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doi:10.1111/jog.12595
J. Obstet. Gynaecol. Res. Vol. 41, No. 4: 590–595, April 2015
Prospective comparison of single port versus conventional laparoscopic surgery for ectopic pregnancy Min Kyung Kim1, Jeong Jin Kim1, Joong Sub Choi2, Jeong Min Eom3 and Jung Hun Lee4 1
Department of Obstetrics and Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Department of Obstetrics and Gynecology, College of Medicine, Hanyang University, 3Department of Obstetrics and Gynecology, National Medical Center, and 4Department of Obstetrics and Gynecology, MizMedi Hospital, Eulji University School of Medicine, Seoul, Korea 2
Abstract Aim: To investigate the feasibility and safety of single port laparoscopic surgery (SP-LS) for ectopic pregnancy, irrespective of type of ectopic pregnancy and hemodynamic stability. Methods: A prospective case–control study of 106 women who underwent SP-LS or conventional LS for a suspected ectopic pregnancy was performed at a university teaching hospital from January 2009 to March 2012. Twenty-six women underwent SP-LS (SP-LS group) and 80 women underwent conventional LS (conventional LS group). Results: There were no statistical differences between the groups in terms of demographic characteristics, operating time, hemoglobin change, return of bowel activity, hospital stay or complication rate. There were no cases of additional trocar use or conversion to laparotomy. Of five women with heterotopic pregnancy, one underwent SP-LS, and three underwent conventional LS for tubal pregnancy, which all resulted in vaginal delivery without obstetric complication; one woman received SP-LS for cornual pregnancy and had an ongoing pregnancy. Conclusion: SP-LS for ectopic pregnancy is feasible and safe regardless of the type of ectopic pregnancy and hemodynamic stability. However, further work is needed to confirm this conclusion and to demonstrate any advantage of SP-LS for ectopic pregnancy. Key words: ectopic pregnancy, gynecology, laparoscopy, single port surgery.
Introduction Laparoscopy has become the primary approach for the surgical management of ectopic pregnancy because of advantages over laparotomy, such as shorter hospitalization, earlier recovery, fewer adhesions and decreased blood loss.1,2 Single port laparoscopic surgery (SP-LS) has been utilized in various gynecologic fields according to the development of laparoscopic equipment and tech-
niques and the increasing demand for minimally invasive surgery.3–5 Although several studies of SP-LS for ectopic pregnancy have been reported, most of these studies were performed only in hemodynamically stable women with tubal pregnancy and excluded other types of ectopic pregnancy.6–9 The clinical usefulness of these prior studies is limited because of the difficulty in differentiating the type of ectopic pregnancy and the considerable rate of hemodynamic instability observed in this population.
Received: December 9 2013. Accepted: August 12 2014. Reprint request to: Professor Jung Hun Lee, Department of Obstetrics and Gynecology, MizMedi Hospital, Eulji University School of Medicine, 295 Gangseo-ro, Gangseo-gu, Seoul 157-723, Korea. Email: [email protected]
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© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
SP-LS for ectopic pregnancy
To obtain more clinically relevant data, we evaluated the feasibility and safety of SP-LS for ectopic pregnancy regardless of the hemodynamic stability and the type of ectopic pregnancy.
Methods This prospective case–control study was performed at a university teaching hospital from January 2009 to March 2012. A total of 106 consecutive women with suspected ectopic pregnancy were enrolled in the study. These subjects did not meet the criteria for methotrexate treatment and were scheduled to undergo SP-LS or conventional laparoscopic surgery (conventional LS) for the suspected ectopic pregnancy, diagnosed by transvaginal ultrasonography and serum human chorionic gonadotropin. The criteria for medical treatment were as follows: (i) stable hemodynamic state; (ii) tubal mass less than 3.5 cm in diameter; (iii) absence of fetal heart beat; (iv) serum beta human chorionic gonadotropin level less than 15 000 mIU/ml; and (v) no refusal to be treated medically.10 Institutional review board approval was obtained at the Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine. After the study participants were informed of the advantages, disadvantages and limitations of SP-LS and conventional LS, each participant chose a procedure, which was then performed with her consent. Especially, compare with conventional LS, SP-LS has theoretical advantages (such as less wound complication, decreased postoperative pain, shorter hospital stay, faster recovery time and better cosmetic outcome) and disadvantages (such as technical difficulty, longer operating time, need for specialized instruments and rising medical cost caused by them). Also, there are limitations of SP-LS, but theoretical advantages and disadvantages of it are based on sparse data. Furthermore, the possibility of additional trocar use or conversion to laparotomy or conventional LS could be needed due to surgical difficulty. The choice of surgical modality was not influenced by the patient’s history of previous abdominal surgery, body mass index or hemodynamic instability. Single port laparoscopic surgery and conventional LS were performed by the same operative technique; the technical difference between the procedures was that SP-LS was performed using transumbilical GelPort access (Alexis; Applied Medical, Rancho Santa Margarita, CA, USA) and articulating instruments (Fig. 1).3,5,11 A 0-degree 5-mm telescope and bipolar
electrocoagulator were commonly used in both procedures. We performed a salpingectomy for tubal pregnancy in 95 cases, an ovarian wedge resection for ovarian pregnancy in seven cases and a cornual wedge resection for cornual pregnancy in four cases.12 Conventional LS was performed by two expert laparoscopists (C. J. S. and L. J. H.), and SP-LS was carried out by one surgeon (L. J. H.). The operating time was defined as the period from the skin incision to the skin closure; the return of bowel activity was defined as the period from the end of anesthesia to the first bowel gas passage; postoperative fever was defined as a body temperature equal to or
Figure 1 (a) Port placement and (b) intraoperative image of conventional laparoscopic surgery. (c) Port placement and (d) intraoperative image of single port laparoscopic surgery using transumbilical GelPort access (Alexis; Applied Medical, Rancho Santa Margarita, CA, USA), monopolar articulating Metzenbaum scissors (Autonomy Laparo-Angle; Cambridge Endo, Framingham, MA, USA), and articulating laparoscopic graspers (RealHand; Novare Surgical Systems, Cupertino, CA, USA).
© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
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greater than 38°C on two consecutive occasions at least 6 h apart, except during the first 24 h; and hemodynamic instability was defined as systolic blood pressure less than 90 mmHg for at least 30 min.13 The gestational age was based on the last documented menstrual period. All cases of ectopic pregnancy were pathologically confirmed. Maximum visual analog scale postoperative day 1 pain scores were documented for all patients. The presence of adhesion was recorded if any adhesions were observed intraoperatively in the pelvic or bowel organs and if adhesiolysis was performed.
Statistical analyses The Shapiro–Wilk test was used to confirm that each variable did not follow a normal (Gaussian) distribution. An unpaired Student’s t-test was used to compare each group’s continuous parametric variables, and the Mann–Whitney U-test was used for non-parametric variables. The Pearson χ2-test and Fisher’s exact test were used to compare the categorical variables. P < 0.05 represented a significant difference. All analyses were performed using the SPSS version 18.0 for Windows (SPSS, Chicago, IL, USA).
Results During the study period, a total of 106 women were enrolled, which included 26 women who underwent
SP-LS (SP-LS group) and 80 women who underwent conventional LS (conventional LS group). There were no statistically significant differences in the clinical and ectopic pregnancy-related characteristics between the two groups (Table 1). No significant difference in operative results was observed between the groups (Table 2). However, maximum pain scores were significantly lower in the SP-LS group compared with the conventional LS group on postoperative day 1. All blood transfusions were done for women with hemodynamic instability or hemoglobin level less than 8 gm/dL preoperatively. Bladder laceration was an intraoperative complication in two women, repaired by primary laparoscopic closure in all these cases. No subjects required conversion to laparotomy or additional trocar insertion. Postoperative fever was resolved with conservative treatment in seven women. As shown in Table 3, there was no significant difference in operating time between the groups due to the presence of hemoperitoneum. However, when there was adhesion, a statistically significant longer operating time was observed in the SP-LS group compared with the conventional LS group (Table 3). Of the five women with heterotopic pregnancy, one underwent SP-LS, and three underwent conventional LS for tubal pregnancy, all resulting in vaginal delivery without obstetric complication; one woman who received SP-LS for cornual pregnancy had an ongoing pregnancy at the study conclusion (Table 4).
Table 1 Clinical and ectopic pregnancy related characteristics SP-LS group Conventional-LS group Median (range)/ no. of subjects (%) No. of patients Age (years) Parity Body mass index (kg/m2) No. of previous abdominal surgeries Duration of amenorrhea (days) Preoperative serum hCG level (mIU/ml) Number of patients who received ART IVF-ET IUI Ovulation induction Type of ectopic pregnancy Tubal pregnancy Cornual pregnancy Ovarian pregnancy Heterotopic pregnancy
26 32 (20–39) 0 (0–3) 20.13 (17.40–24.78) 0 (0–2) 42 (18–59) 6 870.5 (28.51–98 064) 15 (57) 12 (46.2) 2 (7.7) 1 (3.8)
80 31 (17–42) 0 (0–4) 20.93 (17.09–31.13) 0 (0–3) 42 (25–102) 67 53.5 (152.90–166 460) 33 (41) 26 (32.5) 4 (5.0) 3 (3.8)
P
0.759† 0.152‡ 0.189† 0.171‡ 0.602† 0.857‡ 0.143§
0.827§ 21 (80.8) 1 (3.8) 2 (7.7) 2 (7.7)
70 (87.5) 2 (2.5) 5 (6.3) 3 (3.8)
†By unpaired Student’s t-test. ‡By Mann–Whitney U-test. §By Pearson χ2-test. ART, assisted reproductive techniques; Conventional group, group who underwent conventional laparoscopically ectopic pregnancy operation; hCG, human chorionic gonadotropin; IUI, intrauterine insemination; IVF-ET, in vitro fertilization – embryo transfer; SP-LS group, group who underwent single port laparoscopically ectopic pregnancy operation.
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© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
SP-LS for ectopic pregnancy
Table 2 Operative results
Presence of hemoperitoneum Presence of adhesions No. of patients with hemodynamic instability Operation time (min) Estimated blood loss (mL) Hemoglobin change (g/dL) No. of patients who needed transfusion Return of bowel activity (h) Hospital stay (days) Maximal pain score at POD 1 (VAS) Procedure for ectopic pregnancy Salpingectomy Ovarian wedge resection Cornual wedge resection Concurrent procedure Contralateral salpingectomy Laparoscopic fimbrioplasty Laparoscopic myomectomy Ovarian cystectomy Chromopertubation Dilatation and curettage Complications Total complications Intraoperative complications Bladder injury Postoperative complications Postoperative fever
SP-LS group Conventional LS group Median (range)/no. of subjects (%)
P
18 (69.2) 12 (46.2) 5 (19.2) 55 (30–110) 100 (20–350) 1.6 (0.6–2.6) 5 (19.2) 27.8 (14.2–55.9) 4.15 (1–8) 3 (1–7)
0.779† 0.368† 0.632† 0.051‡ 0.309‡ 0.883§ 0.470‡ 0.182§ 0.596‡ 0.032‡ 0.458†
53 (74.6) 29 (36.3) 19 (23.8) 50 (20–130) 100 (10–2000) 1.5 (0.1–3.6) 21 (26.3) 24.0 (9–68.2) 4.31 (3–10) 4 (1–7)
22 (84.6) 2 (7.7) 2 (7.7)
73 (91.3) 5 (6.3) 2 (2.5)
2 (7.7) 1 (3.8) 2 (7.7) 2 (7.7) 1 (3.8) 8 (30.8)
5 (6.3) 4 (5.0) 5 (6.3) 4 (5.0) 1 (1.3) 19 (23.8)
1 (3.8) 0 (0) 0 (0) 1 (3.8) 1 (3.8)
8 (10.0) 2 (2.5) 2 (2.5) 6 (7.5) 6 (7.5)
0.448¶
†By Pearson χ2-test. ‡By Mann–Whitney U-test. §By Student’s t-test. ¶By Fisher’s exact test. Conventional group, group who underwent conventional laparoscopically ectopic pregnancy operation; SP-LS group, group who underwent single port laparoscopically ectopic pregnancy operation; VAS, visual analog scale; POD, postoperative day.
