Erratum to "Efficacy of goal-directed minimally invasive surgery simulation training with the Lübeck Toolbox-Curriculum prior to first operations on patients: Study protocol for a multi-centre randomized controlled validation trial (NOVICE)" [Int. J. Surg. Protoc. 21 (2020) 13-20].

[This corrects the article DOI: 10.1016/j.isjp.2020.02.004.].

Testing Distinct Three-Dimensional Effects in Laparoscopy: A Prospective Randomized Trial Using the Lübecker Toolbox Curriculum.

BACKGROUND: The use of stereoscopic laparoscopic systems in minimally invasive surgery (MIS) allows a three-dimensional (3D) view of the surgical field, which improves hand-eye coordination. Depending on the stereo base used in the construction of the endoscopes, 3D systems may differ regarding the 3D effect. Our aim was to investigate the influence of different stereo bases on the 3D effect. METHODS: This was a prospective randomized study involving 42 MIS-inexperienced study participants. We evaluated two laparoscopic 3D systems with stereo bases of 2.5 mm (system A) and 3.8 mm (system B) for differences in learning MIS skills using the Lübeck Toolbox (LTB) video box trainer. We evaluated participants' performance regarding the times and repetitions required to reach each exercise's goal. After completing the final exercise ("suturing"), participants performed the exercise again using a two-dimensional (2D) representation. Additionally, we retrospectively compared our study results with a preliminary study from participants completing the LTB curriculum with a 2D system. RESULTS: The median number of repetitions until reaching the goals for LTB exercises 1, 2, 3, and 6 for system A were: 18 (range 7-53), 24 (range 8-46), 24 (range 13-51), and 21 (range 10-46), respectively, and for system B were: 12 (range 2-30), 16 (range 6-43), 17 (range 4-47), and 15 (range 6-29), respectively (p = not significant). Changing from a 3D to a 2D representation after completing the learning curve led to a longer average time required, from 95.22 to 119.3 s (p < 0.0001), for the last exercise (exercise 6; "suturing"). When comparing the results retrospectively with the learning curves acquired with the 2D system, there was a significant reduction in the number of repetitions required to reach the LTB exercise goals for exercises 1, 3, and 6 using the 3D system. CONCLUSION: Stereo bases of 2.5 and 3.8 mm provide acceptable bases for designing 3D systems. Additionally, our results indicated that MIS basic skills can be learned quicker using a 3D system versus a 2D system, and that when the 3D effect is eliminated, the corresponding compensatory mechanisms must be relearned.

Efficacy of goal-directed minimally invasive surgery simulation training with the Lübeck Toolbox-Curriculum prior to first operations on patients: Study protocol for a multi-centre randomized controlled validation trial (NOVICE).

BACKGROUND: Minimally invasive surgery (MIS) procedures require special psychomotoric skills. Learning of these MIS basic skills is often performed in the operating room (OR). This is economically inefficient and could be improved in terms of patient safety. Against the background of this problem, various MIS simulators have been developed to train MIS basic skills outside the OR. Aim of this study is to evaluate to what extent MIS training programs and simulators improve the residents' skills in performing their first MIS procedures on patients. METHOD: The current multicentric RCT will be performed with surgical residents without prior active experience in MIS (n = 14). After the participants have completed their first laparoscopic cholecystectomy as baseline evaluation (CHE I), they will be randomized into two groups: 1) The intervention group will perform the Lübeck Toolbox curriculum, whereas 2) the control group will not undergo any MIS training. After 6 weeks, both groups will perform the second laparoscopic CHE (CHE II). Changes or improvements in operative performance (between CHE I and CHE II) will be analyzed and evaluated according to the Global Operative Assessment of Laparoscopic Skill (GOALS) Score (primary endpoint). DISCUSSION: The multicentric randomized controlled trial will help to determine the value of MIS training outside the operation room. Proof of effectiveness in practice transfer could be of considerable relevance with regard to an integration of MIS training programs into surgical education.

Video Tutorials Increase Precision in Minimally Invasive Surgery Training - a Prospective Randomised Trial and Follow-up Study. / Video-Tutorials erhöhen die Präzision im minimalinvasiven Operationstraining ­ eine prospektiv randomisierte Studie und Nachuntersuchung.

