B. P. Müller-Stich

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

BackgroundRobotic 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.MethodsForty 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.ResultsThe 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 vs. € 2743, p = 0.003).ConclusionIn 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.

Status of robotic assistance--a less traumatic and more accurate minimally invasive surgery?

PurposeRobotic assistance is considered one innovation within abdominal surgery over the past decade that has the potential to compensate for the drawbacks of conventional laparoscopy, such as limited degree of freedom, 2D vision, fulcrum, and pivoting effect. Robotic systems provide corresponding solutions as 3D view, intuitive motion and enable additional degrees of freedom. This review provides an overview of the history of medical robotics, experimental studies, clinical state-of-the-art and economic impact.MethodsThe Medline database was searched for the terms “robot*, telemanipulat*, and laparoscop*.” A total of 2573 references were found. All references were considered for information on robotic assistance in advanced laparoscopy. Further references were obtained through cross-referencing the bibliography cited in each work.ResultsIn experimental studies, current robotic systems showed superior handling and ergonomics compared to conventional laparoscopic techniques. In gynecology especially for hysterectomy and in urology especially for prostatectomy, two procedures formerly performed via an open approach, the robot enables a laparoscopic approach. This results in reduced need for pain medication, less blood loss, and shorter hospital stay. Within abdominal surgery, clinical studies were generally unable to prove a benefit of the robot. While the benefit still remains open to discussion, robotic systems are spreading and are available worldwide in tertiary centers.ConclusionRobotic assistance will remain an intensively discussed subject since clinical benefits for most procedures have not yet been proven. The most promising procedures are those in which the robot enables a laparoscopic approach where open surgery is usually required.

Comparison of the laparoscopic versus open live donor nephrectomy: an overview of surgical complications and outcome

BackgroundKidney transplantation (KTx) is considered to be the treatment of choice for end stage renal disease. One of the most challenging dilemmas in KTx is the shortage of suitable organs. The live donor nephrectomy is considered a unique operation performed on healthy donors, which provides a superior outcome in the recipients.Several surgical techniques have been developed so far to minimize donor postoperative complications as much as possible without compromising the quality of the kidney. The development of a minimally invasive surgery, laparoscopic live donor nephrectomy (LDN), was based on this concept.Materials and MethodsBy searching the pubmed, we reviewed the most evidence based clinical studies specifically randomized clinical trials and meta-analyses to give an overview of the efficacy and safety of LDN versus ODN.ResultsThe advantages of a LDN vs. a conventional open donor nephrectomy (ODN) are a smaller incision, better wound cosmetics, a lower rate of incisional hernia and adhesion, less postoperative pain, shorter hospitalization, and earlier return to work. Some concerns are longer operative and warm ischemic times, long-term learning curve for surgeons, and the risk of more serious complications than during an ODN.ConclusionOverall, the review of literature shows that a LDN provides less postoperative pain, a shorter hospital stay, a shorter period of rehabilitation, and earlier return to normal work and physical activities in comparison to the conventional open flank nephrectomy but is comparable to the mini muscle splitting approach. The complication rate is generally lower in centers accustomed to performing LDNs; however, complications can be life threatening and could impose significant costs to the health system. Weighing the longer operation and warm ischemic time, as well as the risk of more serious complications against the advantages of a LDN mandates a precise indication. The risk-benefit assessment for choosing one procedure should be done meticulously. Even though the short-term graft function in both techniques is comparable, there is a lack of enough long-term outcome analyses. Finally, in any transplant center, the cost of the laparoscopic procedure should be considered.

