Laparoscopic Versus Robot-Assisted Versus Transanal Low Anterior Resection: 3-Year Oncologic Results for a Population-Based Cohort in Experienced Centers.

BACKGROUND: Laparoscopic, robot-assisted, and transanal total mesorectal excision are the minimally invasive techniques used most for rectal cancer surgery. Because data regarding oncologic results are lacking, this study aimed to compare these three techniques while taking the learning curve into account. METHODS: This retrospective population-based study cohort included all patients between 2015 and 2017 who underwent a low anterior resection at 11 dedicated centers that had completed the learning curve of the specific technique. The primary outcome was overall survival (OS) during a 3-year follow-up period. The secondary outcomes were 3-year disease-free survival (DFS) and 3-year local recurrence rate. Statistical analysis was performed using Cox-regression. RESULTS: The 617 patients enrolled in the study included 252 who underwent a laparoscopic resection, 205 who underwent a robot-assisted resection, and 160 who underwent a transanal low anterior resection. The oncologic outcomes were equal between the three techniques. The 3-year OS rate was 90% for laparoscopic resection, 90.4% for robot-assisted resection, and 87.6% for transanal low anterior resection. The 3-year DFS rate was 77.8% for laparoscopic resection, 75.8% for robot-assisted resection, and 78.8% for transanal low anterior resection. The 3-year local recurrence rate was in 6.1% for laparoscopic resection, 6.4% for robot-assisted resection, and 5.7% for transanal procedures. Cox-regression did not show a significant difference between the techniques while taking confounders into account. CONCLUSION: The oncologic results during the 3-year follow-up were good and comparable between laparoscopic, robot-assisted, and transanal total mesorectal technique at experienced centers. These techniques can be performed safely in experienced hands.

Comparison of laparoscopic versus robot-assisted versus transanal total mesorectal excision surgery for rectal cancer: a retrospective propensity score-matched cohort study of short-term outcomes.

BACKGROUND: Laparoscopic total mesorectal excision (TME) surgery for rectal cancer has important technical limitations. Robot-assisted and transanal TME (TaTME) may overcome these limitations, potentially leading to lower conversion rates and reduced morbidity. However, comparative data between the three approaches are lacking. The aim of this study was to compare short-term outcomes for laparoscopic TME, robot-assisted TME and TaTME in expert centres. METHODS: Patients undergoing rectal cancer surgery between 2015 and 2017 in expert centres for laparoscopic, robot-assisted or TaTME were included. Outcomes for TME surgery performed by the specialized technique in the expert centres were compared after propensity score matching. The primary outcome was conversion rate. Secondary outcomes were morbidity and pathological outcomes. RESULTS: A total of 1078 patients were included. In rectal cancer surgery in general, the overall rate of primary anastomosis was 39.4, 61.9 and 61.9 per cent in laparoscopic, robot-assisted and TaTME centres respectively (P < 0.001). For specialized techniques in expert centres excluding abdominoperineal resection (APR), the rate of primary anastomosis was 66.7 per cent in laparoscopic, 89.8 per cent in robot-assisted and 84.3 per cent in TaTME (P < 0.001). Conversion rates were 3.7 , 4.6 and 1.9 per cent in laparoscopic, robot-assisted and TaTME respectively (P = 0.134). The number of incomplete specimens, circumferential resection margin involvement rate and morbidity rates did not differ. CONCLUSION: In the minimally invasive treatment of rectal cancer more primary anastomoses are created in robotic and TaTME expert centres.

The results of this study showed similar and acceptable short-term results for laparoscopic, robot-assisted and transanal total mesorectal excision performed in expert centres. In centres with robot-assisted or transanal technique, more primary anastomoses were made.

A multimodal prehabilitation program in high-risk patients undergoing elective resection for colorectal cancer: A retrospective cohort study.

AIM: Up to 50% of the patients experience complications after colorectal cancer (CRC) surgery. Improved preoperative physical and nutritional status can enhance clinical outcomes and reduce postoperative complications. This retrospective, single-center, observational cohort study assessed the impact of a four-week multimodal prehabilitation program on postoperative complications, unplanned readmissions, length of stay, and mortality in elective high-risk CRC patients. METHOD: Elective high-risk CRC patients, defined as ASA ≥3 or ≥65yr, who attended the multimodal prehabilitation program (prehabilitation-group) were compared to a historical cohort receiving standard care (control-group). Differences in outcomes between these groups were tested using Fisher's Exact and Mann-Whitney U test. To adjust for confounding, multivariate logistic regression analysis was performed. The main study outcome was the occurrence of postoperative complications. Secondary outcomes included unplanned readmissions, length of hospital stay, and mortality. RESULTS: 351 patients were included (n = 275 control-group, n = 76 prehabilitation-group). The complication rate was lower in the prehabilitation group compared to the control group, 26.3% (n = 20) versus 40% (n = 110) (p = .032). There were fewer unplanned readmissions in the prehabilitation group compared to the control group, 5.3% (n = 4) versus 16.4% (n = 45), p = .014. Median hospital days of stay was 1 day shorter for the prehabilitation-group (p = .004), mortality did not significantly differ between the groups. CONCLUSION: This study shows that the used multimodal prehabilitation program leads to a reduction of medical postoperative complications, unplanned readmissions, and shortens the median hospital stay compared with standard care in high-risk CRC patients undergoing elective CRC surgery.

