Robotic-Assisted Roux-en-Y Gastric Bypass: Minimizing Morbidity and Mortality

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1 OBES SURG (2010) 20: DOI /s CLINICAL RESEARCH Robotic-Assisted Roux-en-Y Gastric Bypass: Minimizing Morbidity and Mortality Brad Elliott Snyder & Todd Wilson & Benjamin Y. Leong & Connie Klein & Erik B. Wilson Received: 12 December 2008 / Accepted: 7 October 2009 / Published online: 3 November 2009 # Springer Science + Business Media, LLC 2009 Abstract Background Despite the rapid acceptance of laparoscopic Roux-en-Y gastric bypass (RYGB) by the community and increase in the number of these procedures being done, there is still significant morbidity and mortality. Methods At the University of Texas Medical School at Houston, we have performed 320 RYGB with robotic assistance (RARYGB). Surgical times, length of stay, morbidity, and mortality have been recorded since the beginning of our robotic experience and represent the world s largest single institution series of RARYGB. Outcome data were examined in a postoperative cohort. Results The average starting BMI was 49.1 kg/m 2, and it declined by 66% to 32.5 kg/m 2 by the end of 1 year. The average operative time was 192 min, and the average length of stay was 2.7 days. Within the first year, there were a total of 77 (24.1%) complications. The foremost complications noted in the literature to be 3% to 11% were all <1% in our series, and we have no mortalities. Compared to our 356 laparoscopic RYGB, there was a significantly lower gastrointestinal leak rate in the robotic arm. A cohort of 79 postoperative patients was analyzed with respect to weight loss, resolution of co-morbidity, and quality of life. While there was no variation in quality of life over time, weight loss, resolution of co-morbidities, and overall outcome score were significantly improved. Conclusions We effectively perform robotic-assisted RYGB that lowers the morbidity and mortality of this B. E. Snyder (*) : T. Wilson : B. Y. Leong : C. Klein : E. B. Wilson Department of Surgery, University of Texas Health Sciences Center at Houston, 6431 Fannin Street, Suite 4.294, Houston, TX 77030, USA brad.snyder@uth.tmc.edu procedure compared to today s standard while maintaining thriving outcomes. Keywords Robotics. Gastric bypass. Outcome. Bariatrics. Morbidity and mortality Introduction As we continue to utilize robotics in general surgery, we look for the improvement that it offers not only in terms of ergonomics but also to our patients in terms of a safer procedure. We all strive for lower morbidity and mortality. The da Vinci robot (Intuitive Surgical, Sunnyvale, CA, USA) has serviced surgeons in performing Roux-en Y gastric bypass (RYGB) since 2000 [1]. Over the ensuing 5 years, the reports on this technique were especially notable. There are reports of lower complication rates, no gastrointestinal leaks, and no mortality [2 6]; in addition, robotic surgeons are matching the time of the standard laparoscopic RYGB (LRYGB) [5] or even performing the surgery quicker [6, 7]. We have already published our comparison of 356 LRYGB to 249 robotic-assisted RYGB (RARYGB) [3]. In this series, the overall complication rate for the LRYGB was 14%, with a major complication rate of 3.9%, compared to the RARYGB, with an overall complication rate of 14% and major complication rate of 3.6%. While there was no significant difference in overall or major complication rates, the rate of the most dreaded morbidity of gastrointestinal leaks in the LRYGB was 1.7% and 0% in the RARYGB. This was significant (p<0.05). The learning curve with robotics is significant [8 11], but as minimally invasive fellowship-trained surgeons come out into the community, the operative time for gastric bypass during the learning curve may be shorter for the

