Background For patients with esophageal adenocarcinoma or cancer of the gastroesophageal junction, radical esophagectomy with 2-field lymphadenectomy is the cornerstone of the multimodality treatment ...with curative intent. Both conventional minimally invasive esophagectomy (MIE) and robot assisted minimally invasive esophagectomy (RAMIE) were shown to be superior compared to open transthoracic esophagectomy considering postoperative complications. However, no randomized comparison exists between MIE and RAMIE in the Western World for patients with esophageal adenocarcinoma. Methods This is an investigator-initiated and investigator-driven multicenter randomized controlled parallel-group superiority trial. All adult patients (age greater than or equai to 18 and less than or equai to 90 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 218) with resectable esophageal adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction are randomized to either RAMIE (n = 109) or MIE (n = 109). The primary outcome of this study is the total number of resected abdominal and mediastinal lymph nodes specified per lymph node station. Conclusion This is the first randomized controlled trial designed to compare RAMIE to MIE as surgical treatment for resectable esophageal adenocarcinoma or adenocarcinoma of the gastroesophageal junction in the Western World. The hypothesis of the proposed study is that RAMIE will result in a higher abdominal and mediastinal lymph node yield specified per station compared to conventional MIE. Short-term results and the primary endpoint (total number of resected abdominal and mediastinal lymph nodes per lymph node station) will be analyzed and published after discharge of the last randomized patient within this trial. Trial registration ClinicalTrials.gov Identifier: NCT04306458. Registered 13th March 2020, Keywords: MIE, RAMIE, Ivor-Lewis, Esophageal adenocarcinoma, Lymphadenectomy
Background
Hybrid natural‐orifice transluminal endoscopic surgery (NOTES), combining access through a natural orifice with small‐sized abdominal trocars, aims to reduce pain and enhance recovery. The ...objective of this systematic review and meta‐analysis was to compare pain and morbidity in hybrid NOTES and standard laparoscopy.
Methods
A systematic literature search was performed to identify RCTs and non‐RCTs comparing hybrid NOTES and standard laparoscopy. The main outcome was pain on postoperative day (POD) 1. Secondary outcomes were pain during the further postsurgical course, rescue analgesia, complications, and satisfaction with the cosmetic result. The results of meta‐analysis in a random‐effects model were presented as odds ratio (ORs) or standard mean differences (MDs) with 95 per cent confidence intervals.
Results
Six RCTs and 21 non‐randomized trials including 2186 patients were identified. In hybrid NOTES the score on the numerical pain scale was lower on POD 1 (−0·75, 95 per cent c.i. −1·09 to −0·42; P = 0·001) and on POD 2–4 (−0·58, −0·91 to −0·26; P < 0·001) than that for standard laparoscopy. The need for rescue analgesia was reduced in hybrid NOTES (OR 0·36, 0·24 to 0·54; P < 0·001). The reduction in complications found for hybrid NOTES compared with standard laparoscopy (OR 0·52, 0·38 to 0·71; P < 0·001) was not significant when only RCTs were considered (OR 0·83, 0·43 to 1·60; P = 0·570). The score for cosmetic satisfaction was higher after NOTES (MD 1·14, 0·57 to 1·71; P < 0·001).
Conclusion
Hybrid NOTES reduces postoperative pain and is associated with greater cosmetic satisfaction in selected patients.
Less pain was the only gain
Background
The incidence of pancreatic neuroendocrine neoplasms (pNEN) is increasing. This study aimed to evaluate predictors of overall survival and the indication for surgery.
Methods
Data ...collected between October 2001 and December 2012 were analysed. Histological grading and staging was based on the classifications of the World Health Organization, the International Union Against Cancer and the European Neuroendocrine Tumour Society.
