- Email: [email protected]
Laparoscopic, minilaparoscopic, single-port and percutaneous hysterectomy: Comparison of perioperative outcomes of minimally invasive approaches in gynecologic surgery
Accepted Manuscript Title: LAPAROSCOPIC, MINILAPAROSCOPIC, SINGLE-PORT AND PERCUTANEOUS HYSTERECTOMY: COMPARISON OF PERIOPERATIVE OUTCOMES OF MINIMALLY INVASIVE APPROACHES IN GYNECOLOGIC SURGERY Authors: C. Rossitto, S. Cianci, S. Alletti Gueli, E. Perrone, S. Pizzacalla, G. Scambia PII: DOI: Reference:
S0301-2115(17)30360-3 http://dx.doi.org/doi:10.1016/j.ejogrb.2017.07.026 EURO 9996
To appear in:
EURO
Received date: Revised date: Accepted date:
7-2-2017 8-7-2017 17-7-2017
Please cite this article as: Rossitto C, Cianci S, Alletti Gueli S, Perrone E, Pizzacalla S, Scambia G.LAPAROSCOPIC, MINILAPAROSCOPIC, SINGLE-PORT AND PERCUTANEOUS HYSTERECTOMY: COMPARISON OF PERIOPERATIVE OUTCOMES OF MINIMALLY INVASIVE APPROACHES IN GYNECOLOGIC SURGERY.European Journal of Obstetrics and Gynecology and Reproductive Biology http://dx.doi.org/10.1016/j.ejogrb.2017.07.026 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Rossitto C. et Al.
LAPAROSCOPIC, MINILAPAROSCOPIC, SINGLE-PORT AND PERCUTANEOUS HYSTERECTOMY: COMPARISON OF PERIOPERATIVE OUTCOMES OF MINIMALLY INVASIVE APPROACHES IN GYNECOLOGIC SURGERY Rossitto C*., Cianci S*., Gueli Alletti S*., Perrone E.*, Pizzacalla S.*, Scambia G.* * Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Hearth, Rome, Italy. Corresponding Author Emanuele Perrone, MD Division of Gynecologic Oncology, Department of Obstetrics and Gynecology. Catholic University of the Sacred Heart. Electronic address: [email protected]. Precìs: The study confront the latest innovation in minimally invasive gynecologic surgery. The results show the advantages of ultra minimally invasive approach compared to standard laparoscopy. Disclosure: The authors declare no conflict of interests ABSTRACT
1
Rossitto C. et Al.
OBJECTIVES: During the last decade endoscopic surgical procedures have been constantly evolving. The latest innovation in ultra-minimally invasive surgery (MIS) is the percutaneous technology (Percuvance™ Percutaneous Surgical System (PSS), Teleflex Inc., USA). We compared surgical outcome of hysterectomy, in a retrospective cohort study using the most recent MIS techniques as single-site (LESS) surgery, 3mm laparoscopy (MiniLPS) and percutaneous system (PSS) with standard laparoscopy (LPS). STUDY DESIGN: This is a matched retrospective cohort study. Endometrial Hyperplasia/Early stage endometrial cancer or benign pathology were the indication for surgery. Data of laparoscopic hysterectomies performed between May 2013 and April 2016 using PSS, LPS, MiniLPS, and LESS were collected and compared. RESULTS: The characteristics of each group were similar. The median Operative time (OT) was significantly longer in LESS compared to all other groups (120 minutes [range 55–165] in LESS, 91 minutes [range 60180] in MiniLPS, 70 minutes [range 55-230] in LPS and 65 [range 40-180] in PSS; p = 0.0001). No significant differences among the 4 groups were observed in terms of estimated blood loss, conversion to laparoscopy or laparotomy, and intra e post-operative complications. Statistically significant differences were recorded in median VAS 24h (2 [range 0 – 3]
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in PSS, 2 [range 0 – 3] in MiniLPS, 3 [range 2 – 5] in LESS and 2 [range 1 – 5] in LPS; p = 0.0001). The average time of discharge was (1 day [range 1 – 3] in PSS, 1 day [range 1 – 2] in MiniLPS, 1 days [range 1 – 2] in LESS and 1 day [range 1 – 3] in LPS; p = 0.99). CONCLUSIONS: Data show that the effort to minimize the impact of surgical invasiveness can be feasible and could improve the advantages, not only in terms of aesthetic outcomes, even if the differences among the endoscopic approaches have not a relevant clinical impact. The technology innovations like PSS maintain the same triangulation between instruments as standard LPS with an evident decrease of the invasiveness thanks to reduced instruments size, even if the lack of suitability of bipolar energy, that require a multifunction instrument, remain a limit of these instruments. Keywords:
minimally invasive surgery (MIS); hysterectomy; LESS;
Percutaneous instruments; mini-laparoscopy; laparoscopy; gynecology.
3
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INTRODUCTION It is widely recognized that laparoscopy is superior to laparotomy for several gynecological procedures (1). The benefits of endoscopic procedures are mainly related with reduced hospitalization, post-operative pain, complications rate and consequently a consistent improvement in the patient’s quality of life (2,3). Current surgical innovations in minimally invasive surgery (MIS) focus on invasiveness reduction trough the reduction of the ports number or instruments size, but still maintaining the same surgical techniques, efficacy and safety of standard laparoscopy (LPS). The endoscopic singlesite (LESS) surgery and 3mm laparoscopy (MiniLPS) were the principal innovations of the last years. Literature data reporting about these MIS techniques demonstrated a significant reduction of post-operative pain, better aesthetic outcomes and reduction of visceral trauma and port-site hernias (4-9). So far, the last innovation is the ultra-MIS with the assistance of percutaneous instruments (Percuvance™ Percutaneous Surgical System (PSS), Teleflex Inc., USA). PSS allows the surgeon to use laparoscopic instruments, with a less than 3 mm wide diameter, that are percutaneously introduced into the abdomen without trocars. Limits of 3 mm devices in manipulating tissues are overcome in PSS, thanks to the 5 mm operative
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tip that is afterwards locked to the instrument through a 5 mm suprapubic trocar, mimicking standard laparoscopic setting in terms of instruments triangulation and tips dimensions (10, 11). The aim of this study is to compare the most recent MIS techniques (LESS, MiniLPS and PSS) with standard laparoscopy considering perioperative outcomes and complications associated to hysterectomy. MATERIALS AND METHODS This is a matched retrospective cohort study carried out at the Division of Gynecologic Oncology of the “Policlinico A. Gemelli” Foundation of the Catholic University in Rome. The Internal Department Committee approved this study. For the purposes of the study we compared results of total laparoscopic hysterectomy performed between May 2013 and April 2016 using different endoscopic approaches including standard laparoscopy, PSS, MiniLPS, and LESS. The cohort was retrospectively selected, collecting data from our internal electronic database, among patients with overlapping characteristics in terms of performed procedures and clinical features. Endometrial Hyperplasia/Early stage endometrial cancer or benign gynecologic pathology were the indication for surgery.