Table 3 Comparison of operating time in the presence or absence of hemoperitoneum or adhesions
Presence of hemoperitoneum No (n = 8 vs 27) Yes (n = 18 vs 53) Presence of adhesions No (n = 14 vs 51) Yes (n = 12 vs 29)
SP-LS Conventional group LS group Operating time (min)
P
50 (35–100) 57.5 (30–110)
50 (20–120) 50 (25–130)
0.236† 0.113†
52.5 (35–110) 60 (30.0–100)
50 (20–130) 40 (25–90)
0.400† 0.042†
†By the Mann-Whitney U-test. Data are median (range). Conventional group, group who underwent conventional laparoscopically ectopic pregnancy operation; SP-LS group, group who underwent single port laparoscopically ectopic pregnancy operation.
Discussion More than three decades after Shapiro and Alder performed the first laparoscopic salpingectomy for ectopic pregnancy in 1973,14 laparoscopy, with the advancement of surgical techniques, has become
widely used for the surgical management of ectopic pregnancy with numerous benefits, including a faster recovery, less pain, decreased blood loss and a better quality of life postoperatively.15 SP-LS was first introduced by a group of gynecologists who used this approach to perform tubal ligations in the 1960s.16
© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
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M. K. Kim et al.
Table 4 Summary of women with heterotopic pregnancy Case no.
Age (years)
Mode of conception
Gestation (weeks)
Performed procedure
Operating time (min)
Obstetric outcome
1
36
IVF-ET
6
80
2
35
IVF-ET
8
3
36
IVF-ET
8
4
31
IVF-ET
5
5
35
IVF-ET
7
Conventional laparoscopic salpingectomy Single port laparoscopic salpingectomy Conventional laparoscopic salpingectomy Conventional laparoscopic salpingectomy Single port laparoscopic cornual wedge resection
Vaginal delivery at 37 weeks. Live female 3100 g. Vaginal delivery at 39 weeks. Live male 3300 g. Vaginal delivery at 38 weeks. Live female 3000 g. Vaginal delivery at 37 weeks. Live female 2900 g. Ongoing pregnancy at 12 weeks
35 45 60 95
IVF-ET, in vitro fertilization – embryo transfer.
Recently, the use of SP-LS has expanded in many gynecologic fields because of the minimized potential morbidity related to multiple trocar incisions and maximized cosmetic benefits with hidden scars compared to conventional LS.17 Despite the advantages of SP-LS, unstable vital signs, bowel obstruction or adhesion, previous operation history, hernia, massive hemoperitoneum and severe cardiopulmonary problems are frequently cited as contraindications for SP-LS.18 Previous studies on the technical feasibility and safety of SP-LS for ectopic pregnancy included only hemodynamically stable women with tubal pregnancies.3,7–9 However, hemoperitoneum and hemodynamic instability are frequently observed and the type of ectopic pregnancy may not be determined with certainty prior to surgery. Because of the exclusion of these groups, the clinical usefulness of these prior studies is limited. To overcome this limitation, this study included all women scheduled for surgery for ectopic pregnancy regardless of hemodynamic instability, type of ectopic pregnancy and previous abdominal surgery. As shown in Table 2, there were no significant differences in the operative results or complication rates between the SP-LS and conventional LS groups. Therefore, we conclude that SP-LS is feasible and safe in not only hemodynamically stable women with tubal pregnancy but also hemodynamically unstable women with other types of ectopic pregnancy. A longer operating time, a reported disadvantage of SP-LS, was not noted in the present study, which is consistent with a previous study on SP-LS for tubal pregnancy.8 Although various surgeries for ectopic pregnancy and concurrent procedures were included, this result is thought to be due to: (i) the accumulated experience of the participating surgeon; (ii) the sup-
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porting ability for inserted trocars and sufficient flexibility of the GelPort platform; and (iii) more than 80% of each group consisting of women with tubal pregnancies that did not require meticulous surgical technique, as observed in our previous report.5 However, as shown in Table 3, there was no difference in operating time between the groups based on the presence of hemoperitoneum, but there was a significant difference in operating time between the groups based on the presence of adhesion. Two of the women who underwent adhesiolysis in the SP-LS group had concurrent single port laparoscopic myomectomies, which might have contributed to an increased operating time. The difference in operating time between the groups based on the presence of adhesion was minor, with a P-value of 0.042. SP-LS may be considered a reasonable alternative to conventional LS for the surgical management of ectopic pregnancy, with a negligible increase in operating time expected in women with suspected intraperitoneal adhesions. Soriano et al. reported the outcomes of heterotopic pregnancy in 19 women who received conventional LS, which included first-trimester miscarriage in 13%, second-trimester miscarriage in 20%, preterm birth in 26.7% and term birth in 40%.19 Our study enrolled five women with heterotopic pregnancy; one woman underwent SP-LS and three women underwent conventional LS for tubal pregnancy, all resulting in vaginal deliveries without obstetrical complications. The remaining woman received SP-LS for cornual pregnancy and had an ongoing pregnancy at the study conclusion. Although no adverse outcomes were observed in these patients, more studies are needed on the safety and effectiveness of SP-LS for heterotopic pregnancy.
© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
SP-LS for ectopic pregnancy
In addition, only 25% of women with a suspected ectopic pregnancy underwent SP-LS during the study period. We used the GelPort system as the platform for SP-LS and SP-LS is inevitably accompanied by the increased medical cost because of this device (∼$US 800). It seems to be because the additional medical cost acted as a barrier to the choice of SP-LS that a small number of patients choose SP-LS.3 The advantages of this study include a prospective design that includes a relatively large number of patients, and improved clinical applicability of SP-LS for ectopic pregnancy by the inclusion of women with hemodynamic instability and various types of ectopic pregnancy, including ovarian, cornual and heterotopic pregnancy, which were not previously studied. Several limitations of the current study include that the study was: (i) not a large prospective randomized study; (ii) not able to assess decreased postoperative pain and improved cosmetic outcome, which are theoretical advantages of SP-LS, systematically; and (iii) not able to study a learning curve of SP-LS for ectopic pregnancy due to the variety of concurrent surgeries and types of ectopic pregnancy. Single port laparoscopic surgery is feasible and safe in women with ectopic pregnancy regardless of the type of ectopic pregnancy and hemodynamic stability. However, further work is needed to confirm this conclusion and to demonstrate any advantage of SP-LS for ectopic pregnancy.
Disclosure No competing financial interests exist.
References 1. Lim MC, Kim TJ, Kang S, Bae DS, Park SY, Seo SS. Embryonic natural orifice transumbilical endoscopic surgery (E-NOTES) for adnexal tumors. Surg Endosc 2009; 23: 2445– 2449. 2. Takacs P, Chakhtoura N. Laparotomy to laparoscopy: Changing trends in the surgical management of ectopic pregnancy in a tertiary care teaching hospital. J Minim Invasive Gynecol 2006; 13: 175–177. 3. Lee JH, Choi JS, Jeon SW, Son CE, Lee SJ, Lee YS. Single-port laparoscopic myomectomy using transumbilical GelPort access. Eur J Obstet Gynecol Reprod Biol 2010; 153: 81–84. 4. Lee JH, Choi JS, Hong JH, Joo KJ, Kim BY. Does conventional or single port laparoscopically assisted vaginal hysterectomy affect female sexual function? Acta Obstet Gynecol Scand 2011; 90: 1410–1415.
5. Lee JH, Choi JS, Jeon SW, Son CE, Hong JH, Bae JW. A prospective comparison of single-port laparoscopically assisted vaginal hysterectomy using transumbilical GelPort access and multiport laparoscopically assisted vaginal hysterectomy. Eur J Obstet Gynecol Reprod Biol 2011; 158: 294– 297. 6. Yoon BS, Park H, Seong SJ, Park CT, Park SW, Lee KJ. Singleport laparoscopic salpingectomy for the surgical treatment of ectopic pregnancy. J Minim Invasive Gynecol 2010; 17: 26–29. 7. Takeda A, Imoto S, Mori M, Nakano T, Nakamura H. Early experience with isobaric laparoendoscopic single-site surgery using a wound retractor for the management of ectopic pregnancy. Eur J Obstet Gynecol Reprod Biol 2011; 154: 209–214. 8. Yoon BS, Park H, Seong SJ, Park CT, Jun HS, Kim IH. Singleport versus conventional laparoscopic salpingectomy in tubal pregnancy: A comparison of surgical outcomes. Eur J Obstet Gynecol Reprod Biol 2011; 159: 190–193. 9. Bedaiwy MA, Escobar PF, Pinkerton J, Hurd W. Laparoendoscopic single-site salpingectomy in isthmic and ampullary ectopic pregnancy: Preliminary report and technique. J Minim Invasive Gynecol 2011; 18: 230–233. 10. Alleyassin A, Khademi A, Aghahosseini M, Safdarian L, Badenoosh B, Hamed EA. Comparison of success rates in the medical management of ectopic pregnancy with single-dose and multiple-dose administration of methotrexate: A prospective, randomized clinical trial. Fertil Steril 2006; 85: 1661–1666. 11. Choi JS, Kyung YS, Kim KH, Lee KW, Han JS. The four-trocar method for performing laparoscopically-assisted vaginal hysterectomy on large uteri. J Minim Invasive Gynecol 2006; 13: 276–280. 12. Hye Won Kang JHL, Joong Sub C, Jeong Min E. Single-Port Laparoscopic Surgery Using Gelport Access for Cornual Pregnancy. J Laparoendosc Adv Surg Tech B Videoscopy 2011; 910: 2–3. 13. Snyder HS. Lack of a tachycardic response to hypotension with ruptured ectopic pregnancy. Am J Emerg Med 1990; 8: 23–26. 14. Shapiro HI, Adler DH. Excision of an ectopic pregnancy through the laparoscope. Am J Obstet Gynecol 1973; 117: 290– 291. 15. Korolija D, Sauerland S, Wood-Dauphinee S et al. Evaluation of quality of life after laparoscopic surgery: Evidence-based guidelines of the European Association for Endoscopic Surgery. Surg Endosc 2004; 18: 879–897. 16. Wheeless CR, Jr. An inexpensive laparoscopy system for female sterilization. Am J Obstet Gynecol 1975; 123: 727– 733. 17. Podolsky ER, Rottman SJ, Poblete H, King SA, Curcillo PG. Single port access (SPA) cholecystectomy: A completely transumbilical approach. J Laparoendosc Adv Surg Tech A 2009; 19: 219–222. 18. Yuen PM, Rogers MS, Chang A. A review of laparoscopy and laparotomy in the management of tubal pregnancy. Hong Kong Med J 1997; 3: 153–157. 19. Soriano D, Vicus D, Schonman R et al. Long-term outcome after laparoscopic treatment of heterotopic pregnancy: 19 cases. J Minim Invasive Gynecol 2010; 17: 321–324.