BACKGROUND: Simulation-based practice has become increasingly important in minimally invasive surgery (MIS) training. Nevertheless, personnel resources for demonstration and mentoring simulation-based practice are limited. Video tutorials could be a useful tool to overcome this dilemma. However, the effect of video tutorials on MIS training and improvement of MIS skills is unclear. METHODS: A prospective randomised trial (n = 24 MIS novices) was conducted. A video-trainer with three different tasks (#1 - 3) was used for standardised goal-directed MIS training. The subjects were randomised to two groups with standard instructional videos (group A, n = 12) versus comprehensive video tutorials for each training task watched at specific times of repetition (group B, n = 12). Performance was analysed using the MISTELS score. At the beginning and following the curriculum, an MIS cholecystectomy (CHE) was performed on a porcine organ model and analysed using the GOALS score. After 18 weeks, participants performed 10 repetitions of tasks #1 - 3 for follow-up analysis. RESULTS: More participants completed tasks #1 and #2 in group B (83.3 and 75%) than in group A (66.7 and 50%, ns). For task #2, there was a significant improvement in precision in group B (p < 0.001). For the entire cohort, the GOALS-Scores were 12.9 before and 18.9 after the curriculum (p < 0.001), with no significant difference between groups. Upon follow-up, 84.2% (task#1), 26.3% (task#2) and 100% (task#3) of MIS novices were able to reach the defined goals (A vs. B ns). There was a trend for a better MISTELS score in group B upon follow-up. CONCLUSIONS: Standardised comprehensive video tutorials watched frequently throughout practice can significantly improve precision in MIC training. This aspect should be incorporated in MIS training.

Conception of the Lübeck Toolbox curriculum for basic minimally invasive surgery skills.

PURPOSE: Difficulties at the beginning of the learning curve in minimally invasive surgery (MIS) can well be overcome by simulation outside the operating room. Despite a great number of available devices, standardized, structured, and validated training curricula for video simulators are scarce. METHODS: The Lübeck Toolbox (LTB) video trainer provides six training modules and online video tutorials. Proficiency levels for the tasks were defined by performance analysis of MIS experts (n = 15). Mean values of the best performed repetitions were set as benchmarks for a validation study with n = 30 MIS novices and the learning curves calculated. The novices performed a cholecystectomy on a pig organ model before and after the curriculum which were analyzed using the GOALS score. RESULTS: Benchmarks defined by expert performance for the task Nos. 1 to 6 were 72 s (± 8) (Pack Your Luggage), 49 s (± 9) (Weaving), 66 s (± 10) (Chinese Jump Rope), 89 s (± 28) (Triangle Cut), 138 s (± 44) (Hammer Cut), and 98 (± 22) (Suturing). The median numbers of required repetitions by the novices to reach the proficiency level were n = 42 (7-80), n = 26 (9-55), n = 32 (14-77), n = 44 (15-59), n = 19 (6-68), and n = 26 (15-60). These values were all located at the beginning of the plateau phase of the learning curves. GOALS score improved significantly after completion of the curriculum (18.0 (± 2.6) vs. 10.9 (± 1.6), p < 0.0001). CONCLUSION: The LTB curriculum constitutes a new highly standardized and proficiency level-based training program for basic skills in MIS. Transferability of the task content to a (sub)-realistic environment could be demonstrated. Still, future trials will have to further validate the effectiveness of the LTB curriculum.

Laparoscopic navigated liver resection: technical aspects and clinical practice in benign liver tumors.

Laparoscopic liver resection has been performed mostly in centers with an extended expertise in both hepatobiliary and laparoscopic surgery and only in highly selected patients. In order to overcome the obstacles of this technique through improved intraoperative visualization we developed a laparoscopic navigation system (LapAssistent) to register pre-operatively reconstructed three-dimensional CT or MRI scans within the intra-operative field. After experimental development of the navigation system, we commenced with the clinical use of navigation-assisted laparoscopic liver surgery in January 2010. In this paper we report the technical aspects of the navigation system and the clinical use in one patient with a large benign adenoma. Preoperative planning data were calculated by Fraunhofer MeVis Bremen, Germany. After calibration of the system including camera, laparoscopic instruments, and the intraoperative ultrasound scanner we registered the surface of the liver. Applying the navigated ultrasound the preoperatively planned resection plane was then overlain with the patient's liver. The laparoscopic navigation system could be used under sterile conditions and it was possible to register and visualize the preoperatively planned resection plane. These first results now have to be validated and certified in a larger patient collective. A nationwide prospective multicenter study (ProNavic I) has been conducted and launched.

Metachronous metastasis- and survival-analysis show prognostic importance of lymphadenectomy for colon carcinomas.

BACKGROUND: Lymphadenectomy is performed to assess patient prognosis and to prevent metastasizing. Recently, it was questioned whether lymph node metastases were capable of metastasizing and therefore, if lymphadenectomy was still adequate. We evaluated whether the nodal status impacts on the occurrence of distant metastases by analyzing a highly selected cohort of colon cancer patients. METHODS: 1,395 patients underwent surgery exclusively for colon cancer at the University of Lübeck between 01/1993 and 12/2008. The following exclusion criteria were applied: synchronous metastasis, R1-resection, prior/synchronous second carcinoma, age < 50 years, positive family history, inflammatory bowel disease, FAP, HNPCC, and follow-up < 5 years. The remaining 421 patients were divided into groups with (TM+, n = 75) or without (TM-, n = 346) the occurrence of metastasis throughout a 5-year follow-up. RESULTS: Five-year survival rates for TM + and TM- were 21% and 73%, respectively (p < 0.0001). Survival rates differed significantly for N0 vs. N2, grading 2 vs. 3, UICC-I vs. -II and UICC-I vs. -III (p < 0.05). Regression analysis revealed higher age upon diagnosis, increasing N- and increasing T-category to significantly impact on recurrence free survival while increasing N-and T-category were significant parameters for the risk to develop metastases within 5-years after surgery (HR 1.97 and 1.78; p < 0.0001). CONCLUSIONS: Besides a higher T-category, a positive N-stage independently implies a higher probability to develop distant metastases and correlates with poor survival. Our data thus show a prognostic relevance of lymphadenectomy which should therefore be retained until conclusive studies suggest the unimportance of lmyphadenectomy.

