Rodgers, Allison K. MD1; Goldberg, Jeffrey M. MD1; Hammel, Jeffrey P. MS2; Falcone, Tommaso MD1
Tubal ligation is one of the most common and effective means to prevent pregnancy, but as many as 1% of patients subsequently desire further fertility.1,2 Many patients choose tubal anastomosis over in vitro fertilization, because tubal anastomosis has high success rates. It also avoids the need for daily injections, frequent office visits for monitoring, ovarian hyperstimulation syndrome, and increased risk of multiple gestation pregnancies. Additionally, the cost per pregnancy is lower with tubal anastomosis compared with in vitro fertilization.3,4 Pregnancy rates after tubal anastomosis have been shown to be as high as 55–85%.2,3,5 The pregnancy rate is improved in patients aged younger than 35 years with a body mass index of 25 or less and eight or fewer years from the tubal ligation.3 Success rates for tubal anastomosis are also influenced by the method of tubal ligation and the segments being anastomosed.2,5
The traditional tubal anastomosis procedure is performed with microsurgical techniques through a laparotomy with inpatient hospitalization. Recently, these procedures have been performed through minilaparotomy incisions in the outpatient surgical setting, which reduces cost, postoperative pain, and time to full recovery. Tubal anastomosis by minilaparotomy is as safe and as effective with comparable patency rates as the traditional open procedure.6
There is a consumer-driven demand for converting conventional open procedures into minimally invasive ones. Benefits of minimally invasive surgery include less postoperative pain, better cosmesis, shorter recovery time, and earlier resumption of normal activities.7 Laparoscopic tubal anastomosis presents technical challenges, including difficulty with visualization of the tubal lumen, extensive skill for precise intracorporeal knot tying with fine suture, and manipulation of the delicate tubes with long instruments.8
The use of robotic assistance in laparoscopy has been proposed to overcome the disadvantages of traditional laparoscopy in tubal anastomosis while still benefiting from the advantages of the minimally invasive technique.9 The robotic system (da Vinci Surgical System, Intuitive Surgical, Sunnyvale, CA) includes a console where the surgeon sits and operates the robot, the robot itself, and the monitor system (Fig. 1). It offers advanced imaging and enables the operator to visualize the abdominal cavity in a three-dimensional view. It also allows for increased dexterity and precision, which is very important when working with delicate structures such as fallopian tubes. The robotic system also scales the surgeon's movements to filter out natural tremor.10–12 Robotic systems are more precise in knot tying and fine tasks than standard laparoscopic instruments, especially with finer sutures.13–15 Robotic surgery can also minimize differences between novice and expert laparoscopic surgeons, which can allow surgeons to complete more complex tasks with the aid of a robot.15 The purpose of this report was to compare short-term outcomes of robotic surgery with outpatient “minilaparotomy” for tubal anastomosis.
MATERIALS AND METHODS
In this retrospective case–control study, subjects were identified by current procedural terminology code for tubal anastomosis starting 2001 and ending in February 2006 to allow for a minimum of 10-month follow-up. Selection criteria for which type of procedure was performed was dependent on which surgeon they presented to for the procedure. One surgeon (T.F.) performed all cases with the robotic system starting in the middle of 2001, when the robot became available at our institution. The open minilaparotomy cases were performed by a total of three experienced board-certified reproductive endocrinologists. We included all cases of tubal anastomosis for reversal of a prior tubal ligation by the robotic system technique or outpatient laparotomy. Tubal segments had to be a minimum of 4 cm in length. Cases performed with the ZEUS Robotic Surgical System (Computer Motion, Inc., Santa Barbara, CA), which is no longer commercially available, were excluded. Also, cases performed by laparoscopy without the aid of the robot were excluded. Data were collected from both hospital charts and computerized medical records after approval from the institutional review board. Patients were then interviewed over the telephone. The patients were asked how many weeks it took to get back to their normal activities or work. Questions regarding pregnancy were also asked including how long it took them to conceive as well as all outcomes for pregnancies that did occur. We also asked if patients decided to pursue other means of infertility treatment including medical therapy of ovulation induction, intrauterine insemination, in vitro fertilization, or additional surgery. The project was approved by the Institutional Review Board of the Cleveland Clinic and all patients gave written informed consent.
Categorical data per patient are summarized as frequencies and percents, whereas quantitative data are summarized as medians with the interquartile range, and appropriate percentiles over the entire sample and within patient subgroups. Outcome data, including intrauterine pregnancy, ectopic pregnancies, and spontaneous abortions, are also summarized as percents of total pregnancies. Summaries of cost data are expressed only as the difference in median values between groups with an associated 95% confidence interval. Comparisons of patient subgroups defined by surgical method, age, and body mass index (BMI), were performed using χ2 and Fisher exact test with respect to categorical data, and the Wilcoxon rank sum test with respect to quantitative data. Statistical interactions were evaluated using logistic and linear regression models for categorical and quantitative data, respectively, to assess whether differences between BMI or age groups were consistent between the robotic and minilaparotomy methods. Multivariable analysis was performed for outcome data, including pregnancies and return to work.
