Department of Obstetrics and Gynecology, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, Ohio 44195, USA 1 To whom correspondence should be addressed. e-mail: goldbej{at}ccf.org
*Presented at the 56th Annual Meeting of the American Society for Reproductive Medicine, San Diego, California, October 216, 2000.
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Abstract |
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Key words: laparoscopy/robotic surgery/tubal anastomosis
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Introduction |
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Although microsurgical tubal anastomosis is performed through a mini laparotomy incision on an outpatient basis, patients may notice an advantage from having the procedure performed with an even less invasive laparoscopic approach. Unfortunately, laparoscopic suturing is still a very difficult and time consuming task and applying it to microsurgery further raises the degree of difficulty significantly. The use of a remotely controlled robot has the potential to facilitate laparoscopic microsuturing by allowing the surgeon to be seated comfortably, scale the surgeons movements by varying increments and filtering out unintentional tremors.
We performed the worlds first robotically assisted laparoscopic surgery in June of 1998 (Falcone et al. 1999). Ten women underwent laparoscopic microsurgical tubal anastomosis with robotic assistance (Falcone et al. 2000
). The current study compares those results with the outcomes following the same procedure performed on the subsequent 15 patients without robotic assistance.
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Materials and methods |
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Dilute vasopressin (0.2 IU/ml) was injected into the mesosalpinx beneath the occluded segments. The tubal segments were mobilized with a unipolar micro-needle and the occluded ends excised with scissors. Transcervical chromotubation with indigo carmine documented patency of the proximal tubal segments. The proximal end of the distal segments were cannulated and indigo carmine injected to confirm patency. The mesosalpinx was then re-approximated with an interrupted 60 polygalactin suture tied intracorporeally.
The anastomosis was performed by placing four interrupted 80 polygalactin sutures incorporating the muscularis and mucosal layers at the 3, 6, 9 and 12 oclock positions. The 6 oclock suture was placed first. All sutures were placed so that the knots were extraluminal. The knots were tied intracorporeally with three throws, the first being a surgeons knot. The serosa was also closed with interrupted 80 delayed absorbable sutures. No stents were used. Tubal patency was demonstrated intraoperatively with transcervical chromotubation.
The first 10 procedures were performed with robotic assistance using the Zeus system (Computer Motion, Goleta, CA, USA) for the laparoscopic suturing as previously reported (Falcone et al. 2000). The US Food and Drug Administration (FDA) approved this as a pilot study for feasability. The Institutional Review Board of the Cleveland Clinic Foundation also approved the study and all patients provided written informed consent. The inclusion criteria included regular menstrual cycles, a normal semen analysis in the partner and a hysterosalpingogram (HSG) that demonstrated a normal uterine cavity and at least 1 cm of proximal tube bilaterally. Final tubal length had to be at least 4 cm.
The Zeus system consists of three robotic arms fixed to the sides of the surgical table. One arm is the Aesop voice-activated laparoscope holder. The other two are connected to the suturing instruments in the lower quadrant ports. An additional 5 mm port is placed suprapubically in the midline for suction/irrigation, tissue manipulation and suture insertion/removal. All microsuturing was performed with the robotic system. The surgeon was seated at a console with a video monitor and manipulated the handles which translated the movements to the instruments. An HSG was performed to assess the patency of the tubes 6 weeks postoperatively. Pregnancy was confirmed by ultrasonography after 6 weeks gestation.
The subsequent 15 cases were performed without the robot with each surgeon serving as one hand for laparoscopic knot tying. These were our first 15 cases of conventional laparoscopic tubal anastomosis. The total operating room (OPR) and skin-to-skin (procedure) times were recorded as well as the estimated blood loss (EBL), time in the recovery room (RER) and total length of stay (LOS) as defined as the end of the procedure until hospital discharge. All times were recorded in minutes. Statistical analysis was performed with the 2 and Wilcoxon-ranked sum tests as appropriate.
