robotics
a b s t r a c t Objective: To present the initial experience with robotic anterior pelvic exenteration in patients with advanced pelvic cancer at Galaxy Care Laparoscopy Institute, Pune, India. Methods: A retrospective chart review of data from 10 patients with advanced cervical carcinoma and bladder involvement or with vault recurrence following hysterectomy who were treated at the study hospital between November 2009 and May 2011. Clinicopathologic data and postoperative data including operative time, blood loss, blood transfusions, hospital stay, lymph node yield, and complications were recorded. Results: The mean operative time was 180 minutes, the mean blood loss was 110 mL, and the mean duration of hospital stay was 5 days. There were no treatment-related morbidities or mortalities. A mean parametrial clearance of 3 cm with a distal vaginal margin of 3.5 cm was achieved. All patients had tumor-free margins. The mean number of harvested lymph nodes was 24. Six patients had positive lymph nodes on pathologic examination and were treated with chemoradiotherapy. At a median follow-up of 11 months, 8 patients were disease-free. Conclusion: Robot-assisted anterior pelvic exenteration had favorable operative, pathologic, and short-term clinical outcomes. A large multicenter study is required to confirm the results. © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction Advanced pelvic malignancies are often associated with involvement of adjacent organ compartments within the pelvis and occurrence of regional or distant metastases. Patients with pelvic malignancies can experience severe debilitating complications such as recurrent bleeding, urinary or bowel fistulas, lower extremity swelling, and refractory pain, mainly because of local invasion [1,2]. The resulting reduction in life expectancy justifies the use of aggressive surgery in affected women. Pelvic exenteration (PE) is the radical en-bloc resection of multiple pelvic and extrapelvic organs followed by surgical reconstruction to reestablish visceral and parietal functions [3]. During anterior PE (APE), the reproductive tract and the bladder together with the pelvic ureters and the urethra are removed. The main indication for PE is a persistent or recurrent cervical malignancy after primary or adjuvant radiation/chemoradiation treatment [4,5]. Since the introduction of PE in 1948 [6], the continuous evaluation of surgical and reconstructive techniques, the use of stringent patient selection criteria, and improvements in peri- and postoperative care, antibiotic use, and medical management have resulted in decreased morbidity and mortality rates [5,7,8].
⁎ Corresponding author at: Department of Surgical Oncology and Minimal Access Surgery, Galaxy Care Laparoscopy Institute, 25-A, Karve Road, Erandwane, Pune, Maharashtra, 411004 India. Tel.: +91 9822023706; fax: +91 2025466122. E-mail address: [email protected] (S. Puntambekar).
Minimal invasive approaches have many operative and postoperative advantages [9,10]. The laparoscopic approach can also be applied to exenteration, with comparable surgical and oncologic outcomes [11–13]. The procedure is complex and requires advanced laparoscopic skills. However, the introduction of robot-assisted laparoscopic pelvic surgery has opened new doors for PE. The robotic approach provides technical advantages resulting in minimal fatigue of the operating surgeon, a magnified 3-dimensional view of the surgical field, precise dissection in the paravesical and pararectal spaces, and facilitation of complex procedures such as intracorporeal suturing [2,14]. We present our initial experience with robotic APE in patients with advanced pelvic cancer. 2. Materials and methods After obtaining approval from the ethics committee at the study institute, a retrospective chart review was performed of all patients who underwent robotic APE at the Galaxy Care Laparoscopy Institute, Pune, India, between November 1, 2009, and May 31, 2011. Patients with advanced carcinoma of the cervix with bladder involvement or with vault recurrence following radical or plain hysterectomy (after radiation and chemotherapy) were eligible for inclusion. Per institutional policy, informed consent was obtained from all patients prior to the procedure. The inclusion criteria for robotic APE were: biopsy-proven advanced cervical carcinoma with bladder involvement or vault recurrence after
http://dx.doi.org/10.1016/j.ijgo.2013.12.015 0020-7292/© 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
Please cite this article as: Puntambekar S, et al, Initial experience of robotic anterior pelvic exenteration at a single institute, Int J Gynecol Obstet (2014), http://dx.doi.org/10.1016/j.ijgo.2013.12.015
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S. Puntambekar et al. / International Journal of Gynecology and Obstetrics xxx (2014) xxx–xxx
prior treatment, absence of tumor extension up to the lateral pelvic wall, no extrapelvic spread as demonstrated by a negative computer tomography scan, negative para-aortic lymph nodes on preoperative laparoscopic inspection, no involvement of the rectum, absence of peritoneal deposits or distant metastases, and good performance status. Patients with a central pelvic tumor of less than 5 cm without pelvic side-wall involvement, no requirement for pelvic reconstruction, and a body mass index within the normal range were considered to be ideal candidates for robotic APE. All cancers were confirmed by biopsy. Preoperative imaging included a computer tomography scan of the abdomen and pelvis to assess tumor size, tumor location, and presence of distant metastatic disease. Moreover, each examination included a cystoscopy and a proctoscopy. The preoperative anesthetic evaluation included a thorough clinical examination, routine blood and urine chemistry, chest radiography, and electrocardiography and echocardiography as required. A diagnostic laparoscopy was performed in all patients prior to docking of the robot, to rule out peritoneal disease, para-aortic lymph node involvement, and extrapelvic metastases. For each patient, the following data were collected from the medical records: age at the time of surgery, stage and histology of the primary tumor, size and site of the tumor, treatment history, type of surgical procedure, reconstructive technique, and further adjuvant treatments. Operative records were reviewed for operative time, blood loss, number of blood transfusions, duration