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This review summarizes the key applications of a hybrid operating room (HOR) in hepatobiliary surgery and explores the advantages, limitations, and future directions of its utilization. A comprehensive literature search was conducted in PubMed to identify articles reporting on the utilization of HORs in liver surgery. So far, the HOR has been limitedly applied in hepatobiliary surgery. It can offer an optimal environment for combining radiological and surgical interventions and for performing image-guided surgical navigation.
Subject(s)
Operating Rooms , Humans , Surgery, Computer-Assisted/methods , Liver Neoplasms/surgery , Biliary Tract Surgical Procedures/methodsABSTRACT
INTRODUCTION: The variety of robotic surgery systems, training modalities, and assessment tools within robotic surgery training is extensive. This systematic review aimed to comprehensively overview different training modalities and assessment methods for teaching and assessing surgical skills in robotic surgery, with a specific focus on comparing objective and subjective assessment methods. METHODS: A systematic review was conducted following the PRISMA guidelines. The electronic databases Pubmed, EMBASE, and Cochrane were searched from inception until February 1, 2022. Included studies consisted of robotic-assisted surgery training (e.g., box training, virtual reality training, cadaver training and animal tissue training) with an assessment method (objective or subjective), such as assessment forms, virtual reality scores, peer-to-peer feedback or time recording. RESULTS: The search identified 1591 studies. After abstract screening and full-texts examination, 209 studies were identified that focused on robotic surgery training and included an assessment tool. The majority of the studies utilized the da Vinci Surgical System, with dry lab training being the most common approach, followed by the da Vinci Surgical Skills Simulator. The most frequently used assessment methods included simulator scoring system (e.g., dVSS score), and assessment forms (e.g., GEARS and OSATS). CONCLUSION: This systematic review provides an overview of training modalities and assessment methods in robotic-assisted surgery. Dry lab training on the da Vinci Surgical System and training on the da Vinci Skills Simulator are the predominant approaches. However, focused training on tissue handling, manipulation, and force interaction is lacking, despite the absence of haptic feedback. Future research should focus on developing universal objective assessment and feedback methods to address these limitations as the field continues to evolve.
Subject(s)
Clinical Competence , Robotic Surgical Procedures , Robotic Surgical Procedures/education , Humans , Simulation Training/methods , Educational Measurement/methods , Virtual Reality , Animals , CadaverABSTRACT
BACKGROUND: Artificial intelligence (AI) models have been applied in various medical imaging modalities and surgical disciplines, however the current status and progress of ultrasound-based AI models within hepatopancreatobiliary surgery have not been evaluated in literature. Therefore, this review aimed to provide an overview of ultrasound-based AI models used for hepatopancreatobiliary surgery, evaluating current advancements, validation, and predictive accuracies. METHOD: Databases PubMed, EMBASE, Cochrane, and Web of Science were searched for studies using AI models on ultrasound for patients undergoing hepatopancreatobiliary surgery. To be eligible for inclusion, studies needed to apply AI methods on ultrasound imaging for patients undergoing hepatopancreatobiliary surgery. The Probast risk of bias tool was used to evaluate the methodological quality of AI methods. RESULTS: AI models have been primarily used within hepatopancreatobiliary surgery, to predict tumor recurrence, differentiate between tumoral tissues, and identify lesions during ultrasound imaging. Most studies have combined radiomics with convolutional neural networks, with AUCs up to 0.98. CONCLUSION: Ultrasound-based AI models have demonstrated promising accuracies in predicting early tumoral recurrence and even differentiating between tumoral tissue types during and after hepatopancreatobiliary surgery. However, prospective studies are required to evaluate if these results will remain consistent and externally valid.