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The following inclusion criteria were considered in the recruitment of patients undergoing total laparoscopic hysterectomy: no absolute contraindication to LPS (i.e. anesthetic contraindication , inability to tolerate Trendelemburg position or endoabdominal raised pressure throughout all the surgical procedure) , uterine size lower than 16 12 weeks pregnancy (corresponding to 1390 g), no previous major laparotomic abdominal surgery , and informed consent signed by the patient before the procedure took place. Preoperative workup included bimanual pelvic examination and ultrasound pelvic scan. Magnetic resonance (MRI) or computed tomography (CT) were performed if required. All hysterectomies were performed by surgeons with high expertise in gynecologic endoscopic procedures. Operative time (OT) was defined as time intercurrent between the skin incision and the skin suture. Perioperative complications were recorded according to Clavien-Dindo classification (12). Postoperative pain was quantified using the visual analogue scale (VAS) and recorded at 24 hours after the surgery. The management of all patients included the same standardized anesthetic protocol during surgery, and postoperative analgesic therapy (Paracetamol 1000 mg) was administered only if needed, according to patients
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requirement. Patients were discharged only if they recovered full mobility and an acceptable bladder function and without fever. Surgical techniques The surgical technique usually adopted in our Institution for laparoscopic hysterectomy, was considered the standard and replicated in each MIS approach independently by the instrument used. LPS hysterectomy LPS hysterectomy was performed using a transumbilical 10-mm port and three 5-mm suprapubic ancillary ports. A 10-mm 0-HD endoscope (EndoEYE, Olympus Winter and Ibe GmbH, Hamburg, Germany) and standard laparoscopic instruments were utilized, choosing among graspers, cold scissors, suction/irrigation, bipolar coagulator, monopolar hook (Figure 1). For all procedures an intrauterine manipulator was used (Clermont Ferrand uterine manipulator, Karl Storz, Tuttlingen, Germany). First step was coagulation and section of round ligaments to enter into the retroperitoneal space, to identify the ureters and close both uterine arteries at their origin with endoclips. The infundibulopelvic ligaments were subsequently coagulated and transected. The vesico-uterine and vesicovaginal peritoneum were dissected starting from lateral to medial. These surgical steps allow an excellent skeletonization of the corporal branch of uterine vessels, that were cauterized and sectioned. The vagina was incised
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circumferentially with monopolar hook following the porcelain-valve of the uterine manipulator as a guide. Uterus and adnexa were extracted through the vagina. The vaginal vault was closed with a running suture by laparoscopic or vaginal approach with 0 Vicryl. LESS hysterectomy Surgical procedure was performed using a multichannel single trocar (TriPort, Olympus Winter and Ibe GmbH, Hamburg, Germany) inserted in the umbilicus using an open technique (1.5–2-cm cutaneous incision) (13). Once
achieved
pneumoperitoneum
(12
mmHg),
intra-abdominal
visualization was obtained with a 0°5-mm telescope using a flexible tip (EndoEYE, Olympus Winter and Ibe GmbH, Hamburg, Germany) (Figure 2). Working straight 5-mm instruments were inserted into the remaining two ports, choosing among graspers, cold scissors, suction/irrigation bipolar coagulator, monopolar hook and a multifunctional versatile laparoscopic device, which simultaneously grasps, coagulates, and transects (PKS cutting forceps, 5 mm–43 cm, Olympus Winter & Ibe GmbH, Hamburg, Germany). To prevent the instruments from clashing with the surgeon hands and to ease surgical maneuvers, the combination of a 33-cm-long instrument with a 43-cm-long instrument was adopted. The umbilical fascia was closed with a figure-of-eight 0-Vicryl. MiniLPS hysterectomy
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MiniLPS was performed using one optical transumbilical 5-mm trocar (Endopath Xcel 5-mm Optiview, Ethicon Endo-Surgery, Cincinnati, OH) and three 3-mm suprapubic ancillary ports (Karl Storz Endoscope -3-mm trocar set). A 5-mm 0°endoscope (EndoEYE, Olympus Winter & Ibe GmbH, Hamburg, Germany) and 3-mm laparoscopic instruments (Karl Storz Endoscope -3-mm instrument set) were utilized, choosing among graspers, cold scissors, suction/irrigation, monopolar hook and bipolar coagulator (PK 3 mm, Olympus Winter & Ibe GmbH, Hamburg, Germany) (Figure 3). PSS-hysterectomy Once pneumoperitoneum (12 mmHg) was achieved, intra-abdominal visualization was obtained with a 0° 10mm telescope (EndoEye, Olympus Winter & IBE GMBH, Germany). A 5mm standard trocar is placed in suprapubic position. Two needlescopic PSS instruments were used as side graspers for both the first surgeon and the assistant. The Percuvance™ shaft (Percuvance™ Percutaneous Surgical System, Teleflex Inc., USA.) was percutaneously inserted using the specific Veress-like introducer. PSS was introduced from insight to outsight through the supra pubic 5 mm trocar to change the needle tip to a grasper (14). The use of 5 mm tool warranty the same grasping capacity. The 5 mm ancillary suprapubic port was used for a suction/irrigation device, monopolar hook, endoclips
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applicator and multifunctional instrument (Thunderbeat, Olympus Winter & IBE GMBH, Hamburg , Germany) to overcome the absence of bipolar energy for PSS. (Figure 4). Statistical analysis Considering an equivalence test on data from parallel-group designed with sample size of 25 per group. Achieves 83% power of statistics at a 5% significance level when the two difference between the median is 0.75, the standard deviation is 1 and the equivalence limits are 0 and 5. The statistical analysis was conducted to verify any differences among the 4 groups (PSS, MiniLPS, LPS and LESS). From the Shapiro Wilk test we checked that all continuous variables are not distributed according to a normal, so we can use the non-parametric approach. The Kruskall Wallis test and χ2 test were performed if appropriated. Probability (p) values were considered to be statistically significant for a <0.5 value. STATA Data Analysis and Statistical Software, version 14 (StataCorp LP, College Station, TX) was used for all the analyses. RESULTS The 4 groups were comparable for median age, body mass index, previous abdominal surgery and indication for surgery. As reported in Table 1,