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doi:10.1111/jog.12595
J. Obstet. Gynaecol. Res. Vol. 41, No. 4: 590–595, April 2015
Prospective comparison of single port versus conventional laparoscopic surgery for ectopic pregnancy Min Kyung Kim1, Jeong Jin Kim1, Joong Sub Choi2, Jeong Min Eom3 and Jung Hun Lee4 1
Department of Obstetrics and Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Department of Obstetrics and Gynecology, College of Medicine, Hanyang University, 3Department of Obstetrics and Gynecology, National Medical Center, and 4Department of Obstetrics and Gynecology, MizMedi Hospital, Eulji University School of Medicine, Seoul, Korea 2
Abstract Aim: To investigate the feasibility and safety of single port laparoscopic surgery (SP-LS) for ectopic pregnancy, irrespective of type of ectopic pregnancy and hemodynamic stability. Methods: A prospective case–control study of 106 women who underwent SP-LS or conventional LS for a suspected ectopic pregnancy was performed at a university teaching hospital from January 2009 to March 2012. Twenty-six women underwent SP-LS (SP-LS group) and 80 women underwent conventional LS (conventional LS group). Results: There were no statistical differences between the groups in terms of demographic characteristics, operating time, hemoglobin change, return of bowel activity, hospital stay or complication rate. There were no cases of additional trocar use or conversion to laparotomy. Of five women with heterotopic pregnancy, one underwent SP-LS, and three underwent conventional LS for tubal pregnancy, which all resulted in vaginal delivery without obstetric complication; one woman received SP-LS for cornual pregnancy and had an ongoing pregnancy. Conclusion: SP-LS for ectopic pregnancy is feasible and safe regardless of the type of ectopic pregnancy and hemodynamic stability. However, further work is needed to confirm this conclusion and to demonstrate any advantage of SP-LS for ectopic pregnancy. Key words: ectopic pregnancy, gynecology, laparoscopy, single port surgery.
Introduction Laparoscopy has become the primary approach for the surgical management of ectopic pregnancy because of advantages over laparotomy, such as shorter hospitalization, earlier recovery, fewer adhesions and decreased blood loss.1,2 Single port laparoscopic surgery (SP-LS) has been utilized in various gynecologic fields according to the development of laparoscopic equipment and tech-
niques and the increasing demand for minimally invasive surgery.3–5 Although several studies of SP-LS for ectopic pregnancy have been reported, most of these studies were performed only in hemodynamically stable women with tubal pregnancy and excluded other types of ectopic pregnancy.6–9 The clinical usefulness of these prior studies is limited because of the difficulty in differentiating the type of ectopic pregnancy and the considerable rate of hemodynamic instability observed in this population.
Received: December 9 2013. Accepted: August 12 2014. Reprint request to: Professor Jung Hun Lee, Department of Obstetrics and Gynecology, MizMedi Hospital, Eulji University School of Medicine, 295 Gangseo-ro, Gangseo-gu, Seoul 157-723, Korea. Email: [email protected]
590
© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
SP-LS for ectopic pregnancy
To obtain more clinically relevant data, we evaluated the feasibility and safety of SP-LS for ectopic pregnancy regardless of the hemodynamic stability and the type of ectopic pregnancy.
Methods This prospective case–control study was performed at a university teaching hospital from January 2009 to March 2012. A total of 106 consecutive women with suspected ectopic pregnancy were enrolled in the study. These subjects did not meet the criteria for methotrexate treatment and were scheduled to undergo SP-LS or conventional laparoscopic surgery (conventional LS) for the suspected ectopic pregnancy, diagnosed by transvaginal ultrasonography and serum human chorionic gonadotropin. The criteria for medical treatment were as follows: (i) stable hemodynamic state; (ii) tubal mass less than 3.5 cm in diameter; (iii) absence of fetal heart beat; (iv) serum beta human chorionic gonadotropin level less than 15 000 mIU/ml; and (v) no refusal to be treated medically.10 Institutional review board approval was obtained at the Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine. After the study participants were informed of the advantages, disadvantages and limitations of SP-LS and conventional LS, each participant chose a procedure, which was then performed with her consent. Especially, compare with conventional LS, SP-LS has theoretical advantages (such as less wound complication, decreased postoperative pain, shorter hospital stay, faster recovery time and better cosmetic outcome) and disadvantages (such as technical difficulty, longer operating time, need for specialized instruments and rising medical cost caused by them). Also, there are limitations of SP-LS, but theoretical advantages and disadvantages of it are based on sparse data. Furthermore, the possibility of additional trocar use or conversion to laparotomy or conventional LS could be needed due to surgical difficulty. The choice of surgical modality was not influenced by the patient’s history of previous abdominal surgery, body mass index or hemodynamic instability. Single port laparoscopic surgery and conventional LS were performed by the same operative technique; the technical difference between the procedures was that SP-LS was performed using transumbilical GelPort access (Alexis; Applied Medical, Rancho Santa Margarita, CA, USA) and articulating instruments (Fig. 1).3,5,11 A 0-degree 5-mm telescope and bipolar
electrocoagulator were commonly used in both procedures. We performed a salpingectomy for tubal pregnancy in 95 cases, an ovarian wedge resection for ovarian pregnancy in seven cases and a cornual wedge resection for cornual pregnancy in four cases.12 Conventional LS was performed by two expert laparoscopists (C. J. S. and L. J. H.), and SP-LS was carried out by one surgeon (L. J. H.). The operating time was defined as the period from the skin incision to the skin closure; the return of bowel activity was defined as the period from the end of anesthesia to the first bowel gas passage; postoperative fever was defined as a body temperature equal to or
Figure 1 (a) Port placement and (b) intraoperative image of conventional laparoscopic surgery. (c) Port placement and (d) intraoperative image of single port laparoscopic surgery using transumbilical GelPort access (Alexis; Applied Medical, Rancho Santa Margarita, CA, USA), monopolar articulating Metzenbaum scissors (Autonomy Laparo-Angle; Cambridge Endo, Framingham, MA, USA), and articulating laparoscopic graspers (RealHand; Novare Surgical Systems, Cupertino, CA, USA).
© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
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M. K. Kim et al.
greater than 38°C on two consecutive occasions at least 6 h apart, except during the first 24 h; and hemodynamic instability was defined as systolic blood pressure less than 90 mmHg for at least 30 min.13 The gestational age was based on the last documented menstrual period. All cases of ectopic pregnancy were pathologically confirmed. Maximum visual analog scale postoperative day 1 pain scores were documented for all patients. The presence of adhesion was recorded if any adhesions were observed intraoperatively in the pelvic or bowel organs and if adhesiolysis was performed.
Statistical analyses The Shapiro–Wilk test was used to confirm that each variable did not follow a normal (Gaussian) distribution. An unpaired Student’s t-test was used to compare each group’s continuous parametric variables, and the Mann–Whitney U-test was used for non-parametric variables. The Pearson χ2-test and Fisher’s exact test were used to compare the categorical variables. P < 0.05 represented a significant difference. All analyses were performed using the SPSS version 18.0 for Windows (SPSS, Chicago, IL, USA).
Results During the study period, a total of 106 women were enrolled, which included 26 women who underwent
SP-LS (SP-LS group) and 80 women who underwent conventional LS (conventional LS group). There were no statistically significant differences in the clinical and ectopic pregnancy-related characteristics between the two groups (Table 1). No significant difference in operative results was observed between the groups (Table 2). However, maximum pain scores were significantly lower in the SP-LS group compared with the conventional LS group on postoperative day 1. All blood transfusions were done for women with hemodynamic instability or hemoglobin level less than 8 gm/dL preoperatively. Bladder laceration was an intraoperative complication in two women, repaired by primary laparoscopic closure in all these cases. No subjects required conversion to laparotomy or additional trocar insertion. Postoperative fever was resolved with conservative treatment in seven women. As shown in Table 3, there was no significant difference in operating time between the groups due to the presence of hemoperitoneum. However, when there was adhesion, a statistically significant longer operating time was observed in the SP-LS group compared with the conventional LS group (Table 3). Of the five women with heterotopic pregnancy, one underwent SP-LS, and three underwent conventional LS for tubal pregnancy, all resulting in vaginal delivery without obstetric complication; one woman who received SP-LS for cornual pregnancy had an ongoing pregnancy at the study conclusion (Table 4).
Table 1 Clinical and ectopic pregnancy related characteristics SP-LS group Conventional-LS group Median (range)/ no. of subjects (%) No. of patients Age (years) Parity Body mass index (kg/m2) No. of previous abdominal surgeries Duration of amenorrhea (days) Preoperative serum hCG level (mIU/ml) Number of patients who received ART IVF-ET IUI Ovulation induction Type of ectopic pregnancy Tubal pregnancy Cornual pregnancy Ovarian pregnancy Heterotopic pregnancy
26 32 (20–39) 0 (0–3) 20.13 (17.40–24.78) 0 (0–2) 42 (18–59) 6 870.5 (28.51–98 064) 15 (57) 12 (46.2) 2 (7.7) 1 (3.8)
80 31 (17–42) 0 (0–4) 20.93 (17.09–31.13) 0 (0–3) 42 (25–102) 67 53.5 (152.90–166 460) 33 (41) 26 (32.5) 4 (5.0) 3 (3.8)
P
0.759† 0.152‡ 0.189† 0.171‡ 0.602† 0.857‡ 0.143§
0.827§ 21 (80.8) 1 (3.8) 2 (7.7) 2 (7.7)
70 (87.5) 2 (2.5) 5 (6.3) 3 (3.8)
†By unpaired Student’s t-test. ‡By Mann–Whitney U-test. §By Pearson χ2-test. ART, assisted reproductive techniques; Conventional group, group who underwent conventional laparoscopically ectopic pregnancy operation; hCG, human chorionic gonadotropin; IUI, intrauterine insemination; IVF-ET, in vitro fertilization – embryo transfer; SP-LS group, group who underwent single port laparoscopically ectopic pregnancy operation.
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Table 2 Operative results
Presence of hemoperitoneum Presence of adhesions No. of patients with hemodynamic instability Operation time (min) Estimated blood loss (mL) Hemoglobin change (g/dL) No. of patients who needed transfusion Return of bowel activity (h) Hospital stay (days) Maximal pain score at POD 1 (VAS) Procedure for ectopic pregnancy Salpingectomy Ovarian wedge resection Cornual wedge resection Concurrent procedure Contralateral salpingectomy Laparoscopic fimbrioplasty Laparoscopic myomectomy Ovarian cystectomy Chromopertubation Dilatation and curettage Complications Total complications Intraoperative complications Bladder injury Postoperative complications Postoperative fever
SP-LS group Conventional LS group Median (range)/no. of subjects (%)
P
18 (69.2) 12 (46.2) 5 (19.2) 55 (30–110) 100 (20–350) 1.6 (0.6–2.6) 5 (19.2) 27.8 (14.2–55.9) 4.15 (1–8) 3 (1–7)
0.779† 0.368† 0.632† 0.051‡ 0.309‡ 0.883§ 0.470‡ 0.182§ 0.596‡ 0.032‡ 0.458†
53 (74.6) 29 (36.3) 19 (23.8) 50 (20–130) 100 (10–2000) 1.5 (0.1–3.6) 21 (26.3) 24.0 (9–68.2) 4.31 (3–10) 4 (1–7)
22 (84.6) 2 (7.7) 2 (7.7)
73 (91.3) 5 (6.3) 2 (2.5)
2 (7.7) 1 (3.8) 2 (7.7) 2 (7.7) 1 (3.8) 8 (30.8)
5 (6.3) 4 (5.0) 5 (6.3) 4 (5.0) 1 (1.3) 19 (23.8)
1 (3.8) 0 (0) 0 (0) 1 (3.8) 1 (3.8)
8 (10.0) 2 (2.5) 2 (2.5) 6 (7.5) 6 (7.5)
0.448¶
†By Pearson χ2-test. ‡By Mann–Whitney U-test. §By Student’s t-test. ¶By Fisher’s exact test. Conventional group, group who underwent conventional laparoscopically ectopic pregnancy operation; SP-LS group, group who underwent single port laparoscopically ectopic pregnancy operation; VAS, visual analog scale; POD, postoperative day.