Outcome analysis of elderly patients undergoing laparoscopic resection rectopexy for rectal prolapse.

PURPOSE: For treatment of rectal prolapse, abdominal approaches are generally offered to younger patients, whereas perineal, less invasive procedures are considered more beneficial in the elderly. The aim of this study was to analyze whether laparoscopic resection rectopexy (LRR) is suitable for older patients. PATIENTS/METHODS: Patients who received LRR for rectal prolapse were selected from a prospective laparoscopic colorectal surgery database. Perioperative and long-term outcome were compared between patients <75 years old (group A) and ≥75 years old (group B). RESULTS: Of 154 patients, 111 were in group A and 43 in group B. There was one conversion that occurred in group B. Overall mortality rate was 1.3% (n = 2). Both patients were in group B (group B, 4.7%; p = 0.079). Differences in major and minor complications between the groups were not significant. Rates of improvement for incontinence were 62.7% (group A) and 66.7% (group B; p = 0.716); for constipation, the rates were 78.9% (group A) and 73.3% (group B; p = 0.832). All recurrences occurred in group A (n = 10; overall, 10.3%; group A, 13%). After exclusion of patients who had previously received perineal prolapse surgery, recurrence rate was 3.3% overall (group A, 4.3%). CONCLUSIONS: This study supports the benefits of LRR for rectal prolapse in elderly patients. Age per se is not a contraindication for LRR. Elderly patients encounter complications slightly more frequently (although not statistically significant) than younger patients. Therefore, a very careful patient selection in the elderly is of paramount importance. However, the long-term outcome does not seem to differ between younger and elderly patients.

Surgical management of pancreaticoduodenal artery aneurysms in association with celiac trunk occlusion or stenosis.

Aneurysms of the visceral arteries, especially of the pancreaticoduodenal artery, are rare. They show a wide clinical spectrum, ranging from asymptomatic incidental findings to rupture-inducing catastrophic bleedings. Since growth progression and the risk of rupture cannot be foreseen and there is no relation between the size of the aneurysm and propensity to rupture, rupture unfortunately carries a high mortality, >50%. Thus, all aneurysms of the pancreaticoduodenal artery should be treated. The therapy of choice, either operative intervention or catheter embolization, is determined by many factors. Among these are localization, size, relation to other vessels and neighboring organs, the urgency of intervention, and the experience of the therapist. Surgical therapy should be favored in patients with pancreaticoduodenal artery aneurysm due to celiac trunk occlusion. We report here our experience in the surgical treatment of pancreaticoduodenal artery aneurysms in association with celiac trunk occlusion or stenosis over the last 5 years.

Pneumococcal septic shock is associated with the interleukin-10-1082 gene promoter polymorphism.

Polymorphisms in the tumor necrosis factor and interleukin-10 genes, linked to cytokine inducibility, may influence the inflammatory response to infection. We studied the biallelic interleukin-10-1082 promoter, the tumor necrosis factor-alpha-308 promoter, and the lymphotoxin-alpha polymorphisms with regard to the development of septic shock in pneumococcal infection. Sixty-nine patients with pneumococcal disease (61 patients with community-acquired pneumonia, 5 patients with meningitis, and 3 patients with pneumonia and meningitis) and 50 age-matched control subjects were included. The polymorphisms were determined by the polymerase chain reaction. In patients with pneumococcal disease, the lipopolysaccharide-stimulated tumor necrosis factor and interleukin-10 release from whole blood were measured by ELISA. Sepsis severity was documented according to standard criteria. No significant genotypic differences were seen between patients and control subjects. Thirteen of 69 patients with pneumococcal disease developed septic shock. Interleukin-10 allele G homozygous patients had the highest risk for septic shock (odds ratio of 6.1; 95% confidence interval, 1.4-27.2; corrected p = 0.024). The stimulated interleukin-10 release was highest in interleukin-10 G homozygous patients (p = 0.04). In conclusion, interleukin-10 polymorphism, associated with high interleukin-10 inducibility, might influence the outcome of pneumococcal infection via induced immunosuppression and impaired bacterial clearance.