ORIGINAL STUDY
Laparoendoscopic Single-Site Versus Conventional Laparoscopic Surgical Staging for Early-Stage Endometrial Cancer Jeong-Yeol Park, MD, PhD, Dae-Yeon Kim, MD, PhD, Dae-Shik Suh, MD, PhD, Jong-Hyeok Kim, MD, PhD, and Joo-Hyun Nam, MD, PhD
Objective: This study aims to compare the feasibility, safety, and efficacy of laparoendoscopic single-site (LESS) surgical staging for early-stage endometrial cancer with conventional laparoscopic surgical staging. Materials and Methods: The prospective study group consisted of 37 consecutive patients who underwent LESS surgical staging including hysterectomy, bilateral salpingooophorectomy, and pelvic lymph node dissection. The historical control group consisted of 74 consecutive patients who underwent 4-port laparoscopic surgical staging including hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node dissection. Surgical outcomes were compared between the 2 groups. Results: No patient in the LESS or conventional laparoscopic surgery group required an additional trocar or conversion to laparotomy. There were no intergroup differences in mean age, menopause status, body mass index, and previous history of abdominal surgery. Further, there were no inter-group differences in the number of total (LESS vs. conventional, 25.9 T 10.6 vs. 24.6 T 9.0, P = 0.497), pelvic (24.6 T 0.497 vs. 23.3 T 7.7, P = 0.459), and para-aortic (4.9 T 2.5 vs. 6.9 T 7.3, P = 0.494) lymph nodes retrieved; the operating time (183 T 50 min vs. 173 T 106, P = 0.388); estimated blood loss (194 T 149 mL vs. 173 T 106 mL, P = 0.394); number of patients requiring transfusion (5.4% vs. 8.1%, P = 0.717); postoperative hospital stay (5.0 T 1.8 days vs. 5.1 T 1.8 days, P = 0.911); intraoperative complications (2.7% vs. 0%, P = 0.333); and postoperative complications (0% vs. 1.4%, P 9 0.999). The postoperative pain scores and analgesic requirements were significantly lower in the LESS surgical staging group. Conclusions: Laparoendoscopic single-site surgical staging was a feasible, safe, and efficacious procedure for surgical management of early-stage endometrial cancer. It was associated with less postoperative pain and analgesic requirements and was comparable to conventional laparoscopic surgical staging in perioperative outcomes. Key Words: Endometrial cancer, Laparoscopy, Laparoendoscopic single-site surgery, Surgical staging Received September 15, 2013, and in revised form October 23, 2013. Accepted for publication October 24, 2013. (Int J Gynecol Cancer 2014;24: 358Y363)
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. Address correspondence and reprint requests to Joo-Hyun Nam, MD, PhD, Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Copyright * 2014 by IGCS and ESGO ISSN: 1048-891X DOI: 10.1097/IGC.0000000000000046
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Asan Medical Center, #388-1 Poongnap-2 dong, Songpa-gu, Seoul, 138-736, South Korea. E-mail: [email protected]. The authors declare no conflicts of interest. Supplemental digital content is available for this article. Direct URL citation appears in the printed text and is provided in the HTML and PDF versions of this article on the journal’s Web site (www.ijgc.net).
International Journal of Gynecological Cancer
& Volume 24, Number 2, February 2014
Copyright © 2014 by IGCS and ESGO. Unauthorized reproduction of this article is prohibited.
International Journal of Gynecological Cancer
& Volume 24, Number 2, February 2014
cancer is the most common malignancy of the E ndometrial female genital tract in the United States with an estimated
47,130 new cases and 8010 deaths occurring in 2012.1 It is the third most common malignancy of the female genital tract in South Korea, with an estimated 1752 new cases and 222 deaths occurring in 2010; furthermore, its incidence is rapidly increasing.2,3 The standard surgical management of early-stage endometrial cancer is surgical staging including total hysterectomy, bilateral salpingo-oophorectomy (BSO), and pelvic and/or para-arotic lymph node dissection.4 Recent randomized controlled trials5Y13 and meta-analyses14,15 confirmed that laparoscopic surgery is the preferred alternative to laparotomy in the surgical staging of early-stage endometrial cancer. Laparoscopic surgery is associated with less blood loss and transfusion requirements, less pain, faster recovery, and shorter postoperative hospital stay without increasing perioperative complication or compromising survival outcomes.14,15 With the aim of reducing the number and size of ports that are used in conventional laparoscopic surgery, laparoendoscopic single-site surgery (LESS) was developed and is being increasingly used for the surgical management of gynecologic diseases. Laparoendoscopic single-site surgery is a feasible and more advanced minimally invasive surgery for patients with benign gynecologic diseases.16,17 After the successful introduction of LESS, its indications are now being expanded to include surgical management of gynecologic cancers, including surgical staging of early-stage endometrial cancer; however, the surgical outcomes are not well established. The aim of this study was to compare the feasibility, safety, and efficacy of LESS surgical staging for early-stage endometrial cancer with conventional laparoscopic surgical staging.
LESS vs Conventional Staging Surgery
MATERIALS AND METHODS Study Population The prospective study group consisted of 37 consecutive patients who underwent LESS surgical staging including hysterectomy, BSO, and pelvic lymph node dissection (PLND). The historical control group consisted of 74 consecutive patients who underwent 4-port laparoscopic surgical staging including hysterectomy, BSO, and PLND. Surgical outcomes were compared between the 2 groups. This study was approved by the institutional review board of Asan Medical Center (Seoul, South Korea).