Objective assessment of technical surgical skills.

BACKGROUND: Surgeons are increasingly being scrutinized for their performance and there is growing interest in objective assessment of technical skills. The purpose of this study was to review all evidence for these methods, in order to provide a guideline for use in clinical practice. METHODS: A systematic search was performed using PubMed and Web of Science for studies addressing the validity and reliability of methods for objective skills assessment within surgery and gynaecology only. The studies were assessed according to the Oxford Centre for Evidence-based Medicine levels of evidence. RESULTS: In total 104 studies were included, of which 20 (19.2 per cent) had a level of evidence 1b or 2b. In 28 studies (26.9 per cent), the assessment method was used in the operating room. Virtual reality simulators and Objective Structured Assessment of Technical Skills (OSATS) have been studied most. Although OSATS is seen as the standard for skills assessment, only seven studies, with a low level of evidence, addressed its use in the operating room. CONCLUSION: Based on currently available evidence, most methods of skills assessment are valid for feedback or measuring progress of training, but few can be used for examination or credentialing. The purpose of the assessment determines the choice of method.

Serious gaming and voluntary laparoscopic skills training: a multicenter study.

This study assesses the issue of voluntary training of a standardized online competition (serious gaming) between surgical residents. Surgical residents were invited to join a competition on a virtual reality (VR) simulator for laparoscopic motor skills. A final score was calculated based on the task performance of three exercises and was presented to all the participants through an online database on the Internet. The resident with the best score would win a lap-top computer. During three months, 31 individuals from seven hospitals participated (22 surgical residents, 3 surgeons and six interns). A total of 777 scores were logged in the database. In order to out-perform others some participants scheduled themselves voluntarily for additional training. More attempts correlated with higher scores. The serious gaming concept may enhance voluntary skills training. Online data capturing could facilitate monitoring of skills progression in surgical trainees and enhance (VR) simulator validation.

Requirements for the design and implementation of checklists for surgical processes.

BACKGROUND: The use of checklists is a promising strategy for improving patient safety in all types of surgical processes inside and outside the operating room. This article aims to provide requirements and implementation of checklists for surgical processes. METHODS: The literature on checklist use in the operating room was reviewed based on research using Medline, Pubmed, and Google Scholar. Although all the studies showed positive effects and important benefits such as improved team cohesion, improved awareness of safety issues, and reduction of errors, their number still is limited. The motivation of team members is considered essential for compliance. Currently, no general guidelines exist for checklist design in the surgical field. Based on the authors' experiences and on guidelines used in the aviation industry, requirements for the checklist design are proposed. The design depends on the checklist purpose, philosophy, and method chosen. The methods consist of the "call-do-response" approach," the "do-verify" approach, or a combination of both. The advantages and disadvantages of paper versus electronic solutions are discussed. Furthermore, a step-by-step strategy of how to implement a checklist in the clinical situation is suggested. CONCLUSIONS: The use of structured checklists in surgical processes is most likely to be effective because it standardizes human performance and ensures that procedures are followed correctly instead of relying on human memory alone. Several studies present promising and positive first results, providing a solid basis for further investigation. Future research should focus on the effect of various checklist designs and strategies to ensure maximal compliance.

Can a structured checklist prevent problems with laparoscopic equipment?