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patients characteristics are not statistically different in the 4 groups for median age, median BMI and previous abdominal surgery. The analysis of perioperative outcomes is showed in Table 2. The median OT was significantly longer in LESS rather than all the other groups (120 minutes [range 55–165] in LESS, 91 minutes [range 60-180] in MiniLPS, 70 minutes [range 55-230] in LPS and 65 [range 40-180] in PSS; p = 0.0001). There were no significant differences between the 4 groups in terms of estimated blood loss, median uterus weight, conversion to laparoscopy, conversion to laparotomy, intraoperative complications and median ileus. Median VAS 24h was 2 [range 0 – 3] in PSS, 2 [range 0 – 3] in MiniLPS, 3 [range 2 – 5] in LESS and 2 [range 1 – 5] in LPS (p = 0.0001). This statistical result seems suggest that the post-operative pain is lower in LESS and PSS cohort. However, event if the VAS score is similar for all procedures, the significance is related with the small number of sample size and the VAS range. This data need a larger population sample to be confirmed. The median discharge time was 1 day [range 1 – 3] in PSS, 1 day [range 1 – 2] in MiniLPS, 1 days [range 1 – 2] in LESS and 1 day [range 1 – 3] in LPS (p = 0.99).
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DISCUSSION The current trend of endoscopy is to minimize progressively the invasiveness but still maintaining safety and surgical effectiveness, optimizing surgical outcomes, improving cosmetic impact. So far, latest innovations in this field were LESS and Mini-LPS consisting in the use of single access trocar and 3 mm trocar respectively: both have been widely compared with the standard laparoscopy and their main advantages and limits are nowadays well known (15-17). In LESS surgery, the main limit is the absence of instruments triangulation. This alteration of surgeon ergonomics is often related with an increased surgical time. A main characteristic in the mini-laparoscopic approach is the maintenance of the surgical field triangulation but, in the same time, the reduced size of operative surface of the instruments jaw can sometimes create difficulties in traction of tissues. Moreover the 3 mm bipolar grasper sometimes does not allow the same performance of standard bipolar instruments (18). We recently published a pilot study (14) demonstrating the surgical feasibility of hysterectomy using the PSS. These instruments as previously specified, overcome the limits of other approaches thanks to the 5 mm jaws and the maintenance of surgical instrument triangulation. Furthermore, the
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absence of trocars and the smallest size of these devices, compared with other technologies, could reduce the aesthetic impact. Here we present the first study comparing the different minimally invasive approaches actually available in Gynecological surgery. The operative time was significantly longer in LESS group while the PSS group reported the shortest surgical time. This last finding was probably due to the fact that in all PSS procedures we used a multifunction instrument to overcome the absence of energy in the percutaneous devices and therefore we also reduced the changing of instruments normally performed during a surgical procedure. Consequently the operative time could have an impact to the post-operative pain [19]. At the same time, the size of grasper jaws allowed the necessary tractions during the surgical steps permitting in all cases the maintenance of standard surgical setting. Thanks to this configuration all surgeons involved in PSS procedures, did not report any difference or discomfort compared to standard laparoscopy. Longer operative time of MiniLPS group is probably linked to the 3mm “specific limited size performances”. Another important data is the very low rate of conversion to standard laparoscopy or laparotomy for all groups. In PSS and LPS groups two cases of service transverse suprapubic minilaparotomy (< 5 cm) were recorded to extract the high weight specimens
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(1360 gr in PSS and 468 gr in LPS): after the hysterectomy the uterus was inserted into an endobag to avoid intra-abdominal spreading. No perioperative complications were recorded in PSS group and it could represent a promising result. In LESS group only one intraoperative complication was recorded: a small lesion of the bladder posterior wall occurred during the dissection of vesico-vaginal space in a two-previous cesarean section patient. The complication was managed maintaining the same approach, with a 3/0 vicryl single stich. The discharge time were not statistically significant among different groups, however the post-operatory pain recorded at 24 hours (VAS) was statistically significant lower in PSS and LESS groups. Anyway even if more studies are needed to affirm that some techniques are better then others, the results reported in our study suggest that PSS and LESS surgery could furnish more benefits in terms of post operatory pain and cosmetic outcomes. Moreover in LESS and PSS groups the reduction of painkillers administration were recorded even if did not affect the clinical outcomes. In conclusion, our study demonstrates that, even if the differences among the endoscopic approaches have not a relevant clinical impact, the further reduction of surgical invasiveness is feasible and could improve the advantages of using endoscopy for hysterectomy, not only in term of aesthetic outcomes.
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This aspect could be opening new frontiers in the reduction of invasiveness maintaining the same standard laparoscopic configuration, allowing to perform even complex procedures with these innovative instruments. The maintained triangulation between instruments and tissues is an important key point that contributes to faster surgical procedures. Even though technical improvements should be achieved, such as the bipolar energy, the new PSS technology represents a new important step in the world of Minimally Invasive Surgery.