Surgical Procedures Conventional laparoscopic surgical staging was performed using a 4-port system as previously described.18,19 In brief, a 10-mm, a 12-mm, and two 5-mm laparoscopic ports were placed in the umbilicus, left lower abdomen, suprapubic area, and right lower abdomen, respectively (Fig. 1). Under a dorsal lithotomy (15-degree Trendelenburg) position pneumoperitoneum was made using carbon dioxide gas at 10 to 12 mm Hg. A first assistant (training fellow) stood on the right side of the patient and handled a rigid (0 degree) 12-mm laparoscope with the left hand and assistant forceps with the right hand. A second assistant (training resident) stood between the legs of patients and handled the uterine manipulator (Cohen cannula). The surgeon stood on the left side of the patients and used rigid laparoscopic instruments including scissors, forceps, monopolar Bovie, suction irrigator, Ligasure, and/or Endo-GIA with both hands. After laparoscopic-assisted vaginal hysterectomy with or without BSO, systematic PLND was performed. If the patient had deep myometrial invasion (outer half of the
FIGURE 1. Laparoendoscopic single-site surgery versus conventional laparoscopic surgery. * 2014 IGCS and ESGO
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International Journal of Gynecological Cancer
Park et al
myometrium), grade 3 differentiation, high-risk histologic type (papillary serous carcinoma or clear cell carcinoma), pelvic lymph node metastasis, and/or extrauterine disease revealed by frozen biopsy, para-aortic lymph node dissection was performed. Laparoendoscopic single-site surgical staging was performed using a commercially available 4-channel, single-port system (Fig. 1). After making a 15-mm vertical skin incision at the base of the umbilicus, a single port was placed. The surgical staging procedures were identical to those of conventional laparoscopic surgical staging excluding the port placement.
Postoperative Management After surgery, a Foley catheter was placed for 1 day in all patients. All patients also received patient-controlled analgesia for 48 hours after surgery. The patient-controlled analgesia regimen consisted of fentanyl 1000 Kg in normal saline (total volume, 50 mL) and was programed to deliver 1 mL/h as a basal infusion rate and 0.5 mL/demand with a 15-minute lockout. Postoperative pain was recorded using the Visual Analog Pain Scale, scored from 1 to 10 (0 is no pain and 10 is agonizing pain),20,21 every 8 hours and whenever the patients notified the medical staff of pain, for 3 days after surgery. If the pain score was greater than 3 or the patient requested additional analgesia, additional analgesics were provided. Normal diet was resumed at postoperative day 1. Patients were recommended to be discharged at postoperative day 3 if they reestablished their normal diet, were passing feces or gas, voided well, and had no symptoms or signs of postoperative complications that may require reoperation or readmission. Adjuvant therapy was recommended if the patients were in a high-risk group for recurrence according to the postoperative pathologic report.4 After the completion of primary treatment, clinical follow-up was scheduled at 3-month intervals for 2 years, then at 6-month intervals for the subsequent 3 years, and then annually thereafter.
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required an additional port or conversion to laparotomy. The patient characteristics are shown in Table 1. There was no difference in age, weight, height, body mass index, menopause status, history of abdominal surgery, and preoperative cancer antigen 125 levels between the 2 groups. However, more patients in the conventional group had parity greater than 3 (P = 0.014), and more patients in the LESS group had comorbid medical disease (P = 0.003). The comparison of surgical outcomes by surgical approach is shown in Table 2. The mean operating time was slightly longer in the LESS group, but the difference was not statistically significant. There was no difference in the mean estimated blood loss, transfusion requirement, and the mean transfusion amount between the 2 groups. The mean length of postoperative hospital stay was 5 days in both groups. There was no difference in the number of retrieved pelvic, paraarotic, and total lymph nodes between the 2 surgery groups. An intraoperative complication occurred in 1 patient in the LESS groupVa bladder injury that was successfully managed by transvaginal repair without the need for an additional port or conversion to laparotomy. There was no difference in the intraoperative complication rate between the LESS and conventional groups (2.7% vs 0%, respectively; P = 0.333). A postoperative complication occurred in 1 patient in the conventional groupVan intraperitoneal abscess that was successfully managed with conservative treatment. There was no difference in the postoperative complication rate between the LESS and conventional groups (0% vs 1.4%, respectively; P 9 0.999). There was no incisional hernia in both groups. The 8-hour interval postoperative mean pain scores are shown in Figure 2. Between 16 hours and 32 hours after TABLE 1. Characteristics of patients (n = 111) LESS (n = 37)
Statistical Analysis
Characteristics
The mean or median values were compared between groups using the Student t test or Mann-Whitney U test according to the normality of distribution in the KolmogorovSmironov test. The intergroup frequency distributions were compared using the W2 test, and if at least 1 expected frequency was less than 5, the Fisher exact test was used. Disease-free survival time was calculated in months from the date of surgery to the date of recurrence or censoring. Survival curves and rates were calculated using the Kaplan-Meier method, and survival rates were compared between groups using the log-rank test. P values less than 0.05 in 2-sided tests were regarded as statistically significant. SPSS for Windows (version 11.0; SPSS Inc, Chicago, IL) was used for all statistical analyses.
Age, y 52.6 T 7.8 Body weight, kg 60.8 T 9.3 Height, cm 156.4 T 6.0 BMI, kg/m2 24.87 T 3.59 Parity 0Y2 31 (83.8) 3 6 (16.2) Menopause No 17 (45.9) Yes 20 (54.1) Previous No 20 (54.1) abd surgery Yes 17 (45.9) Comorbid No 22 (59.5) med disease Yes 15 (40.5) Preoperative CA 125 15.5 T 13.0
RESULTS Thirty-seven consecutive patients underwent LESS staging surgery, and 74 consecutive patients underwent conventional laparoscopic staging surgery. All patients underwent PLND; 7 (18.9%) and 14 (18.9%) patients in the LESS and conventional groups underwent para-aortic lymph node dissection, respectively (P 9 0.999). No patient in either group
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Conventional Laparoscopic (n = 74) 55.1 59.5 156.0 24.47 45 29 21 53 49
T 10.1 T 9.6 T 4.8 T 3.89 (60.8) (39.2) (28.4) (71.6) (66.2)
P 0.208 0.510 0.745 0.601 0.014 0.066 0.213
25 (33.8) 63 (85.1)
0.003
11 (14.9) 17.5 T 29.3
0.695
Data are shown as mean T SD or n (%). BMI, body mass index; Abd, abdominal; Med, medical; CA 125, cancer antigen 125.
