Introduction: Revisional procedures in bariatric surgery are regarded as technically more demanding and riskier than primary interventions. While the use of the surgical robot has not yet proven to be advantageous in primary bariatric interventions, the question remains whether its use is justified for more complex revisional procedures. Objective: To show that revisional bariatric surgery can be performed safely using the da Vinci® Xi surgical system. Methods: We performed a retrospective analysis of prospectively recorded data for revisional bariatric procedures between January 2016 and November 2019. Results: Of 78 revision operations, four (5.1%) were performed by open surgery, 30 (38.5%) by laparoscopic surgery, and 44 (56.4%) by robotic surgery. A comparative analysis of robotic (n = 41) versus laparoscopic (n = 18) revisional Roux-en-Y gastric bypasses (rRYGB) revealed significant differences favoring the robotic approach for operative time (130.7 vs. 167.6 min), C-reactive protein values at days 1 (27.9 vs. 49.1 mg/L) and 2 (48.2 vs. 83.6 mg/L) after surgery, and length of stay (4.9 vs. 6.2 days). Lower complication rates (Clavien-Dindo II–V) were found after rRRYGB (7.3 vs. 22.2%, not significant). Conclusions: Revisional bariatric surgery using a robotic system is safe. The operative time performing rRRYGB is significantly shorter than rLRYGB in our experience. Otherwise, results were largely comparable. Due to different indications, different index operations and a wide range of revisional procedures, further studies are necessary to confirm these results.

Bariatric surgery is well established in the treatment of morbid obesity. The therapy is highly effective and improves life expectancy and quality of life [1]. However, in addition to the risk of recurrent obesity, there are operative risks and side effects. Due to insufficient weight loss, weight regain, reflux problems, and dysphagia, revisions or conversions are often necessary [2]. Revisional procedures are regarded as technically more demanding and riskier than primary interventions [3]. The indication for revision should be based on a multidisciplinary evaluation and individual risk-benefit assessment, according to current guidelines [4]. Recommended revisional procedures after adjustable gastric banding (AGB) and sleeve gastrectomy (SG) are primarily Roux-en-Y gastric bypass (RYGB), SG and one anastomosis gastric bypass (OAGB) [2, 5].

Robotic systems are increasingly being used in visceral surgery. In addition to three-dimensional, high-definition visualization, intuitive handling with tremor compensation and downscaling, robotic bariatric surgery balances the sometimes massive torque of the abdominal wall. The system seems to be safe in SG [6], but clear advantages are not evident considering higher costs and longer operative times [7, 8]. With regard to primary RYGB, most studies show that robotic procedures are safe and efficient [9-16]. There are slight advantages in terms of complications, burdened by a longer operative time and higher costs. Differing results from meta-analyses and register studies could result from publication bias and negative effects of the learning curve [17-19].

While primary bariatric interventions generally have a very low complication rate [20], advantages of the robotic system in revision interventions with higher complication rates may be more relevant. So far, there are several reports and case series with good results [21-25] but only a few comparative cohort studies [26, 27]. A low complication rate has been reported, albeit with a low (n = 11) number of robotic interventions [26]. Another group found a comparable safety profile of robotic interventions, while robotic revisional surgeries after stapled procedures were performed more quickly than laparoscopic ones [27]. Evaluation of registry databases showed no advantages when using the robot [28]. In particular revisional robotic SG (rRSG) showed worse results than rLSG [29]. A clear benefit is not yet apparent, and it remains unclear whether the use of the surgical robot in revision operations is justified.

We present the largest German series of da Vinci® Xi (Intuitive Surgical, Sunnyvale, CA, USA) revisional bariatric procedures, with a comparative analysis of revisional RYGB operations in terms of safety and efficacy.

All bariatric surgeries of the certified obesity center (Referenzzentrum, German Society of General and Visceral Surgery, DGAV) have been prospectively recorded in a database since January 2016. Participating surgeons were accredited as bariatric surgeons by the DGAV. At the time of initiating the evaluation, the department had a cumulative experience of more than 600 bariatric operations (57% SG, 36% RYGB, 5% revisional procedures, and 2% other). On average, 120 procedures were performed annually between 2013 and 2015. Our department has been using the da Vinci robotic system since 2013. By the end of 2015, 230 robotic procedures were performed within the department, none by the participating surgeons. The first RSG was in 2016, while RYGB procedures were performed robotically from January 2017 [9], using the Xi System from August 2017.

All indications for revisional procedures were made on an interdisciplinary basis. In 2016, only laparoscopic surgery was performed. From mid-2017, the surgical procedure was selected according to availability. There was no specific selection for the use of the robot.