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BACKGROUND: There is a trend towards laparoscopic sleeve gastrectomy (SG) with same-day discharge (SDD), as an efficient healthcare pathway to alleviate the burden on clinical capacity. This approach seems to be safe, if patients are carefully selected. In our bariatric center, a protocol for Roux-en-Y gastric bypass with SDD has already been successfully implemented. The aim of this study was to evaluate feasibility of applying the same SDD protocol for SG. METHODS: A single-center prospective feasibility study was conducted at a high-volume bariatric center. Low-risk patients who were scheduled for primary SG were included. Strict criteria were used for approval upon SDD. The primary outcome was the rate of successful SDD without readmission within 48 h. Secondary outcomes included short-term complications, emergency department visits, readmissions, and mortality. RESULTS: Fifty patients were included in the study, of whom 45 were successfully discharged on the same day of the surgery. Nausea and vomiting were the most common reasons for overnight hospitalization (three patients). One patient was readmitted within the first 48 h due to a mild complication related to bleeding, resulting in a success rate of 88% for SDD without readmission within 48 h. No severe complications or mortality were reported in the cohort. CONCLUSION: Our SDD protocol for SG has demonstrated feasibility, with a high success rate of SDD and no severe complications. Strict conditions should be met for the safe implementation of a SDD protocol, including careful patient selection and the establishment of a safety net to detect early complications.
Subject(s)
Gastric Bypass , Laparoscopy , Obesity, Morbid , Humans , Patient Discharge , Obesity, Morbid/surgery , Obesity, Morbid/complications , Prospective Studies , Netherlands , Feasibility Studies , Gastric Bypass/methods , Gastrectomy/methods , Laparoscopy/methods , Retrospective Studies , Postoperative Complications/etiology , Postoperative Complications/surgeryABSTRACT
BACKGROUND: Robotic suturing training is in increasing demand and can be done using suture-pads or robotic simulation training. Robotic simulation is less cumbersome, whereas a robotic suture-pad approach could be more effective but is more costly. A training curriculum with crossover between both approaches may be a practical solution. However, studies assessing the impact of starting with robotic simulation or suture-pads in robotic suturing training are lacking. METHODS: This was a randomized controlled crossover trial conducted with 20 robotic novices from 3 countries who underwent robotic suturing training using an Intuitive Surgical® X and Xi system with the SimNow (robotic simulation) and suture-pads (dry-lab). Participants were randomized to start with robotic simulation (intervention group, n = 10) or suture-pads (control group, n = 10). After the first and second training, all participants completed a robotic hepaticojejunostomy (HJ) in biotissue. Primary endpoint was the objective structured assessment of technical skill (OSATS) score during HJ, scored by two blinded raters. Secondary endpoints were force measurements and a qualitative analysis. After training, participants were surveyed regarding their preferences. RESULTS: Overall, 20 robotic novices completed both training sessions and performed 40 robotic HJs. After both trainings, OSATS was scored higher in the robotic simulation-first group (3.3 ± 0.9 vs 2.5 ± 0.8; p = 0.049), whereas the median maximum force (N) (5.0 [3.2-8.0] vs 3.8 [2.3-12.8]; p = 0.739) did not differ significantly between the groups. In the survey, 17/20 (85%) participants recommended to include robotic simulation training, 14/20 (70%) participants preferred to start with robotic simulation, and 20/20 (100%) to include suture-pad training. CONCLUSION: Surgical performance during robotic HJ in robotic novices was significantly better after robotic simulation-first training followed by suture-pad training. A robotic suturing curriculum including both robotic simulation and dry-lab suturing should ideally start with robotic simulation.
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BACKGROUND: Minimally invasive liver surgery (MILS) is increasingly performed via the robot-assisted approach but may be associated with increased costs. This study is a post-hoc comparison of healthcare cost expenditure for robotic liver resection (RLR) and laparoscopic liver resection (LLR) in a high-volume center. METHODS: In-hospital and 30-day postoperative healthcare costs were calculated per patient in a retrospective series (October 2015-December 2022). RESULTS: Overall, 298 patients were included (143 RLR and 155 LLR). Benefits of RLR were lower conversion rate (2.8% vs 12.3%, p = 0.002), shorter operating time (167 min vs 198 min, p = 0.044), and less blood loss (50 mL vs 200 mL, p < 0.001). Total per-procedure costs of RLR (10260) and LLR (9931) were not significantly different (mean difference 329 [95% bootstrapped confidence interval (BCI) -1179-2120]). Lower costs with RLR due to shorter surgical and operating room time were offset by higher disposable instrumentation costs resulting in comparable intraoperative costs (5559 vs 5247, mean difference 312 [95% BCI -25-648]). Postoperative costs were similar for RLR (4701) and LLR (4684), mean difference 17 [95% BCI -1357-1727]. When also considering purchase and maintenance costs, RLR resulted in higher total per-procedure costs. DISCUSSION: In a high-volume center, RLR can have similar per-procedure cost expenditure as LLR when disregarding capital investment.