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International Journal of Gynecological Cancer
& Volume 24, Number 2, February 2014
TABLE 2. Comparison of surgical outcomes (n = 111) LESS (n = 37)
Characteristics
Operating time, 183 T 50 min Estimated blood 194 T 149 loss, mL Transfusion 2 (5.4) required in Transfusion 1.5 T 0.7 amount, pt Postoperative 5.0 T 1.8 hospital stay, d Total lymph node 25.9 T 10.6 yield, n Pelvic lymph node 24.6 T 11.4 yield, n Para-aortic lymph 4.9 T 2.5 node yield, n PALND performed in 7 (18.9)
Conventional Laparoscopic (n = 74)
P
173 T 58
0.388
173 T 106
0.394
6 (8.1)
0.717
2.5 T 0.8
0.184
5.1 T 1.8
0.911
24.6 T 9.0
0.497
23.3 T 7.7
0.459
6.9 T 7.3
0.494
14 (18.9)
90.999
Data are shown as mean T SD or n (%). PALND, para-aortic lymph node dissection.
surgery, the pain scores were significantly lower in the LESS group. Additional analgesics were required in 75.7% (28/37) and 100% (74/74) of patients in the LESS and conventional groups, respectively (P G 0.001). Additional analgesics were required on the day of surgery in 75.7% (28/37) and 98.6% (73/74) of patients in the LESS and conventional groups, respectively (P G 0.001). This percentage was 62.2% (23/37) and 93.2% (69/74) at postoperative day 1 (P G 0.001), 54.1% (20/37) and 78.4% (58/74) at postoperative day 2 (P = 0.008), and 24.3% (9/37) and 56.8% (42/74) at postoperative day 3 (P = 0.001) for the LESS and conventional groups, respectively. The mean amount of additional analgesics was 4.9 and
7.7 ample for the LESS and conventional groups, respectively (P G 0.001). The need for additional analgesics was significantly lower in the LESS group at each postoperative day (Table 3). The pathologic outcomes after surgical staging are shown in Table 4. One patient (2.7%) in the LESS group and 3 patients (4.1%) in the conventional group were upstaged to stage IIIC because of lymph node metastasis (P 9 0.999). There was no difference in the histologic type, grade of differentiation, myometrial invasion, lymphovascular space invasion, cytologic finding, and the International Federation of Gynecology and Obstetrics stage between the 2 groups. Six patients (16.2%) in the LESS group and 13 patients (17.6%) in the conventional group received adjuvant therapy (P = 0.964). After a median follow-up time of 17 months (range, 6Y38 months), 1 patient in the conventional group had recurrent disease.
DISCUSSION Laparoendoscopic single-site surgical staging was feasible in patients with early-stage endometrial cancer as evidenced by the outcomes in our consecutive case series in which no patient required additional ports or conversion to laparotomy. The surgical outcomes including operating time, estimated blood loss, transfusion requirement, postoperative hospital stay, perioperative complications, and lymph node yield were comparable to those of conventional laparoscopic surgical staging. However, LESS surgical staging was associated with a significantly lower pain score during the early TABLE 3. Requirement of additional analgesics after surgery (n = 111) Amount of LESS Conventional Additional (n = 37), Laparoscopic Analgesics n (%) (n = 74), n (%) Operative day
POD 1
POD 2
POD 3
FIGURE 2. Postoperative pain score (n = 111). *P G 0.001, †P = 0.014, and §P = G 0.001 when compared between the conventional laparoscopic surgical staging group and the LESS survival staging group.
LESS vs Conventional Staging Surgery
0 1 2 3 0 1 2 3 0 1 2 3 4 0 1 2 3 4
9 (24.3) 11 (29.7) 14 (37.8) 3 (8.1) 14 (37.8) 2 (5.4) 0 (0) 21 (56.8) 17 (45.9) 4 (10.8) 2 (5.4) 14 (37.8) 0 (0) 24 (72.7) 3 (9.1) 1 (3.0) 5 (15.2) 0 (0)
1 (1.4) 19 (25.7) 51 (68.9) 3 (4.1) 5 (6.8) 3 (4.1) 9 (12.2) 57 (77) 16 (21.6) 11 (14.9) 10 (13.5) 36 (48.6) 1 (1.4) 26 (38.2) 8 (11.8) 7 (10.3) 26 (38.2) 1 (1.5)
P G0.001
G0.001
0.097
0.023
POD, postoperative day.
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& Volume 24, Number 2, February 2014
TABLE 4. Pathological outcomes and adjuvant therapy (n = 111) Characteristics Histologic finding Grade
Myometrial invasion
LVSI LN metastasis Cytology FIGO stage
Adjuvant therapy
LESS (n = 37), n (%) Endometrioid Serous 1 2 3 None G1/2 91/2 Yes Yes Positive IA IB IIA IIIC1 IIIC2 None RT CCRT Chemotherapy
34 3 21 10 6 13 19 5 4 1 1 31 5 0 0 1 31 3 1 2
(91.9) (8.1) (56.8) (27) (16.2) (35.1) (51.4) (13.5) (10.8) (2.7) (2.7) (83.8) (13.5) (0) (0) (2.7) (83.8) (8.1) (2.7) (5.4)
Conventional Laparoscopic (n = 74), n (%)
P
70 (94.6) 4 (5.4) 46 (62.2) 15 (20.3) 13 (17.6) 18 (24.3) 47 (63.5) 9 (12.2) 6 (8.1) 3 (4.1) 4 (5.4) 60 (81.1) 8 (10.8) 3 (4.1) 3 (4.1) 0 (0) 61 (82.4) 7 (9.5) 3 (4.1) 3 (4.1)
0.581 0.724
0.431
0.639 90.999 0.663 0.270
0.964
LVSI, lymphovascular space invasion; LN, lymph node; FIGO, International Federation of Gynecology and Obstetrics; RT, radiation therapy; CCRT, concurrent chemoradiation therapy.