OpenHELP (Heidelberg laparoscopy phantom): development of an open-source surgical evaluation and training tool

AbstractBackgroundApart from animal testing and clinical trials, surgical research and laparoscopic training mainly rely on phantoms. The aim of this project was to design a phantom with realistic anatomy and haptic characteristics, modular design and easy reproducibility. The phantom was named open-source Heidelberg laparoscopic phantom (OpenHELP) and serves as an open-source platform. MethodsThe phantom was based on an anonymized CT scan of a male patient. The anatomical structures were segmented to obtain digital three-dimensional models of the torso and the organs. The digital models were materialized via rapid prototyping. One flexible, using an elastic abdominal wall, and one rigid method, using a plastic shell, to simulate pneumoperitoneum were developed. Artificial organ production was carried out sequentially starting from raw gypsum models to silicone molds to final silicone casts. The reproduction accuracy was exemplarily evaluated for ten silicone rectum models by comparing the digital 3D surface of the original rectum with CT scan by calculating the root mean square error of surface variations. Haptic realism was also evaluated to find the most realistic silicone compositions on a visual analog scale (VAS, 0–10).ResultsThe rigid and durable plastic torso and soft silicone organs of the abdominal cavity were successfully produced. A simulation of pneumoperitoneum could be created successfully by both methods. The reproduction accuracy of ten silicone rectum models showed an average root mean square error of 2.26 (0–11.48) mm. Haptic realism revealed an average value on a VAS of 7.25 (5.2–9.6) for the most realistic rectum.ConclusionThe OpenHELP phantom proved to be feasible and accurate. The phantom was consecutively applied frequently in the field of computer-assisted surgery at our institutions and is accessible as an open-source project at www.open-cas.org for the academic community.

Influence of bariatric surgery on quality of life, body image, and general self-efficacy within 6 and 24 months—a prospective cohort study

BACKGROUND It has been proven that bariatric surgery affects weight loss. Patients with morbid obesity have a significantly lower quality of life (QOL) and body image compared with the general population. OBJECTIVE To evaluate QOL, body image, and general self-efficacy (GSE) in patients with morbid obesity undergoing bariatric surgery within clinical parameters. SETTINGS Monocentric, prospective, longitudinal cohort study. METHODS Patients completed the short form 36 (SF-36) for QOL, body image questionnaire, and GSE scale 3 times: before surgery and within 6 months and 24 months after surgery. Influence of gender, age, and type of procedure, either laparoscopic sleeve gastrectomy (SG) or laparoscopic Roux-en-Y gastric bypass, were analyzed. RESULTS Thirty patients completed the questionnaires before and within 6 and 24 months after surgery. SF-36 physical summary score improved significantly from 34.3±11.0 before surgery to 46.0±10.4 within 6 months (P<.001) and to 49.8±8.2 within 24 months (P<.001) after surgery. SF-36 mental summary score improved significantly from 42.1±14.7 before surgery to 52.3±8.4 within 6 months (P<.001) and to 48.4±12.2 within 24 months (P<.001) after surgery. There were no significant differences between gender, age, and type of operation. Body image and GSE improved significantly after bariatric surgery (P<.001), and both correlated to the SF-36 mental summary score. CONCLUSION QOL, body image, and GSE improved significantly within 6 months and remained stable within 24 months after bariatric surgery. Improvements were independent of gender, age, and type of operation. Mental QOL was influenced by body image and GSE.

Risk awareness and training for prevention of complications in minimally invasive surgery