Subject(s)
Health Expenditures , Hepatectomy , Laparoscopy , Robotic Surgical Procedures , Humans , Laparoscopy/economics , Hepatectomy/economics , Robotic Surgical Procedures/economics , Male , Retrospective Studies , Female , Middle Aged , Aged , Hospital Costs , Cost-Benefit Analysis , Operative Time , Health Care Costs , Treatment Outcome , Time FactorsABSTRACT
BACKGROUND: RCTs are essential in guiding clinical decision-making but are difficult to perform, especially in surgery. This review assessed the trend in volume and methodological quality of published surgical RCTs over two decades. METHODS: PubMed was searched systematically for surgical RCTs published in 1999, 2009, and 2019. The primary outcomes were volume of trials and RCTs with a low risk of bias. Secondary outcomes were clinical, geographical, and funding characteristics. RESULTS: Some 1188 surgical RCTs were identified, of which 300 were published in 1999, 450 in 2009, and 438 in 2019. The most common subspecialty in 2019 was gastrointestinal surgery (50.7 per cent). The volume of surgical RCTs increased mostly in Asia (61, 159, and 199 trials), especially in China (7, 40, and 81). In 2019, countries with the highest relative volume of published surgical RCTs were Finland and the Netherlands. Between 2009 and 2019, the proportion of RCTs with a low risk of bias increased from 14.7 to 22.1 per cent (P = 0.004). In 2019, the proportion of trials with a low risk of bias was highest in Europe (30.5 per cent), with the UK and the Netherlands as leaders in this respect. CONCLUSION: The volume of published surgical RCTs worldwide remained stable in the past decade but their methodological quality improved. Considerable geographical shifts were observed, with Asia and especially China leading in terms of volume. Individual European countries are leading in their relative volume and methodological quality of surgical RCTs.
An RCT is a form of research in which patients are divided randomly into two or more treatment groups to allow a fair and unbiased comparison of both treatments. RCTs are essential in guiding clinical decision-making, but are difficult to perform, especially in surgery. This review assessed the trend in volume and quality of published surgical RCTs over two decades. Surgical RCTs published in 1999, 2009, and 2019 were identified. The main outcome measures were volume of RCTs and trials with a low risk of bias. Different forms of bias can occur when research results are influenced by external factors. Some 1188 surgical RCTs were identified, of which 300 were published in 1999, 450 in 2009, and 438 in 2019. The volume of surgical RCTs published in these years increased mostly in Asia (61, 159, and 199 RCTs), especially in China (7, 40, and 81). In 2019, the countries with highest relative volume of published surgical RCTs were Finland and the Netherlands. Between 2009 and 2019, the proportion of RCTs with a low risk of bias increased from 14.7 to 22.1 per cent (P = 0.004). In 2019, the proportion of trials with a low risk of bias was highest in Europe (30.5 per cent), with the UK and the Netherlands as leaders in this respect. The volume of published surgical RCTs worldwide remained stable in the past decade but their methodological quality improved. Considerable geographical shifts were observed, with Asia and especially China leading in terms of volume. Individual European countries are leading in their relative volume and methodological quality of surgical RCTs.