recovery phase and a significantly lower analgesics requirement postoperatively than conventional laparoscopic surgical staging. Three previous studies reported the outcomes of LESS surgical staging in early-stage endometrial cancer.20Y22 Fanfani et al20 reported their initial experience with LESS in the surgical treatment of 20 consecutive patients with low-risk, early-stage endometrial cancer. All patients underwent extrafascial hysterectomy, but no patient underwent lymph node dissection. Laparotomic conversion or insertion of additional ports was not required in any patient. The median operating time and estimated blood loss was 105 minutes and 20 mL, respectively. All patients were satisfied with the cosmetic result and postoperative pain control. Fagotti et al21 performed a retrospective multicenter study to assess the feasibility and outcomes for LESS in 100 patients with early-stage endometrial cancer. All patients underwent total hysterectomy and BSO, but only 48 patients underwent lymph node dissection. Each of the patients required laparotomic conversion and insertion of additional ports. The median number of retrieved pelvic and para-aortic lymph nodes was 16 and 7, respectively. The median operating time and estimated blood loss was 129 minutes and 70 mL, respectively. Patients responded positively regarding the cosmetic result, and there was only a minimal requirement for postoperative pain control. These 2 studies demonstrated the feasibility, safety, and efficacy of LESS in the surgical management of early-stage endometrial cancer and concluded that LESS may further minimize the invasive nature of surgery.20,21
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However, there were no control groups for the comparison of surgical outcomes in these 2 studies.20,21 Escobar et al22 compared early surgical outcomes among patients who underwent LESS (n = 30), conventional laparoscopic surgery (n = 30), and robotic surgery (n = 30) for surgical staging of early-stage endometrial cancer in a matched case-control study. Lymph node dissection was performed in 15, 11, and 7 patients in the LESS, conventional laparoscopic surgery, and robotic surgery groups, respectively (P = 0.03). The number of retrieved pelvic lymph nodes was significantly higher in the LESS and robotic groups compared with that in the conventional laparoscopic group (P = 0.04). The surgical outcomes of LESS including the operating time (155 minutes), estimated blood loss (100 mL), postoperative hospital stay, and complication rates were comparable to those of conventional laparoscopic surgery and robotic surgery. Neither the number of patients who required laparotomic conversion or insertion of additional ports nor the postoperative pain scores were reported in their study. Reduced early postoperative pain may be associated with early recovery and discharge and may improve the quality of life of patients in early recovery phase. Further studies are required to confirm this assumption. If LESS can reduce early postoperative pain effectively, it should be a preferred surgical alternative for surgical staging of early endometrial cancer although it is technically more challenging. Recently, robotic single-site hysterectomy for early-stage endometrial cancer has been reported by some surgeons.23,24 With further improvements in robotic surgical instrument in * 2014 IGCS and ESGO
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International Journal of Gynecological Cancer
& Volume 24, Number 2, February 2014
the near future, we expect that the technical difficulty of LESS surgical staging would be solved. Fanfani et al20 reported the learning curve of the LESS surgical staging for low-risk earlystage endometrial cancer. They observed a statistically significant improvement of operating time after 10 cases.20 We think that the learning curve may not be long if LESS surgical staging is performed by a surgeon who is experienced in conventional laparoscopic surgical staging. The outcomes of the present study should be interpreted within the limitation of the small number of cases included in the analysis. However, this is the second case-control study comparing feasibility and surgical outcomes of LESS and conventional laparoscopic surgery, adding confirmation to the previous findings. Two strengths of the present study were the consecutive nature of the included patients who underwent LESS or conventional laparoscopic surgery and that all included subjects underwent lymph node dissection. Furthermore, this is the first study to demonstrate that LESS surgical staging is associated with less pain and need for analgesics than conventional laparoscopic surgical staging in patients with early-stage endometrial cancer. These results should be confirmed in future prospective trials. To this end, a randomized controlled trial to evaluate the feasibility, safety, and efficacy of LESS surgical staging in early-stage endometrial cancer has recently begun at our institution (clinicaltrial.gov identifier: NCT01679522). In conclusion, LESS surgical staging was demonstrated to be a feasible, safe, and efficacious procedure for surgical management of patients with early-stage endometrial cancer. It was associated with less postoperative pain and analgesic requirements and was comparable to conventional laparoscopic surgical staging in perioperative outcomes. A supplemental video, laparoendoscopic single-site surgical staging for early endometrial cancer, is available at http://links.lww.com/IGC/A193.