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REFERENCE 1. Johnson N, Barlow D, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2006;CD003677. 2. Johnson N, Barlow D, Lethaby A, et al. Methods of hysterectomy: systematic review and meta-analysis of randomised controlled trials. BMJ. 2005. 330(7506):1478. 3. Kluivers KB, Johnson NP, Chien P,et al. Comparison of laparoscopic and abdominal hysterectomy in terms of quality of life: a systematicreview. Eur J Obstet Gynecol Reprod Biol. 2008 136:3–8. 4. Fanfani F, Fagotti A, Gagliardi ML, et al. Minilaparoscopic Versus Single-Port Total Hysterectomy:A Randomized Trial. J Minim Invasive Gynecol. 2013. 20(2):192-7. 5. Fagotti A, Bottoni C, Vizzielli G, et al. Postoperative pain after conventional laparoscopy and laparoendoscopic single site surgery (LESS) for benign adnexal disease: a randomized trial. Fertil Steril. 2011. 96:255–259 6. Hosono S, Osaka H. Minilaparoscopic versus conventional laparoscopic cholecystectomy: a meta-analysis of randomized controlled trials. J Laparoendosc Adv Surg Tech A. 2007. 17:191–199 7. Yim GW, Jung YW, Paek J, et al. Transumbilical single-port access versus conventional total laparoscopic hysterectomy: surgical outcomes. Am J Obstet Gynecol. 2010. 203:26. 8. Kim TJ, Lee YY, Cha HH, et al. Single-port-access laparoscopic-assisted vaginal hysterectomy versus conventional laparoscopic-assisted vaginal hysterectomy: a comparison of perioperative outcomes. Surg Endosc. 2010. 24:2248–2252. 9. Jung YW, Lee M, Yim GW, et al. A randomized prospective study of single-port and fourport approaches for hysterectomy in terms of postoperative pain. Surg Endosc. 2011. 25:2462–2469. 10. Rossitto C, Gueli Alletti S, Costantini B, et al. Total Laparoscopic Hysterectomy with percutaneous (PERCUVANCE tm) instruments: new frontier of minimally invasive gynecological surgery. J Minim Invasive Gynecol. 2015. DOI: 10.1016/j.jmig.2015.09.004, Sep 16,2015. 11. Gueli Alletti S, Rossitto C, Perrone E, et al. Needleoscopic Conservative Staging Of Borderline Ovarian Tumor. J Minim Invasive Gynecol.. pii: S1553-4650(16)31151-7. doi: 10.1016/j.jmig.2016.10.009. Oct 27 2016 [Epub ahead of print] 12. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. 13. 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. 37:1085–1092 14. Rossitto C, Gueli Alletti S, Rotolo S, et al. Total laparoscopic hysterectomy using a percutaneous surgical system: a pilot study towards scarless surgery. Eur J Obstet Gynecol Reprod Biol. 2016. 203:132-135.
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15. Hart S, Yeung P Jr, Sobolewski CJ. Laparo-endoscopic single site hysterectomy in gynecologic surgery. Surg Technol Int. 2010. 20:195-206. 16. Corrado G, Fanfani F, Ghezzi F, et al. Mini-laparoscopic versus robotic radical hysterectomy plus systematic pelvic lymphadenectomy in early cervical cancer patients. A multi-institutional study. Eur J Surg Oncol. 2015. 41(1):136-41. 17. Paek J, Kim S, Lee S, et al. Learning curve and surgical outcome for single-port access total laparoscopic hysterectomy in 100 consecutive cases. Gynecol Obstet Invest. 2011. 72:227–233. 18. Fanfani F, Fagotti A, Rossitto C, et al. Laparoscopic, mini-laparoscopic and single-port hysterectomy: peri-operative outcomes. Surg Endosc. 2012; 26:3592–3596. 19. Fagotti A, Vizzielli G, Fanfani F, Gallotta V, Rossitto C, Costantini B, Gueli-Alletti S, Avenia N, Iodice R, Scambia G. Randomized study comparing use of THUNDERBEAT technology vs standard electrosurgery during laparoscopic radical hysterectomy and pelvic lymphadenectomy for gynecologic cancer. J Minim Invasive Gynecol. 2014 May-Jun;21(3):447-53. FIGURE 1: Standard laparoscopy FIGURE 2: single site laparoscopy FIGURE 3: mini‐laparoscopy FIGURE 4: percutaneous surgical system Figr‐1
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Figr‐2
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Figr‐3
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Figr‐4
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TABLE 1: Patients Baseline Characteristics and indication for surgery, comparison of PSS, mini-LPS, LESS, LPS
Patients Baseline Characteristics
Number of patients AGE (year), median (range) BMI, median (range) Previous Abdominal Surgery, n (%) Indication for surgery , n (%)
PSS 25 51 (32 ‐ 72) 23 (18 ‐ 37,9) 12 (48 %)
Endometrial Hyperplasia/Early stage endometrial cancer
20 (%)
MiniLPS 25 50 (39 ‐ 70) 23 (20 ‐ 33) 11 (44 %) 19 (%)
Benign pathology
5 (%)
6 (0%)
LESS 25 55 (37‐ 68) 23 (16,5 ‐ 30) 12 (48 %) 20 (%) 5 (%)
L 2 52 (34 24,3 (18 12 (4
21
TABLE 2: Surgical procedures, perioperative outcomes, and post‐operative complications. Comparison of PSS, mini-LPS, LESS, LPS.
Perioperative outcomes Operative Time (min), median (range) EBL (ml), median (range)
PSS
MiniLPS
LESS
LPS
p value
65 (40 ‐ 180) 20 (10 ‐ 100)
91 (60 ‐ 180) 30 (10 ‐ 200)
120 (55 ‐ 165) 30 (10 ‐ 300)
70 (55 ‐ 230) 30 (0 ‐ 200)
p = 0.0001 p = 0.33
22
4
Uterus weight (gr) 140 (60 – median (range) 1360) Hysterectomy + BSO , 25 (100) n (%) Conversion to 0 (0) Laparoscopy Conversion to 1 (4) Laparotomy Intraoperative 0 (0) complications Ileus (h), median 12 (8 ‐ 24) (range) VAS 24h (h), median 2 (0 ‐ 3) (range) 30‐days 0 (0) complications 24 (24‐ Discharge time 72) (hours), median (range)
Rossitto C. et Al.