Results
Some 310 patients (150 female, 48·4 per cent) underwent surgical resection. The final survival analysis included 291 patients. Five‐year overall survival differed according to tumour grade (G): 91·0 per cent among 156 patients with pancreatic neuroendocrine tumours (pNET) G1, 70·8 per cent in 111 patients with pNET G2, and 20 per cent in 24 patients with pancreatic neuroendocrine carcinomas (pNEC) G3 (P < 0·001). Tumours graded G3 (hazard ratio (HR) 6·96, 95 per cent confidence interval 3·67 to 13·21), the presence of distant metastasis (HR 2·41, 1·32 to 4·42) and lymph node metastasis (HR 2·10, 1·07 to 4·16) were independent predictors of worse survival (P < 0·001, P = 0·004 and P = 0·032 respectively). Eight of 61 asymptomatic patients with pNEN smaller than 2 cm had tumours graded G2 or G3, and six of 51 patients had lymph node metastasis. Among patients with pNEC G3, the presence of distant metastasis had a significant impact on the 5‐year overall survival rate: 0 per cent versus 43 per cent in those without distant metastasis (P = 0·036).
Conclusion
Neuroendocrine tumours graded G3, lymph node and distant metastasis are independent predictors of worse overall survival in patients with pNEN.
Small tumours are sometimes nasty
Background
This study aimed to examine the effect of metabolic surgery on pre‐existing and future microvascular complications in patients with type 2 diabetes mellitus (T2DM) in comparison with ...medical treatment. Although metabolic surgery is the most effective treatment for obese patients with T2DM regarding glycaemic control, it is unclear whether the incidence or severity of microvascular complications is reduced.
Methods
A systematic literature search was performed in MEDLINE, Embase, Web of Science and the Cochrane Central Register of Controlled Trials (CENTRAL) with no language restrictions, looking for RCTs, case–control trials and cohort studies that assessed the effect of metabolic surgery on the incidence of microvascular diabetic complications compared with medical treatment as control. The study was registered in the International prospective register of systematic reviews (CRD42016042994).
Results
The literature search yielded 1559 articles. Ten studies (3 RCTs, 7 controlled clinical trials) investigating 17 532 patients were included. Metabolic surgery reduced the incidence of microvascular complications (odds ratio 0·26, 95 per cent c.i. 0·16 to 0·42; P < 0·001) compared with medical treatment. Pre‐existing diabetic nephropathy was strongly improved by metabolic surgery versus medical treatment (odds ratio 15·41, 1·28 to 185·46; P = 0·03).
Conclusion
In patients with T2DM, metabolic surgery prevented the development of microvascular complications better than medical treatment . Metabolic surgery improved pre‐existing diabetic nephropathy compared with medical treatment.
Surgery is better
Abstract
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.
Graphical Abstract
Graphical Abstract
This systematic review and meta-analysis presents current evidence on transferability of surgical skills acquired on robotic VR simulators to the real operating room, and on the predictability of intraoperative performance by robotic VR simulator performances. The limited data currently available support the use of robotic VR simulators for surgical skill acquisition and assessment.
This systematic review and meta-analysis presents current evidence on transferability of surgical skills acquired on robotic VR simulators to the real operating room, and on the predictability of intraoperative performance by robotic VR simulator performances. The limited data currently available support the use of robotic VR simulators for surgical skill acquisition and assessment.
Minimally invasive oesophagectomy (MIO) for oesophageal cancer may reduce surgical complications compared with open oesophagectomy. MIO is, however, technically challenging and may impair optimal ...oncological resection. The aim of the present study was to assess if MIO for cancer is beneficial.
A systematic literature search in MEDLINE, Web of Science and CENTRAL was performed and randomized controlled trials (RCTs) comparing MIO with open oesophagectomy were included in a meta-analysis. Survival was analysed using individual patient data. Random-effects model was used for pooled estimates of perioperative effects.
Among 3219 articles, six RCTs were identified including 822 patients. Three-year overall survival (56 (95 per cent c.i. 49 to 62) per cent for MIO versus 52 (95 per cent c.i. 44 to 60) per cent for open; P = 0.54) and disease-free survival (54 (95 per cent c.i. 47 to 61) per cent versus 50 (95 per cent c.i. 42 to 58) per cent; P = 0.38) were comparable. Overall complication rate was lower for MIO (odds ratio 0.33 (95 per cent c.i. 0.20 to 0.53); P < 0.010) mainly due to fewer pulmonary complications (OR 0.44 (95 per cent c.i. 0.27 to 0.72); P < 0.010), including pneumonia (OR 0.41 (95 per cent c.i. 0.22 to 0.77); P < 0.010).
