- Email: [email protected]
Robotic tubal anastomosis: surgical technique and cost effectiveness
REPRODUCTIVE SURGERY Robotic tubal anastomosis: surgical technique and cost effectiveness Sejal P. Dharia Patel, M.D.,a Michael P. Steinkampf, M.D.,b Scott J. Whitten, M.D.,c and Beth A. Malizia, M.D.d a
Department of Obstetrics and Gynecology, the Ohio State University, Columbus, Ohio; b Alabama Fertility Specialists, Birmingham, Alabama; c Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; and d Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
Objective: To evaluate the feasibility of robotic microsurgical tubal anastomosis and compare the results and cost effectiveness with the same procedure performed by laparotomy. Design: Prospective cohort study. Setting: University hospital. Patient(s): Patients with a history of bilateral tubal ligation who desired reversal for future fertility. Intervention(s): Tubal anastomoses through either a robotic approach or through a laparotomy. Main Outcome Measure(s): Operative times, hospitalization, complications, postoperative patency, clinical outcomes, and the cost per live birth. Result(s): The mean operative time for robotic anastomoses was statistically significantly greater than open anastomoses (ROBOT 201 minutes; OPEN 155.3 minutes), although hospitalization times were statistically significantly shorter (ROBOT 4 hours; OPEN 34.7 hours). The return to instrumental activities of daily living was accelerated in the patients who had undergone a robotic anastomosis (ROBOT 11.1 days; OPEN 28.1 days). Although this was a small series, the pregnancy rates were comparable between groups (ROBOT 62.5%; OPEN 50%), yet the rate of abnormal pregnancy was higher in the robotic group (ectopic: ROBOT 4, OPEN 1; spontaneous pregnancy loss: ROBOT 2, OPEN 1). The cost per delivery was similar between the groups (ROBOT $92,488.00, OPEN $92,205.90). Conclusion(s): Robotically assisted laparoscopic microsurgical tubal anastomosis is feasible and cost effective with results that are comparable with the traditional open approach. (Fertil Steril 2008;90:1175–9. 2008 by American Society for Reproductive Medicine.) Key Words: Tubal anastomosis, robotic-assisted surgery, tubal surgery, cost-effectiveness
Worldwide, more than 153 million women have chosen sterilization as their contraceptive method (1). As many as 20% will subsequently express regret after a change in family circumstances such as the death of a child, improved economic situation, or change in marital partner (2), and 1% to 5% of these patients will request sterilization reversal (1, 3, 4). For couples who desire fertility with their own genetic material after tubal ligation, only two options are available: surgical tubal anastomosis and in vitro fertilization (IVF).
tomosis include increased postoperative hospitalization and increased postoperative analgesic requirements (10, 11). Laparoscopy can circumvent some of these problems through decreased blood loss, diminished postsurgical discomfort, and hastened recovery times (10, 11). This has led some reproductive surgeons to explore minimally invasive techniques for this procedure.
Currently, for patients who desire reversal of surgical sterilization, microsurgical tubal anastomosis is performed through a traditional laparotomy incision with success rates (term pregnancy rates) that are reported between 33% to 87% (5–9). The disadvantages to an open microsurgical anas-
Laparoscopic tubal reversal has been performed since the 1990s (12–14). However, the laparoscopic approach has been hindered by the learning curve associated with precise intracorporeal suturing (15, 16). This is attributed to restrictive degrees of freedom, fatigue-induced intention tremor, and movements that are counterintuitive with hand–eye misalignment (17, 18).
Received March 12, 2007; revised and accepted July 5, 2007. Reprint requests: Sejal P. Dharia Patel, M.D., Assistant Professor and Co-Director, Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Ohio State University, 1654 Upham Drive, Means Hall Room 567, Columbus, Ohio 43210 (FAX: 614-293-5877; E-mail: [email protected]).
The introduction of robotic technology may bridge the gap between laparoscopy and laparotomy. There are three forms of robotic technology used in gynecologic surgery (19). The AESOP (automated endoscopic system for optimal positioning), the first robotic arm to be approved by the U.S. Food and Drug Administration, provided control of the laparoscope
0015-0282/08/$34.00 doi:10.1016/j.fertnstert.2007.07.1392
Fertility and Sterility Vol. 90, No. 4, October 2008 Copyright ª2008 American Society for Reproductive Medicine, Published by Elsevier Inc.
1175
through voice-activated programming. A second system, the Zeus Surgical System (Intuitive Surgical, Sunnyvale, CA), provided two-dimensional vision with remotely controlled robotic arms attached to the surgical table, but this system is no longer in production (20). The most recent system in the evolution of robotic-assisted surgery is the da Vinci Surgical System (Intuitive Surgical) (17, 20) (Fig. 1). This remotely controlled, integrated system provides true three-dimensional vision, intra-abdominal articulation with 6 degrees of freedom comparable with the human hand, and tremor filtration. This system potentially affords the surgeon the benefits of laparotomy along with the advantages of minimally invasive surgery for the patient. Our study demonstrated the feasibility of robotic tubal anastomosis and compared the efficacy and cost effectiveness of robotic surgery with the same procedure performed by laparotomy. MATERIALS AND METHODS Between February 2003 and January 2004, we performed robotic tubal anastomoses using the da Vinci Surgical System in 18 patients (age range: 27 to 38 years) who desired reversal of surgical sterilization. The outcomes of these patients were compared with 10 patients who underwent an open microsurgical tubal anastomosis between November 2002 and February 2003 before the robotic surgical system became available. Each case was performed by the same faculty mentor and the
FIGURE 1 Standard port placement for robotic tubal anastomosis. The camera port (12 mm) is placed at the umbilicus. The da Vinci ports (8 mm) are placed in the midclavicular line, 1 to 2 cm below the level of the umbilicus and lateral to the rectus muscle. An accessory port (10 mm) is positioned on left side of patient, between the camera and the da Vinci port.