After general anesthesia is achieved, the patient is placed in the dorsal lithotomy position and a RUMI Uterine Manipulator Sytem (Cooper Surgical, Shelton, CT) is placed transcervically. The laparoscope is inserted through a 12-mm trocar in the umbilicus, and adequate pneumoperitoneum is obtained with carbon dioxide gas. Two 8-mm trocars are placed in the right and left lateral abdominal areas under direct visualization lateral to the rectus muscle and a few centimeters below the level of the umbilicus. Another 5-mm trocar is placed suprapubically. The umbilical and lateral trocars will be attached to the three robotic arms and the suprapubic trocar is an accessory port used to introduce and remove suture as well as for irrigation and suction. The patient is then placed in steep Trendelenburg position, and the robot is positioned between the legs.
The occluded tubal segment is excised, and the distal and proximal tubal segments for anastomosis are identified. The mesosalpinx is approximated with polyglactin (Vicryl, Ethicon Endo-Surgery, Inc., Cincinnati, OH) 6–0 sutures until the two segments are in close proximity. Interrupted polyglactin 8–0 sutures are used to complete the anastomosis of the mucosal-muscularis and the muscularis-serosal layers. The first suture is tied at the most inferior aspect of the tubal segments followed by two or three additional sutures. These additional sutures are not tied until all sutures are placed to allow for visualization of the tubal lumen. All sutures are then tied. If needed, a few additional serosal sutures are placed for additional support. Patency of the repair is demonstrated with transcervical injection of indigo carmine.
For the outpatient minilaparotomy technique, after induction of general anesthesia, the patient is placed in the dorsal lithotomy position. A diagnostic hysteroscopy and laparoscopy are usually performed. A HUMI (UNIMAR, Wilton, CT) manipulator is inserted into the cervix for elevation of the uterus and chromotubation. A 5–6 cm Pfannenstiel incision is made. The uterine fundus is elevated through the incision with the aid of the HUMI manipulator. Pitressin in a solution of 20 units in 100 mL of injectable saline is injected into the mesosalpinx below the occluded segments. The two segments are then mobilized with the microunipolar needle with visualization through the operating microscope. The two ends are then opened with iris scissors. Both transcervical and retrograde chromotubation are performed to demonstrate patency of both segments. A single stitch of interrupted 6–0 polyglactin is placed through the mesosalpinx to approximate and align the tubal ends. The anastomosis is performed in two layers with interrupted 8–0 polyglactin sutures. The first layer anastomoses the muscularis with four stitches such that the knots are extraluminal. The second layer is through the tubal serosa and is performed in a similar fashion. Transcervical chromotubation is performed to confirm patency of the anastomosed tubes.
We identified 26 cases of tubal anastomosis performed with the robotic system technique and 41 cases performed by outpatient minilaparotomy during the same time period from January 2001 to February 2006. The two groups were comparable in age, BMI, gravidity, parity, and percentage of patients who underwent bilateral tubal anastomosis (Table 1). Because most patients did not have their initial tubal ligation at our institution, data on which type of initial surgery was done was not gathered. We did compare anatomic place of anastomosis and there was no difference between the groups. There was no difference between the two groups in the percentage of patients with an estimated blood loss greater than 100 mL. Surgical and anesthesia times were significantly longer with the robotic technique. Anesthesia time for the robotic technique (median with interquartile range) was 283 (267–290) minutes compared with 205 (170–230) minutes with outpatient minilaparotomy (P<.001). Surgical times for the robot and minilaparotomy were 229 (205–252) minutes and 181 (154–202) minutes, respectively (P=.001). There was no significant difference in the mean hospitalization time, but patients returned to work an average of 1 week earlier and a median of 2 weeks earlier after robotic surgery (P=.013) (Table 2). The robotic technique was more costly than the outpatient laparotomy technique. The median difference in costs of the procedures was $1,446 with 95% confidence interval of $1,112–1,812 (P<.001). The costs include the operating room, anesthesia, and physician fees. These costs do not include the 1.5 million dollars for the robot itself or the $130,000 per year in maintenance fees because the model for purchase and distribution of cost initially and over time is quite variable (Table 2).