MIO for cancer is associated with a lower risk of postoperative complications compared with open resection. Overall and disease-free survival are comparable for the two techniques.
Oesophagectomy for cancer is associated with a high risk of complications. A minimally invasive approach might be less traumatic, leading to fewer complications and may also improve oncological outcome. A meta-analysis of randomized controlled trials comparing minimally invasive to open oesophagectomy was performed. The analysis showed that the minimally invasive approach led to fewer postoperative complications, in particular, fewer pulmonary complications. Survival after surgery was comparable for the two techniques.
Surgical resection is crucial for curative treatment of rectal cancer. Through multidisciplinary treatment, including radiochemotherapy and total mesorectal excision, survival has improved ...substantially. Consequently, more patients have to deal with side effects of treatment. The most recently introduced surgical technique is robotic-assisted surgery (RAS) which seems equally effective in terms of oncological control compared to laparoscopy. However, RAS enables further advantages which maximize the precision of surgery, thus providing better functional outcomes such as sexual function or contience without compromising oncological results. This review was done according to the PRISMA and AMSTAR-II guidelines and registered with PROSPERO (CRD42018104519). The search was planned with PICO criteria and conducted on Medline, Web of Science and CENTRAL. All screening steps were performed by two independent reviewers. Inclusion criteria were original, comparative studies for laparoscopy vs. RAS for rectal cancer and reporting of functional outcomes. Quality was assessed with the Newcastle–Ottawa scale. The search retrieved 9703 hits, of which 51 studies with 24,319 patients were included. There was a lower rate of urinary retention (non-RCTs: Odds ratio (OR) 95% Confidence Interval (CI) 0.65 0.46, 0.92; RCTs: ORCI 1.290.08, 21.47), ileus (non-RCTs: ORCI 0.860.75, 0.98; RCTs: ORCI 0.800.33, 1.93), less urinary symptoms (non-RCTs mean difference (MD) CI − 0.60 − 1.17, − 0.03; RCTs: − 1.37 − 4.18, 1.44), and higher quality of life for RAS (only non-RCTs: MDCI: 2.99 2.02, 3.95). No significant differences were found for sexual function (non-RCTs: standardized MDCI: 0.46− 0.13, 1.04; RCTs: SMDCI: 0.09− 0.14, 0.31). The current meta-analysis suggests potential benefits for RAS over laparoscopy in terms of functional outcomes after rectal cancer resection. The current evidence is limited due to non-randomized controlled trials and reporting of functional outcomes as secondary endpoints.
Objective
To compare outcomes of endoscopic and surgical treatment for infected necrotizing pancreatitis (INP) based on results of randomized controlled trials (RCT).
Background
Treatment of INP has ...changed in the last two decades with adoption of interventional, endoscopic and minimally invasive surgical procedures for drainage and necrosectomy. However, this relies mostly on observational studies.
Methods
We performed a systematic review following Cochrane and PRISMA guidelines and AMSTAR-2 criteria and searched CENTRAL, Medline and Web of Science. Randomized controlled trails that compared an endoscopic treatment to a surgical treatment for patients with infected walled-off necrosis and included one of the main outcomes were eligible for inclusion. The main outcomes were mortality and new onset multiple organ failure. Prospero registration ID: CRD42019126033
Results
Three RCTs with 190 patients were included. Intention to treat analysis showed no difference in mortality. However, patients in the endoscopic group had statistically significant lower odds of experiencing new onset multiple organ failure (odds ratio (OR) confidence interval CI 0.31 0.10, 0.98) and were statistically less likely to suffer from perforations of visceral organs or enterocutaneous fistulae (OR CI 0.31 0.10, 0.93), and pancreatic fistulae (OR CI 0.09 0.03, 0.28). Patients with endoscopic treatment had a statistically significant lower mean hospital stay (Mean difference CI − 7.86 days − 14.49, − 1.22). No differences in bleeding requiring intervention, incisional hernia, exocrine or endocrine insufficiency or ICU stay were apparent. Overall certainty of evidence was moderate.