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early stage endometrial cancer: results from a randomised controlled trial. Eur J Cancer. 2012;48:1147Y1153. Tozzi R, Malur S, Koehler C, et al. Analysis of morbidity in patients with endometrial cancer: is there a commitment to offer laparoscopy? Gynecol Oncol. 2005;97:4Y9. Walker JL, Piedmonte MR, Spirtos NM, et al. Recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group LAP2 Study. J Clin Oncol. 2012;30:695Y700. Walker JL, Piedmonte MR, Spirtos NM, et al. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009;27:5331Y5336. Zorlu CG, Simsek T, Ari ES. Laparoscopy or laparotomy for the management of endometrial cancer. JSLS. 2005;9:442Y446. Zullo F, Palomba S, Falbo A, et al. Laparoscopic surgery vs laparotomy for early-stage endometrial cancer: long-term data of a randomized controlled trial. Am J Obstet Gynecol. 2009;200:296 e1Ye9. Galaal K, Bryant A, Fisher AD, et al. Laparoscopy versus laparotomy for the management of early-stage endometrial cancer. Cochrane Database Syst Rev. 2012;9:CD006655. Zullo F, Falbo A, Palomba S. Safety of laparoscopy vs laparotomy in the surgical staging of endometrial cancer: a systematic review and metaanalysis of randomized controlled trials. Am J Obstet Gynecol. 2012;207:94Y100. Chen YJ, Wang PH, Ocampo EJ, et al. Single-port compared with conventional laparoscopic-assisted vaginal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2011;117:906Y912. Jung YW, Lee M, Yim GW, et al. A randomized prospective study of single-port and four-port approaches for hysterectomy in terms of postoperative pain. Surg Endosc. 2011;25: 2462Y2469. Kim DY, Kim MK, Kim JH, et al. Laparoscopic-assisted vaginal hysterectomy versus abdominal hysterectomy in patients with stage I and II endometrial cancer. Int J Gynecol Cancer. 2005;15:932Y937. Cho YH, Kim DY, Kim JH, et al. Laparoscopic management of early uterine cancer: 10-year experience in Asan Medical Center. Gynecol Oncol. 2007;106:585Y590. Fanfani F, Rossitto C, Gagliardi ML, et al. Total laparoendoscopic single-site surgery (LESS) hysterectomy in low-risk early endometrial cancer: a pilot study. Surg Endosc. 2012;26:41Y46. Fagotti A, Boruta DM 2nd, Scambia G, et al. First 100 early endometrial cancer cases treated with laparoendoscopic single-site surgery: a multicentric retrospective study. Am J Obstet Gynecol. 2012;206:353 e1Ye6. Escobar PF, Frumovitz M, Soliman PT, et al. Comparison of single-port laparoscopy, standard laparoscopy, and robotic surgery in patients with endometrial cancer. Ann Surg Oncol. 2012;19:1583Y1588. Fagotti A, Corrado G, Fanfani F, et al. Robotic single-site hysterectomy (RSS-H) versus laparoendoscopic single-site hysterectomy (LESS-H) in early endometrial cancer: a double-institution case-control study. Gynecol Oncol. 2013;130:219Y223. Vizza E, Corrado G, Mancini E, et al. Robotic single-site hysterectomy in low risk endometrial cancer: a pilot study. Ann Surg Oncol. 2013;20:2759Y2764.
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Laparoendoscopic Single-Site Versus Conventional Laparoscopic Surgical Staging for Early-Stage Endometrial Cancer Jeong-Yeol Park, MD, PhD, Dae-Yeon Kim, MD, PhD, Dae-Shik Suh, MD, PhD, Jong-Hyeok Kim, MD, PhD, and Joo-Hyun Nam, MD, PhD
Objective: This study aims to compare the feasibility, safety, and efficacy of laparoendoscopic single-site (LESS) surgical staging for early-stage endometrial cancer with conventional laparoscopic surgical staging. Materials and Methods: The prospective study group consisted of 37 consecutive patients who underwent LESS surgical staging including hysterectomy, bilateral salpingooophorectomy, and pelvic lymph node dissection. The historical control group consisted of 74 consecutive patients who underwent 4-port laparoscopic surgical staging including hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node dissection. Surgical outcomes were compared between the 2 groups. Results: No patient in the LESS or conventional laparoscopic surgery group required an additional trocar or conversion to laparotomy. There were no intergroup differences in mean age, menopause status, body mass index, and previous history of abdominal surgery. Further, there were no inter-group differences in the number of total (LESS vs. conventional, 25.9 T 10.6 vs. 24.6 T 9.0, P = 0.497), pelvic (24.6 T 0.497 vs. 23.3 T 7.7, P = 0.459), and para-aortic (4.9 T 2.5 vs. 6.9 T 7.3, P = 0.494) lymph nodes retrieved; the operating time (183 T 50 min vs. 173 T 106, P = 0.388); estimated blood loss (194 T 149 mL vs. 173 T 106 mL, P = 0.394); number of patients requiring transfusion (5.4% vs. 8.1%, P = 0.717); postoperative hospital stay (5.0 T 1.8 days vs. 5.1 T 1.8 days, P = 0.911); intraoperative complications (2.7% vs. 0%, P = 0.333); and postoperative complications (0% vs. 1.4%, P 9 0.999). The postoperative pain scores and analgesic requirements were significantly lower in the LESS surgical staging group. Conclusions: Laparoendoscopic single-site surgical staging was a feasible, safe, and efficacious procedure for surgical management of early-stage endometrial cancer. It was associated with less postoperative pain and analgesic requirements and was comparable to conventional laparoscopic surgical staging in perioperative outcomes. Key Words: Endometrial cancer, Laparoscopy, Laparoendoscopic single-site surgery, Surgical staging Received September 15, 2013, and in revised form October 23, 2013. Accepted for publication October 24, 2013. (Int J Gynecol Cancer 2014;24: 358Y363)
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. Address correspondence and reprint requests to Joo-Hyun Nam, MD, PhD, Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Copyright * 2014 by IGCS and ESGO ISSN: 1048-891X DOI: 10.1097/IGC.0000000000000046
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Asan Medical Center, #388-1 Poongnap-2 dong, Songpa-gu, Seoul, 138-736, South Korea. E-mail: [email protected]. The authors declare no conflicts of interest. Supplemental digital content is available for this article. Direct URL citation appears in the printed text and is provided in the HTML and PDF versions of this article on the journal’s Web site (www.ijgc.net).
International Journal of Gynecological Cancer
& Volume 24, Number 2, February 2014
Copyright © 2014 by IGCS and ESGO. Unauthorized reproduction of this article is prohibited.
International Journal of Gynecological Cancer
& Volume 24, Number 2, February 2014
cancer is the most common malignancy of the E ndometrial female genital tract in the United States with an estimated
47,130 new cases and 8010 deaths occurring in 2012.1 It is the third most common malignancy of the female genital tract in South Korea, with an estimated 1752 new cases and 222 deaths occurring in 2010; furthermore, its incidence is rapidly increasing.2,3 The standard surgical management of early-stage endometrial cancer is surgical staging including total hysterectomy, bilateral salpingo-oophorectomy (BSO), and pelvic and/or para-arotic lymph node dissection.4 Recent randomized controlled trials5Y13 and meta-analyses14,15 confirmed that laparoscopic surgery is the preferred alternative to laparotomy in the surgical staging of early-stage endometrial cancer. Laparoscopic surgery is associated with less blood loss and transfusion requirements, less pain, faster recovery, and shorter postoperative hospital stay without increasing perioperative complication or compromising survival outcomes.14,15 With the aim of reducing the number and size of ports that are used in conventional laparoscopic surgery, laparoendoscopic single-site surgery (LESS) was developed and is being increasingly used for the surgical management of gynecologic diseases. Laparoendoscopic single-site surgery is a feasible and more advanced minimally invasive surgery for patients with benign gynecologic diseases.16,17 After the successful introduction of LESS, its indications are now being expanded to include surgical management of gynecologic cancers, including surgical staging of early-stage endometrial cancer; however, the surgical outcomes are not well established. The aim of this study was to compare the feasibility, safety, and efficacy of LESS surgical staging for early-stage endometrial cancer with conventional laparoscopic surgical staging.