Table 3 Comparison of operating time in the presence or absence of hemoperitoneum or adhesions
Presence of hemoperitoneum No (n = 8 vs 27) Yes (n = 18 vs 53) Presence of adhesions No (n = 14 vs 51) Yes (n = 12 vs 29)
SP-LS Conventional group LS group Operating time (min)
P
50 (35–100) 57.5 (30–110)
50 (20–120) 50 (25–130)
0.236† 0.113†
52.5 (35–110) 60 (30.0–100)
50 (20–130) 40 (25–90)
0.400† 0.042†
†By the Mann-Whitney U-test. Data are median (range). Conventional group, group who underwent conventional laparoscopically ectopic pregnancy operation; SP-LS group, group who underwent single port laparoscopically ectopic pregnancy operation.
Discussion More than three decades after Shapiro and Alder performed the first laparoscopic salpingectomy for ectopic pregnancy in 1973,14 laparoscopy, with the advancement of surgical techniques, has become
widely used for the surgical management of ectopic pregnancy with numerous benefits, including a faster recovery, less pain, decreased blood loss and a better quality of life postoperatively.15 SP-LS was first introduced by a group of gynecologists who used this approach to perform tubal ligations in the 1960s.16
© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
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M. K. Kim et al.
Table 4 Summary of women with heterotopic pregnancy Case no.
Age (years)
Mode of conception
Gestation (weeks)
Performed procedure
Operating time (min)
Obstetric outcome
1
36
IVF-ET
6
80
2
35
IVF-ET
8
3
36
IVF-ET
8
4
31
IVF-ET
5
5
35
IVF-ET
7
Conventional laparoscopic salpingectomy Single port laparoscopic salpingectomy Conventional laparoscopic salpingectomy Conventional laparoscopic salpingectomy Single port laparoscopic cornual wedge resection
Vaginal delivery at 37 weeks. Live female 3100 g. Vaginal delivery at 39 weeks. Live male 3300 g. Vaginal delivery at 38 weeks. Live female 3000 g. Vaginal delivery at 37 weeks. Live female 2900 g. Ongoing pregnancy at 12 weeks
35 45 60 95
IVF-ET, in vitro fertilization – embryo transfer.
Recently, the use of SP-LS has expanded in many gynecologic fields because of the minimized potential morbidity related to multiple trocar incisions and maximized cosmetic benefits with hidden scars compared to conventional LS.17 Despite the advantages of SP-LS, unstable vital signs, bowel obstruction or adhesion, previous operation history, hernia, massive hemoperitoneum and severe cardiopulmonary problems are frequently cited as contraindications for SP-LS.18 Previous studies on the technical feasibility and safety of SP-LS for ectopic pregnancy included only hemodynamically stable women with tubal pregnancies.3,7–9 However, hemoperitoneum and hemodynamic instability are frequently observed and the type of ectopic pregnancy may not be determined with certainty prior to surgery. Because of the exclusion of these groups, the clinical usefulness of these prior studies is limited. To overcome this limitation, this study included all women scheduled for surgery for ectopic pregnancy regardless of hemodynamic instability, type of ectopic pregnancy and previous abdominal surgery. As shown in Table 2, there were no significant differences in the operative results or complication rates between the SP-LS and conventional LS groups. Therefore, we conclude that SP-LS is feasible and safe in not only hemodynamically stable women with tubal pregnancy but also hemodynamically unstable women with other types of ectopic pregnancy. A longer operating time, a reported disadvantage of SP-LS, was not noted in the present study, which is consistent with a previous study on SP-LS for tubal pregnancy.8 Although various surgeries for ectopic pregnancy and concurrent procedures were included, this result is thought to be due to: (i) the accumulated experience of the participating surgeon; (ii) the sup-
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porting ability for inserted trocars and sufficient flexibility of the GelPort platform; and (iii) more than 80% of each group consisting of women with tubal pregnancies that did not require meticulous surgical technique, as observed in our previous report.5 However, as shown in Table 3, there was no difference in operating time between the groups based on the presence of hemoperitoneum, but there was a significant difference in operating time between the groups based on the presence of adhesion. Two of the women who underwent adhesiolysis in the SP-LS group had concurrent single port laparoscopic myomectomies, which might have contributed to an increased operating time. The difference in operating time between the groups based on the presence of adhesion was minor, with a P-value of 0.042. SP-LS may be considered a reasonable alternative to conventional LS for the surgical management of ectopic pregnancy, with a negligible increase in operating time expected in women with suspected intraperitoneal adhesions. Soriano et al. reported the outcomes of heterotopic pregnancy in 19 women who received conventional LS, which included first-trimester miscarriage in 13%, second-trimester miscarriage in 20%, preterm birth in 26.7% and term birth in 40%.19 Our study enrolled five women with heterotopic pregnancy; one woman underwent SP-LS and three women underwent conventional LS for tubal pregnancy, all resulting in vaginal deliveries without obstetrical complications. The remaining woman received SP-LS for cornual pregnancy and had an ongoing pregnancy at the study conclusion. Although no adverse outcomes were observed in these patients, more studies are needed on the safety and effectiveness of SP-LS for heterotopic pregnancy.
© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
SP-LS for ectopic pregnancy
In addition, only 25% of women with a suspected ectopic pregnancy underwent SP-LS during the study period. We used the GelPort system as the platform for SP-LS and SP-LS is inevitably accompanied by the increased medical cost because of this device (∼$US 800). It seems to be because the additional medical cost acted as a barrier to the choice of SP-LS that a small number of patients choose SP-LS.3 The advantages of this study include a prospective design that includes a relatively large number of patients, and improved clinical applicability of SP-LS for ectopic pregnancy by the inclusion of women with hemodynamic instability and various types of ectopic pregnancy, including ovarian, cornual and heterotopic pregnancy, which were not previously studied. Several limitations of the current study include that the study was: (i) not a large prospective randomized study; (ii) not able to assess decreased postoperative pain and improved cosmetic outcome, which are theoretical advantages of SP-LS, systematically; and (iii) not able to study a learning curve of SP-LS for ectopic pregnancy due to the variety of concurrent surgeries and types of ectopic pregnancy. Single port laparoscopic surgery is feasible and safe in women with ectopic pregnancy regardless of the type of ectopic pregnancy and hemodynamic stability. However, further work is needed to confirm this conclusion and to demonstrate any advantage of SP-LS for ectopic pregnancy.
Disclosure No competing financial interests exist.
References 1. Lim MC, Kim TJ, Kang S, Bae DS, Park SY, Seo SS. Embryonic natural orifice transumbilical endoscopic surgery (E-NOTES) for adnexal tumors. Surg Endosc 2009; 23: 2445– 2449. 2. Takacs P, Chakhtoura N. Laparotomy to laparoscopy: Changing trends in the surgical management of ectopic pregnancy in a tertiary care teaching hospital. J Minim Invasive Gynecol 2006; 13: 175–177. 3. Lee JH, Choi JS, Jeon SW, Son CE, Lee SJ, Lee YS. Single-port laparoscopic myomectomy using transumbilical GelPort access. Eur J Obstet Gynecol Reprod Biol 2010; 153: 81–84. 4. Lee JH, Choi JS, Hong JH, Joo KJ, Kim BY. Does conventional or single port laparoscopically assisted vaginal hysterectomy affect female sexual function? Acta Obstet Gynecol Scand 2011; 90: 1410–1415.
5. Lee JH, Choi JS, Jeon SW, Son CE, Hong JH, Bae JW. A prospective comparison of single-port laparoscopically assisted vaginal hysterectomy using transumbilical GelPort access and multiport laparoscopically assisted vaginal hysterectomy. Eur J Obstet Gynecol Reprod Biol 2011; 158: 294– 297. 6. Yoon BS, Park H, Seong SJ, Park CT, Park SW, Lee KJ. Singleport laparoscopic salpingectomy for the surgical treatment of ectopic pregnancy. J Minim Invasive Gynecol 2010; 17: 26–29. 7. Takeda A, Imoto S, Mori M, Nakano T, Nakamura H. Early experience with isobaric laparoendoscopic single-site surgery using a wound retractor for the management of ectopic pregnancy. Eur J Obstet Gynecol Reprod Biol 2011; 154: 209–214. 8. Yoon BS, Park H, Seong SJ, Park CT, Jun HS, Kim IH. Singleport versus conventional laparoscopic salpingectomy in tubal pregnancy: A comparison of surgical outcomes. Eur J Obstet Gynecol Reprod Biol 2011; 159: 190–193. 9. Bedaiwy MA, Escobar PF, Pinkerton J, Hurd W. Laparoendoscopic single-site salpingectomy in isthmic and ampullary ectopic pregnancy: Preliminary report and technique. J Minim Invasive Gynecol 2011; 18: 230–233. 10. Alleyassin A, Khademi A, Aghahosseini M, Safdarian L, Badenoosh B, Hamed EA. Comparison of success rates in the medical management of ectopic pregnancy with single-dose and multiple-dose administration of methotrexate: A prospective, randomized clinical trial. Fertil Steril 2006; 85: 1661–1666. 11. Choi JS, Kyung YS, Kim KH, Lee KW, Han JS. The four-trocar method for performing laparoscopically-assisted vaginal hysterectomy on large uteri. J Minim Invasive Gynecol 2006; 13: 276–280. 12. Hye Won Kang JHL, Joong Sub C, Jeong Min E. Single-Port Laparoscopic Surgery Using Gelport Access for Cornual Pregnancy. J Laparoendosc Adv Surg Tech B Videoscopy 2011; 910: 2–3. 13. Snyder HS. Lack of a tachycardic response to hypotension with ruptured ectopic pregnancy. Am J Emerg Med 1990; 8: 23–26. 14. Shapiro HI, Adler DH. Excision of an ectopic pregnancy through the laparoscope. Am J Obstet Gynecol 1973; 117: 290– 291. 15. Korolija D, Sauerland S, Wood-Dauphinee S et al. Evaluation of quality of life after laparoscopic surgery: Evidence-based guidelines of the European Association for Endoscopic Surgery. Surg Endosc 2004; 18: 879–897. 16. Wheeless CR, Jr. An inexpensive laparoscopy system for female sterilization. Am J Obstet Gynecol 1975; 123: 727– 733. 17. Podolsky ER, Rottman SJ, Poblete H, King SA, Curcillo PG. Single port access (SPA) cholecystectomy: A completely transumbilical approach. J Laparoendosc Adv Surg Tech A 2009; 19: 219–222. 18. Yuen PM, Rogers MS, Chang A. A review of laparoscopy and laparotomy in the management of tubal pregnancy. Hong Kong Med J 1997; 3: 153–157. 19. Soriano D, Vicus D, Schonman R et al. Long-term outcome after laparoscopic treatment of heterotopic pregnancy: 19 cases. J Minim Invasive Gynecol 2010; 17: 321–324.
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