110 (59 – 250) 25 (100)
99 (56 – 190) 25 (100)
121 (69 – 468) 25 (100)
p = 0.10
1 (4)
2 (8)
_
p = 0.41
0 (0)
0 (0)
1 (4)
p = 0.56
0 (0)
1 (4)
0 (0)
p = 0.39
12 (8 ‐ 48)
12 (8 ‐ 48) 2 (1 ‐ 5)
p = 0.08
2 (0 ‐ 3)
12 (8 ‐ 48) 3 (2 ‐ 5)
0 (0)
0 (0)
0 (0)
24 (24‐48)
24 (24‐ 48)
24 (24‐ 72)
‐
p = 0.0001 ‐ p = 0.99
23
S0301-2115(17)30360-3 http://dx.doi.org/doi:10.1016/j.ejogrb.2017.07.026 EURO 9996
To appear in:
EURO
Received date: Revised date: Accepted date:
7-2-2017 8-7-2017 17-7-2017
Please cite this article as: Rossitto C, Cianci S, Alletti Gueli S, Perrone E, Pizzacalla S, Scambia G.LAPAROSCOPIC, MINILAPAROSCOPIC, SINGLE-PORT AND PERCUTANEOUS HYSTERECTOMY: COMPARISON OF PERIOPERATIVE OUTCOMES OF MINIMALLY INVASIVE APPROACHES IN GYNECOLOGIC SURGERY.European Journal of Obstetrics and Gynecology and Reproductive Biology http://dx.doi.org/10.1016/j.ejogrb.2017.07.026 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Rossitto C. et Al.
LAPAROSCOPIC, MINILAPAROSCOPIC, SINGLE-PORT AND PERCUTANEOUS HYSTERECTOMY: COMPARISON OF PERIOPERATIVE OUTCOMES OF MINIMALLY INVASIVE APPROACHES IN GYNECOLOGIC SURGERY Rossitto C*., Cianci S*., Gueli Alletti S*., Perrone E.*, Pizzacalla S.*, Scambia G.* * Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Hearth, Rome, Italy. Corresponding Author Emanuele Perrone, MD Division of Gynecologic Oncology, Department of Obstetrics and Gynecology. Catholic University of the Sacred Heart. Electronic address: [email protected]. Precìs: The study confront the latest innovation in minimally invasive gynecologic surgery. The results show the advantages of ultra minimally invasive approach compared to standard laparoscopy. Disclosure: The authors declare no conflict of interests ABSTRACT
1
Rossitto C. et Al.
OBJECTIVES: During the last decade endoscopic surgical procedures have been constantly evolving. The latest innovation in ultra-minimally invasive surgery (MIS) is the percutaneous technology (Percuvance™ Percutaneous Surgical System (PSS), Teleflex Inc., USA). We compared surgical outcome of hysterectomy, in a retrospective cohort study using the most recent MIS techniques as single-site (LESS) surgery, 3mm laparoscopy (MiniLPS) and percutaneous system (PSS) with standard laparoscopy (LPS). STUDY DESIGN: This is a matched retrospective cohort study. Endometrial Hyperplasia/Early stage endometrial cancer or benign pathology were the indication for surgery. Data of laparoscopic hysterectomies performed between May 2013 and April 2016 using PSS, LPS, MiniLPS, and LESS were collected and compared. RESULTS: The characteristics of each group were similar. The median Operative time (OT) was significantly longer in LESS compared to all other groups (120 minutes [range 55–165] in LESS, 91 minutes [range 60180] in MiniLPS, 70 minutes [range 55-230] in LPS and 65 [range 40-180] in PSS; p = 0.0001). No significant differences among the 4 groups were observed in terms of estimated blood loss, conversion to laparoscopy or laparotomy, and intra e post-operative complications. Statistically significant differences were recorded in median VAS 24h (2 [range 0 – 3]
2
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in PSS, 2 [range 0 – 3] in MiniLPS, 3 [range 2 – 5] in LESS and 2 [range 1 – 5] in LPS; p = 0.0001). The average time of discharge was (1 day [range 1 – 3] in PSS, 1 day [range 1 – 2] in MiniLPS, 1 days [range 1 – 2] in LESS and 1 day [range 1 – 3] in LPS; p = 0.99). CONCLUSIONS: Data show that the effort to minimize the impact of surgical invasiveness can be feasible and could improve the advantages, not only in terms of aesthetic outcomes, even if the differences among the endoscopic approaches have not a relevant clinical impact. The technology innovations like PSS maintain the same triangulation between instruments as standard LPS with an evident decrease of the invasiveness thanks to reduced instruments size, even if the lack of suitability of bipolar energy, that require a multifunction instrument, remain a limit of these instruments. Keywords:
minimally invasive surgery (MIS); hysterectomy; LESS;
Percutaneous instruments; mini-laparoscopy; laparoscopy; gynecology.
3
Rossitto C. et Al.
INTRODUCTION It is widely recognized that laparoscopy is superior to laparotomy for several gynecological procedures (1). The benefits of endoscopic procedures are mainly related with reduced hospitalization, post-operative pain, complications rate and consequently a consistent improvement in the patient’s quality of life (2,3). Current surgical innovations in minimally invasive surgery (MIS) focus on invasiveness reduction trough the reduction of the ports number or instruments size, but still maintaining the same surgical techniques, efficacy and safety of standard laparoscopy (LPS). The endoscopic singlesite (LESS) surgery and 3mm laparoscopy (MiniLPS) were the principal innovations of the last years. Literature data reporting about these MIS techniques demonstrated a significant reduction of post-operative pain, better aesthetic outcomes and reduction of visceral trauma and port-site hernias (4-9). So far, the last innovation is the ultra-MIS with the assistance of percutaneous instruments (Percuvance™ Percutaneous Surgical System (PSS), Teleflex Inc., USA). PSS allows the surgeon to use laparoscopic instruments, with a less than 3 mm wide diameter, that are percutaneously introduced into the abdomen without trocars. Limits of 3 mm devices in manipulating tissues are overcome in PSS, thanks to the 5 mm operative
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tip that is afterwards locked to the instrument through a 5 mm suprapubic trocar, mimicking standard laparoscopic setting in terms of instruments triangulation and tips dimensions (10, 11). The aim of this study is to compare the most recent MIS techniques (LESS, MiniLPS and PSS) with standard laparoscopy considering perioperative outcomes and complications associated to hysterectomy. MATERIALS AND METHODS This is a matched retrospective cohort study carried out at the Division of Gynecologic Oncology of the “Policlinico A. Gemelli” Foundation of the Catholic University in Rome. The Internal Department Committee approved this study. For the purposes of the study we compared results of total laparoscopic hysterectomy performed between May 2013 and April 2016 using different endoscopic approaches including standard laparoscopy, PSS, MiniLPS, and LESS. The cohort was retrospectively selected, collecting data from our internal electronic database, among patients with overlapping characteristics in terms of performed procedures and clinical features. Endometrial Hyperplasia/Early stage endometrial cancer or benign gynecologic pathology were the indication for surgery.