Due to the wide range of revisional procedures, a comparative statistical analysis of all laparoscopic and da Vinci Xi revisional RYGB (rLRYGB and rRRYGB, respectively) procedures was performed. Preoperative parameters included: gender, height, weight, BMI, age, Edmonton Obesity Staging System (EOSS) [30], hemoglobin, white blood cells (WBC), and C-reactive protein (CRP). Operative time, docking time, and intraoperative complications were recorded, as were laboratory values on postoperative days 1 and 2, and length of stay (LOS). In addition to the inpatient course, standardized follow-up data were collected after 1 month and 1 year. The primary endpoint was morbidity after 30 days, according to Clavien-Dindo [31].

Besides a case report of a complex open revision operation [32], a subgroup of 13 rRRYGB operations was published as case series in 2019 [33].

Surgical Techniques

The different index operations and indications required various surgical procedures. Standard LRYGB and RRYGB have already been described [9, 33]. The da Vinci Xi robotic platform (Intuitive Surgical, Sunnyvale, CA, USA) was used for all robotic revisional procedures. When performing rRYGB, the pouch was formed using 45-mm linear stapler (Echelon FlexTM Endopath; Ethicon, Johnson & Johnson, USA), operated by the assistant surgeon in robotic procedures. The gastrojejunostomy in rRYGB and rOAGB was performed side-to-side using a linear stapler. The enterotomy was closed by a running suture with resorbable material (e.g., Vicryl, Stratafix; Ethicon, Johnson & Johnson, USA). The jejunojejunostomy in rRYGB was performed similarly. The limb lengths in rRYGB and rOAGB varied, depending on the indication for revision. After AGB, the band was usually explanted 6 weeks before final conversion in a two-step procedure. For rSG, a 14-mm bougie was inserted before resection. The proximal staple line was inverted by a continuous suture with Stratafix. For single pouch revision, the pouch was reduced using a linear stapler and the gastrojejunostomy narrowed by a running suture.

Statistical Analysis

The statistical analyses were performed using SPSS 24 (SPSS Inc., Chicago, IL, USA). Continuous parameters were compared by a two-sided t test, categorical parameters by a χ2test. A p value <0.05 was regarded as statistically significant. Values are presented as mean ± standard deviation (SD) or n (%), as appropriate.

Index Procedure and Indication

A total of 78 bariatric revisional procedures were performed. The type of revision surgery was dependent on the index operation and revision indication (online suppl. Table 1; for all online suppl. material, see www.karger.com/doi/10.1159/000507742). The most frequent index operation was SG (n = 53, 67.9%), followed by AGB (n = 11, 14.1%), and RYGB (n = 8, 10.3%). Of all SG, one-third was converted as a planned second step, a third due to insufficient weight loss or weight gain, and a third due to reflux symptoms. In one case, a chronic and refractory fistula required robotic conversion to RYGB. After AGB, all revision surgeries were performed due to insufficient weight loss or weight regain. After RYGB, revisions were required because of weight regain (n = 2), reflux problems (n = 1), pouch dilatation (n = 3), refractory hypoglycemia (n = 1), and gastrogastric fistula (n = 1). Six further revisions were performed following vertical banded gastroplasty, OAGB, and biliopancreatic diversion.

Revisional Procedures

Of 78 revision operations, four (5.1%) were performed by open surgery, 30 (38.5%) by laparoscopic surgery, and 44 (56.4%) by robotic surgery. rRYGB was performed most frequently (n = 62, 79.5%), followed by rSG and rOAGB (n = 4 each, 5.1%). In individual cases, a hiatal hernia repair and/or a cholecystectomy were performed in parallel. Baseline characteristics are listed in online supplementary Table 2.

Results are shown in online supplementary Table 3. There were no intraoperative complications and no conversions resulting from intraoperative difficulties. Two robotically planned rRYGB procedures were performed openly after initial laparoscopy and evidence of severe adhesions (classified as primarily open). There was no mortality in the postoperative course. One leak of the gastrojejunostomy occurred after open revision of a complex gastrogastric fistula after external RYGB. Six patients underwent postoperative reoperation due to insufficiency (n = 1) or hemorrhage (n = 4); one re-laparoscopy due to elevated CRP levels after revisional LSG remained without evidence of any cause. We also found one hematoma of the abdominal wall requiring transfusion. In another case, gastrointestinal bleeding occurred but stopped spontaneously, and did not require endoscopy or transfusion. Lower complication rates and shorter surgery times were found after robotic revision surgery (online suppl. Table 3). For details on all cases, see online supplementary Table 4 (raw data).