BACKGROUND: A high incidence of problems with the technical equipment is known to occur during routine laparoscopic procedures. Use of a structured checklist of preparatory measures could help to prevent these problems. This study aimed to determine the extent to which a checklist reduced the number of incidents with technical laparoscopic equipment. METHODS: A 28-item checklist was developed based on frequently occurring laparoscopic equipment problems during 30 laparoscopic cholecystectomies (the control group). A further 30 procedures were conducted with the checklist (the checklist group). The number and type of incidents with the technical equipment were compared between the groups. All the procedures were recorded using a special audio-video system (black-box). RESULTS: In the checklist group, the total number of incidents per procedure was 53% lower than in the control group (23/30 versus 49/30). The checklist led to fewer incidents of wrong positioning (9/30 versus 22/30), and wrong settings and connections (7/30 versus 12/30) of the equipment. Defects or malfunctions decreased from 15/30 in the control group to 7/30 in the checklist group. One or more incidents with the equipment occurred in 47% (14/30) of the checklist procedures compared with 87% (26/30) of the control procedures. Median time taken to complete the checklist items was 3.3 min (range 1.0-8.3 min). CONCLUSIONS: Use of a checklist was feasible and helped to reduce problems with the laparoscopic equipment in the operating room. Future research should aim to implement checklists for different procedures and investigate their effects.

Incorporation of proficiency criteria for basic laparoscopic skills training: how does it work?

BACKGROUND: It is desirable that surgical trainees are proficient in basic laparoscopic motor skills (eye-hand coordination). The present study evaluated the use of predefined proficiency criteria on a basic virtual reality (VR) simulator in preparation for a laparoscopic course on animal models. METHODS: Twenty-eight surgical trainees who enrolled for a basic laparoscopic course were trained on a basic (VR) simulator until their performance met predefined criteria. Two different criteria were defined, based on the performance of experienced laparoscopic surgeons on the simulator. In the first group (n = 10), the criteria were set at the 75th percentile of the laparoscopic surgeons' performance on the simulator and in the second group, at the 50th percentile (n = 18). Training time and number of attempts needed until the performance criteria were met were measured. RESULTS: In the first group, training time needed to pass the test ranged from 29 to 77 min (median: 63 min) with a range of 43-90 attempts (median 61 attempts). In the second group, training time ranged from 38 to 180 min (median 80 min) with a range of 55-233 attempts (median 95 attempts). Experience with assisting or performing laparoscopic procedures varied widely and was not correlated with the training time and number of attempts needed to pass the criteria. CONCLUSIONS: The performance criteria for training laparoscopic motor skills on a (VR) simulator resulted in wide variation between surgical trainees in time and number of attempts needed to pass the criteria. This demands training courses with a flexible time span tailored to the individual level of the trainee.

Transfer validity of laparoscopic knot-tying training on a VR simulator to a realistic environment: a randomized controlled trial.

BACKGROUND: Laparoscopic suturing is one of the most difficult tasks in endoscopic surgery, requiring extensive training. The aim of this study was to determine the transfer validity of knot-tying training on a virtual-reality (VR) simulator to a realistic laparoscopic environment. METHODS: Twenty surgical trainees underwent basic eye-hand coordination training on a VR simulator (SIMENDO, DelltaTech, Delft, The Netherlands) until predefined performance criteria were met. Then, they were randomized into two groups. Group A (the experimental group) received additional training with the knot-tying module on the simulator, during which they had to tie a double laparoscopic knot ten times. Group B (controls) did not receive additional manual training. Within a week the participants tied a double knot in the abdominal cavity of an anaesthetized porcine model. Their performance was captured on digital video and coded. Objective analysis parameters were: time taken to tie the knot and number of predefined errors made. Subjective assessments were also made by two laparoscopic surgeons using a global rating list with a five-point Likert scale. RESULTS: Trainees in group A (n = 9) were significantly faster than the controls (n = 10), with a median of 262 versus 374 seconds (p = 0.034). Group A made a significantly lower number of errors than the controls (median of 24 versus 36 errors, p = 0.030). Subjective assessments by the laparoscopic experts did not show any significant differences in economy of movement and erroneous behavior between the two groups. CONCLUSION: Surgical trainees who received knot-tying training on the VR simulator were faster and made fewer errors than the controls. The VR module is a useful tool to train laparoscopic knot-tying. Opportunities arose to improve simulator-based instruction that might enhance future training.

Construct validity and assessment of the learning curve for the SIMENDO endoscopic simulator.