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The following inclusion criteria were considered in the recruitment of patients undergoing total laparoscopic hysterectomy: no absolute contraindication to LPS (i.e. anesthetic contraindication , inability to tolerate Trendelemburg position or endoabdominal raised pressure throughout all the surgical procedure) , uterine size lower than 16 12 weeks pregnancy (corresponding to 1390 g), no previous major laparotomic abdominal surgery , and informed consent signed by the patient before the procedure took place. Preoperative workup included bimanual pelvic examination and ultrasound pelvic scan. Magnetic resonance (MRI) or computed tomography (CT) were performed if required. All hysterectomies were performed by surgeons with high expertise in gynecologic endoscopic procedures. Operative time (OT) was defined as time intercurrent between the skin incision and the skin suture. Perioperative complications were recorded according to Clavien-Dindo classification (12). Postoperative pain was quantified using the visual analogue scale (VAS) and recorded at 24 hours after the surgery. The management of all patients included the same standardized anesthetic protocol during surgery, and postoperative analgesic therapy (Paracetamol 1000 mg) was administered only if needed, according to patients
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requirement. Patients were discharged only if they recovered full mobility and an acceptable bladder function and without fever. Surgical techniques The surgical technique usually adopted in our Institution for laparoscopic hysterectomy, was considered the standard and replicated in each MIS approach independently by the instrument used. LPS hysterectomy LPS hysterectomy was performed using a transumbilical 10-mm port and three 5-mm suprapubic ancillary ports. A 10-mm 0-HD endoscope (EndoEYE, Olympus Winter and Ibe GmbH, Hamburg, Germany) and standard laparoscopic instruments were utilized, choosing among graspers, cold scissors, suction/irrigation, bipolar coagulator, monopolar hook (Figure 1). For all procedures an intrauterine manipulator was used (Clermont Ferrand uterine manipulator, Karl Storz, Tuttlingen, Germany). First step was coagulation and section of round ligaments to enter into the retroperitoneal space, to identify the ureters and close both uterine arteries at their origin with endoclips. The infundibulopelvic ligaments were subsequently coagulated and transected. The vesico-uterine and vesicovaginal peritoneum were dissected starting from lateral to medial. These surgical steps allow an excellent skeletonization of the corporal branch of uterine vessels, that were cauterized and sectioned. The vagina was incised
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circumferentially with monopolar hook following the porcelain-valve of the uterine manipulator as a guide. Uterus and adnexa were extracted through the vagina. The vaginal vault was closed with a running suture by laparoscopic or vaginal approach with 0 Vicryl. LESS hysterectomy Surgical procedure was performed using a multichannel single trocar (TriPort, Olympus Winter and Ibe GmbH, Hamburg, Germany) inserted in the umbilicus using an open technique (1.5–2-cm cutaneous incision) (13). Once
achieved
pneumoperitoneum
(12
mmHg),
intra-abdominal
visualization was obtained with a 0°5-mm telescope using a flexible tip (EndoEYE, Olympus Winter and Ibe GmbH, Hamburg, Germany) (Figure 2). Working straight 5-mm instruments were inserted into the remaining two ports, choosing among graspers, cold scissors, suction/irrigation bipolar coagulator, monopolar hook and a multifunctional versatile laparoscopic device, which simultaneously grasps, coagulates, and transects (PKS cutting forceps, 5 mm–43 cm, Olympus Winter & Ibe GmbH, Hamburg, Germany). To prevent the instruments from clashing with the surgeon hands and to ease surgical maneuvers, the combination of a 33-cm-long instrument with a 43-cm-long instrument was adopted. The umbilical fascia was closed with a figure-of-eight 0-Vicryl. MiniLPS hysterectomy
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MiniLPS was performed using one optical transumbilical 5-mm trocar (Endopath Xcel 5-mm Optiview, Ethicon Endo-Surgery, Cincinnati, OH) and three 3-mm suprapubic ancillary ports (Karl Storz Endoscope -3-mm trocar set). A 5-mm 0°endoscope (EndoEYE, Olympus Winter & Ibe GmbH, Hamburg, Germany) and 3-mm laparoscopic instruments (Karl Storz Endoscope -3-mm instrument set) were utilized, choosing among graspers, cold scissors, suction/irrigation, monopolar hook and bipolar coagulator (PK 3 mm, Olympus Winter & Ibe GmbH, Hamburg, Germany) (Figure 3). PSS-hysterectomy Once pneumoperitoneum (12 mmHg) was achieved, intra-abdominal visualization was obtained with a 0° 10mm telescope (EndoEye, Olympus Winter & IBE GMBH, Germany). A 5mm standard trocar is placed in suprapubic position. Two needlescopic PSS instruments were used as side graspers for both the first surgeon and the assistant. The Percuvance™ shaft (Percuvance™ Percutaneous Surgical System, Teleflex Inc., USA.) was percutaneously inserted using the specific Veress-like introducer. PSS was introduced from insight to outsight through the supra pubic 5 mm trocar to change the needle tip to a grasper (14). The use of 5 mm tool warranty the same grasping capacity. The 5 mm ancillary suprapubic port was used for a suction/irrigation device, monopolar hook, endoclips
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applicator and multifunctional instrument (Thunderbeat, Olympus Winter & IBE GMBH, Hamburg , Germany) to overcome the absence of bipolar energy for PSS. (Figure 4). Statistical analysis Considering an equivalence test on data from parallel-group designed with sample size of 25 per group. Achieves 83% power of statistics at a 5% significance level when the two difference between the median is 0.75, the standard deviation is 1 and the equivalence limits are 0 and 5. The statistical analysis was conducted to verify any differences among the 4 groups (PSS, MiniLPS, LPS and LESS). From the Shapiro Wilk test we checked that all continuous variables are not distributed according to a normal, so we can use the non-parametric approach. The Kruskall Wallis test and χ2 test were performed if appropriated. Probability (p) values were considered to be statistically significant for a <0.5 value. STATA Data Analysis and Statistical Software, version 14 (StataCorp LP, College Station, TX) was used for all the analyses. RESULTS The 4 groups were comparable for median age, body mass index, previous abdominal surgery and indication for surgery. As reported in Table 1,
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patients characteristics are not statistically different in the 4 groups for median age, median BMI and previous abdominal surgery. The analysis of perioperative outcomes is showed in Table 2. The median OT was significantly longer in LESS rather than all the other groups (120 minutes [range 55–165] in LESS, 91 minutes [range 60-180] in MiniLPS, 70 minutes [range 55-230] in LPS and 65 [range 40-180] in PSS; p = 0.0001). There were no significant differences between the 4 groups in terms of estimated blood loss, median uterus weight, conversion to laparoscopy, conversion to laparotomy, intraoperative complications and median ileus. Median VAS 24h was 2 [range 0 – 3] in PSS, 2 [range 0 – 3] in MiniLPS, 3 [range 2 – 5] in LESS and 2 [range 1 – 5] in LPS (p = 0.0001). This statistical result seems suggest that the post-operative pain is lower in LESS and PSS cohort. However, event if the VAS score is similar for all procedures, the significance is related with the small number of sample size and the VAS range. This data need a larger population sample to be confirmed. The median discharge time was 1 day [range 1 – 3] in PSS, 1 day [range 1 – 2] in MiniLPS, 1 days [range 1 – 2] in LESS and 1 day [range 1 – 3] in LPS (p = 0.99).