2 266 OBES SURG (2010) 20: robotic cases compared to traditional laparoscopic RYGB [6, 7, 10, 11]. Robotics is more expensive, and there is little argument about that [5, 8]; however, it is reasonable to believe that if we can document lower morbidity (especially gastrointestinal leaks), then the fee of using the robot is justifiable. In fact, we may presume that the expenditure associated with taking care of a gastrointestinal leak, gastrointestinal (GI) bleed, or anastomosis stricture far outweighs the difference in charge between the traditional and robotic RYGB. Overall, lower complications results in superior outcomes for our patients, improve utilization of hospital and community resources, and places less physical burden on laparoscopic surgeons [6, 10, 11]. So are we lowering the morbidity of gastric bypass surgeries enough to justify the use of robotics? In our practice at the University of Texas Medical School at Houston, we now use the da Vinci robot for all of our gastric bypasses and perform a RARYGB. We have previously reported on the learning curve from our first 100 cases and showed good outcomes with no gastrointestinal leaks [10]. Since this report, we have performed another 220 RARYGB without any GI leaks and recently compared our RARYGB results to LRYGB, finding a significant difference in gastrointestinal leak rates [3]. With this in mind, we recaptured data on all RARYGB performed to date and analyzed the demographics, operative time, complication rate, and readmission rate. Furthermore, what good is a device that improves the quality of the operation if it does not uphold or improve the achievement of the standard operation? That is, we have to prove that the RARYGB has corollaries that are at least up to standard and generate sustained weight loss, resolution of co-morbid disease, and improvement of quality of life. Therefore, we used the newly created Measured Outcomes Results of Bariatric Interval Data (MORBID) score to determine success in these areas, allowing descriptive statistical analysis to be performed with veracity. Quality of life is measured using the Moorehead Ardelt quality of life questionnaire-ii (MA-QoL QII). This is a validated, disease-specific tool for measuring the quality of life before and after surgery on the morbidly obese patient. The percent excessive weight loss (%EWL) and percent comorbid conditions improved were weighted to equal QoL, and the three components are added together for a total score. This total is the MORBID score and is scaled from 0 to 18 points, with 0 being the most successful score (Table 1). Materials and Methods Table 1 MORBID classification by total score Excellent 0 to 3 Very good 4 to 6 Good 7 to 9 Well 10 to 12 Fair 13 to 15 Poor 16 to 18 Our practice has been performing RARYGB since 2003, and our hybrid technique used to close the jejunojejunosotmy and gastrojejunostomy is described elsewhere [3, 10]. Since that time, we have collected data on all our patients in a prospective database with IRB approval and patient consent. We exploited this database to review the records on 320 RARYGB that have been performed since the beginning of our robotic experience, including those in the original learning curve. We accumulated their age, starting weight (SW), starting body mass index (sbmi, kg/m 2 ), follow-up BMI, excessive weight (EW), %EWL, length of stay, operative time, readmission rate, and complication rate. The average and standard deviations were calculated with Microsoft excel software. The percentage of specific complications was also calculated in this way. Quality of life data were collected on a cohort of patients in the clinic as they were followed up for their postoperative visit. They were asked to complete the six questions on the MA-QoL QII. To our knowledge and owing to the simplicity of the MA-QoL QII, all patients filled out their questionnaire and gave them back to the surgeon or nurse practitioner. The questionnaires were assessed for completeness, and subsequent data were added from the prospective database in order to gauge the MORBID score and determine outcome. Once these data were collected, the total sample was divided into quartiles based on years out from surgery (YOS). These quartiles were analyzed for differences in age, SW, sbmi, EW, MA-QoL QII, excessive weight loss score (E), resolution of co-morbidity (M), and MORBID score (MORBID) using ANOVA that was created and run with Microsoft excel. Grafts and correlations were also run on Microsoft excel. Percent of perioperative complications (within 30 days of surgery) were compiled for both our series of 356 LRYGB and compared to those of our 320 RARYGB. Z test scores were calculated to determine the significant differences between the groups (p values). The results were judged significant when the probability of error was less than 5% (p<0.05) or the correlation coefficient (r) was 0.7, where applicable. Post hoc analysis of significant ANOVA was performed using a protected t test.