Laparoscopic versus Robotic rRYGB

Due to the very different procedures and indications, a comparative analysis of all minimally invasive RYGB revision operations was performed. Table 1 shows the characteristics of 18 rLRYGB versus 41 rRRYGB patients.

Table 1.

Patient characteristics in the revisional (r) laparoscopic (L) and robotic (R) RYGB groups

Patient characteristics in the revisional (r) laparoscopic (L) and robotic (R) RYGB groups
Patient characteristics in the revisional (r) laparoscopic (L) and robotic (R) RYGB groups

While the two groups were largely comparable regarding age, sex, height, comorbidities, and preoperative laboratory parameters, there was a significant difference in preoperative weight (heavier in the rLRYGB group, although the BMI was not significantly different), resulting from the differences in indication: 15 (83.3%) rLRYGB patients were converted because of insufficient weight loss, weight regain, or planned second step; only 3 (16.7%) were revised due to reflux problems or other non-weight associated problems. For rRRYGB, 24 (58.5%) patients were revised due to body weight, with a higher proportion of reflux patients (n = 17, 41.5%).

The operative time differed significantly, robotically completed 37 min earlier on average (Table 2). The mean time for docking was 5 min. Postoperative laboratory values did not differ regarding hemoglobin and WBC, but significantly lower CRP values were found on days 1 and 2 with rRRYGB. The inpatient stay after rRRYGB was also significantly shorter. The overall rate of complications (Clavien-Dindo classification II–V) was lower after rRRYGB (7.3%) than rLRYGB (22.2%), although not significantly, and there was no significant difference in individual complications. Weight loss tended to be greater with rLRYGB, with a significantly greater reduction in BMI after 30 days.

Table 2.

Operative parameters and 30-day complication rates between revisional (r) laparoscopic (L) and robotic (R) RYGB

Operative parameters and 30-day complication rates between revisional (r) laparoscopic (L) and robotic (R) RYGB
Operative parameters and 30-day complication rates between revisional (r) laparoscopic (L) and robotic (R) RYGB

Further subgroup analyses divided according to the indication for rRYGB (reflux or weight related) yielded comparable results with lower operative times in the two robotic groups as well as reduced postoperative CRP values and LOS (data not shown, online supplementary Table 4).

Complex bariatric rRYGB procedures can be performed safely with the robotic system, with significantly shorter operative times and low complication rates.

The role of the robot in bariatric surgery is still not clearly defined. While performing RSG, the disadvantages may outweigh the advantages [6-8]. The robot seems to be advantageous in primary RYGB regarding postoperative complications [17, 18], but at the expense of higher costs and longer operative times [19]. Revision interventions are considered more complex and complicated [34], and the potential advantages of the robot system are likely to become more apparent. The literature indicates that several case series, two controlled non-randomized studies, and an analysis of the MBSAQIP have been published (Table 3), as discussed below.

Table 3.

Results of the literature search for robotic revisional bariatric surgery

Results of the literature search for robotic revisional bariatric surgery
Results of the literature search for robotic revisional bariatric surgery

Pros

By using the da Vinci Xi System, we achieve significantly shorter operative times compared to rLRYGB surgery. Previous studies mostly reported extended operative times when using the robot [26, 28, 29], up to 6 h in one study [26]. It has been argued that the results differ only in operative time and LOS in comparable cohorts, and that no benefit is apparent [28]. However, there was a significantly higher proportion of technical simple gastric band removals in the laparoscopic revision group, while consecutively the relative share of complex RYGB operations was higher in the robot group. One study reported a significant reduction in operative time in a subgroup of rRRYGB (193 min, da Vinci Xi) versus rLRYGB (238 min) [27]. We also used the Xi System. With a mean surgical time of 126 min (rRRYGB), we were well below previous publications (range 167–352 min; Table 3) including MBSAQIP evaluations [28, 29]. The docking time of 5 min no longer plays a significant role with corresponding experience using the system.

Regarding postoperative complications (Clavien-Dindo [31]), there was a lower number of complications with rRRYGB in our study. The difference was not significant due to the low number of cases and incidence of complications. Other groups have also reported low complication and leakage rates (Table 3). In the largest case series of 99 robotic procedures, a high rate of minor complications (17%) was found, without hemorrhages or leaks as a major complication [21]. Another group concluded that there is no clear benefit with robotic revisional bariatric surgery in terms of patient safety, reporting a higher complication rate after robotic surgery in unmatched rSG [29].

We found significantly lower CRP values on postoperative days 1 and 2 after rRRYGB compared to rLRYGB. The lower CRP levels in the robotic group cannot be solely explained by lower complication rates. The subgroup analysis of all rRYGB patients without complications (Clavien-Dindo 0 and I) also showed significantly lower CRP levels after rRRYGB (p = 0.00014, data not shown). We consider this a possible sign of a more precise and atraumatic surgical approach using the robot.