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DISCUSSION The current trend of endoscopy is to minimize progressively the invasiveness but still maintaining safety and surgical effectiveness, optimizing surgical outcomes, improving cosmetic impact. So far, latest innovations in this field were LESS and Mini-LPS consisting in the use of single access trocar and 3 mm trocar respectively: both have been widely compared with the standard laparoscopy and their main advantages and limits are nowadays well known (15-17). In LESS surgery, the main limit is the absence of instruments triangulation. This alteration of surgeon ergonomics is often related with an increased surgical time. A main characteristic in the mini-laparoscopic approach is the maintenance of the surgical field triangulation but, in the same time, the reduced size of operative surface of the instruments jaw can sometimes create difficulties in traction of tissues. Moreover the 3 mm bipolar grasper sometimes does not allow the same performance of standard bipolar instruments (18). We recently published a pilot study (14) demonstrating the surgical feasibility of hysterectomy using the PSS. These instruments as previously specified, overcome the limits of other approaches thanks to the 5 mm jaws and the maintenance of surgical instrument triangulation. Furthermore, the
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absence of trocars and the smallest size of these devices, compared with other technologies, could reduce the aesthetic impact. Here we present the first study comparing the different minimally invasive approaches actually available in Gynecological surgery. The operative time was significantly longer in LESS group while the PSS group reported the shortest surgical time. This last finding was probably due to the fact that in all PSS procedures we used a multifunction instrument to overcome the absence of energy in the percutaneous devices and therefore we also reduced the changing of instruments normally performed during a surgical procedure. Consequently the operative time could have an impact to the post-operative pain [19]. At the same time, the size of grasper jaws allowed the necessary tractions during the surgical steps permitting in all cases the maintenance of standard surgical setting. Thanks to this configuration all surgeons involved in PSS procedures, did not report any difference or discomfort compared to standard laparoscopy. Longer operative time of MiniLPS group is probably linked to the 3mm “specific limited size performances”. Another important data is the very low rate of conversion to standard laparoscopy or laparotomy for all groups. In PSS and LPS groups two cases of service transverse suprapubic minilaparotomy (< 5 cm) were recorded to extract the high weight specimens
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(1360 gr in PSS and 468 gr in LPS): after the hysterectomy the uterus was inserted into an endobag to avoid intra-abdominal spreading. No perioperative complications were recorded in PSS group and it could represent a promising result. In LESS group only one intraoperative complication was recorded: a small lesion of the bladder posterior wall occurred during the dissection of vesico-vaginal space in a two-previous cesarean section patient. The complication was managed maintaining the same approach, with a 3/0 vicryl single stich. The discharge time were not statistically significant among different groups, however the post-operatory pain recorded at 24 hours (VAS) was statistically significant lower in PSS and LESS groups. Anyway even if more studies are needed to affirm that some techniques are better then others, the results reported in our study suggest that PSS and LESS surgery could furnish more benefits in terms of post operatory pain and cosmetic outcomes. Moreover in LESS and PSS groups the reduction of painkillers administration were recorded even if did not affect the clinical outcomes. In conclusion, our study demonstrates that, even if the differences among the endoscopic approaches have not a relevant clinical impact, the further reduction of surgical invasiveness is feasible and could improve the advantages of using endoscopy for hysterectomy, not only in term of aesthetic outcomes.
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This aspect could be opening new frontiers in the reduction of invasiveness maintaining the same standard laparoscopic configuration, allowing to perform even complex procedures with these innovative instruments. The maintained triangulation between instruments and tissues is an important key point that contributes to faster surgical procedures. Even though technical improvements should be achieved, such as the bipolar energy, the new PSS technology represents a new important step in the world of Minimally Invasive Surgery.