of hospital stay, and lymph node yield. The operative time was calculated as the time from insertion of the first port to undocking of the robot; the time taken for urinary diversion was not included. Blood loss was estimated based on measurement of the amount of blood lost through the suction drain system. The criterion for a blood transfusion was blood loss of more than 400 mL or a fall in hemoglobin levels by 1.5 g/dL. Postoperative early complications (within 30 days of the procedure), late complications (30 days to 1 year after the procedure), and postoperative mortality were also recorded. Mechanical bowel preparation was achieved using a polyethylene glycol solution. Combined regional and general anesthesia was administered. The patient was placed in a modified Lloyd-Davies position. A bolster was placed beneath the patient at the level of the anterior superior iliac spine. The positioning of the patient helped to achieve a clear operative field. The vagina was packed with gauze. The procedure was performed with a 3-arm da Vinci robotic system (Intuitive Surgical, Sunnyvale, CA, USA) using a 0-degree telescope. The da Vinci patient unit was positioned between the legs. A total of 5 ports were placed as follows: a 12-mm camera port was placed just above the umbilicus; an 8-mm robotic port was placed on the left side such that it was 10 cm lateral and 5 cm caudal to the camera port; a mirror image configuration was used for the right-sided robotic port; finally, 2 assistant 10-mm ports were placed pararectally at the level of the camera port for uterine manipulation, insertion of clips, and energy delivery. A myoma screw was inserted through the left upper pararectal assistant port for uterine manipulation. The dissection was started by taking a peritoneal cut medial to the right ureter at the level of the sacral promontory. The ureter was then pushed medially and the pararectal space lateral to the ureter was opened. The internal iliac artery was seen as the lateral limit of the pararectal space. The anterior division was clipped or ligated and then cut. The uterine artery and the superior vesical artery and vein were identified, clipped, and cut. The dissection was carried on anteriorly to the paravesical space and caudally to the levator ani. Similar steps were repeated on the left side. A posterior “U” cut was made, as in radical hysterectomy. Dissection in the pouch of Douglas was carried out in between the 2 layers of the Denonvilliers fascia and thus the rectum was separated from the posterior vaginal wall. The ureter was pushed medially to expose the cardinal ligaments and the uterosacral ligaments, which were then cut on both sides. The limit of the dissection was the levator ani. The anterior dissection was performed by cutting the anterior leaf of the broad ligament, and the peritoneal cut was extended to separate the
bladder from the anterior abdominal wall. Similar steps were repeated on the left side. The bladder was then brought down from the anterior abdominal wall to enter the retropubic space (cave of Retzius). The tissue anterior and lateral to the urethra and vagina was cut. The urethra was accessed anteriorly. The posterior urethral wall and the anterior vaginal wall were cut. A good length of the vagina below the growth was exposed. Generally, a vaginal cuff of 2.5–3.0 cm is achieved at the study institute. A colpotomy was then performed. An ilio-obturator nodal dissection was done on both sides. The entire specimen along with the nodes was placed in an endobag and removed vaginally. The vagina was repacked to prevent air leakage. All patients had an ileal conduit for urinary diversion. This was performed extracorporeally by making a 5-cm transverse incision in the right iliac fossa. The vagina was then sutured with a 2-0 Vicryl (Ethicon, Somerville, NJ, USA) continuous intracorporeal suture. Hemostasis was achieved. An abdominal drain was placed through the right lower port. The ports were then removed under vision and closed. The patients were admitted to the intensive care unit for at least 24 hours postoperatively and then transferred to the regular ward. The data are presented using descriptive statistics (mean and range) as applicable. 3. Results In total, 10 patients underwent robot-assisted APE during the study period. The mean age was 54.2 years (range 45–60 years) and the mean body mass index (calculated as weight in kilograms divided by the square of height in meters) was 23.8 (range 18–28) (Table 1). Five (50.0%) patients had previously received chemoradiotherapy. The remaining 5 (50.0%) patients had undergone primary surgery, including 2 (20.0%) women with a vesicovaginal fistula, 2 (20.0%) women with a vault recurrence following radical hysterectomy, and 1 (10.0%) woman with a central lesion with bladder involvement. All patients had a squamous carcinoma with bladder involvement on histopathology. The mean operative time was 180 minutes (range 150–240 minutes) (Table 2). The mean blood loss was 110 mL (90–150 mL). No patient needed a blood transfusion. There were no intraoperative complications, and no conversion to laparoscopic or open surgery was required during the procedure. The mean duration of hospital stay was 5.0 days (range 3.5–8.0 days). No major early or late morbidities were reported during the postoperative period, and there was no surgery-related mortality. We achieved a parametrial clearance of 3.0 cm (range 2.5–3.5 cm) with a distal vaginal margin of 3.5 cm (range 3–3.8 cm) (Table 2). All patients had tumor-free margins. The mean number of harvested lymph nodes was 24 (range 20–28). Six (60.0%) patients had positive lymph nodes on pathologic examination. Of these, 3 (50.0%) had already received chemoradiotherapy and were therefore treated with radiotherapy to the para-aortic region. The other 3 (50.0%) patients received adjuvant concurrent chemoradiation. The median duration of follow-up was 11 months. One (16.7%) patient died after 7 months because of
Table 1 Clinicopathologic data (n = 10). Parameter
Valuea
Age, y Body mass indexb Histology Squamous cell carcinoma Site of the lesion Primary cancer of the cervix Vault recurrence Vesicovaginal fistula Central tumor with bladder involvement
54.2 ± 4.94 (45–60) 23.8 ± 3.41 (18–28)
a b
10 (100.0) 5 (50.0) 2 (20.0) 2 (20.0) 1 (10.0)
Values are given as mean ± SD (range) or number (percentage). Calculated as weight in kilograms divided by the square of height in meters.