BACKGROUND Minimally invasive surgery (MIC) requires surgeons to have a different set of skills and capabilities from that of open surgery. The indirect camera view, lack of a three-dimensional view, restricted haptic feedback with lack of tissue feeling and difficult instrument coordination with fulcrum and pivoting effects result in an additional learning curve compared to open surgery. The prolonged learning curve leads to a higher risk of complications and special awareness of these risks is therefore mandatory. Training of special laparoscopic skills outside the operating room is needed to optimize patient outcome and to minimize the ocurrence of complications related to the learning curve. RESULTS AND DISCUSSION Training modalities for laparoscopic surgery include simple box trainers, computer simulation with virtual reality, the use of artificial and cadaver organs, as well as live animal models and cadaver training. These training modalities have been proven in studies to have a beneficial effect on the learning curve for acquisition of laparoscopic skills and for improving operative performance as well as avoidance of complications. Laparoscopic training is currently gaining a more and more important role for official education and accreditation purposes. In some countries the participation in laparoscopic training courses has become mandatory prior to participation in laparoscopic operations. Future research will include the optimization of multimodal training curricula, the development of individualized training approaches that allow both trainee and patient-specific preparation, as well as the use of novel devices to facilitate the collection and transfer of expertise between the generations and schools of surgeons.ZusammenfassungHintergrundDie minimal-invasive Chirurgie (MIC) fordert vom Chirurgen im Vergleich zur offenen Chirurgie zusätzliches Geschick und Fähigkeiten. Die indirekte Kamerasicht, fehlende dreidimensionale Sicht, mangelndes Gewebegefühl sowie die schwierige Instrumentenkoordination mit Drehpunkt- und Hebeleffekt führen zu einer verlängerten Lernkurve. Das resultierende höhere Risiko zur Entstehung von Komplikationen bedingt ein spezielles Risikobewusstsein. Ein Training der speziellen Fähigkeiten für die Laparoskopie außerhalb des Operationssaales scheint notwendig, um die Sicherheit der Patienten zu optimieren und die mit der Lernkurve einhergehenden Komplikationsrisiken zu minimieren.Ergebnisse und DiskussionDie Trainingsmodalitäten für die laparoskopische Chirurgie beinhalten Box-Trainer, Computersimulatoren mit virtueller Realität, künstliche und Kadaverorgane sowie Lebendtiermodelle und Kadavermodelle. Diese Trainingsmodalitäten haben einen in Studien bewiesenen Einfluss auf die Lernkurve der laparoskopischen Fähigkeiten sowie auf die Qualität der Durchführung von Operationen und die Vermeidung von Komplikationen. Das Laparoskopietraining spielt eine immer wichtigere Rolle in der Akkreditierung und fachlichen Anerkennung. In einigen Ländern wurden laparoskopische Trainingskurse vor dem ersten Einsatz im Operationssaal am Patienten bereits verpflichtend eingeführt. Zukünftige Studien werden die optimale Zusammensetzung multimodaler Trainingskurrikula untersuchen und individualisierte Trainee- und patientenspezifische Trainingsansätze entwickeln. Neue technische Entwicklungen werden die Kollektion und Weitergabe von Erfahrung und Können zwischen den Generationen und Schulen der Chirurgie vereinfachen, um letztlich die Behandlung der Patienten in der Chirurgie so sicher und schonend wie möglich zu gestalten.AbstractBackgroundMinimally invasive surgery (MIC) requires surgeons to have a different set of skills and capabilities from that of open surgery. The indirect camera view, lack of a three-dimensional view, restricted haptic feedback with lack of tissue feeling and difficult instrument coordination with fulcrum and pivoting effects result in an additional learning curve compared to open surgery. The prolonged learning curve leads to a higher risk of complications and special awareness of these risks is therefore mandatory. Training of special laparoscopic skills outside the operating room is needed to optimize patient outcome and to minimize the ocurrence of complications related to the learning curve.Results and discussionTraining modalities for laparoscopic surgery include simple box trainers, computer simulation with virtual reality, the use of artificial and cadaver organs, as well as live animal models and cadaver training. These training modalities have been proven in studies to have a beneficial effect on the learning curve for acquisition of laparoscopic skills and for improving operative performance as well as avoidance of complications. Laparoscopic training is currently gaining a more and more important role for official education and accreditation purposes. In some countries the participation in laparoscopic training courses has become mandatory prior to participation in laparoscopic operations. Future research will include the optimization of multimodal training curricula, the development of individualized training approaches that allow both trainee and patient-specific preparation, as well as the use of novel devices to facilitate the collection and transfer of expertise between the generations and schools of surgeons.