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REFERENCE 1. Johnson N, Barlow D, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2006;CD003677. 2. Johnson N, Barlow D, Lethaby A, et al. Methods of hysterectomy: systematic review and meta-analysis of randomised controlled trials. BMJ. 2005. 330(7506):1478. 3. Kluivers KB, Johnson NP, Chien P,et al. Comparison of laparoscopic and abdominal hysterectomy in terms of quality of life: a systematicreview. Eur J Obstet Gynecol Reprod Biol. 2008 136:3–8. 4. Fanfani F, Fagotti A, Gagliardi ML, et al. Minilaparoscopic Versus Single-Port Total Hysterectomy:A Randomized Trial. J Minim Invasive Gynecol. 2013. 20(2):192-7. 5. Fagotti A, Bottoni C, Vizzielli G, et al. Postoperative pain after conventional laparoscopy and laparoendoscopic single site surgery (LESS) for benign adnexal disease: a randomized trial. Fertil Steril. 2011. 96:255–259 6. Hosono S, Osaka H. Minilaparoscopic versus conventional laparoscopic cholecystectomy: a meta-analysis of randomized controlled trials. J Laparoendosc Adv Surg Tech A. 2007. 17:191–199 7. Yim GW, Jung YW, Paek J, et al. Transumbilical single-port access versus conventional total laparoscopic hysterectomy: surgical outcomes. Am J Obstet Gynecol. 2010. 203:26. 8. Kim TJ, Lee YY, Cha HH, et al. Single-port-access laparoscopic-assisted vaginal hysterectomy versus conventional laparoscopic-assisted vaginal hysterectomy: a comparison of perioperative outcomes. Surg Endosc. 2010. 24:2248–2252. 9. Jung YW, Lee M, Yim GW, et al. A randomized prospective study of single-port and fourport approaches for hysterectomy in terms of postoperative pain. Surg Endosc. 2011. 25:2462–2469. 10. Rossitto C, Gueli Alletti S, Costantini B, et al. Total Laparoscopic Hysterectomy with percutaneous (PERCUVANCE tm) instruments: new frontier of minimally invasive gynecological surgery. J Minim Invasive Gynecol. 2015. DOI: 10.1016/j.jmig.2015.09.004, Sep 16,2015. 11. Gueli Alletti S, Rossitto C, Perrone E, et al. Needleoscopic Conservative Staging Of Borderline Ovarian Tumor. J Minim Invasive Gynecol.. pii: S1553-4650(16)31151-7. doi: 10.1016/j.jmig.2016.10.009. Oct 27 2016 [Epub ahead of print] 12. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. 13. 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. 37:1085–1092 14. Rossitto C, Gueli Alletti S, Rotolo S, et al. Total laparoscopic hysterectomy using a percutaneous surgical system: a pilot study towards scarless surgery. Eur J Obstet Gynecol Reprod Biol. 2016. 203:132-135.
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15. Hart S, Yeung P Jr, Sobolewski CJ. Laparo-endoscopic single site hysterectomy in gynecologic surgery. Surg Technol Int. 2010. 20:195-206. 16. Corrado G, Fanfani F, Ghezzi F, et al. Mini-laparoscopic versus robotic radical hysterectomy plus systematic pelvic lymphadenectomy in early cervical cancer patients. A multi-institutional study. Eur J Surg Oncol. 2015. 41(1):136-41. 17. Paek J, Kim S, Lee S, et al. Learning curve and surgical outcome for single-port access total laparoscopic hysterectomy in 100 consecutive cases. Gynecol Obstet Invest. 2011. 72:227–233. 18. Fanfani F, Fagotti A, Rossitto C, et al. Laparoscopic, mini-laparoscopic and single-port hysterectomy: peri-operative outcomes. Surg Endosc. 2012; 26:3592–3596. 19. Fagotti A, Vizzielli G, Fanfani F, Gallotta V, Rossitto C, Costantini B, Gueli-Alletti S, Avenia N, Iodice R, Scambia G. Randomized study comparing use of THUNDERBEAT technology vs standard electrosurgery during laparoscopic radical hysterectomy and pelvic lymphadenectomy for gynecologic cancer. J Minim Invasive Gynecol. 2014 May-Jun;21(3):447-53. FIGURE 1: Standard laparoscopy FIGURE 2: single site laparoscopy FIGURE 3: mini‐laparoscopy FIGURE 4: percutaneous surgical system Figr‐1
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Figr‐2
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Figr‐3
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Figr‐4
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TABLE 1: Patients Baseline Characteristics and indication for surgery, comparison of PSS, mini-LPS, LESS, LPS
Patients Baseline Characteristics
Number of patients AGE (year), median (range) BMI, median (range) Previous Abdominal Surgery, n (%) Indication for surgery , n (%)
PSS 25 51 (32 ‐ 72) 23 (18 ‐ 37,9) 12 (48 %)
Endometrial Hyperplasia/Early stage endometrial cancer
20 (%)
MiniLPS 25 50 (39 ‐ 70) 23 (20 ‐ 33) 11 (44 %) 19 (%)
Benign pathology
5 (%)
6 (0%)
LESS 25 55 (37‐ 68) 23 (16,5 ‐ 30) 12 (48 %) 20 (%) 5 (%)
L 2 52 (34 24,3 (18 12 (4
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TABLE 2: Surgical procedures, perioperative outcomes, and post‐operative complications. Comparison of PSS, mini-LPS, LESS, LPS.
Perioperative outcomes Operative Time (min), median (range) EBL (ml), median (range)
PSS
MiniLPS
LESS
LPS
p value
65 (40 ‐ 180) 20 (10 ‐ 100)
91 (60 ‐ 180) 30 (10 ‐ 200)
120 (55 ‐ 165) 30 (10 ‐ 300)
70 (55 ‐ 230) 30 (0 ‐ 200)
p = 0.0001 p = 0.33
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4
Uterus weight (gr) 140 (60 – median (range) 1360) Hysterectomy + BSO , 25 (100) n (%) Conversion to 0 (0) Laparoscopy Conversion to 1 (4) Laparotomy Intraoperative 0 (0) complications Ileus (h), median 12 (8 ‐ 24) (range) VAS 24h (h), median 2 (0 ‐ 3) (range) 30‐days 0 (0) complications 24 (24‐ Discharge time 72) (hours), median (range)
Rossitto C. et Al.
110 (59 – 250) 25 (100)
99 (56 – 190) 25 (100)
121 (69 – 468) 25 (100)
p = 0.10
1 (4)
2 (8)
_
p = 0.41
0 (0)
0 (0)
1 (4)
p = 0.56
0 (0)
1 (4)
0 (0)
p = 0.39
12 (8 ‐ 48)
12 (8 ‐ 48) 2 (1 ‐ 5)
p = 0.08
2 (0 ‐ 3)
12 (8 ‐ 48) 3 (2 ‐ 5)
0 (0)
0 (0)
0 (0)
24 (24‐48)
24 (24‐ 48)
24 (24‐ 72)
‐
p = 0.0001 ‐ p = 0.99
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