Please cite this article as: Puntambekar S, et al, Initial experience of robotic anterior pelvic exenteration at a single institute, Int J Gynecol Obstet (2014), http://dx.doi.org/10.1016/j.ijgo.2013.12.015
S. Puntambekar et al. / International Journal of Gynecology and Obstetrics xxx (2014) xxx–xxx Table 2 Operative and oncopathologic results (n = 10).a Operative time, min Blood loss, mL Requirement for blood transfusion Duration of hospital stay, d Conversion to open surgery/laparoscopy Complications (intraoperative/postoperative) Treatment related mortality Parametrium clearance, cm Vaginal cuff, cm Number of harvested lymph nodesb Positive margins Positive lymph nodes
180 ± 26.95 (150–240) 110 ± 22.48 (90–150) 0 (0.0) 5.0 ± 1.41 (3.5–8.0) 0 (0.0) 0 (0.0) 0 (0.0) 3.0 ± 0.42 (2.5–3.5) 3.5 ± 0.26 (3.0–3.8) 24 (20–28) 0 (0.0) 6 (60.0)
a Values are given as mean ± SD (range) or number (percentage) unless indicated otherwise. b Value is given as number (range).
hepatic metastases. One (16.7%) patient had a para-aortic nodal recurrence with hepatic metastasis 6 months after surgery and received further treatment. The other 4 (66.7%) patients were disease-free.
4. Discussion The management of patients with advanced or recurrent pelvic cancer remains a challenge. In the past, patients with advanced pelvic cancer were not considered to be suitable candidates for major surgery given that a cure was not possible and the rates of perioperative morbidity and mortality were high [2]. In particular, most surgeons did not attempt PE, given the complexity of the procedure, and it was seen as the surgery of last resort. Deckers et al. [15] changed this perception by reporting the use of PE for the palliation of malignant disease with acceptable morbidity and mortality rates. More recently, the role of APE has shifted from a palliative role to a curative role for selected patients with advanced or recurrent pelvic cancer [4,16,17]. This is the result of improvements in operative technique and medical care. Advances in the field of robotics have also affected pelvic surgery in a positive way. The use of robotics for surgery has advantages such as a magnified 3-dimensional view, improved dissection in narrow areas such as the paravesical and pararectal spaces, reduced bleeding because of minimal tissue damage, and shorter hospital stay [2,14]. The 3-arm da Vinci robotic surgical system was installed at the study institute in November 2009. Since then, many cases of pelvic cancer have been managed with this system. Our single-institute experience with robot-assisted APE shows favorable results in terms of surgical outcome and survival. Although long-term survival was not measured, 90% of the patients were alive at the median follow-up of 11 months. No treatment-related death occurred during or after APE. Other authors [3,5,18] have also reported significant reductions in treatment-related mortality following PE by various approaches, owing to advances in medical care. However, despite these improvements, morbidity rates of more than 50% have been observed after PE [3,7,18,19]. Interestingly, no morbidity was seen in the present series, probably because of the minimal invasive approach and the enhanced operative skill owing to the use of robotic instruments. Also, stringent patient selection criteria, preoperative investigations, and perioperative management are crucial in determining the success of any surgical procedure. Although no morbidities were reported in the present series, we recommend comprehensive perioperative management to maximize the benefits of APE. In most patients—especially in those with longterm catheterization, extensive intraoperative bladder manipulation, and urinary conduit creation—early complications are caused by infections. However, the rates of infection are on the decline because of improvements in operative technique and antibiotic therapy. The complications reported in other studies [3,4] include anastomotic leakage,
3
fever, infections, deep venous thrombosis, ileus or small bowel obstruction, and ureteral obstruction. Compared with our previously reported experience with laparoscopic APE [11], the use of robotic instruments resulted in reductions in operative time and blood loss. Operative time and blood loss in the present series were also lower than those reported in other studies [20,21] that used a robotic system (3 hours and 110 mL compared with 4 hours and more than 200 mL, respectively). More importantly, no patient in the present study required a blood transfusion. Measures such as operative time, blood loss, and duration of hospital stay can have an impact on patient morbidity and recovery status [20,21], and these factors probably contributed to the absence of early and late morbidity in the present series. Moreover, the time taken for the operative procedure reflects the surgical difficulty and the learning curve of the surgeon [22]. Novel procedures should not result in excess morbidity by exposing patients to undue risk. We attempted robot-assisted APE after a rich experience in both open and laparoscopic