fellow in training. Both surgeons completed formal inanimate and animate training on the surgical system and performed one robotic tubal reversal on a patient before data collection. Evidence of normal ovulatory status and semen parameters were documented preoperatively. This study was reviewed and approved by the University of Alabama at Birmingham institutional review board. Positioning of the Robotic Surgical System After induction of general anesthesia, the patient was placed in a modified dorsal lithotomy position in Trendelenburg, and mobilization of the uterus was provided with a Cohen intrauterine cannula. Peritoneal access was obtained using a 12mm trocar placed directly through the umbilicus. Two lateral 8-mm da Vinci ports were placed in the midaxillary line 2-cm below the level of the umbilicus, separated by a minimum of 8 cm between port sites (see Fig. 1). At this point, a diagnostic laparoscopy was performed to assess the feasibility of the anastomosis. An accessory 10-mm port placed on the left side between the umbilical and the lateral port was used for irrigation, introduction, and retrieval of suture material. The robot was then positioned between the patient’s legs, and the robotic arms were connected to their respective ports. The Procedure Once the set up was completed, the distal tubal segment was stripped of its serosa using microscissors, and the tip was resected. The proximal segment was mobilized, and the proximal segment was transected. Chromopertubation demonstrated patency of the proximal tubal segment. The mesosalpinx was reapproximated with one to two interrupted 6-0 polyglactin sutures. The mucosal and muscular layers of the tubal segments were sutured with four interrupted 7-0 polypropylene sutures. The serosa was closed separately with a running 7-0-polypropylene suture, and patency of the surgical repair was determined by chromopertubation. In each case, one side was completed by the faculty mentor and the other side by the fellow in training. Open Microsurgical Tubal Anastomosis After induction of general anesthesia, the patient was positioned in the supine position. A 6- to 8-cm transverse suprapubic incision was made, and the peritoneal cavity was entered in the usual fashion. No self-retaining retractor was required. The uterus was elevated with a single 0-polypropylene stitch placed through the uterine fundus, without the use of packed laparotomy pads. An 18-gauge Angiocath was placed at the fundus of the uterus for chromopertubation. Lactated Ringer’s solution was used for irrigation to prevent tissue desiccation. The microsurgical tubal anastomosis was performed in similar fashion to the robotic procedure that has been delineated except with the use of the Zeiss operating microscope at 12.5 magnification (Zeiss, Thornwood, NY).
Dharia Patel. Robotic tubal anastomosis. Fertil Steril 2008.
1176
Dharia Patel et al.
Robotic tubal anastomosis
Postoperative Care Postoperatively, each patient who underwent an open anastomosis was hospitalized overnight with an intravenous Vol. 90, No. 4, October 2008
patient-controlled analgesic pump. Discharge criteria included ambulation, tolerance of a regular oral diet, and control of pain with oral medication. Each patient who underwent a robotically assisted laparoscopic tubal anastomosis was sent home from the recovery room after the same discharge criteria had been met. All patients were given prescriptions for 600 mg of ibuprofen (Motrin; McNeil-PPC Inc, Fort Washington, PA) and 7.5/500 mg of hydrocodone/ acetaminophen (Tylox; McNeilab Inc., Spring House, PA). Each patient was then followed postoperatively, and the number of tablets consumed and the number of days until return to instrumental activities of daily living (IADL) were documented by the patient’s responses during a postoperative phone call. Instrumental activities of daily living include preparing meals, managing money, shopping, housework, making telephone cells, and the ability to travel (21). Data Collection Outcome measures included operative times, hospitalization time, hospitalization charges, complications, postoperative recovery, postoperative tubal patency, and clinical outcomes. The statistical analysis used the chi-square, Fisher exact test, and analysis of variance in the SAS computer statistical program version 9.0 (SAS Institute, Cary NC). For the evaluation of cost effectiveness, the perspective of a third-party payer was assumed. All charges were obtained from patient billing records. These charges included those incurred during hospitalization, postoperative complications (ectopics/miscarriages), postoperative evaluation (hysterosalpingogram), and time lost from work and time to return of IADLS. The assumed depreciation cost is based on a 10year useful life and depreciates at 1/10th of the purchase price per year. It was assumed that based upon multiple specialty use that 100 to 150 cases would be performed in 1 year resulting in a cost per case of $1000. The time lost from work was obtained from the patient and then multiplied by the median hourly wage averaged for all occupations for the United States obtained from the Department of Labor, Bureau of Wages, Earnings and Benefits, from which the cost was calculated (22). The cost for time to return to IADLS was calculated from the median hourly wage for personal care and service occupations from the November 2003 National Occupational Wage Estimates from the Department of Labor multiplied by the number of days required for return to IADLS obtained from the patient (22). For consistency, all charges were converted to costs using a multiplier of 0.6 provided by the University of Alabama at Birmingham billing department. In addition, all costs were extrapolated to 2004 dollars assuming a 4% inflation rate per year. Costs were calculated for 100 women undergoing a tubal anastomosis either robotically or via laparotomy.