Risikobewusstsein und Training zur Prävention von Komplikationen in der minimal-invasiven Chirurgie

BACKGROUND Minimally invasive surgery (MIC) requires surgeons to have a different set of skills and capabilities from that of open surgery. The indirect camera view, lack of a three-dimensional view, restricted haptic feedback with lack of tissue feeling and difficult instrument coordination with fulcrum and pivoting effects result in an additional learning curve compared to open surgery. The prolonged learning curve leads to a higher risk of complications and special awareness of these risks is therefore mandatory. Training of special laparoscopic skills outside the operating room is needed to optimize patient outcome and to minimize the ocurrence of complications related to the learning curve. RESULTS AND DISCUSSION Training modalities for laparoscopic surgery include simple box trainers, computer simulation with virtual reality, the use of artificial and cadaver organs, as well as live animal models and cadaver training. These training modalities have been proven in studies to have a beneficial effect on the learning curve for acquisition of laparoscopic skills and for improving operative performance as well as avoidance of complications. Laparoscopic training is currently gaining a more and more important role for official education and accreditation purposes. In some countries the participation in laparoscopic training courses has become mandatory prior to participation in laparoscopic operations. Future research will include the optimization of multimodal training curricula, the development of individualized training approaches that allow both trainee and patient-specific preparation, as well as the use of novel devices to facilitate the collection and transfer of expertise between the generations and schools of surgeons.ZusammenfassungHintergrundDie minimal-invasive Chirurgie (MIC) fordert vom Chirurgen im Vergleich zur offenen Chirurgie zusätzliches Geschick und Fähigkeiten. Die indirekte Kamerasicht, fehlende dreidimensionale Sicht, mangelndes Gewebegefühl sowie die schwierige Instrumentenkoordination mit Drehpunkt- und Hebeleffekt führen zu einer verlängerten Lernkurve. Das resultierende höhere Risiko zur Entstehung von Komplikationen bedingt ein spezielles Risikobewusstsein. Ein Training der speziellen Fähigkeiten für die Laparoskopie außerhalb des Operationssaales scheint notwendig, um die Sicherheit der Patienten zu optimieren und die mit der Lernkurve einhergehenden Komplikationsrisiken zu minimieren.Ergebnisse und DiskussionDie Trainingsmodalitäten für die laparoskopische Chirurgie beinhalten Box-Trainer, Computersimulatoren mit virtueller Realität, künstliche und Kadaverorgane sowie Lebendtiermodelle und Kadavermodelle. Diese Trainingsmodalitäten haben einen in Studien bewiesenen Einfluss auf die Lernkurve der laparoskopischen Fähigkeiten sowie auf die Qualität der Durchführung von Operationen und die Vermeidung von Komplikationen. Das Laparoskopietraining spielt eine immer wichtigere Rolle in der Akkreditierung und fachlichen Anerkennung. In einigen Ländern wurden laparoskopische Trainingskurse vor dem ersten Einsatz im Operationssaal am Patienten bereits verpflichtend eingeführt. Zukünftige Studien werden die optimale Zusammensetzung multimodaler Trainingskurrikula untersuchen und individualisierte Trainee- und patientenspezifische Trainingsansätze entwickeln. Neue technische Entwicklungen werden die Kollektion und Weitergabe von Erfahrung und Können zwischen den Generationen und Schulen der Chirurgie vereinfachen, um letztlich die Behandlung der Patienten in der Chirurgie so sicher und schonend wie möglich zu gestalten.AbstractBackgroundMinimally invasive surgery (MIC) requires surgeons to have a different set of skills and capabilities from that of open surgery. The indirect camera view, lack of a three-dimensional view, restricted haptic feedback with lack of tissue feeling and difficult instrument coordination with fulcrum and pivoting effects result in an additional learning curve compared to open surgery. The prolonged learning curve leads to a higher risk of complications and special awareness of these risks is therefore mandatory. Training of special laparoscopic skills outside the operating room is needed to optimize patient outcome and to minimize the ocurrence of complications related to the learning curve.Results and discussionTraining modalities for laparoscopic surgery include simple box trainers, computer simulation with virtual reality, the use of artificial and cadaver organs, as well as live animal models and cadaver training. These training modalities have been proven in studies to have a beneficial effect on the learning curve for acquisition of laparoscopic skills and for improving operative performance as well as avoidance of complications. Laparoscopic training is currently gaining a more and more important role for official education and accreditation purposes. In some countries the participation in laparoscopic training courses has become mandatory prior to participation in laparoscopic operations. Future research will include the optimization of multimodal training curricula, the development of individualized training approaches that allow both trainee and patient-specific preparation, as well as the use of novel devices to facilitate the collection and transfer of expertise between the generations and schools of surgeons.