LESS vs Conventional Staging Surgery
MATERIALS AND METHODS Study Population The prospective study group consisted of 37 consecutive patients who underwent LESS surgical staging including hysterectomy, BSO, and pelvic lymph node dissection (PLND). The historical control group consisted of 74 consecutive patients who underwent 4-port laparoscopic surgical staging including hysterectomy, BSO, and PLND. Surgical outcomes were compared between the 2 groups. This study was approved by the institutional review board of Asan Medical Center (Seoul, South Korea).
Surgical Procedures Conventional laparoscopic surgical staging was performed using a 4-port system as previously described.18,19 In brief, a 10-mm, a 12-mm, and two 5-mm laparoscopic ports were placed in the umbilicus, left lower abdomen, suprapubic area, and right lower abdomen, respectively (Fig. 1). Under a dorsal lithotomy (15-degree Trendelenburg) position pneumoperitoneum was made using carbon dioxide gas at 10 to 12 mm Hg. A first assistant (training fellow) stood on the right side of the patient and handled a rigid (0 degree) 12-mm laparoscope with the left hand and assistant forceps with the right hand. A second assistant (training resident) stood between the legs of patients and handled the uterine manipulator (Cohen cannula). The surgeon stood on the left side of the patients and used rigid laparoscopic instruments including scissors, forceps, monopolar Bovie, suction irrigator, Ligasure, and/or Endo-GIA with both hands. After laparoscopic-assisted vaginal hysterectomy with or without BSO, systematic PLND was performed. If the patient had deep myometrial invasion (outer half of the
FIGURE 1. Laparoendoscopic single-site surgery versus conventional laparoscopic surgery. * 2014 IGCS and ESGO
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myometrium), grade 3 differentiation, high-risk histologic type (papillary serous carcinoma or clear cell carcinoma), pelvic lymph node metastasis, and/or extrauterine disease revealed by frozen biopsy, para-aortic lymph node dissection was performed. Laparoendoscopic single-site surgical staging was performed using a commercially available 4-channel, single-port system (Fig. 1). After making a 15-mm vertical skin incision at the base of the umbilicus, a single port was placed. The surgical staging procedures were identical to those of conventional laparoscopic surgical staging excluding the port placement.
Postoperative Management After surgery, a Foley catheter was placed for 1 day in all patients. All patients also received patient-controlled analgesia for 48 hours after surgery. The patient-controlled analgesia regimen consisted of fentanyl 1000 Kg in normal saline (total volume, 50 mL) and was programed to deliver 1 mL/h as a basal infusion rate and 0.5 mL/demand with a 15-minute lockout. Postoperative pain was recorded using the Visual Analog Pain Scale, scored from 1 to 10 (0 is no pain and 10 is agonizing pain),20,21 every 8 hours and whenever the patients notified the medical staff of pain, for 3 days after surgery. If the pain score was greater than 3 or the patient requested additional analgesia, additional analgesics were provided. Normal diet was resumed at postoperative day 1. Patients were recommended to be discharged at postoperative day 3 if they reestablished their normal diet, were passing feces or gas, voided well, and had no symptoms or signs of postoperative complications that may require reoperation or readmission. Adjuvant therapy was recommended if the patients were in a high-risk group for recurrence according to the postoperative pathologic report.4 After the completion of primary treatment, clinical follow-up was scheduled at 3-month intervals for 2 years, then at 6-month intervals for the subsequent 3 years, and then annually thereafter.
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required an additional port or conversion to laparotomy. The patient characteristics are shown in Table 1. There was no difference in age, weight, height, body mass index, menopause status, history of abdominal surgery, and preoperative cancer antigen 125 levels between the 2 groups. However, more patients in the conventional group had parity greater than 3 (P = 0.014), and more patients in the LESS group had comorbid medical disease (P = 0.003). The comparison of surgical outcomes by surgical approach is shown in Table 2. The mean operating time was slightly longer in the LESS group, but the difference was not statistically significant. There was no difference in the mean estimated blood loss, transfusion requirement, and the mean transfusion amount between the 2 groups. The mean length of postoperative hospital stay was 5 days in both groups. There was no difference in the number of retrieved pelvic, paraarotic, and total lymph nodes between the 2 surgery groups. An intraoperative complication occurred in 1 patient in the LESS groupVa bladder injury that was successfully managed by transvaginal repair without the need for an additional port or conversion to laparotomy. There was no difference in the intraoperative complication rate between the LESS and conventional groups (2.7% vs 0%, respectively; P = 0.333). A postoperative complication occurred in 1 patient in the conventional groupVan intraperitoneal abscess that was successfully managed with conservative treatment. There was no difference in the postoperative complication rate between the LESS and conventional groups (0% vs 1.4%, respectively; P 9 0.999). There was no incisional hernia in both groups. The 8-hour interval postoperative mean pain scores are shown in Figure 2. Between 16 hours and 32 hours after TABLE 1. Characteristics of patients (n = 111) LESS (n = 37)
Statistical Analysis
Characteristics
The mean or median values were compared between groups using the Student t test or Mann-Whitney U test according to the normality of distribution in the KolmogorovSmironov test. The intergroup frequency distributions were compared using the W2 test, and if at least 1 expected frequency was less than 5, the Fisher exact test was used. Disease-free survival time was calculated in months from the date of surgery to the date of recurrence or censoring. Survival curves and rates were calculated using the Kaplan-Meier method, and survival rates were compared between groups using the log-rank test. P values less than 0.05 in 2-sided tests were regarded as statistically significant. SPSS for Windows (version 11.0; SPSS Inc, Chicago, IL) was used for all statistical analyses.