RESULTS Eighteen patients underwent a robotically assisted tubal reversal (ROBOT) and 10 patients underwent an open microFertility and Sterility
surgical tubal reversal (OPEN). Their mean age was 33.2 years (ROBOT 30.9 years, range: 27–38; OPEN 33.3 years, range: 30–39; P¼.7), and their average body mass index was 30.2 kg/m2 (ROBOT 30.5 kg/m2, range: 20.8–39.8; OPEN 30.0 kg/m2, range: 19–40; P¼.3), which was not statistically significantly different between groups. Twenty patients (ROBOT 15; OPEN 5) had undergone a postpartum tubal ligation, five patients had undergone laparoscopic bipolar cautery (ROBOT 1; OPEN 4), and three patients previously had laparoscopic placement of silastic bands (ROBOT 2; OPEN 1). The mean time from sterilization to reversal was 8.5 years (ROBOT 8.1 years, range: 3–18; OPEN 7.8 years, range: 3–18; P¼.23). Twenty-three patients (ROBOT 16; OPEN 7) underwent bilateral tubal anastomoses, and five (ROBOT 2; OPEN 3) had unilateral tubal anastomoses due to inadequate tubal length on the contralateral side. The mean operative time for robotic anastomoses was 201 minutes (range: 140–263), which was statistically significantly greater than for open anastomosis (155.3 minutes, range: 120–183; P¼.001). However, the average operative time on the console for robotic tubal reversal was 156 minutes (range: 130–220 minutes). Postsurgical tubal lengths on the right side were 5.7 cm (ROBOT 5.8 cm, range: 3.5– 8.0; OPEN 6.1 cm, range 3.5–9.0; P¼.1629), and on the left side were 5.4 cm (ROBOT 5.5 cm, range: 4–8; OPEN 5.3 cm, range: 4–9; P¼.6216). One patient who underwent a robotic anastomosis had a trocar injury to the inferior epigastric artery, which was recognized intraoperatively and controlled with bipolar cautery. There were no other operative complications. All patients who underwent a robotic tubal reversal were discharged to home within 4 hours postoperatively, whereas the average hospitalization for the open procedure was 34.7 hours (range: 26–84; P¼.0001) (see Fig. 2A). Our first patient in the series undergoing an open tubal reversal had poor tolerance of pain, which required an additional 48 hours to obtain pain control with oral pain medication. In terms of postoperative analgesia, the average consumption of ibuprofen was statistically significantly less after robotic anastomoses (ROBOT 29.3 tablets, range:2–90; OPEN 90 tablets; range: 88–90; P¼.0001), as was the consumption of hydrocodone/acetaminophen (ROBOT 16.6 tablets, range: 0–40; OPEN 36 tablets, range: 0–40; P¼.003) (see Fig. 2B). Time to recovery as measured by return to IADL was statistically significantly less for the robotic anastomoses (ROBOT 11.1 days, range: 2–28; OPEN 28.1 days, range: 21–42; P¼.0001) (see Fig. 2C). In all patients, patency was established in at least one tube by hysterosalpingogram or subsequent pregnancy. The mean follow-up time was 8.9 months (ROBOT 7.9 months, range: 0.25–11.00; OPEN 13.2 months, range: 12–14), and the pregnancy rate (defined as a qualitatively positive level of beta human chorionic gonadotropin) was 54% (ROBOT 62.5%; OPEN 50%; P¼.12). Among the patients who underwent a robotic anastomosis, five patients had confirmed intrauterine pregnancies (28%), four patients had ectopic pregnancies 1177
FIGURE 2 (A) Hospitalization times were statistically significantly decreased for patients who underwent a robotic anastomosis, who were sent home the same day of surgery. (B) Postoperative analgesic requirements were statistically significantly greater for patients who underwent open anastomoses. Although patients were given a prescription for analgesic medications, over-the-counter selfmedication usage could not be excluded. (C) Time to recovery as measured by independent activities of daily living (IADLS) was accelerated in patients who underwent robotic surgery, which improved the overall cost effectiveness of robotic tubal anastomoses.
(22%), and two patients had spontaneous pregnancy losses (11%). In comparison, among the patients who underwent an open anastomosis, three patients had confirmed intrauterine pregnancies (30%), one had an ectopic pregnancy (10%), and one had a spontaneous pregnancy loss (10%). The hospital cost for the robotic tubal reversal was $13,773.55, which was more than the open procedure at $11,742.97. For the hospital cost, each robotic anastomosis encompassed a calculated charge for the surgical system and four da Vinci instruments, for an instrument charge of $800. However, the cost per delivery for robotic tubal reversal was approximately $92,000, which was similar to that of the open procedure (ROBOT: $92,488.00; OPEN: $92,205.90) (Table 1). DISCUSSION Our report represents one of the largest published series of patients to have undergone a robotic-assisted laparoscopic tubal reversal. Previously published human data using robotic-assisted surgery in tubal anastomoses are limited. Falcone et al. (23) evaluated 10 patients who underwent a tubal anastomosis using the Zeus surgical system, with a 50% pregnancy rate after anastomosis. This was later compared with laparoscopic tubal anastomosis with comparable clinical outcomes but longer operative times (24). In a second series by Degueldre et al. (25), eight patients who had undergone previous sterilization with clips or through a Pomeroy procedure underwent a tubal anastomosis using the da Vinci surgical system. Although the follow-up period was only 4 months, two pregnancies were documented. Both studies demonstrated feasibility and delineated the technique and methods. One unique consideration with robotic surgery is the lack of haptic feedback when using fine sutures, which requires reliance on visual cues to determine when the suture has been ligated properly. Our study affirms the feasibility of this technique for the reproductive endocrinologist and provides data on comparative outcomes and cost effectiveness. Although these preliminary data appear promising, there are a few limitations to this study. First, this study was based on single center with small numbers, and the patients were not randomized. There was a shorter follow-up period in the patients undergoing robotic surgery, suggesting that pregnancy rates might ultimately higher in this group. In addition, charges were converted to costs by an arbitrary multiplier provided by our financial department. The assimilation of new medical technology can be a financial burden. In our study, robotic microsurgical tubal anastomosis was cost effective in terms of cost per live birth as compared with open surgery. Increased operative times and equipment costs for robotic surgery were counterbalanced by increased hospitalization and recovery times in open surgery.