exenteration. The margin status is an important factor that is consistently associated with prognosis. Overall and progression-free survival are better following complete tumor resection [23,24]. Moreover, in previous series by Berek et al. [5] and Shingleton et al. [25], no patient survived 3 years following exenteration when the surgical margins were positive. In the present study, no patient had positive surgical margins, which could explain the favorable prognosis at the median follow-up of 11 months. Six of 10 patients in the present series had positive lymph nodes. However, following chemoradiotherapy, this did not affect the survival. We were able to harvest a good number of lymph nodes (mean 24) with the use of the robotic system, compared with our previous experience with the laparoscopic approach (mean 14) [11]. Collectively, these results indicate that the robotic performance of exenteration did not compromise the limits of resection and nodal clearance. Furthermore, there is no danger of subsequent port metastasis because the entire specimen was removed vaginally. The main limitations of the present study were the small number of patients and the retrospective nature of data collection. Given the small number of patients and the absence of observed deaths, a conventional survival analysis was not possible. The present experience provides encouraging evidence that robotassisted APE is a feasible option with favorable operative, pathologic, and short-term clinical outcomes. The results need to be confirmed in a large multicenter study, preferably a randomized controlled trial.
Conflict of interest The authors have no conflicts of interest.
References [1] Kecmanovic DM, Pavlov MJ, Kovacevic PA, Sepetkovski AV, Ceranic MS, Stamenkovic AB. Management of advanced pelvic cancer by exenteration. Eur J Surg Oncol 2003;29(9):743–6. [2] Boustead GB, Feneley MR. Pelvic exenterative surgery for palliation of malignant disease in the robotic era. Clin Oncol (R Coll Radiol) 2010;22(9):740–6. [3] Höckel M, Dornhöfer N. Pelvic exenteration for gynaecological tumours: achievements and unanswered questions. Lancet Oncol 2006;7(10):837–47. [4] Maggioni A, Roviglione G, Landoni F, Zanagnolo V, Peiretti M, Colombo N, et al. Pelvic exenteration: ten-year experience at the European Institute of Oncology in Milan. Gynecol Oncol 2009;114(1):64–8. [5] Berek JS, Howe C, Lagasse LD, Hacker NF. Pelvic exenteration for recurrent gynecologic malignancy: survival and morbidity analysis of the 45-year experience at UCLA. Gynecol Oncol 2005;99(1):153–9. [6] Brunschwig A. Complete excision of pelvic viscera for advanced carcinoma; a one-stage abdominoperineal operation with end colostomy and bilateral ureteral implantation into the colon above the colostomy. Cancer 1948;1(2):177–83. [7] Symmonds RE, Pratt JH, Webb MJ. Exenterative operations: experience with 198 patients. Am J Obstet Gynecol 1975;121(7):907–18. [8] Hatch KD, Gelder MS, Soong SJ, Baker VV, Shingleton HM. Pelvic exenteration with low rectal anastomosis: survival, complications, and prognostic factors. Gynecol Oncol 1990;38(3):462–7.
Please cite this article as: Puntambekar S, et al, Initial experience of robotic anterior pelvic exenteration at a single institute, Int J Gynecol Obstet (2014), http://dx.doi.org/10.1016/j.ijgo.2013.12.015
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[9] Davis MA, Adams S, Eun D, Lee D, Randall TC. Robotic-assisted laparoscopic exenteration in recurrent cervical cancer Robotics improved the surgical experience for 2 women with recurrent cervical cancer. Am J Obstet Gynecol 2010;202(6):663.e1. [10] Magrina JF, Zanagnolo VL. Robotic surgery for cervical cancer. Yonsei Med J 2008;49 (6):879–85. [11] Puntambekar S, Kudchadkar RJ, Gurjar AM, Sathe RM, Chaudhari YC, Agarwal GA, et al. Laparoscopic pelvic exenteration for advanced pelvic cancers: a review of 16 cases. Gynecol Oncol 2006;102(3):513–6. [12] Puntambekar SP, Palep RJ, Puntambekar SS, Wagh GN, Patil AM, Rayate NV, et al. Laparoscopic total radical hysterectomy by the Pune technique: our experience of 248 cases. J Minim Invasive Gynecol 2007;14(6):682–9. [13] Puntambekar SP, Kudchadkar RJ, Chaudhari YP, Patil AV, Kulkarni SB, Patki PS. Role of Anterior Exenterations in Advanced and Recurrent Pelvic Tumours. Female Pelvic Med Reconstr Surg 2002;8(5):241–5. [14] Pruthi RS, Stefaniak H, Hubbard JS, Wallen EM. Robot-assisted laparoscopic anterior pelvic exenteration for bladder cancer in the female patient. J Endourol 2008;22 (10):2397–402. [15] Deckers PJ, Olsson C, Williams LA, Mozden PJ. Pelvic exenteration as palliation of malignant disease. Am J Surg 1976;131(4):509–15. [16] Schmidt AM, Imesch P, Fink D, Egger H. Indications and long-term clinical outcomes in 282 patients with pelvic exenteration for advanced or recurrent cervical cancer. Gynecol Oncol 2012;125(3):604–9. [17] Andikyan V, Khoury-Collado F, Sonoda Y, Gerst SR, Alektiar KM, Sandhu JS, et al. Extended pelvic resections for recurrent or persistent uterine and cervical malignancies: an update on out of the box surgery. Gynecol Oncol 2012;125(2):404–8.