3 OBES SURG (2010) 20: Table 2 The complete list of all complications noted for our laparoscopic (LRYGB) versus robotic-assisted (RARYGB) Roux-en-Y gastric bypass patients a Denotes significant difference Complication LARYGB n=356 RARYGB n=320 p Nos. % Nos. % Abdom pain unsp site a 8 a 2.2 a 17 a 5.3 a 0.05 a Anastomotic Stricture Backache unspecified Bowel obstruction C difficile enteritis Dehydration Diarrhea Dysphagia Fever Gastric/duodenal fistula GI bleeding Intestinal obstruct unspec Marginal ulcers Nausea with vomiting Ot postop infection Pulmonary embolism/infarct Rhabdomyolysis Unsp constipation Wound infection Ventral hernia unspec Gastrointestinal leak 6 a a 0.0 a 0.05 a Total Results We collected results on 320 RARYGB performed over the last 5 years. The average age was 45±10 years, and the average sbmi was 49.1±10.5 kg/m 2. We had 115 patients (36%) followed up at 1 year whose average BMI dropped to 32.2±6.8 kg/m 2 (66% decrease in BMI). There were 51 patients (16%) who were followed up in the database at 2 years, and their average BMI was 32.5±8.3 (66% decrease in BMI). The drop in BMI was significantly different from sbmi to 12 months postop when compared with Student s t test (p<0.0001), but there was no difference in BMI between the first and second year after surgery. The average length of stay was 2.7±1.7 days in the Table 3 The results of the ANOVA ANOVA A B C D df F value p Age 45.7± ± ± ±10.7 3, SW 299.7± ± ± ±45.8 3, sbmi 47.2± ± ± ±6.9 3, EW 155± ± ± ±39.6 3, Q 1.4± ± ± ±1.0 3, EWL 0.5± ± ± ±0.8 3, <0.01 M 0.8± ± ± ±1.2 3, MORBID 6.4± ± ± ±2.1 3, <0.01 Mean±standard deviation is given for each variable. Clinical significance is give at p<0.01. Age is in years, SW is starting weight in pounds, sbmi is starting body mass index (kg/m 2 ), EW is excessive weight in pounds, Q is quality of life score, EWL is excessive weight score (direct measure of percent excessive weight loss), M is the resolution of co-morbidity score, and MORBID is the sum of Q, EWL, and M and represents their total outcome. Degree of freedom is represented by df

4 268 OBES SURG (2010) 20: Table 4 Post hoc-protected t test PhPt test F p BQ F A B F B C F A C F A D F B D 4.73 <0.01 F C D BM F A B F B C F A C 5.85 <0.01 F A D 9.58 <0.01 F B D F C D BE F A B 6.60 <0.01 F B C <0.01 F A C <0.01 F A D <0.01 F B D <0.01 F C D BT F A B 5.86 <0.01 F B C F A C <0.01 F A D <0.01 F B D F C D All the post hoc-protected t test run for all combinations between groups. Significance is considered when p<0.01 Fig. 2 MORBID scores by quartile shows the MORBID score for each quartile. The first quartile is significantly different then all the rest. The lower the score, the more successful the patient is hospital. Our operative time averaged 193±48 min. We had 30 (9.4%) readmissions within 30 days of the operation. Complications were sorted by type, number, and percentage (Table 2). The general complication rate (including nausea, vomiting, unspecified abdominal pain, etc.) was 22.5%. Major complications included stricture, internal hernia (resulting in bowel obstruction), GI bleeding, marginal ulceration, pulmonary embolism, and gastrointestinal leak. We had a total of nine (2.8%) major complications: three strictures (0.9%), three bowel obstructions (0.9%), two GI bleed (0.6%), one ulcer (0.3%), and two pulmonary embolisms (0.6%); however, there were no gastrointestinal leaks (0%). Compared to our LARYGB series (Table 2), Score Years out from Surgery Q E M Fig. 1 E scores by quartile shows the excessive weight loss scores for each quartile. All are significantly different other than C and D Fig. 3 Q, E, M, and MORBID scores over time shows the trend of quality of life (Q), excessive weight loss (E), resolution of co-morbid disease (M), and total (MORBID) scores over time. There is a significant correlation (r>0.70) for E, M, and MORBID, but not for Q

5 OBES SURG (2010) 20: there was significantly more abdominal pain (p=0.05), but a significantly lower gastrointestinal leak rate (p=0.05). We accumulated 4 months of outcome and QoL data, obtaining 79 RYGB patients into our postoperative cohort. All of them underwent RARYGB. Their YOS ranged from 0 to 5.3 years (averaged 0.7±1 year). This group was divided into quartiles based on YOS and termed group A, B, C, or D. Group A had an average YOS of 0±0 (range 0 to 0.1), group B had an average YOS of 0.2±0.1 (range 0.1 to 0.3), group C had an average YOS of 0.6±0.3 (range 0.3 to 1), and group D had an average YOS of 2.1±1.2 (range 1.1 to 5.3). There was no considerable difference