Age, y 52.6 T 7.8 Body weight, kg 60.8 T 9.3 Height, cm 156.4 T 6.0 BMI, kg/m2 24.87 T 3.59 Parity 0Y2 31 (83.8) 3 6 (16.2) Menopause No 17 (45.9) Yes 20 (54.1) Previous No 20 (54.1) abd surgery Yes 17 (45.9) Comorbid No 22 (59.5) med disease Yes 15 (40.5) Preoperative CA 125 15.5 T 13.0
RESULTS Thirty-seven consecutive patients underwent LESS staging surgery, and 74 consecutive patients underwent conventional laparoscopic staging surgery. All patients underwent PLND; 7 (18.9%) and 14 (18.9%) patients in the LESS and conventional groups underwent para-aortic lymph node dissection, respectively (P 9 0.999). No patient in either group
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Conventional Laparoscopic (n = 74) 55.1 59.5 156.0 24.47 45 29 21 53 49
T 10.1 T 9.6 T 4.8 T 3.89 (60.8) (39.2) (28.4) (71.6) (66.2)
P 0.208 0.510 0.745 0.601 0.014 0.066 0.213
25 (33.8) 63 (85.1)
0.003
11 (14.9) 17.5 T 29.3
0.695
Data are shown as mean T SD or n (%). BMI, body mass index; Abd, abdominal; Med, medical; CA 125, cancer antigen 125.
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International Journal of Gynecological Cancer
& Volume 24, Number 2, February 2014
TABLE 2. Comparison of surgical outcomes (n = 111) LESS (n = 37)
Characteristics
Operating time, 183 T 50 min Estimated blood 194 T 149 loss, mL Transfusion 2 (5.4) required in Transfusion 1.5 T 0.7 amount, pt Postoperative 5.0 T 1.8 hospital stay, d Total lymph node 25.9 T 10.6 yield, n Pelvic lymph node 24.6 T 11.4 yield, n Para-aortic lymph 4.9 T 2.5 node yield, n PALND performed in 7 (18.9)
Conventional Laparoscopic (n = 74)
P
173 T 58
0.388
173 T 106
0.394
6 (8.1)
0.717
2.5 T 0.8
0.184
5.1 T 1.8
0.911
24.6 T 9.0
0.497
23.3 T 7.7
0.459
6.9 T 7.3
0.494
14 (18.9)
90.999
Data are shown as mean T SD or n (%). PALND, para-aortic lymph node dissection.
surgery, the pain scores were significantly lower in the LESS group. Additional analgesics were required in 75.7% (28/37) and 100% (74/74) of patients in the LESS and conventional groups, respectively (P G 0.001). Additional analgesics were required on the day of surgery in 75.7% (28/37) and 98.6% (73/74) of patients in the LESS and conventional groups, respectively (P G 0.001). This percentage was 62.2% (23/37) and 93.2% (69/74) at postoperative day 1 (P G 0.001), 54.1% (20/37) and 78.4% (58/74) at postoperative day 2 (P = 0.008), and 24.3% (9/37) and 56.8% (42/74) at postoperative day 3 (P = 0.001) for the LESS and conventional groups, respectively. The mean amount of additional analgesics was 4.9 and
7.7 ample for the LESS and conventional groups, respectively (P G 0.001). The need for additional analgesics was significantly lower in the LESS group at each postoperative day (Table 3). The pathologic outcomes after surgical staging are shown in Table 4. One patient (2.7%) in the LESS group and 3 patients (4.1%) in the conventional group were upstaged to stage IIIC because of lymph node metastasis (P 9 0.999). There was no difference in the histologic type, grade of differentiation, myometrial invasion, lymphovascular space invasion, cytologic finding, and the International Federation of Gynecology and Obstetrics stage between the 2 groups. Six patients (16.2%) in the LESS group and 13 patients (17.6%) in the conventional group received adjuvant therapy (P = 0.964). After a median follow-up time of 17 months (range, 6Y38 months), 1 patient in the conventional group had recurrent disease.
DISCUSSION Laparoendoscopic single-site surgical staging was feasible in patients with early-stage endometrial cancer as evidenced by the outcomes in our consecutive case series in which no patient required additional ports or conversion to laparotomy. The surgical outcomes including operating time, estimated blood loss, transfusion requirement, postoperative hospital stay, perioperative complications, and lymph node yield were comparable to those of conventional laparoscopic surgical staging. However, LESS surgical staging was associated with a significantly lower pain score during the early TABLE 3. Requirement of additional analgesics after surgery (n = 111) Amount of LESS Conventional Additional (n = 37), Laparoscopic Analgesics n (%) (n = 74), n (%) Operative day
POD 1
POD 2
POD 3
FIGURE 2. Postoperative pain score (n = 111). *P G 0.001, †P = 0.014, and §P = G 0.001 when compared between the conventional laparoscopic surgical staging group and the LESS survival staging group.
LESS vs Conventional Staging Surgery
0 1 2 3 0 1 2 3 0 1 2 3 4 0 1 2 3 4
9 (24.3) 11 (29.7) 14 (37.8) 3 (8.1) 14 (37.8) 2 (5.4) 0 (0) 21 (56.8) 17 (45.9) 4 (10.8) 2 (5.4) 14 (37.8) 0 (0) 24 (72.7) 3 (9.1) 1 (3.0) 5 (15.2) 0 (0)
1 (1.4) 19 (25.7) 51 (68.9) 3 (4.1) 5 (6.8) 3 (4.1) 9 (12.2) 57 (77) 16 (21.6) 11 (14.9) 10 (13.5) 36 (48.6) 1 (1.4) 26 (38.2) 8 (11.8) 7 (10.3) 26 (38.2) 1 (1.5)
P G0.001
G0.001
0.097
0.023
POD, postoperative day.