[18] Rutledge FN, Smith JP, Wharton JT, O'Quinn AG. Pelvic exenteration: analysis of 296 patients. Am J Obstet Gynecol 1977;129(8):881–92. [19] Kiselow M, Butcher Jr HR, Bricker EM. Results of the radical surgical treatment of advanced pelvic cancer: a fifteen-year study. Ann Surg 1967;166(3): 428–36. [20] Kaufmann OG, Young JL, Sountoulides P, Kaplan AG, Dash A, Ornstein DK. Robotic radical anterior pelvic exenteration: the UCI experience. Minim Invasive Ther Allied Technol 2011;20(4):240–6. [21] Pruthi RS, Stefaniak H, Hubbard JS, Wallen EM. Robotic anterior pelvic exenteration for bladder cancer in the female: outcomes and comparisons to their male counterparts. J Laparoendosc Adv Surg Tech A 2009;19(1):23–7. [22] Herrell SD, Smith Jr JA. Robotic-assisted laparoscopic prostatectomy: what is the learning curve? Urology 2005;66(5 Suppl.):105–7. [23] Fotopoulou C, Neumann U, Kraetschell R, Schefold JC, Weidemann H, Lichtenegger W, et al. Long-term clinical outcome of pelvic exenteration in patients with advanced gynecological malignancies. J Surg Oncol 2010;101 (6):507–12. [24] Marnitz S, Köhler C, Müller M, Behrens K, Hasenbein K, Schneider A. Indications for primary and secondary exenterations in patients with cervical cancer. Gynecol Oncol 2006;103(3):1023–30. [25] Shingleton HM, Soong SJ, Gelder MS, Hatch KD, Baker VV, Austin Jr JM. Clinical and histopathologic factors predicting recurrence and survival after pelvic exenteration for cancer of the cervix. Obstet Gynecol 1989;73(6):1027–34.
Please cite this article as: Puntambekar S, et al, Initial experience of robotic anterior pelvic exenteration at a single institute, Int J Gynecol Obstet (2014), http://dx.doi.org/10.1016/j.ijgo.2013.12.015
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Initial experience of robotic anterior pelvic exenteration at a single institute Shailesh Puntambekar ⁎, Akhil Lawande, Riddhi Desai, Seema Puntambekar, Geetanjali A. Joshi, Saurabh N. Joshi Department of Surgical Oncology and Minimal Access Surgery, Galaxy Care Laparoscopy Institute, Pune, India
a r t i c l e
i n f o
Article history: Received 23 July 2013 Received in revised form 13 December 2013 Accepted 26 March 2014 Keywords: Minimally invasive exenterative surgery Pelvic cancer Pelvic exenteration Robotics
a b s t r a c t Objective: To present the initial experience with robotic anterior pelvic exenteration in patients with advanced pelvic cancer at Galaxy Care Laparoscopy Institute, Pune, India. Methods: A retrospective chart review of data from 10 patients with advanced cervical carcinoma and bladder involvement or with vault recurrence following hysterectomy who were treated at the study hospital between November 2009 and May 2011. Clinicopathologic data and postoperative data including operative time, blood loss, blood transfusions, hospital stay, lymph node yield, and complications were recorded. Results: The mean operative time was 180 minutes, the mean blood loss was 110 mL, and the mean duration of hospital stay was 5 days. There were no treatment-related morbidities or mortalities. A mean parametrial clearance of 3 cm with a distal vaginal margin of 3.5 cm was achieved. All patients had tumor-free margins. The mean number of harvested lymph nodes was 24. Six patients had positive lymph nodes on pathologic examination and were treated with chemoradiotherapy. At a median follow-up of 11 months, 8 patients were disease-free. Conclusion: Robot-assisted anterior pelvic exenteration had favorable operative, pathologic, and short-term clinical outcomes. A large multicenter study is required to confirm the results. © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction Advanced pelvic malignancies are often associated with involvement of adjacent organ compartments within the pelvis and occurrence of regional or distant metastases. Patients with pelvic malignancies can experience severe debilitating complications such as recurrent bleeding, urinary or bowel fistulas, lower extremity swelling, and refractory pain, mainly because of local invasion [1,2]. The resulting reduction in life expectancy justifies the use of aggressive surgery in affected women. Pelvic exenteration (PE) is the radical en-bloc resection of multiple pelvic and extrapelvic organs followed by surgical reconstruction to reestablish visceral and parietal functions [3]. During anterior PE (APE), the reproductive tract and the bladder together with the pelvic ureters and the urethra are removed. The main indication for PE is a persistent or recurrent cervical malignancy after primary or adjuvant radiation/chemoradiation treatment [4,5]. Since the introduction of PE in 1948 [6], the continuous evaluation of surgical and reconstructive techniques, the use of stringent patient selection criteria, and improvements in peri- and postoperative care, antibiotic use, and medical management have resulted in decreased morbidity and mortality rates [5,7,8].