BACKGROUND: The SIMENDO is an affordable virtual reality simulator designed to train basic psychomotor skills for endoscopic surgery. This study aimed first to establish construct validity by determining which parameters can discriminate groups with different experience levels, and second to establish the extent to which training is useful by determining when inexperienced groups reach expert level. METHODS: The study participants were divided into four groups according to their experience with endoscopic procedures: experienced group (group A, >50 procedures performed, n = 15), intermediate group (group B, 1-50 procedures performed, n = 18), endoscope navigation group (group C, endoscope navigation experience, n = 14), and novice group (group D, no endoscopic experience, n = 14). Each participant performed three repetitions of six consecutive exercises. The parameters studied were task time, path length of the instruments, and number of errors (collisions). Some participants continued training up to 10 repetitions to get insight in the learning curve. RESULTS: Group A (expert) outperformed all the other groups (B, C, and D) in terms of total median task time (p < 0.05), groups C and D in terms of path length, and group D in terms of collision frequency in the first two repetitions. Group B (intermediate) outperformed group D (novice) in total time and endoscope path length for all repetitions, and group C (camera navigation) outperformed group D (novice) in the first repetition. Less experienced groups D and C did not reach expert level for the task time within 10 repetitions, and group B reached it after the eighth repetition (p < 0.05). CONCLUSION: The study was able to establish construct validity for the training program with the simulator under study. The learning curve showed that training with this simulator is useful for subjects with or without limited endoscopic experience. Furthermore, previous endoscopic camera navigation already improves motor skills to more than the basic level.

Analysis of verbal communication during teaching in the operating room and the potentials for surgical training.

BACKGROUND: Verbal communication in the operating room during surgical procedures affects team performance, reflects individual skills, and is related to the complexity of the operation process. During the procedural training of surgeons (residents), feedback and guidance is given through verbal communication. A classification method based on structural analysis of the contents was developed to analyze verbal communication. This study aimed to evaluate whether a classification method for the contents of verbal communication in the operating room could provide insight into the teaching processes. METHODS: Eight laparoscopic cholecystectomies were videotaped. Two entire cholecystectomies and the dissection phase of six additional procedures were analyzed by categorization of the communication in terms of type (4 categories: commanding, explaining, questioning, and miscellaneous) and content (9 categories: operation method, location, direction, instrument handling, visualization, anatomy and pathology, general, private, undefinable). The operation was divided into six phases: start, dissection, clipping, separating, control, closing. RESULTS: Classification of the communication during two entire procedures showed that each phase of the operation was dominated by different kinds of communication. A high percentage of explaining anatomy and pathology was found throughout the whole procedure except for the control and closing phases. In the dissection phases, 60% of verbal communication concerned explaining. These explaining communication events were divided as follows: 27% operation method, 19% anatomy and pathology, 25% location (positioning of the instrument-tissue interaction), 15% direction (direction of tissue manipulation), 11% instrument handling, and 3% other nonclassified instructions. CONCLUSION: The proposed classification method is feasible for analyzing verbal communication during surgical procedures. Communication content objectively reflects the interaction between surgeon and resident. This information can potentially be used to specify training needs, and may contribute to the evaluation of different training methods.

Problems with technical equipment during laparoscopic surgery. An observational study.

BACKGROUND: This study was designed to investigate the incidence of technical equipment problems during laparoscopic procedures. METHODS: A video-capturing system was used, consisting of an analog video recorder with three camera image inputs and a microphone. Problems with all technical equipment used by the surgical team, such as the insufflator, diathermy apparatus, monitors, light source, camera and camera unit, endoscope, suction devices, and instruments, were registered. RESULTS: In total, 30 procedures were randomly videotaped. In 87% (26/30) of the procedures, one or more incidents with technical equipment (49 incidents) or instruments (9 incidents) occurred. In 22 of those incidents (45%) the technical equipment was not correctly positioned or not present at all; in the other 27 (55%), the equipment malfunctioned as a result of a faulty connection (9), a defect (5), or the wrong setting of the equipment (3). In 10 (20%) cases the exact cause of equipment malfunctioning was unclear. CONCLUSIONS: The incidence of problems with laparoscopic technical equipment is high. To prevent such problems, improvement and standardization of equipment is needed, combined with the incorporation of checklist use before the start of a surgical procedure. Future research should be aimed at development, implementation, and evaluation of these measures into the operating room.

The influence of different training schedules on the learning of psychomotor skills for endoscopic surgery.

BACKGROUND: Psychomotor skills for endoscopic surgery can be trained with virtual reality simulators. Distributed training is more effective than massed training, but it is unclear whether distributed training over several days is more effective than distributed training within 1 day. This study aimed to determine which of these two options is the most effective for training endoscopic psychomotor skills. METHODS: Students with no endoscopic experience were randomly assigned either to distributed training on 3 consecutive days (group A, n = 10) or distributed training within 1 day (group B, n = 10). For this study the SIMENDO virtual reality simulator for endoscopic skills was used. The training involved 12 repetitions of three different exercises (drop balls, needle manipulation, 30 degree endoscope) in differently distributed training schedules. All the participants performed a posttraining test (posttest) for the trained tasks 7 days after the training. The parameters measured were time, nontarget environment collisions, and instrument path length. RESULTS: There were no significant differences between the groups in the first training session for all the parameters. In the posttest, group A (training over several days) performed 18.7% faster than group B (training on 1 day) (p = 0.013). The collision and path length scores for group A did not differ significantly from the scores for group B. CONCLUSION: The distributed group trained over several days was faster, with the same number of errors and the same instrument path length used. Psychomotor skill training for endoscopic surgery distributed over several days is superior to training on 1 day.