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Randomized Controlled Trials as Topic , Humans , Europe , China , Finland , NetherlandsABSTRACT
BACKGROUND: Machine learning (ML) has seen an increase in application, and is an important element of a digital evolution. The role of ML within upper gastrointestinal surgery for malignancies has not been evaluated properly in the literature. Therefore, this systematic review aims to provide a comprehensive overview of ML applications within upper gastrointestinal surgery for malignancies. METHODS: A systematic search was performed in PubMed, EMBASE, Cochrane, and Web of Science. Studies were only included when they described machine learning in upper gastrointestinal surgery for malignancies. The Cochrane risk-of-bias tool was used to determine the methodological quality of studies. The accuracy and area under the curve were evaluated, representing the predictive performances of ML models. RESULTS: From a total of 1821 articles, 27 studies met the inclusion criteria. Most studies received a moderate risk-of-bias score. The majority of these studies focused on neural networks (n = 9), multiple machine learning (n = 8), and random forests (n = 3). Remaining studies involved radiomics (n = 3), support vector machines (n = 3), and decision trees (n = 1). Purposes of ML included predominantly prediction of metastasis, detection of risk factors, prediction of survival, and prediction of postoperative complications. Other purposes were predictions of TNM staging, chemotherapy response, tumor resectability, and optimal therapy. CONCLUSIONS: Machine Learning algorithms seem to contribute to the prediction of postoperative complications and the course of disease after upper gastrointestinal surgery for malignancies. However, due to the retrospective character of ML studies, these results require trials or prospective studies to validate this application of ML.
Subject(s)
Gastrointestinal Neoplasms , Machine Learning , Humans , Algorithms , Gastrointestinal Neoplasms/surgery , Prospective Studies , Retrospective StudiesABSTRACT
INTRODUCTION: Prediction of proficiency of laparoscopic skills is essential to establish personalized training programs. Objective assessment of laparoscopic skills has been validated in a laparoscopic box trainer with force, motion and time recognition. The aim of this study is to investigate whether acquiring proficiency of laparoscopic skills can be predicted based on performance in such a training box. METHODS: Surgical residents in their first year of training performed six different tasks in the Lapron box trainer. Force, motion and time data, three objective measures of tissue manipulation and instrument handling, were collected and analyzed for the six different tasks. Linear regression tests were used to predict the learning curve and the number of repetitions required to reach proficiency. RESULTS: A total of 6010 practice sessions performed by 42 trainees from 13 Dutch hospitals were assessed and included for analysis. Proficiency level was determined as a mean result of seven experts performing 42 trials. Learning curve graphs and prediction models for each task were calculated. A significant relationship between force, motion and time during six different tasks and prediction of proficiency was present in 17 out of 18 analyses. CONCLUSION: The learning curve of proficiency of laparoscopic skills can accurately be predicted after three repetitions of six tasks in a training box with force, path length and time recognition. This will facilitate personalized training programs in laparoscopic surgery.
Subject(s)
Laparoscopy , Learning Curve , Humans , Clinical Competence , Laparoscopy/education , HospitalsABSTRACT
BACKGROUND: Open inguinal hernia repair is the most commonly performed procedure in general surgery in sub-Saharan Africa, but data on its learning curve are lacking. This study evaluated the learning curve characteristics to improve surgical training and enable scaling up hernia surgery in low- and middle-income countries. METHODS: Logbook data of associate clinicians enrolled in a surgical training program in Sierra Leone were collected and their first 55 hernia surgeries following the Bassini technique (herniorrhaphies) were analyzed in cohorts of five cases. Studied variables were gradient of decline of operating time, variation in operating time, and length of stay (LOS). Eleven subsequent cohorts of each five herniorrhaphies were investigated. RESULTS: Seventy-five trainees enrolled in the training program between 2011 and 2020 were eligible for inclusion. Thirty-one (41.3%) performed the minimum of 55 herniorrhaphies, and had also complete personal logbook data. Mean operating times dropped from 79.6 (95% CI 75.3-84.0) to 48.6 (95% CI 44.3-52.9) minutes between the first and last cohort, while standard deviation in operating time nearly halved to 15.4 (95% CI 11.7-20.0) minutes, and LOS was shortened by 3 days (8.5 days, 95%CI 6.1-10.8 vs. 5.4 days, 95% 3.1-7.6). Operating times flattened after 31-35 cases which corresponded with 1.5 years of training. CONCLUSIONS: The learning curve of inguinal hernia surgery for associate clinicians flattens after 31-35 procedures. Training programs can be tailored based on this finding. The recorded learning curve may serve as a baseline for future training techniques.