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Results |
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The study protocol for the robotic group excluded any other infertility factors. Among the nonrobotic group, there was one male factor, two anovulatory patients, one with an elevated serum FSH, one smoker, one with a prior failed tubal anastomosis and one that had two previous IVF cycles without success. There were five pregnancies in the robotic assistance group for a 50% pregnancy rate with all pregnancies delivered. There were three pregnancies in the nonrobotic group, one delivered and two spontaneous abortions. Assuming that the six patients lost to follow-up did not conceive and excluding the patients >40 years old and those with male or ovulatory factors the rate was 37.5% (P = not significant). There were no ectopic pregnancies in either group. All of the patients have been followed for over a year and all of the pregnancies occurred within the first year.
Operative times were significantly longer with robotic assistance even though several patients in the nonrobotic group were obese and had more prior laparotomies. The EBL in the robotic group was significantly greater statistically but not clinically. There were no differences in the RER times or LOS (Table II).
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Discussion |
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The skin-to-skin procedure time was over 1.5 h longer with robotic assistance. This was predominantly the result of broken sutures due to the lack of tactile feedback during knot tying. Total time in the operating room was 2 h longer with robotic assistance as a result of the longer procedure time in addition to the time required to set up the robots. An engineer from Computer Motion, Inc. was present the entire time for all of the robotic procedures. In spite of this, malfunctions were not infrequent.
Our procedure time of 190.7 min for our first 15 cases without robotic assistance is comparable with the 230.5 min reported by Yoon et al. for their first 15 cases using an identical technique (Yoon et al., 1999). They note that the times decreased significantly after 6 months to a mean of 140.2 min with 202 patients. They did not state whether pregnancy rates also improved with the learning curve. Bissonnette et al. reported excellent results with 102 laparoscopic tubal anastomoses with a mean operating time of only 71.4 min (Bissonnette et al., 1999
) using the one-stitch technique originally described by Dubuisson and Swolin (Dubuisson and Swolin, 1995
).
The major difficulty with laparoscopic tubal anastomosis, with or without robotic assistance, is the limited needle angles to the tubes due to operating through fixed ports. This requires undue tissue manipulation and trauma to position the tubes at a suitable angle to place the sutures or alternatively, compromising precise suture placement. The 50% pregnancy rate in the robotic group, which excluded women >40 years of age and with other infertility factors, was less than expected compared with conventional open microsurgery (Dubuisson et al., 1995; Kim et al., 1997
).
Degueldre et al. recently reported the results of a pilot study with eight patients undergoing laparoscopic tubal anastomosis with robotic assistance using the da Vinci Surgical System (Intuitive Surgical, Mountain View, CA, USA) (Degueldre et al., 2000). The intra-abdominal ends of the micro-instruments in this system have an articulating wrist action with two additional degrees of freedom, comparable with those of the human wrist. This enables more precise needle placement for tissue alignment. This system also incorporates a duel lens laparoscope for true three dimensional stereoscopic viewing. Their operating time of 181.5 min was similar to our procedure time without the robot and 1.5 h shorter than with the Zeus robotic system. It may be anticipated that clinical results could also be improved.
There is no real learning curve between the robotic and non-robotic groups because they are very different procedures. For robotic surgery, one surgeon performs the procedure while seated whereas two surgeons simultaneously perform the procedure standing at the OPR table for the non-robotic group. If anything, the learning curve would be biased in favour of the robotic group since many hours were spent in the dry laboratory practising with the robot in addition to performing the procedure on animals and human cadavers prior to the first patient. We went directly to the non-robotic group without the benefit of practising first and learning to work as a coordinated team. Also, the OPR times were biased against the non-robotic group since these patients tended to be heavier and had more prior laparotomies as well as more concurrent treatments. Even allowing for that, the times were still substantially less than the robotic group. Heterogeneity between the robotic and nonrobotic groups, and the small sample sizes, preclude making any valid comparisons in tubal patency or pregnancy rates from our data.
The currently available robots carry a price tag in the range of US$600 000 to US$1 000 000 plus yearly service contracts. This expense plus the additional OPR time and disposable items for the robot greatly increases the cost of the procedure. Since patients did not benefit from the addition of robotic assistance with the Zeus system, its use cannot be justified at this time. A large prospective randomized study comparing laparoscopic tubal anastomosis with and without robotic assistance using the Zeus and DaVinci systems is needed to clarify whether there may be a role for them in this procedure.
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Acknowledgement |
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References |
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Submitted on May 8, 2001; resubmitted on May 22, 2002;. accepted on September 18, 2002