Dharia Patel. Robotic tubal anastomosis. Fertil Steril 2008.
1178
Dharia Patel et al.
Robotic tubal anastomosis
Robotic-assisted surgery appears to provide the same surgical outcomes and cost effectiveness when compared with traditional open tubal anastomoses. The high patency rates Vol. 90, No. 4, October 2008
TABLE 1 Cost analysis based on type of procedure. Robot
Tubal anastomosis þ associated care Singleton gestation Twin gestation Spontaneous abortion Ectopic and associated care HSG Time to return to work IADL Ibuprofen usage Hydrocodone/acetaminophen usage TOTAL Singleton þ Twin Cost for live birth
Open
Occurrences
Cost ($U.S.)
Occurrences
Cost ($U.S.)
100 27.5 0.5 11.1 22.2 39 100 100 100 100
$1,600,080 $265,969.90 $18,639.50 $45,983.00 $229,987.80 $17,280.51 $309,056 $99,456 $965 $2,246 $2,589,664
100 29.6 0.4 10 10 50 100 100 100 100
$1,397,022 $286,280.40 $14,911.59 $41,426.10 $103,598.10 $22,154.50 $643,398 $251,776 $1,516 $4,094 $2,766,177
28
30 $92,488.00
$92,205.90
Note: HSG ¼ hysterosalpingogram; IADL ¼ instrumental activities of daily living. Dharia Patel. Robotic tubal anastomosis. Fertil Steril 2008.
provide optimism for the role of robotics in training programs. REFERENCES 1. UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), World Health Organization. Advances in female sterilization research. Prog Reprod Health Res Newsl 1995;36:1. Available at: http://www.who.int/ reproductive-health/hrp/progress/35/prog35.pdf. Accessed on August 16, 2007. 2. Hillis SD, Marchbanks PA, Tylor LR, Peterson HB. Poststerilization regret: findings from the United States Collaborative Review of Sterilization. Obstet Gyecol 1999;93:889–95. 3. Spivak MM, Librach CL, Rosenthal DM. Microsurgical reversal of sterilization: a six year study. Am J Obstet Gynecol 1986;154:355–61. 4. Divers WA Jr. Characteristics of women requesting reversal of sterilization. Fertil Steril 1984;41:233–6. 5. Siegler AM, Hulka J, Peretz A. Reversibility of human sterilization. Fertil Steril 1985;43:499–510. 6. Posaci C, Camus M, Osmanagaoglu K, Devroey P. Tubal surgery in the era of assisted reproductive technology: clinical options. Hum Reprod 1999;14:120–36. 7. Winston RM. Reversal of tubal sterilization. Clin Obstet Gynecol 1980;23:1261–8. 8. Silber SJ, Cohen R. Microsurgical reversal of female sterilization: the role of tubal length. Fertil Steril 1980;33:598–601. 9. Rock JA, Guzick DS, Katz E, Zacur HA, King TM. Tubal anastomosis: pregnancy success following reversal of Falope ring or monopolar cautery sterilization. Fertil Steril 1987;48:13–7. 10. Yuen PM, Yu KM, Yip SK, Lau WC, Rogers MS, Chang A. A randomized prospective study of laparoscopy and laparotomy in the management of benign ovarian masses. Am J Obstet Gynecol 1997;177:109–14.
Fertility and Sterility
11. Lo L, Pun TC, Chan S. Tubal ectopic pregnancy: an evaluation of laparoscopic surgery versus laparotomy in 614 patients. Aust NZ J Obstet Gynaecol 1999;39:185–7. 12. Koh CH, Janik GM. Laparoscopic microsurgical tubal anastomosis. Obstet Gynecol Clin North Am 1999;26:189–200. 13. Reich H, McGlynn F, Parente C, Sekel L, Levie M. Laparoscopic tubal anastomosis. J Am Assoc Gynecol Laparosc 1993;1:16–9. 14. Sedbon E, Delajoulinieres JB, Boudouris O, Madelenat P. Tubal desterilisation through exclusive laparoscopy. Hum Reprod 1989;4:158–9. 15. Stylopoulos N, Rattner D. Robotics and ergonomics. Surg Clin North Am 2003;83:1–12. 16. Sturges RH, Wright PK. A quantification of dexterity. J Robot Comp Integr Manuf 1989;6:3–14. 17. Ballantyne GH. Robotic surgery, telerobotic surgery, telepresence, and telementoring. Surg Endosc 2002;16:1389–402. 18. Berguer R, Forkey DL, Smith WD. Ergonomic problems associated with laparoscopic surgery. Surg Endosc 1999;13:466–8. 19. Falcone T, Goldberg JM. Robotics in gynecology. Surg Clin North Am 2003;83:1483–9. 20. Satava RM. Robotic surgery: from past to future—a personal journey. Surg Clin North Am 2003;83:1–6. 21. Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist 1969;9:179–86. 22. Department of Labor, Bureau of Wages, Earning and Benefits. Available at: www.bls.gov. Accessed on: April 1, 2004. 23. Falcone T, Goldberg JM, Margossian H, Stevens L. Robotic-assisted laparoscopic microsurgical tubal anastomosis: a human pilot study. Fertil Steril 2000;73:1040–2. 24. Goldberg JM, Falcone T. Laparoscopic microsurgical tubal anastomosis with and without robotic assistance. Hum Reprod 2003;18:145–7. 25. Degueldre M, Vandromme J, Huong PT, Cadiere GB. Robotically assisted laparoscopic microsurgical tubal reanastomosis: a feasibility study. Fertil Steril 2000;74:1020–3.