Regarding the LOS, results to date are contradictory. A reduction in the LOS was found in one study using the robot [27], while the registry data showed an extended LOS [28]. In the study by Clapp et al. [28], the clear differences between cohorts regarding index operation and procedure must be mentioned. Our data show a significant reduction in LOS with rRRYGB. Due to the temporal divergence of the two groups, we believe that LOS was influenced by a more stringent patient management in this group.

Apart from well measurable parameters, an additional advantage is the comfort for the surgeon, in particular in patients with a very high BMI. A survey among bariatric surgeons shows a prevalence of 73–88% of physical complaints caused by laparoscopic bariatric surgery [35]. However, the study is not yet able to provide valid data on robotically active colleagues.

Cons

Although the steering of the system is intuitive, it is complex. Moreover, haptic feedback is missing. Therefore, simulator training and training on mini pig and human cadavers are essential before using the system [36]. A Proctoring program is available, whereby centers are accompanied by experienced robotic surgeons during their first procedures. The program is recommended to avoid typical pitfalls in the initial phase.

Higher costs hamper a wider use of the system. A detailed analysis of all incurring costs cannot be provided. The average additional costs for the use of the Xi system have already been calculated in other publications and amount to approximately EUR 2,000 [9, 37]. The cost of the operating room per minute in our clinic has been estimated at EUR 15. With a reduction in the operative time by 37 min, the remaining additional costs are about EUR 1,450. It has been discussed to what extent the additional costs are compensated by avoiding complications [38], or whether the investments are amortized by advertising effects [15]. Currently, we do not assume that the use of the robot in bariatric surgery is cost free.

Weaknesses and Strengths

This study gives a comprehensive overview of revisional bariatric surgery using the robotic da Vinci Xi System against laparoscopy, with a complete evaluation of complications after 30 days. Due to the different indications and index surgery, the sample size is small and groups are not comparable in all points. In addition, the laparoscopic surgeries were performed earlier. At the beginning of the study, our cumulative institutional experience was limited to some more than 600 bariatric procedures. On the other hand, the entire learning curve with the Xi System can be found in the robotic group. While the latter benefits the laparoscopic cohort, the overall experience with the procedure gained in the laparoscopic RYGB would favor the robotic cohort. Furthermore, the study cannot offer a complete annual follow-up, as some operations have only recently been performed.

Retrospective analysis shows that revisional bariatric surgery using a robotic system is safe. Performing rRRYGB results in a low rate of complications. The operative time is shorter in rRRYGB than rLRYGB. Otherwise, results were largely comparable. Structured training and participation in a Proctoring program seem to be reasonable to overcome the learning curve and typical pitfalls. Further studies are necessary to confirm these results.

The manuscript was edited by Deborah Nock (Medical WriteAway, Norwich, UK).

The study was conducted ethically in accordance with the World Medical Association Declaration of Helsinki and with the approval of the local ethics committee. Informed written consent was obtained from all individual participants included in the study.

J.H.B., W.S., and T.T. are active as speakers for Johnson & Johnson Medical. J.H.B., T.T., J.-H.E., and T.B. received grants for training with the da Vinci Xi Surgical System through Intuitive Surgical Sàrl. J.H.B. and J.-H.E. work as proctors for Intuitive Surgical Sàrl. T.B. received the da Vinci® Xi Surgical System from Intuitive. Surgical Sàrl for the purpose of clinical research. A.-S.M., J.-N.K., and M.L. state that they have no conflicts of interest to declare. The authors declare that they have no further competing interests.

The robotic procedures were performed on the da Vinci® Xi Surgical System, provided by Intuitive Surgical Sàrl for the purpose of clinical research to the Department of General, Visceral-, Thoracic-, Transplantation-, and Pediatric Surgery, Kurt-Semm Center for Laparoscopic and Robotic Assisted Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Germany. The services of the medical writer were funded by Intuitive Surgical Sàrl. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

J.H.B. is the corresponding author and drafted the manuscript. A.-S.M. and J.-N.K. acquired the patients’ data in the postoperative course. M.L. provided the pre-surgical data of the patient and supported with the nutritional expertise. J.H.B., T.T., and T.B. provided the bariatric expertise. W.S. and T.T. acquired the patient’s consent to participate in the study and carried out the statistical analysis. J.-H.E. and T.B. designed the study and helped structuring and revising the manuscript. All authors read and revised the manuscript critically and approved the final manuscript.

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