between the groups with respect to age, SW, sbmi, EW, QoL, or morbidity score. However, there was a significant difference in %EWL and MORBID score (Table 3). When the post hoc protected t tests were performed (Table 4), all groups were different with respect to weight loss except C and D, and there was a positive trend (Fig. 1) with a correlation coefficient of MORBID scores were significantly different between group A and all other groups (Fig. 2), and the correlation coefficient was Though there was no significant difference between the groups with respect to resolution of co-morbidities, there was a noteworthy and affirmative trend (r=0.84). However, the alterations in QoL scores did not differ between groups nor was there a linear correlation (r= 0.55). Figure 3 reflects on the trends over time for QoL, EWL, M, and MORBID. Conclusion Robotic-assisted RYGB awards patients a lower threat of surgical complications compared to the current literature with the same long-term, postoperative benefits of excessive weight loss and resolution of co-morbid disease. We previously illustrated the comparison of RARYGB complication rates to traditional laparoscopic RYGB [3], showing a significantly diminished incidence of gastrointestinal leaks than the reported and presently tolerable leak rate of 1% to 3% [4, 12 17]. Furthermore, we present the ample number of case needed [14] to statistically substantiate these results as accurate. Now, in addition to others [5], we indicate acceptable outcomes. Together, lower morbidity and agreeable end result represents a proper clinical advantage and profit of RARYGB [4]. The extra overheads of the robot are absorbed by the hospital by increasing the market share [6] and, in return, probably result in increased revenue when marketed well because patients are seeking out new technology [4]. In addition, the money saved in less intensive care and hospital days as a result of a lower gastrointestinal leak may be significant and ameliorate the extra cost [5]; however, unearthing the true cost of the robot from a hospital s perspective is not easy to acquire because administrators are not forthcoming with this knowledge. It is suspected that the upfront cost of RARYGB is higher than LRYGB, but the overall cost may not be significantly higher when cost of increased complications are included [6]. Hopefully, we will be able to report on the exact cost of robotic usage in the near future. Nonetheless, any tools that result in lower complication rates should be considered even if it is more expensive. To date, we boast the largest reported RARYGB series in the world and demonstrate below average complication rates for what is arguably the most complicated elective laparoscopic surgery [6 8, 11]. The surgery is fraught with complications like splenic injury, anastomotic leaks, deep venous thrombosis and pulmonary embolism, wound infection, ventral hernia, and respiratory complications [15 17]. We have avoided the high early postoperative complication rate of 3% to 11% [9, 19 23] reported in the literature. These outcomes are achieved because of rigid training, devoted practice, and earnest dedication to roboticassisted procedures. Robotics imparts to surgeons precision [1 4, 6, 10, 11, 18], extra degrees of freedom [2, 4, 6, 8, 11], ability to work in small spaces with the assistance of an extra arm [2, 4, 18], control of the binocular and digital camera (with magnification) [2, 5, 6, 8, 11], ergonomics [6, 10, 11, 18], and decreased distractions while at the console [2, 5]. As minimally invasive, fellowship-trained surgeons who learned traditional ( Higa technique [15, 24]) and robotic-assisted techniques, we are convinced that our RYGB patients are best served with the assistance of the da Vinci robot. Further advances in robotics stands poised to revolutionize general surgery in the near future as much as laparoscopy already has. In the era of natural orifice transluminal endoscopic surgery and single port surgeries, robotics cannot be ignored and will rightfully find its place in every operating room in some form or another. References 1. Horgan S, Vanuno D. Robots in laparoscopic surgery. J Laparoendosc Adv Surg Tech. 2001;11: Jocobsen G, Berger R, Horgan S. The role of robotic surgery in morbid obesity. J Laparoenosc Adv Surg Tech. 2003;13: Snyder BE, Wilson T, Scarborough T, et al. Lowering gastrointestinal leak rates: a comparative analysis of robotic and laparoscopic gastric bypass. J Robot Surg. 2008;2: Moser F, Horagn S. 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