⁎ Corresponding author at: Department of Surgical Oncology and Minimal Access Surgery, Galaxy Care Laparoscopy Institute, 25-A, Karve Road, Erandwane, Pune, Maharashtra, 411004 India. Tel.: +91 9822023706; fax: +91 2025466122. E-mail address: [email protected] (S. Puntambekar).
Minimal invasive approaches have many operative and postoperative advantages [9,10]. The laparoscopic approach can also be applied to exenteration, with comparable surgical and oncologic outcomes [11–13]. The procedure is complex and requires advanced laparoscopic skills. However, the introduction of robot-assisted laparoscopic pelvic surgery has opened new doors for PE. The robotic approach provides technical advantages resulting in minimal fatigue of the operating surgeon, a magnified 3-dimensional view of the surgical field, precise dissection in the paravesical and pararectal spaces, and facilitation of complex procedures such as intracorporeal suturing [2,14]. We present our initial experience with robotic APE in patients with advanced pelvic cancer. 2. Materials and methods After obtaining approval from the ethics committee at the study institute, a retrospective chart review was performed of all patients who underwent robotic APE at the Galaxy Care Laparoscopy Institute, Pune, India, between November 1, 2009, and May 31, 2011. Patients with advanced carcinoma of the cervix with bladder involvement or with vault recurrence following radical or plain hysterectomy (after radiation and chemotherapy) were eligible for inclusion. Per institutional policy, informed consent was obtained from all patients prior to the procedure. The inclusion criteria for robotic APE were: biopsy-proven advanced cervical carcinoma with bladder involvement or vault recurrence after
http://dx.doi.org/10.1016/j.ijgo.2013.12.015 0020-7292/© 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
Please cite this article as: Puntambekar S, et al, Initial experience of robotic anterior pelvic exenteration at a single institute, Int J Gynecol Obstet (2014), http://dx.doi.org/10.1016/j.ijgo.2013.12.015
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S. Puntambekar et al. / International Journal of Gynecology and Obstetrics xxx (2014) xxx–xxx
prior treatment, absence of tumor extension up to the lateral pelvic wall, no extrapelvic spread as demonstrated by a negative computer tomography scan, negative para-aortic lymph nodes on preoperative laparoscopic inspection, no involvement of the rectum, absence of peritoneal deposits or distant metastases, and good performance status. Patients with a central pelvic tumor of less than 5 cm without pelvic side-wall involvement, no requirement for pelvic reconstruction, and a body mass index within the normal range were considered to be ideal candidates for robotic APE. All cancers were confirmed by biopsy. Preoperative imaging included a computer tomography scan of the abdomen and pelvis to assess tumor size, tumor location, and presence of distant metastatic disease. Moreover, each examination included a cystoscopy and a proctoscopy. The preoperative anesthetic evaluation included a thorough clinical examination, routine blood and urine chemistry, chest radiography, and electrocardiography and echocardiography as required. A diagnostic laparoscopy was performed in all patients prior to docking of the robot, to rule out peritoneal disease, para-aortic lymph node involvement, and extrapelvic metastases. For each patient, the following data were collected from the medical records: age at the time of surgery, stage and histology of the primary tumor, size and site of the tumor, treatment history, type of surgical procedure, reconstructive technique, and further adjuvant treatments. Operative records were reviewed for operative time, blood loss, number of blood transfusions, duration of hospital stay, and lymph node yield. The operative time was calculated as the time from insertion of the first port to undocking of the robot; the time taken for urinary diversion was not included. Blood loss was estimated based on measurement of the amount of blood lost through the suction drain system. The criterion for a blood transfusion was blood loss of more than 400 mL or a fall in hemoglobin levels by 1.5 g/dL. Postoperative early complications (within 30 days of the procedure), late complications (30 days to 1 year after the procedure), and postoperative mortality were also recorded. Mechanical bowel preparation was achieved using a polyethylene glycol solution. Combined regional and general anesthesia was administered. The patient was placed in a modified Lloyd-Davies position. A bolster was placed beneath the patient at the level of the anterior superior iliac spine. The positioning of the patient helped to achieve a clear operative field. The vagina was packed with gauze. The procedure was performed with a 3-arm da Vinci robotic system (Intuitive Surgical, Sunnyvale, CA, USA) using a 0-degree telescope. The da Vinci patient unit was positioned between the legs. A total of 5 ports were placed as follows: a 12-mm camera port was placed just above the umbilicus; an 8-mm robotic port was placed