Conclusion
There seem to be possible benefits of endoscopic treatment procedure. Given the heterogenous procedures in the surgical group as well as the low amount of randomized evidence, further studies are needed to evaluate the combination of different approaches and appropriate timepoints for interventions.
Aims
In minimally invasive surgery (MIS), intraoperative guidance has been limited to verbal communication without direct visual guidance. Communication issues and mistaken instructions in training ...procedures can hinder correct identification of anatomical structures on the MIS screen. The iSurgeon system was developed to provide visual guidance in the operating room by telestration with augmented reality (AR).
Methods
Laparoscopic novices (
n
= 60) were randomized in two groups in a cross-over design: group 1 trained only with verbal guidance first and then with additional telestration with AR on the operative screen and vice versa for group 2. Training consisted of laparoscopic basic training and subsequently a specifically designed training course, including a porcine laparoscopic cholecystectomy (LC). Outcome included time needed for training, performance with Global Operative Assessment of Laparoscopic Skills (GOALS), and Objective Structured Assessment of Technical Skills (OSATS) score for LC, complications, and subjective workload (NASA-TLX questionnaire).
Results
Telestration with AR led to significantly faster total training time (1163 ± 275 vs. 1658 ± 375 s,
p
< 0.001) and reduced error rates. LC on a porcine liver was performed significantly better (GOALS 21 ± 5 vs. 18 ± 4,
p
< 0.007 and OSATS 67 ± 11 vs. 61 ± 8,
p
< 0.015) and with less complications (13.3% vs. 40%,
p
< 0.020) with AR. Subjective workload and stress were significantly reduced during training with AR (33.6 ± 12.0 vs. 30.6 ± 12.9,
p
< 0.022).
Conclusion
Telestration with AR improves training success and safety in MIS. The next step will be the clinical application of telestration with AR and the development of a mobile version for remote guidance.
Aims
The aim of this study was to investigate whether shifting the focus to solution orientation and developing coping strategies for common errors could increase the efficiency of laparoscopic ...training and influence learning motivation. The concept of coping has been particularly defined by the psychologist Richard Lazarus Lazarus and Folkman in Stress, appraisal, and coping, Springer publishing company, New York, 1984. Based on this model, we examined the use of observational learning with a coping model for its effectiveness as a basic teaching model in laparoscopic training.
Methods
55 laparoscopically naive medical students learned a standardized laparoscopic knot tying technique with video-based instructions. The control group was only offered a mastery video that showed the ideal technique and was free from mistakes. The intervention group was instructed on active error analysis and watched freely selectable videos of common errors including solution strategies (coping model) in addition to the mastery videos.
Results
There was no statistically significant difference between the intervention and control groups for number of knot tying attempts until proficiency was reached (18.8 ± 5.5 vs. 21.3 ± 6.5,
p
= 0.142). However, there was a significantly higher fraction of knots achieving technical proficiency in the intervention group after first use of the coping model (0.7 ± 0.1 vs. 0.6 ± 0.2,
p
= 0.026). Additionally, the proportion of blinded attempts that met the criteria for technical proficiency was significantly higher for the intervention group at 60.9% vs. 38.0% in control group (
p
= 0.021). The motivational subscore “interest” of the validated score on current motivation (QCM) was significantly higher for the intervention group (
p
= 0.032), as well as subjective learning benefit (
p
= 0.002) and error awareness (
p
< 0.001).
Conclusion
Using video-based learning of coping strategies for common errors improves learning motivation and understanding of the technique with a significant difference in its qualitative implementation in laparoscopy training. The ability to think in a solution-oriented, independent way is necessary in surgery in order to recognize and adequately deal with technical difficulties and complications.
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