1179
Department of Obstetrics and Gynecology, the Ohio State University, Columbus, Ohio; b Alabama Fertility Specialists, Birmingham, Alabama; c Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; and d Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
Objective: To evaluate the feasibility of robotic microsurgical tubal anastomosis and compare the results and cost effectiveness with the same procedure performed by laparotomy. Design: Prospective cohort study. Setting: University hospital. Patient(s): Patients with a history of bilateral tubal ligation who desired reversal for future fertility. Intervention(s): Tubal anastomoses through either a robotic approach or through a laparotomy. Main Outcome Measure(s): Operative times, hospitalization, complications, postoperative patency, clinical outcomes, and the cost per live birth. Result(s): The mean operative time for robotic anastomoses was statistically significantly greater than open anastomoses (ROBOT 201 minutes; OPEN 155.3 minutes), although hospitalization times were statistically significantly shorter (ROBOT 4 hours; OPEN 34.7 hours). The return to instrumental activities of daily living was accelerated in the patients who had undergone a robotic anastomosis (ROBOT 11.1 days; OPEN 28.1 days). Although this was a small series, the pregnancy rates were comparable between groups (ROBOT 62.5%; OPEN 50%), yet the rate of abnormal pregnancy was higher in the robotic group (ectopic: ROBOT 4, OPEN 1; spontaneous pregnancy loss: ROBOT 2, OPEN 1). The cost per delivery was similar between the groups (ROBOT $92,488.00, OPEN $92,205.90). Conclusion(s): Robotically assisted laparoscopic microsurgical tubal anastomosis is feasible and cost effective with results that are comparable with the traditional open approach. (Fertil Steril 2008;90:1175–9. 2008 by American Society for Reproductive Medicine.) Key Words: Tubal anastomosis, robotic-assisted surgery, tubal surgery, cost-effectiveness
Worldwide, more than 153 million women have chosen sterilization as their contraceptive method (1). As many as 20% will subsequently express regret after a change in family circumstances such as the death of a child, improved economic situation, or change in marital partner (2), and 1% to 5% of these patients will request sterilization reversal (1, 3, 4). For couples who desire fertility with their own genetic material after tubal ligation, only two options are available: surgical tubal anastomosis and in vitro fertilization (IVF).
tomosis include increased postoperative hospitalization and increased postoperative analgesic requirements (10, 11). Laparoscopy can circumvent some of these problems through decreased blood loss, diminished postsurgical discomfort, and hastened recovery times (10, 11). This has led some reproductive surgeons to explore minimally invasive techniques for this procedure.
Currently, for patients who desire reversal of surgical sterilization, microsurgical tubal anastomosis is performed through a traditional laparotomy incision with success rates (term pregnancy rates) that are reported between 33% to 87% (5–9). The disadvantages to an open microsurgical anas-
Laparoscopic tubal reversal has been performed since the 1990s (12–14). However, the laparoscopic approach has been hindered by the learning curve associated with precise intracorporeal suturing (15, 16). This is attributed to restrictive degrees of freedom, fatigue-induced intention tremor, and movements that are counterintuitive with hand–eye misalignment (17, 18).
Received March 12, 2007; revised and accepted July 5, 2007. Reprint requests: Sejal P. Dharia Patel, M.D., Assistant Professor and Co-Director, Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Ohio State University, 1654 Upham Drive, Means Hall Room 567, Columbus, Ohio 43210 (FAX: 614-293-5877; E-mail: [email protected]).
The introduction of robotic technology may bridge the gap between laparoscopy and laparotomy. There are three forms of robotic technology used in gynecologic surgery (19). The AESOP (automated endoscopic system for optimal positioning), the first robotic arm to be approved by the U.S. Food and Drug Administration, provided control of the laparoscope
0015-0282/08/$34.00 doi:10.1016/j.fertnstert.2007.07.1392
Fertility and Sterility Vol. 90, No. 4, October 2008 Copyright ª2008 American Society for Reproductive Medicine, Published by Elsevier Inc.
1175
through voice-activated programming. A second system, the Zeus Surgical System (Intuitive Surgical, Sunnyvale, CA), provided two-dimensional vision with remotely controlled robotic arms attached to the surgical table, but this system is no longer in production (20). The most recent system in the evolution of robotic-assisted surgery is the da Vinci Surgical System (Intuitive Surgical) (17, 20) (Fig. 1). This remotely controlled, integrated system provides true three-dimensional vision, intra-abdominal articulation with 6 degrees of freedom comparable with the human hand, and tremor filtration. This system potentially affords the surgeon the benefits of laparotomy along with the advantages of minimally invasive surgery for the patient. Our study demonstrated the feasibility of robotic tubal anastomosis and compared the efficacy and cost effectiveness of robotic surgery with the same procedure performed by laparotomy. MATERIALS AND METHODS Between February 2003 and January 2004, we performed robotic tubal anastomoses using the da Vinci Surgical System in 18 patients (age range: 27 to 38 years) who desired reversal of surgical sterilization. The outcomes of these patients were compared with 10 patients who underwent an open microsurgical tubal anastomosis between November 2002 and February 2003 before the robotic surgical system became available. Each case was performed by the same faculty mentor and the
FIGURE 1 Standard port placement for robotic tubal anastomosis. The camera port (12 mm) is placed at the umbilicus. The da Vinci ports (8 mm) are placed in the midclavicular line, 1 to 2 cm below the level of the umbilicus and lateral to the rectus muscle. An accessory port (10 mm) is positioned on left side of patient, between the camera and the da Vinci port.