Subject(s)
Hernia, Inguinal , Laparoscopy , Humans , Hernia, Inguinal/surgery , Learning Curve , Forecasting , Herniorrhaphy/methods , Groin/surgery , Laparoscopy/methodsABSTRACT
BACKGROUNDS: COVID-19 related reduction of surgical procedures jeopardizes learning on the job of surgical residents. Many educators resorted to digital resources in the search for alternatives. However, these resources are often limited to the extent they offer resident-surgeon interaction like a joint surgical performance does. Here we present a roadmap of livestreaming surgical procedures, and evaluate how surgical livestreams on human cadavers address the unmet educational needs of surgical residents in our Dutch nationwide initiative. METHODS: Technical and organizational feasibility, and definition of outcome deliverables for the livestream series and per livestream were essential in livestream development. Faculty selected interventions, lecture contents, and participant preparations. Appropriate location, technical setup, and support were imperative for a stable, high-quality stream with integrated interaction, while maintaining digital privacy. A survey was sent to livestream participants to evaluate each livestream, and allow for constant improvement during the broadcasting of the series. Only surveys which were completed by surgical residents were included in the analysis of this study. RESULTS: Each livestream attracted 139-347 unique viewers and a total of 307 surveys were completed by participants (response rate of 23-38% per livestream). Sixty percent of surveys (n = 185) were completed by surgical residents. Livestreams were highly valued (appreciation 7.7 ± 1.1 and recommendation 8.6 ± 1.1), especially the live procedures combined with interaction and theoretical backgrounds. Criticized were technical difficulties and timing of the livestreams between 5 and 7 pm, which interfered with clinical duties. CONCLUSION: Livestreaming surgical procedures on human cadavers is a valid and valued solution to augment resident education. Digital privacy and a stable, high-quality interactive stream are essential, as are appropriate moderation and relevant lectures. While livestreaming cannot replace hands-on training in the operating room, it enables surgeon-resident interaction which is key in education-and missed in pre-recorded surgical procedures which are currently available online.
Subject(s)
COVID-19 , Internship and Residency , COVID-19/epidemiology , COVID-19/prevention & control , Cadaver , Clinical Competence , Humans , Surveys and QuestionnairesABSTRACT
BACKGROUND: Necrotizing soft tissue infections (NSTI) affect long-term quality of life in survivors. Different approaches to debridement may influence quality of life. The aim of this study was to assess the current practice of the debridement of NSTI in the Netherlands. METHODS: An animated, interactive online survey was distributed among general surgeons and plastic surgeons in the Netherlands. Two NSTI-cases were presented, followed by questions regarding the preferred surgical approach. Case one described a woman with a swollen, red leg, with signs of sepsis and without visible necrosis. Case two described an immunocompromised man with septic shock syndrome and extensive necrosis. RESULTS: In total 232 responses were included (143 general surgeons, 89 plastic surgeons). In case one, 32% chose to preserve all skin, while 17% chose to resect all skin above the affected fascia, including normal-looking skin. In case two, all participants resected necrotic skin, and most (88%) also blue discolored skin. While 32% did not resect more than blue discolored and necrotic skin, 35% also resected red-colored skin, and 21% all skin overlying the affected fascia, including normal colored skin. Respondents working in a hospital with a burn center tended to preserve more skin, whereas plastic surgeons chose more often for skin resection compared to general surgeons. CONCLUSIONS: By using a novel approach to a survey, the authors demonstrate the existence of extensive practice variety regarding the approach to debridement of NSTI among Dutch general and plastic surgeons. Consensus is needed, followed by targeted education of surgeons.