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& Volume 24, Number 2, February 2014
TABLE 4. Pathological outcomes and adjuvant therapy (n = 111) Characteristics Histologic finding Grade
Myometrial invasion
LVSI LN metastasis Cytology FIGO stage
Adjuvant therapy
LESS (n = 37), n (%) Endometrioid Serous 1 2 3 None G1/2 91/2 Yes Yes Positive IA IB IIA IIIC1 IIIC2 None RT CCRT Chemotherapy
34 3 21 10 6 13 19 5 4 1 1 31 5 0 0 1 31 3 1 2
(91.9) (8.1) (56.8) (27) (16.2) (35.1) (51.4) (13.5) (10.8) (2.7) (2.7) (83.8) (13.5) (0) (0) (2.7) (83.8) (8.1) (2.7) (5.4)
Conventional Laparoscopic (n = 74), n (%)
P
70 (94.6) 4 (5.4) 46 (62.2) 15 (20.3) 13 (17.6) 18 (24.3) 47 (63.5) 9 (12.2) 6 (8.1) 3 (4.1) 4 (5.4) 60 (81.1) 8 (10.8) 3 (4.1) 3 (4.1) 0 (0) 61 (82.4) 7 (9.5) 3 (4.1) 3 (4.1)
0.581 0.724
0.431
0.639 90.999 0.663 0.270
0.964
LVSI, lymphovascular space invasion; LN, lymph node; FIGO, International Federation of Gynecology and Obstetrics; RT, radiation therapy; CCRT, concurrent chemoradiation therapy.
recovery phase and a significantly lower analgesics requirement postoperatively than conventional laparoscopic surgical staging. Three previous studies reported the outcomes of LESS surgical staging in early-stage endometrial cancer.20Y22 Fanfani et al20 reported their initial experience with LESS in the surgical treatment of 20 consecutive patients with low-risk, early-stage endometrial cancer. All patients underwent extrafascial hysterectomy, but no patient underwent lymph node dissection. Laparotomic conversion or insertion of additional ports was not required in any patient. The median operating time and estimated blood loss was 105 minutes and 20 mL, respectively. All patients were satisfied with the cosmetic result and postoperative pain control. Fagotti et al21 performed a retrospective multicenter study to assess the feasibility and outcomes for LESS in 100 patients with early-stage endometrial cancer. All patients underwent total hysterectomy and BSO, but only 48 patients underwent lymph node dissection. Each of the patients required laparotomic conversion and insertion of additional ports. The median number of retrieved pelvic and para-aortic lymph nodes was 16 and 7, respectively. The median operating time and estimated blood loss was 129 minutes and 70 mL, respectively. Patients responded positively regarding the cosmetic result, and there was only a minimal requirement for postoperative pain control. These 2 studies demonstrated the feasibility, safety, and efficacy of LESS in the surgical management of early-stage endometrial cancer and concluded that LESS may further minimize the invasive nature of surgery.20,21
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However, there were no control groups for the comparison of surgical outcomes in these 2 studies.20,21 Escobar et al22 compared early surgical outcomes among patients who underwent LESS (n = 30), conventional laparoscopic surgery (n = 30), and robotic surgery (n = 30) for surgical staging of early-stage endometrial cancer in a matched case-control study. Lymph node dissection was performed in 15, 11, and 7 patients in the LESS, conventional laparoscopic surgery, and robotic surgery groups, respectively (P = 0.03). The number of retrieved pelvic lymph nodes was significantly higher in the LESS and robotic groups compared with that in the conventional laparoscopic group (P = 0.04). The surgical outcomes of LESS including the operating time (155 minutes), estimated blood loss (100 mL), postoperative hospital stay, and complication rates were comparable to those of conventional laparoscopic surgery and robotic surgery. Neither the number of patients who required laparotomic conversion or insertion of additional ports nor the postoperative pain scores were reported in their study. Reduced early postoperative pain may be associated with early recovery and discharge and may improve the quality of life of patients in early recovery phase. Further studies are required to confirm this assumption. If LESS can reduce early postoperative pain effectively, it should be a preferred surgical alternative for surgical staging of early endometrial cancer although it is technically more challenging. Recently, robotic single-site hysterectomy for early-stage endometrial cancer has been reported by some surgeons.23,24 With further improvements in robotic surgical instrument in * 2014 IGCS and ESGO
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& Volume 24, Number 2, February 2014
the near future, we expect that the technical difficulty of LESS surgical staging would be solved. Fanfani et al20 reported the learning curve of the LESS surgical staging for low-risk earlystage endometrial cancer. They observed a statistically significant improvement of operating time after 10 cases.20 We think that the learning curve may not be long if LESS surgical staging is performed by a surgeon who is experienced in conventional laparoscopic surgical staging. The outcomes of the present study should be interpreted within the limitation of the small number of cases included in the analysis. However, this is the second case-control study comparing feasibility and surgical outcomes of LESS and conventional laparoscopic surgery, adding confirmation to the previous findings. Two strengths of the present study were the consecutive nature of the included patients who underwent LESS or conventional laparoscopic surgery and that all included subjects underwent lymph node dissection. Furthermore, this is the first study to demonstrate that LESS surgical staging is associated with less pain and need for analgesics than conventional laparoscopic surgical staging in patients with early-stage endometrial cancer. These results should be confirmed in future prospective trials. To this end, a randomized controlled trial to evaluate the feasibility, safety, and efficacy of LESS surgical staging in early-stage endometrial cancer has recently begun at our institution (clinicaltrial.gov identifier: NCT01679522). In conclusion, LESS surgical staging was demonstrated to be a feasible, safe, and efficacious procedure for surgical management of patients with early-stage endometrial cancer. It was associated with less postoperative pain and analgesic requirements and was comparable to conventional laparoscopic surgical staging in perioperative outcomes. A supplemental video, laparoendoscopic single-site surgical staging for early endometrial cancer, is available at http://links.lww.com/IGC/A193.
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