fellow in training. Both surgeons completed formal inanimate and animate training on the surgical system and performed one robotic tubal reversal on a patient before data collection. Evidence of normal ovulatory status and semen parameters were documented preoperatively. This study was reviewed and approved by the University of Alabama at Birmingham institutional review board. Positioning of the Robotic Surgical System After induction of general anesthesia, the patient was placed in a modified dorsal lithotomy position in Trendelenburg, and mobilization of the uterus was provided with a Cohen intrauterine cannula. Peritoneal access was obtained using a 12mm trocar placed directly through the umbilicus. Two lateral 8-mm da Vinci ports were placed in the midaxillary line 2-cm below the level of the umbilicus, separated by a minimum of 8 cm between port sites (see Fig. 1). At this point, a diagnostic laparoscopy was performed to assess the feasibility of the anastomosis. An accessory 10-mm port placed on the left side between the umbilical and the lateral port was used for irrigation, introduction, and retrieval of suture material. The robot was then positioned between the patient’s legs, and the robotic arms were connected to their respective ports. The Procedure Once the set up was completed, the distal tubal segment was stripped of its serosa using microscissors, and the tip was resected. The proximal segment was mobilized, and the proximal segment was transected. Chromopertubation demonstrated patency of the proximal tubal segment. The mesosalpinx was reapproximated with one to two interrupted 6-0 polyglactin sutures. The mucosal and muscular layers of the tubal segments were sutured with four interrupted 7-0 polypropylene sutures. The serosa was closed separately with a running 7-0-polypropylene suture, and patency of the surgical repair was determined by chromopertubation. In each case, one side was completed by the faculty mentor and the other side by the fellow in training. Open Microsurgical Tubal Anastomosis After induction of general anesthesia, the patient was positioned in the supine position. A 6- to 8-cm transverse suprapubic incision was made, and the peritoneal cavity was entered in the usual fashion. No self-retaining retractor was required. The uterus was elevated with a single 0-polypropylene stitch placed through the uterine fundus, without the use of packed laparotomy pads. An 18-gauge Angiocath was placed at the fundus of the uterus for chromopertubation. Lactated Ringer’s solution was used for irrigation to prevent tissue desiccation. The microsurgical tubal anastomosis was performed in similar fashion to the robotic procedure that has been delineated except with the use of the Zeiss operating microscope at 12.5 magnification (Zeiss, Thornwood, NY).
Dharia Patel. Robotic tubal anastomosis. Fertil Steril 2008.
1176
Dharia Patel et al.
Robotic tubal anastomosis
Postoperative Care Postoperatively, each patient who underwent an open anastomosis was hospitalized overnight with an intravenous Vol. 90, No. 4, October 2008
patient-controlled analgesic pump. Discharge criteria included ambulation, tolerance of a regular oral diet, and control of pain with oral medication. Each patient who underwent a robotically assisted laparoscopic tubal anastomosis was sent home from the recovery room after the same discharge criteria had been met. All patients were given prescriptions for 600 mg of ibuprofen (Motrin; McNeil-PPC Inc, Fort Washington, PA) and 7.5/500 mg of hydrocodone/ acetaminophen (Tylox; McNeilab Inc., Spring House, PA). Each patient was then followed postoperatively, and the number of tablets consumed and the number of days until return to instrumental activities of daily living (IADL) were documented by the patient’s responses during a postoperative phone call. Instrumental activities of daily living include preparing meals, managing money, shopping, housework, making telephone cells, and the ability to travel (21). Data Collection Outcome measures included operative times, hospitalization time, hospitalization charges, complications, postoperative recovery, postoperative tubal patency, and clinical outcomes. The statistical analysis used the chi-square, Fisher exact test, and analysis of variance in the SAS computer statistical program version 9.0 (SAS Institute, Cary NC). For the evaluation of cost effectiveness, the perspective of a third-party payer was assumed. All charges were obtained from patient billing records. These charges included those incurred during hospitalization, postoperative complications (ectopics/miscarriages), postoperative evaluation (hysterosalpingogram), and time lost from work and time to return of IADLS. The assumed depreciation cost is based on a 10year useful life and depreciates at 1/10th of the purchase price per year. It was assumed that based upon multiple specialty use that 100 to 150 cases would be performed in 1 year resulting in a cost per case of $1000. The time lost from work was obtained from the patient and then multiplied by the median hourly wage averaged for all occupations for the United States obtained from the Department of Labor, Bureau of Wages, Earnings and Benefits, from which the cost was calculated (22). The cost for time to return to IADLS was calculated from the median hourly wage for personal care and service occupations from the November 2003 National Occupational Wage Estimates from the Department of Labor multiplied by the number of days required for return to IADLS obtained from the patient (22). For consistency, all charges were converted to costs using a multiplier of 0.6 provided by the University of Alabama at Birmingham billing department. In addition, all costs were extrapolated to 2004 dollars assuming a 4% inflation rate per year. Costs were calculated for 100 women undergoing a tubal anastomosis either robotically or via laparotomy.