Subject(s)
Shock, Septic , Soft Tissue Infections , Debridement , Female , Humans , Male , Quality of Life , Soft Tissue Infections/surgery , Surveys and QuestionnairesABSTRACT
BACKGROUND: Understanding the burden of diseases requiring surgical care at national levels is essential to advance universal health coverage. The PREvalence Study on Surgical COnditions (PRESSCO) 2020 is a cross-sectional household survey to estimate the prevalence of physical conditions needing surgical consultation, to investigate healthcare-seeking behavior, and to assess changes from before the West African Ebola epidemic. METHODS: This study (ISRCTN: 12353489) was built upon the Surgeons Overseas Surgical Needs Assessment (SOSAS) tool, including expansions. Seventy-five enumeration areas from 9671 nationwide clusters were sampled proportional to population size. In each cluster, 25 households were randomly assigned and visited. Need for surgical consultations was based on verbal responses and physical examination of selected household members. RESULTS: A total of 3,618 individuals from 1,854 households were surveyed. Compared to 2012, the prevalence of individuals reporting one or more relevant physical conditions was reduced from 25 to 6.2% (95% CI 5.4-7.0%) of the population. One-in-five conditions rendered respondents unemployed, disabled, or stigmatized. Adult males were predominantly prone to untreated surgical conditions (9.7 vs. 5.9% women; p < 0.001). Financial constraints were the predominant reason for not seeking care. Among those seeking professional health care, 86.7% underwent surgery. CONCLUSION: PRESSCO 2020 is the first surgical needs household survey which compares against earlier study data. Despite the 2013-2016 Ebola outbreak, which profoundly disrupted the national healthcare system, a substantial reduction in reported surgical conditions was observed. Compared to one-time measurements, repeated household surveys yield finer granular data on the characteristics and situations of populations in need of surgical treatment.
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Hemorrhagic Fever, Ebola , Adult , Cross-Sectional Studies , Developing Countries , Disease Outbreaks , Female , Health Services Needs and Demand , Hemorrhagic Fever, Ebola/epidemiology , Humans , Male , Prevalence , Sierra Leone/epidemiologyABSTRACT
BACKGROUND: Laparoscopy has reduced tactile and visual feedback compared to open surgery. There is increasing evidence that visual and haptic information converge to form a more robust mental representation of an object. We investigated whether tactile exploration of an object prior to executing a laparoscopic action on it improves performance. METHODS: A prospective cohort study with 20 medical students randomized in two different groups was conducted. A silicone ileocecal model, on which a laparoscopic action had to be performed, was used inside an outside a ForceSense box trainer. During the pre-test, students either did a combined manual and visual exploration or only visual exploration of the caecum model. To track performance during the trials of the study we used force, motion and time parameters as representatives of technical skills development. The final trial data were used for statistical comparison between groups. RESULTS: All included time and motion parameters did not show any clear differences between groups. However, the force parameters Mean force non-zero (p = 004), Maximal force (p = 0.01) Maximal impulse (p = 0.02), Force volume (p = 0.02) and SD force (p = 0.01) showed significant lower values in favour of the tactile exploration group for the final trials. CONCLUSIONS: By adding haptic sensation to the existing visual information during training of laparoscopic tasks on life-like models, tissue manipulation skills improve during training.
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Laparoscopy , Simulation Training , Students, Medical , Clinical Competence , Humans , Prospective StudiesABSTRACT
BACKGROUND: In line with demographic changes, there is an increase in ED presentations and unplanned return presentations by older patients (≥70 years). It is important to know why these patients return to the ED shortly after their initial presentation. Therefore, the aim of this study was to provide insight into the root causes and potential preventability of unplanned return presentations (URP) to the ED within 30 days for older patients. METHODS: A prospective observational study was conducted from February 2018 to November 2018 in an academic hospital in Amsterdam. We included 83 patients, aged 70 years and older, with an URP to the ED within 30 days of the initial ED presentation. Patients, GPs and doctors at the ED were interviewed by trained interviewers and basic administrative data were collected in order to conduct a root cause analysis using the PRISMA-method. RESULTS: One hundred fifty-one root causes were identified and almost half (49%) of them were disease-related. Fifty-two percent of the patients returned to the ED within 7 days after the initial presentation. In 77% of the patients the URP was related to the initial presentation. Patients judged 17% of the URPs as potentially preventable, while doctors at the ED judged 25% and GPs 23% of the URPs as potentially preventable. In none of the cases, there was an overall agreement from all three perspectives on the judgement that an URP was potentially preventable. CONCLUSION: Disease-related factors were most often identified for an URP and half of the patients returned to the ED within 7 days. The majority of the URPs was judged as not preventable. However, an URP should trigger healthcare workers to focus on the patient's process of care and their needs and to anticipate on potential progression of disease. Future research should assess whether this may prevent that patients have to return to the ED.