Comparison of two different transection techniques in liver surgery—an experimental study in a porcine model

AimsPostoperative morbidity and mortality after liver resection is closely related to the degree of intraoperative blood loss; the majority of which occurs during transection of the liver parenchyma. Many approaches and devices have therefore been developed to limit bleeding, but none has yet achieved perfect results up to now. The aim of this standardized chronic animal study was to compare the safety and efficacy of the LigaSure™ Vessel Sealing System (LVSS) with the stapler technique, which is one of the modern techniques for transecting the parenchyma in liver surgery.MethodsSixteen pigs underwent a left liver resection (LLR). Eight pigs received a LLR by means of an Endo GIA, whereas the other eight pigs underwent liver parenchymal transection followed by simultaneous sealing by the LVSS. The operating time, transection time, blood loss during transection, and time of hemostasis were measured on the day of LLR (postoperative day 0/POD 0). Animals were re-explored on postoperative day 7 (POD 7) and the transection surface of remnant liver was observed for fluid collection (hematoma, biloma, and abscess), necrosis, and other pathologies. A biopsy was taken from the area of transection for histopathological examination.ResultsAll animals survived until POD 7. Operating time and transection time of the liver parenchyma on POD 0 was significantly shorter in the stapler group. There was no significant difference between the two groups in terms of blood loss during transection, time of hemostasis and number of sutures for hemostasis on POD 0, morbidity rate, as well as the histopathological examination on POD 7. Furthermore, the material costs were significantly higher in the stapler group than in the LVSS group.ConclusionIn this standardized chronic animal study concerning transection of the parenchyma in liver surgery, LVSS seems not only to be safe, but also comparable with the stapler technique in terms of morbidity and mortality. Additionally, LVSS significantly reduces material costs. However, the transection time is significantly longer for LVSS than for the stapler resection technique.

Does rating the operation videos with a checklist score improve the effect of E-learning for bariatric surgical training? Study protocol for a randomized controlled trial

BackgroundLaparoscopic training has become an important part of surgical education. Laparoscopic Roux-en-Y gastric bypass (RYGB) is the most common bariatric procedure performed. Surgeons must be well trained prior to operating on a patient. Multimodality training is vital for bariatric surgery. E-learning with videos is a standard approach for training. The present study investigates whether scoring the operation videos with performance checklists improves learning effects and transfer to a simulated operation.Methods/designThis is a monocentric, two-arm, randomized controlled trial. The trainees are medical students from the University of Heidelberg in their clinical years with no prior laparoscopic experience. After a laparoscopic basic virtual reality (VR) training, 80 students are randomized into one of two arms in a 1:1 ratio to the checklist group (group A) and control group without a checklist (group B). After all students are given an introduction of the training center, VR trainer and laparoscopic instruments, they start with E-learning while watching explanations and videos of RYGB. Only group A will perform ratings with a modified Bariatric Objective Structured Assessment of Technical Skill (BOSATS) scale checklist for all videos watched. Group B watches the same videos without rating. Both groups will then perform an RYGB in the VR trainer as a primary endpoint and small bowel suturing as an additional test in the box trainer for evaluation.DiscussionThis study aims to assess if E-learning and rating bariatric surgical videos with a modified BOSATS checklist will improve the learning curve for medical students in an RYGB VR performance. This study may help in future laparoscopic and bariatric training courses.Trial registrationGerman Clinical Trials Register, DRKS00010493. Registered on 20 May 2016.

Study protocol for a randomized controlled trial on a multimodal training curriculum for laparoscopic cholecystectomy – LapTrain

Highlights • The first structured multi-modality laparoscopy training curriculum.• Assessing the value of a multimodal training platform in medical education.• Optimizing efficiency of facilities and courses in laparoscopic surgical training.