RESULTS Eighteen patients underwent a robotically assisted tubal reversal (ROBOT) and 10 patients underwent an open microFertility and Sterility
surgical tubal reversal (OPEN). Their mean age was 33.2 years (ROBOT 30.9 years, range: 27–38; OPEN 33.3 years, range: 30–39; P¼.7), and their average body mass index was 30.2 kg/m2 (ROBOT 30.5 kg/m2, range: 20.8–39.8; OPEN 30.0 kg/m2, range: 19–40; P¼.3), which was not statistically significantly different between groups. Twenty patients (ROBOT 15; OPEN 5) had undergone a postpartum tubal ligation, five patients had undergone laparoscopic bipolar cautery (ROBOT 1; OPEN 4), and three patients previously had laparoscopic placement of silastic bands (ROBOT 2; OPEN 1). The mean time from sterilization to reversal was 8.5 years (ROBOT 8.1 years, range: 3–18; OPEN 7.8 years, range: 3–18; P¼.23). Twenty-three patients (ROBOT 16; OPEN 7) underwent bilateral tubal anastomoses, and five (ROBOT 2; OPEN 3) had unilateral tubal anastomoses due to inadequate tubal length on the contralateral side. The mean operative time for robotic anastomoses was 201 minutes (range: 140–263), which was statistically significantly greater than for open anastomosis (155.3 minutes, range: 120–183; P¼.001). However, the average operative time on the console for robotic tubal reversal was 156 minutes (range: 130–220 minutes). Postsurgical tubal lengths on the right side were 5.7 cm (ROBOT 5.8 cm, range: 3.5– 8.0; OPEN 6.1 cm, range 3.5–9.0; P¼.1629), and on the left side were 5.4 cm (ROBOT 5.5 cm, range: 4–8; OPEN 5.3 cm, range: 4–9; P¼.6216). One patient who underwent a robotic anastomosis had a trocar injury to the inferior epigastric artery, which was recognized intraoperatively and controlled with bipolar cautery. There were no other operative complications. All patients who underwent a robotic tubal reversal were discharged to home within 4 hours postoperatively, whereas the average hospitalization for the open procedure was 34.7 hours (range: 26–84; P¼.0001) (see Fig. 2A). Our first patient in the series undergoing an open tubal reversal had poor tolerance of pain, which required an additional 48 hours to obtain pain control with oral pain medication. In terms of postoperative analgesia, the average consumption of ibuprofen was statistically significantly less after robotic anastomoses (ROBOT 29.3 tablets, range:2–90; OPEN 90 tablets; range: 88–90; P¼.0001), as was the consumption of hydrocodone/acetaminophen (ROBOT 16.6 tablets, range: 0–40; OPEN 36 tablets, range: 0–40; P¼.003) (see Fig. 2B). Time to recovery as measured by return to IADL was statistically significantly less for the robotic anastomoses (ROBOT 11.1 days, range: 2–28; OPEN 28.1 days, range: 21–42; P¼.0001) (see Fig. 2C). In all patients, patency was established in at least one tube by hysterosalpingogram or subsequent pregnancy. The mean follow-up time was 8.9 months (ROBOT 7.9 months, range: 0.25–11.00; OPEN 13.2 months, range: 12–14), and the pregnancy rate (defined as a qualitatively positive level of beta human chorionic gonadotropin) was 54% (ROBOT 62.5%; OPEN 50%; P¼.12). Among the patients who underwent a robotic anastomosis, five patients had confirmed intrauterine pregnancies (28%), four patients had ectopic pregnancies 1177
FIGURE 2 (A) Hospitalization times were statistically significantly decreased for patients who underwent a robotic anastomosis, who were sent home the same day of surgery. (B) Postoperative analgesic requirements were statistically significantly greater for patients who underwent open anastomoses. Although patients were given a prescription for analgesic medications, over-the-counter selfmedication usage could not be excluded. (C) Time to recovery as measured by independent activities of daily living (IADLS) was accelerated in patients who underwent robotic surgery, which improved the overall cost effectiveness of robotic tubal anastomoses.
(22%), and two patients had spontaneous pregnancy losses (11%). In comparison, among the patients who underwent an open anastomosis, three patients had confirmed intrauterine pregnancies (30%), one had an ectopic pregnancy (10%), and one had a spontaneous pregnancy loss (10%). The hospital cost for the robotic tubal reversal was $13,773.55, which was more than the open procedure at $11,742.97. For the hospital cost, each robotic anastomosis encompassed a calculated charge for the surgical system and four da Vinci instruments, for an instrument charge of $800. However, the cost per delivery for robotic tubal reversal was approximately $92,000, which was similar to that of the open procedure (ROBOT: $92,488.00; OPEN: $92,205.90) (Table 1). DISCUSSION Our report represents one of the largest published series of patients to have undergone a robotic-assisted laparoscopic tubal reversal. Previously published human data using robotic-assisted surgery in tubal anastomoses are limited. Falcone et al. (23) evaluated 10 patients who underwent a tubal anastomosis using the Zeus surgical system, with a 50% pregnancy rate after anastomosis. This was later compared with laparoscopic tubal anastomosis with comparable clinical outcomes but longer operative times (24). In a second series by Degueldre et al. (25), eight patients who had undergone previous sterilization with clips or through a Pomeroy procedure underwent a tubal anastomosis using the da Vinci surgical system. Although the follow-up period was only 4 months, two pregnancies were documented. Both studies demonstrated feasibility and delineated the technique and methods. One unique consideration with robotic surgery is the lack of haptic feedback when using fine sutures, which requires reliance on visual cues to determine when the suture has been ligated properly. Our study affirms the feasibility of this technique for the reproductive endocrinologist and provides data on comparative outcomes and cost effectiveness. Although these preliminary data appear promising, there are a few limitations to this study. First, this study was based on single center with small numbers, and the patients were not randomized. There was a shorter follow-up period in the patients undergoing robotic surgery, suggesting that pregnancy rates might ultimately higher in this group. In addition, charges were converted to costs by an arbitrary multiplier provided by our financial department. The assimilation of new medical technology can be a financial burden. In our study, robotic microsurgical tubal anastomosis was cost effective in terms of cost per live birth as compared with open surgery. Increased operative times and equipment costs for robotic surgery were counterbalanced by increased hospitalization and recovery times in open surgery.