on the left side such that it was 10 cm lateral and 5 cm caudal to the camera port; a mirror image configuration was used for the right-sided robotic port; finally, 2 assistant 10-mm ports were placed pararectally at the level of the camera port for uterine manipulation, insertion of clips, and energy delivery. A myoma screw was inserted through the left upper pararectal assistant port for uterine manipulation. The dissection was started by taking a peritoneal cut medial to the right ureter at the level of the sacral promontory. The ureter was then pushed medially and the pararectal space lateral to the ureter was opened. The internal iliac artery was seen as the lateral limit of the pararectal space. The anterior division was clipped or ligated and then cut. The uterine artery and the superior vesical artery and vein were identified, clipped, and cut. The dissection was carried on anteriorly to the paravesical space and caudally to the levator ani. Similar steps were repeated on the left side. A posterior “U” cut was made, as in radical hysterectomy. Dissection in the pouch of Douglas was carried out in between the 2 layers of the Denonvilliers fascia and thus the rectum was separated from the posterior vaginal wall. The ureter was pushed medially to expose the cardinal ligaments and the uterosacral ligaments, which were then cut on both sides. The limit of the dissection was the levator ani. The anterior dissection was performed by cutting the anterior leaf of the broad ligament, and the peritoneal cut was extended to separate the
bladder from the anterior abdominal wall. Similar steps were repeated on the left side. The bladder was then brought down from the anterior abdominal wall to enter the retropubic space (cave of Retzius). The tissue anterior and lateral to the urethra and vagina was cut. The urethra was accessed anteriorly. The posterior urethral wall and the anterior vaginal wall were cut. A good length of the vagina below the growth was exposed. Generally, a vaginal cuff of 2.5–3.0 cm is achieved at the study institute. A colpotomy was then performed. An ilio-obturator nodal dissection was done on both sides. The entire specimen along with the nodes was placed in an endobag and removed vaginally. The vagina was repacked to prevent air leakage. All patients had an ileal conduit for urinary diversion. This was performed extracorporeally by making a 5-cm transverse incision in the right iliac fossa. The vagina was then sutured with a 2-0 Vicryl (Ethicon, Somerville, NJ, USA) continuous intracorporeal suture. Hemostasis was achieved. An abdominal drain was placed through the right lower port. The ports were then removed under vision and closed. The patients were admitted to the intensive care unit for at least 24 hours postoperatively and then transferred to the regular ward. The data are presented using descriptive statistics (mean and range) as applicable. 3. Results In total, 10 patients underwent robot-assisted APE during the study period. The mean age was 54.2 years (range 45–60 years) and the mean body mass index (calculated as weight in kilograms divided by the square of height in meters) was 23.8 (range 18–28) (Table 1). Five (50.0%) patients had previously received chemoradiotherapy. The remaining 5 (50.0%) patients had undergone primary surgery, including 2 (20.0%) women with a vesicovaginal fistula, 2 (20.0%) women with a vault recurrence following radical hysterectomy, and 1 (10.0%) woman with a central lesion with bladder involvement. All patients had a squamous carcinoma with bladder involvement on histopathology. The mean operative time was 180 minutes (range 150–240 minutes) (Table 2). The mean blood loss was 110 mL (90–150 mL). No patient needed a blood transfusion. There were no intraoperative complications, and no conversion to laparoscopic or open surgery was required during the procedure. The mean duration of hospital stay was 5.0 days (range 3.5–8.0 days). No major early or late morbidities were reported during the postoperative period, and there was no surgery-related mortality. We achieved a parametrial clearance of 3.0 cm (range 2.5–3.5 cm) with a distal vaginal margin of 3.5 cm (range 3–3.8 cm) (Table 2). All patients had tumor-free margins. The mean number of harvested lymph nodes was 24 (range 20–28). Six (60.0%) patients had positive lymph nodes on pathologic examination. Of these, 3 (50.0%) had already received chemoradiotherapy and were therefore treated with radiotherapy to the para-aortic region. The other 3 (50.0%) patients received adjuvant concurrent chemoradiation. The median duration of follow-up was 11 months. One (16.7%) patient died after 7 months because of
Table 1 Clinicopathologic data (n = 10). Parameter
Valuea
Age, y Body mass indexb Histology Squamous cell carcinoma Site of the lesion Primary cancer of the cervix Vault recurrence Vesicovaginal fistula Central tumor with bladder involvement
54.2 ± 4.94 (45–60) 23.8 ± 3.41 (18–28)
a b
10 (100.0) 5 (50.0) 2 (20.0) 2 (20.0) 1 (10.0)
Values are given as mean ± SD (range) or number (percentage). Calculated as weight in kilograms divided by the square of height in meters.