Laparoscopic rectovaginopexy for rectal prolapse.

BACKGROUND: Open rectovaginopexy is an effective procedure for the treatment of both rectal prolapse and anterior rectocele. This study investigates our results of laparoscopic rectovaginopexy (LRVP). METHODS: A consecutive series of 14 patients (median age, 73 years; range 24-92) with rectal prolapse was planned for LRVP. Pre-, per- and postoperative parameters were recorded. Followup was performed at the outpatients' clinic. RESULTS: The median length of hospital stay was 6 days (range, 3-14). There was one fatal cerebrovascular accident 14 days postoperatively; this patient was excluded from further analysis. Median follow-up was 7 months (range, 0.75-38). During follow-up, 11 of 13 patients (85%) experienced resolution or major improvement of their symptoms. Anal incontinence was diminished in 9 of 13 cases (69%). Constipation improved in 2 of 3 patients (66%). These three patients experienced a combination of both anal incontinence and costipation, preoperatively. Recurrence occurred in 2 patients (15%). Two others had a minor residual mucosal prolapse. No patients reported symptoms suggestive of operation-induced constipation or dyspareunia. CONCLUSIONS: LRVP is feasible, and seems to be an effective procedure for rectal prolapse. No operation-induced constipation was observed in this series. Taking into account the age and co-morbidities of these patients, morbidity and mortality may be considered acceptable.

Validation of a new basic virtual reality simulator for training of basic endoscopic skills: the SIMENDO.

BACKGROUND: The aim of this study was to establish content, face, concurrent, and the first step of construct validity of a new simulator, the SIMENDO, in order to determine its usefulness for training basic endoscopic skills. METHODS: The validation started with an explanation of the goals, content, and features of the simulator (content validity). Then, participants from eight different medical centers consisting of experts (> or =100 laparoscopic procedures performed) and surgical trainees (<100) were informed of the goals and received a "hands-on tour" of the virtual reality (VR) trainer. Subsequently, they were asked to answer 28 structured questions about the simulator (face validity). Ratings were scored on a scale from 1 (very bad/useless) to 5 (excellent/very useful). Additional comments could be given as well. Furthermore, two experiments were conducted. In experiment 1, aimed at establishing concurrent validity, the training effect of a single-handed hand-eye coordination task in the simulator was compared with a similar task in a conventional box trainer and with the performance of a control group that received no training. In experiment 2 (first step of construct validity), the total score of task time, collisions, and path length of three consecutive runs in the simulator was compared between experts (>100 endoscopic procedures) and novices (no experience). RESULTS: A total of 75 participants (36 expert surgeons and 39 surgical trainees) filled out the questionnaire. Usefulness of tasks, features, and movement realism were scored between a mean value of 3.3 for depth perception and 4.3 for appreciation of training with the instrument. There were no significant differences between the mean values of the scores given by the experts and surgical trainees. In response to statements, 81% considered this VR trainer generally useful for training endoscopic techniques to residents, and 83% agreed that the simulator was useful to train hand-eye coordination. In experiment 1, the training effect for the single-handed task showed no significant difference between the conventional trainer and the VR simulator (concurrent validity). In experiment 2, experts scored significantly better than novices on all parameters used (construct validity). CONCLUSION: Content, face, and concurrent validity of the SIMENDO is established. The simulator is considered useful for training eye-hand coordination for endoscopic surgery. The evaluated task could discriminate between the skills of experienced surgeons and novices, giving the first indication of construct validity.

Fundamental aspects of learning minimally invasive surgical skills.

With the introduction of minimally invasive surgery (MIS) the necessity to develop training methods to learn skills outside the operating room (OR) became clear. Several training simulators have become commercially available. However, fundamental research into the requirements for effective and efficient training in MIS is still lacking. Yet in the literature several learning models have been described that may be used when designing the structure of a training program. While learning skills, three stages can be observed: cognitive, associative and autonomous. The learning cycle also includes different learning styles and, moreover, every trainee has his/her preferred learning style. Furthermore, training should be adapted to the level of behaviour: skill-based, rule-based or knowledge-based. Training of complex skills should include multiple performance objectives, such as just-in-time supportive information and part-task practice. Finally, motivation for training can be created by assessment. In conclusion, several theories on learning can be found in the literature. These theories may help in the development of effective training programs for training MIS skills outside the OR.