Dharia Patel. Robotic tubal anastomosis. Fertil Steril 2008.
1178
Dharia Patel et al.
Robotic tubal anastomosis
Robotic-assisted surgery appears to provide the same surgical outcomes and cost effectiveness when compared with traditional open tubal anastomoses. The high patency rates Vol. 90, No. 4, October 2008
TABLE 1 Cost analysis based on type of procedure. Robot
Tubal anastomosis þ associated care Singleton gestation Twin gestation Spontaneous abortion Ectopic and associated care HSG Time to return to work IADL Ibuprofen usage Hydrocodone/acetaminophen usage TOTAL Singleton þ Twin Cost for live birth
Open
Occurrences
Cost ($U.S.)
Occurrences
Cost ($U.S.)
100 27.5 0.5 11.1 22.2 39 100 100 100 100
$1,600,080 $265,969.90 $18,639.50 $45,983.00 $229,987.80 $17,280.51 $309,056 $99,456 $965 $2,246 $2,589,664
100 29.6 0.4 10 10 50 100 100 100 100
$1,397,022 $286,280.40 $14,911.59 $41,426.10 $103,598.10 $22,154.50 $643,398 $251,776 $1,516 $4,094 $2,766,177
28
30 $92,488.00
$92,205.90
Note: HSG ¼ hysterosalpingogram; IADL ¼ instrumental activities of daily living. Dharia Patel. Robotic tubal anastomosis. Fertil Steril 2008.
provide optimism for the role of robotics in training programs. REFERENCES 1. UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), World Health Organization. Advances in female sterilization research. Prog Reprod Health Res Newsl 1995;36:1. Available at: http://www.who.int/ reproductive-health/hrp/progress/35/prog35.pdf. Accessed on August 16, 2007. 2. Hillis SD, Marchbanks PA, Tylor LR, Peterson HB. Poststerilization regret: findings from the United States Collaborative Review of Sterilization. Obstet Gyecol 1999;93:889–95. 3. Spivak MM, Librach CL, Rosenthal DM. Microsurgical reversal of sterilization: a six year study. Am J Obstet Gynecol 1986;154:355–61. 4. Divers WA Jr. Characteristics of women requesting reversal of sterilization. Fertil Steril 1984;41:233–6. 5. Siegler AM, Hulka J, Peretz A. Reversibility of human sterilization. Fertil Steril 1985;43:499–510. 6. Posaci C, Camus M, Osmanagaoglu K, Devroey P. Tubal surgery in the era of assisted reproductive technology: clinical options. Hum Reprod 1999;14:120–36. 7. Winston RM. Reversal of tubal sterilization. Clin Obstet Gynecol 1980;23:1261–8. 8. Silber SJ, Cohen R. Microsurgical reversal of female sterilization: the role of tubal length. Fertil Steril 1980;33:598–601. 9. Rock JA, Guzick DS, Katz E, Zacur HA, King TM. Tubal anastomosis: pregnancy success following reversal of Falope ring or monopolar cautery sterilization. Fertil Steril 1987;48:13–7. 10. Yuen PM, Yu KM, Yip SK, Lau WC, Rogers MS, Chang A. A randomized prospective study of laparoscopy and laparotomy in the management of benign ovarian masses. Am J Obstet Gynecol 1997;177:109–14.
Fertility and Sterility
11. Lo L, Pun TC, Chan S. Tubal ectopic pregnancy: an evaluation of laparoscopic surgery versus laparotomy in 614 patients. Aust NZ J Obstet Gynaecol 1999;39:185–7. 12. Koh CH, Janik GM. Laparoscopic microsurgical tubal anastomosis. Obstet Gynecol Clin North Am 1999;26:189–200. 13. Reich H, McGlynn F, Parente C, Sekel L, Levie M. Laparoscopic tubal anastomosis. J Am Assoc Gynecol Laparosc 1993;1:16–9. 14. Sedbon E, Delajoulinieres JB, Boudouris O, Madelenat P. Tubal desterilisation through exclusive laparoscopy. Hum Reprod 1989;4:158–9. 15. Stylopoulos N, Rattner D. Robotics and ergonomics. Surg Clin North Am 2003;83:1–12. 16. Sturges RH, Wright PK. A quantification of dexterity. J Robot Comp Integr Manuf 1989;6:3–14. 17. Ballantyne GH. Robotic surgery, telerobotic surgery, telepresence, and telementoring. Surg Endosc 2002;16:1389–402. 18. Berguer R, Forkey DL, Smith WD. Ergonomic problems associated with laparoscopic surgery. Surg Endosc 1999;13:466–8. 19. Falcone T, Goldberg JM. Robotics in gynecology. Surg Clin North Am 2003;83:1483–9. 20. Satava RM. Robotic surgery: from past to future—a personal journey. Surg Clin North Am 2003;83:1–6. 21. Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist 1969;9:179–86. 22. Department of Labor, Bureau of Wages, Earning and Benefits. Available at: www.bls.gov. Accessed on: April 1, 2004. 23. Falcone T, Goldberg JM, Margossian H, Stevens L. Robotic-assisted laparoscopic microsurgical tubal anastomosis: a human pilot study. Fertil Steril 2000;73:1040–2. 24. Goldberg JM, Falcone T. Laparoscopic microsurgical tubal anastomosis with and without robotic assistance. Hum Reprod 2003;18:145–7. 25. Degueldre M, Vandromme J, Huong PT, Cadiere GB. Robotically assisted laparoscopic microsurgical tubal reanastomosis: a feasibility study. Fertil Steril 2000;74:1020–3.
1179