Please cite this article as: Puntambekar S, et al, Initial experience of robotic anterior pelvic exenteration at a single institute, Int J Gynecol Obstet (2014), http://dx.doi.org/10.1016/j.ijgo.2013.12.015
S. Puntambekar et al. / International Journal of Gynecology and Obstetrics xxx (2014) xxx–xxx Table 2 Operative and oncopathologic results (n = 10).a Operative time, min Blood loss, mL Requirement for blood transfusion Duration of hospital stay, d Conversion to open surgery/laparoscopy Complications (intraoperative/postoperative) Treatment related mortality Parametrium clearance, cm Vaginal cuff, cm Number of harvested lymph nodesb Positive margins Positive lymph nodes
180 ± 26.95 (150–240) 110 ± 22.48 (90–150) 0 (0.0) 5.0 ± 1.41 (3.5–8.0) 0 (0.0) 0 (0.0) 0 (0.0) 3.0 ± 0.42 (2.5–3.5) 3.5 ± 0.26 (3.0–3.8) 24 (20–28) 0 (0.0) 6 (60.0)
a Values are given as mean ± SD (range) or number (percentage) unless indicated otherwise. b Value is given as number (range).
hepatic metastases. One (16.7%) patient had a para-aortic nodal recurrence with hepatic metastasis 6 months after surgery and received further treatment. The other 4 (66.7%) patients were disease-free.
4. Discussion The management of patients with advanced or recurrent pelvic cancer remains a challenge. In the past, patients with advanced pelvic cancer were not considered to be suitable candidates for major surgery given that a cure was not possible and the rates of perioperative morbidity and mortality were high [2]. In particular, most surgeons did not attempt PE, given the complexity of the procedure, and it was seen as the surgery of last resort. Deckers et al. [15] changed this perception by reporting the use of PE for the palliation of malignant disease with acceptable morbidity and mortality rates. More recently, the role of APE has shifted from a palliative role to a curative role for selected patients with advanced or recurrent pelvic cancer [4,16,17]. This is the result of improvements in operative technique and medical care. Advances in the field of robotics have also affected pelvic surgery in a positive way. The use of robotics for surgery has advantages such as a magnified 3-dimensional view, improved dissection in narrow areas such as the paravesical and pararectal spaces, reduced bleeding because of minimal tissue damage, and shorter hospital stay [2,14]. The 3-arm da Vinci robotic surgical system was installed at the study institute in November 2009. Since then, many cases of pelvic cancer have been managed with this system. Our single-institute experience with robot-assisted APE shows favorable results in terms of surgical outcome and survival. Although long-term survival was not measured, 90% of the patients were alive at the median follow-up of 11 months. No treatment-related death occurred during or after APE. Other authors [3,5,18] have also reported significant reductions in treatment-related mortality following PE by various approaches, owing to advances in medical care. However, despite these improvements, morbidity rates of more than 50% have been observed after PE [3,7,18,19]. Interestingly, no morbidity was seen in the present series, probably because of the minimal invasive approach and the enhanced operative skill owing to the use of robotic instruments. Also, stringent patient selection criteria, preoperative investigations, and perioperative management are crucial in determining the success of any surgical procedure. Although no morbidities were reported in the present series, we recommend comprehensive perioperative management to maximize the benefits of APE. In most patients—especially in those with longterm catheterization, extensive intraoperative bladder manipulation, and urinary conduit creation—early complications are caused by infections. However, the rates of infection are on the decline because of improvements in operative technique and antibiotic therapy. The complications reported in other studies [3,4] include anastomotic leakage,
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fever, infections, deep venous thrombosis, ileus or small bowel obstruction, and ureteral obstruction. Compared with our previously reported experience with laparoscopic APE [11], the use of robotic instruments resulted in reductions in operative time and blood loss. Operative time and blood loss in the present series were also lower than those reported in other studies [20,21] that used a robotic system (3 hours and 110 mL compared with 4 hours and more than 200 mL, respectively). More importantly, no patient in the present study required a blood transfusion. Measures such as operative time, blood loss, and duration of hospital stay can have an impact on patient morbidity and recovery status [20,21], and these factors probably contributed to the absence of early and late morbidity in the present series. Moreover, the time taken for the operative procedure reflects the surgical difficulty and the learning curve of the surgeon [22]. Novel procedures should not result in excess morbidity by exposing patients to undue risk. We attempted robot-assisted APE after a rich experience in both open and laparoscopic exenteration. The margin status is an important factor that is consistently associated with prognosis. Overall and progression-free survival are better following complete tumor resection [23,24]. Moreover, in previous series by Berek et al. [5] and Shingleton et al. [25], no patient survived 3 years following exenteration when the surgical margins were positive. In the present study, no patient had positive surgical margins, which could explain the favorable prognosis at the median follow-up of 11 months. Six of 10 patients in the present series had positive lymph nodes. However, following chemoradiotherapy, this did not affect the survival. We were able to harvest a good number of lymph nodes (mean 24) with the use of the robotic system, compared with our previous experience with the laparoscopic approach (mean 14) [11]. Collectively, these results indicate that the robotic performance of exenteration did not compromise the limits of resection and nodal clearance. Furthermore, there is no danger of subsequent port metastasis because the entire specimen was removed vaginally. The main limitations of the present study were the small number of patients and the retrospective nature of data collection. Given the small number of patients and the absence of observed deaths, a conventional survival analysis was not possible. The present experience provides encouraging evidence that robotassisted APE is a feasible option with favorable operative, pathologic, and short-term clinical outcomes. The results need to be confirmed in a large multicenter study, preferably a randomized controlled trial.
Conflict of interest The authors have no conflicts of interest.
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