Outcome data regarding recovery time and pregnancies after the surgery was collected from 23 of 26 patients (88%) in the robotic group and 33 of 41 patients (80%) in the minilaparotomy group (P=.34) (Table 3). Patients not included in outcome information either had no current contact information or refused to participate. Sixty-one percent of patients in the robotic group achieved pregnancy, whereas 79% of patients in the laparotomy group achieved pregnancy (P=.10). The robotic group achieved 19 pregnancies from 14 patients, whereas 47 pregnancies were conceived from 26 patients in the minilaparotomy group (P=.16). The time to conception was similar. The ectopic pregnancy of 11% and 13 % was similar between the two groups (P=.70). The spontaneous abortion rate was lower for the robotic group (26 %) than the laparotomy group (51 %) due to two patients with recurrent pregnancy loss who accounted for 9 of the 18 spontaneous abortions (P=.26). Approximately one third of the patients in both groups received additional infertility treatments such as clomiphene citrate, intrauterine insemination, or in vitro fertilization after their surgery (P=.82) (Table 3). Complications were more frequently reported in the laparotomy group, although this did not reach statistical significance (P=.23). The robotic group documented one complication of readmission for tachycardia, but the laparotomy group documented six complications including postoperative fever, cellulitis, wound separation, readmission for abdominal pain, reoperation for an incisional hernia, and excessive nausea and vomiting.
Robotic surgery for tubal anastomosis was successfully accomplished without conversion to laparotomy. Other studies report a less than 10 % conversion to laparotomy with use of the robotic system.15,16 Pregnancy outcomes were similar between the two groups. The small sample size also precluded subgroup analysis by age, BMI, and anatomic tubal segments anastomosed, which may influence operative time and pregnancy outcome. This is a nonrandomized review, and there is selection bias in this study because the technique of the procedure was solely dependant on which provider patients presented to for their surgery.
The use of a surgical robot for gynecologic surgery was first reported in 1999 by Falcone et al.17 Since then several advances in technology has made the surgical robot more useful for surgery. Early studies of robotically assisted tubal anastomosis were first done with the Zeus system (Computer Motion Inc.) in pigs, then in humans. They were found to be safe with adequate patency rates.9,17–20 Comparison of laparoscopic tubal anastomosis with and without robotic assistance showed that that robotic surgery required more operative time but had the same recovery times, tubal patency and clinical pregnancy rates.21 This is the first comparison of robotic assisted laparoscopy with outpatient minilaparotomy for tubal anastomosis.
The robotic approach offers the surgeon the ability to perform laparoscopic microsurgery with far more precision than conventional laparoscopy.20 Robotic surgery does have some disadvantages over traditional laparoscopy. The robot is very large and assistants have difficulty maneuvering around it to change instruments. Also, to reposition a patient once operating, the entire system needs to be disengaged. The robot also does not allow for tactile feedback.12 This disadvantage may be partially overcome by the three-dimensional image.
The robotic technique of tubal anastomosis was associated with significantly longer surgical and anesthesia times as well as a greater cost per case than outpatient minilaparotomy (P<.001). The longer operative times were due in part to the setup time of the robot that would be expected to decrease as the surgical team gains experience. Although comparable in time, tubal surgeries were performed with surgeons that had at least a decade of experience with laparotomy, but the robotic cases were the initial experience with the robotic tubal reversal technique. There was no difference in mean operative time for the robotic cases from the first cases performed in 2001 to those performed later in the study as would be expected from increased experience with the robot and the new technique. One explanation is that the learning curve is steeper than the number of cases reported.
The offsetting benefit to the robot was a quicker return to activity by one week. These data are, however, confounded by recall bias. The time between surgery and interviewing ranged from 10 months to 5 years. Patients with shorter interview intervals would theoretically have a more realistic idea of how much time it took to get back to regular activity. Cost analysis did not include those costs related to time away from work nor did they include the base cost of the robot or the annual maintenance fees. If these were included the cost analysis results would be different and possibly prohibitive for the robotic procedure. Furthermore, the observations on cost apply to outpatient tubal reversal. If the patient is hospitalized overnight, then the cost differences could easily be eliminated or even make the robotic approach more cost-effective. Complications occurred less frequently in the robotic group, although this was not statistically significant. Cost analysis did not include those costs associated with complications such as readmission or reoperation.
Overall, there do not seem to be any advantages of robotic surgery compared with outpatient minilaparotomy for tubal anastomosis. However, this study suffers from a retrospective design and small sample size. The role of the robot may be better reserved for patients that are not good candidates for outpatient minilaparotomy such as those with a high BMI. The current robotic technology should be considered early prototypes. Smaller, cheaper and easier to use robots will be needed to make robotic surgery both faster and more cost efficient than traditional techniques. This technology, however, has exciting potential for future applications.
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