Randomized controlled trial of robotic-assisted versus conventional laparoscopic fundoplication: 12 years follow-up.

AIMS: Numerous reports have addressed the feasibility and safety of robotic-assisted (RALF) and conventional laparoscopic fundoplication (CLF). Long-term follow-up after direct comparison of these two minimally invasive approaches is scarce. The aim of the present study was to assess long-term disease-specific symptoms and quality of life (QOL) in patients with gastroesophageal reflux disease (GERD) treated with RALF or CLF after 12 years in the randomized ROLAF trial. METHODS: In the ROLAF trial 40 patients with GERD were randomized to RALF (n = 20) or CLF (n = 20) between August 2004 and December 2005. At 12 years after surgery, all patients were invited to complete the standardized Gastrointestinal Symptom Rating Scale (GSRS) and the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD). Failure of treatment was assessed according to Lundell score. RESULTS: The GSRS score was similar for RALF (n = 15) and CLF (n = 15) at 12 years´ follow-up (2.1 ± 0.7 vs. 2.2 ± 1.3, p = 0.740). There was no difference in QOLRAD score (RALF 6.4 ± 1.2; CLF 6.4 ± 1.5, p = 0.656) and the QOLRAD score sub items. Long-term failure of treatment according to the definition by Lundell was not different between RALF and CLF [46% (6/13) vs. 33% (4/12), p = 0.806]. CONCLUSION: In accordance with previous short-term outcome studies, the long-term results 12 years after surgery showed no difference between RALF and CLF regarding postoperative symptoms, QOL and failure of treatment. Relief of symptoms and patient satisfaction were high after both procedures on the long-term. REGISTRATION NUMBER: DRKS00014690 ( https://www.drks.de ).

Virtual reality simulation in robot-assisted surgery: meta-analysis of skill transfer and predictability of skill.

BACKGROUND: The value of virtual reality (VR) simulators for robot-assisted surgery (RAS) for skill assessment and training of surgeons has not been established. This systematic review and meta-analysis aimed to identify evidence on transferability of surgical skills acquired on robotic VR simulators to the operating room and the predictive value of robotic VR simulator performance for intraoperative performance. METHODS: MEDLINE, Cochrane Central Register of Controlled Trials, and Web of Science were searched systematically. Risk of bias was assessed using the Medical Education Research Study Quality Instrument and the Newcastle-Ottawa Scale for Education. Correlation coefficients were chosen as effect measure and pooled using the inverse-variance weighting approach. A random-effects model was applied to estimate the summary effect. RESULTS: A total of 14 131 potential articles were identified; there were eight studies eligible for qualitative and three for quantitative analysis. Three of four studies demonstrated transfer of surgical skills from robotic VR simulators to the operating room measured by time and technical surgical performance. Two of three studies found significant positive correlations between robotic VR simulator performance and intraoperative technical surgical performance; quantitative analysis revealed a positive combined correlation (r = 0.67, 95 per cent c.i. 0.22 to 0.88). CONCLUSION: Technical surgical skills acquired through robotic VR simulator training can be transferred to the operating room, and operating room performance seems to be predictable by robotic VR simulator performance. VR training can therefore be justified before operating on patients.

Evaluation of the combined laparoscopic and mediastinoscopic esophagectomy technique.

BACKGROUND: Laparoscopic esophagectomy is technically difficult especially during dissection in the upper mediastinum. This limitation may be surpassed with the help of mediastinoscopy or of the recently introduced robotic surgical systems. The aim of the present study was to evaluate in an experimental porcine model the feasibility of the combined laparoscopic and mediastinoscopic transhiatal esophagectomy technique and to compare it with the robotic-assisted transhiatal and conventional approaches. MATERIALS AND METHODS: Transhiatal esophagectomy was performed in Landrace pigs under general anesthesia using three different techniques: Group A (n = 9): combined laparoscopic and mediastinoscopic, group B (n = 4): robotic-assisted and group C (n = 8): conventional "open". The feasibility, difficulty and accuracy of the procedure along with operative time, blood loss, intraoperative incidents and overall satisfaction of the surgical team were assessed for each technique. RESULTS: Operations in group A were feasible and reproducible. Although the procedure was technically difficult, the constant view on the operative field was highly appreciated by the operative team and facilitated an accurate and safe dissection. The main intraoperative complications were related to the side-effects of tension pneumothorax accompanying pleural injuries. In group B the features of the robotic system reduced the difficulty of dissection and obviated the need for mediastinoscopy. Operations in group C were quick and almost incident-free, facilitated also by the particularities of the animal model that could not reproduce identically the clinical situation. CONCLUSIONS: The combined laparoscopic and mediastinoscopic esophagectomy technique is feasible and offers certain advantages over the open approach while the robotic-assisted approach is an emerging less difficult alternative. Further studies are required to establish whether the advantages of minimally-invasive approach compensate for the increased technical difficulty and prolonged operative time.

Robot-assisted versus conventional laparoscopic fundoplication: short-term outcome of a pilot randomized controlled trial.

BACKGROUND: Robotic technology represents the latest development in minimally-invasive surgery. Nevertheless, robotic-assisted surgery seems to have specific disadvantages such as an increase in costs and prolongation of operative time. A general clinical implementation of the technique would only be justified if a relevant improvement in outcome could be demonstrated. This is also true for laparoscopic fundoplication. The present study was designed to compare robotic-assisted (RALF) and conventional laparoscopic fundoplication (CLF) with the focus on operative time, costs und perioperative outcome. METHODS: Forty patients with gastro-esophageal reflux disease were randomized to either RALF by use of the daVinci Surgical System or CLF. Nissen fundoplication was the standard anti-reflux procedure. Peri-operative data such as length of operative procedure, intra-and postoperative complications, length of hospital stay, overall costs and symptomatic short-term outcome were compared. RESULTS: The total operative time was shorter for RALF compared to CLF (88 vs. 102 min; p = 0.033) consisting of a longer set-up (23 vs. 20 min; p = 0.050) but a shorter effective operative time (65 vs. 82 min; p = 0.006). Intraoperative complications included one pneumothorax and two technical problems in the RALF group and two bleedings in the CLF group. There were no conversions to an open approach. Mean length of hospital stay (2.8 vs. 3.3 days; p = 0.086) and symptomatic outcome thirty days postoperatively (10% vs. 15% with ongoing PPI therapy; p = 1.0 and 25% vs. 20% with persisting mild dysphagia; p = 1.0) was similar in both groups. Costs were higher for RALF than for CLF (3244 euros vs. 2743 euros, p = 0.003). CONCLUSION: In comparison with CLF, operative time can be shorter for RALF if performed by an experienced team. However, costs are higher and short-term outcome is similar. Thus, RALF can not be favoured over CLF regarding perioperative outcome.