Subject(s)
Emergency Service, Hospital/statistics & numerical data , Patient Readmission/statistics & numerical data , Root Cause Analysis , Aged , Aged, 80 and over , Female , Health Services for the Aged , Humans , Male , Physicians , Prospective StudiesABSTRACT
OBJECTIVE: The aim of this study was to evaluate the risk of bowel obstruction, incisional, and parastomal hernia following laparoscopic versus open surgery for rectal cancer. SUMMARY BACKGROUND DATA: Laparoscopic surgery for rectal cancer has been adopted worldwide, after trials reported similar oncological outcomes compared with open surgery. Little is known about long-term morbidity, including bowel obstruction, incisional, and parastomal hernia following surgery. METHODS: Patients included in the international, multicenter, noninferior, open-label, randomized COLOR II trial were followed for five years. Primary endpoint was local recurrence at 3-year follow-up. Secondary endpoints included bowel obstruction, incisional and parastomal hernia within 5 years, and the current article reports on these secondary endpoints. RESULTS: All 1044 patients included in the COLOR II trial were analyzed. There was no difference in risk of bowel obstruction, incisional, or parastomal hernia following laparoscopic or open surgery for rectal cancer. CONCLUSION: Based on long-term morbidity outcomes, laparoscopic surgery for rectal cancer could be considered a routine technique as there are no differences with open surgery.
Subject(s)
Hernia, Ventral/etiology , Intestinal Obstruction/etiology , Intestine, Small , Laparoscopy/adverse effects , Laparotomy/adverse effects , Postoperative Complications , Rectal Neoplasms/surgery , Adult , Aged , Aged, 80 and over , Europe/epidemiology , Female , Hernia, Ventral/diagnosis , Hernia, Ventral/epidemiology , Humans , Incidence , Intestinal Obstruction/diagnosis , Intestinal Obstruction/epidemiology , Male , Middle AgedABSTRACT
OBJECTIVE: The aim of this study was to develop an objective and reliable surgical quality assurance system (SQA) for COLOR III, an international multicenter randomized controlled trial (RCT) comparing transanal total mesorectal excision (TaTME) with laparoscopic approach for rectal cancer. BACKGROUND OF SUMMARY DATA: SQA influences outcome measures in RCTs such as lymph nodes harvest, in-hospital mortality, and locoregional cancer recurrence. However, levels of SQA are variable. METHOD: Hierarchical task analysis of TaTME was performed. A 4-round Delphi methodology was applied for standardization of TaTME steps. Semistructured interviews were conducted in round 1 to identify key steps and tasks, which were rated as mandatory, optional, or prohibited in rounds 2 to 4 using questionnaires. Competency assessment tool (CAT) was developed and its content validity was examined by expert surgeons. Twenty unedited videos were assessed to test reliability using generalizability theory. RESULTS: Eighty-three of 101 surgical tasks identified reached 70% agreement (26 mandatory, 56 optional, and 1 prohibited). An operative guide of standardized TaTME was created. CAT is matrix of 9 steps and 4 performance qualities: exposure, execution, adverse event, and end-product. The overall G-coefficient was 0.883. Inter-rater and interitem reliability were 0.883 and 0.986. To enter COLOR III, 2 unedited TaTME and 1 laparoscopic TME videos were submitted and assessed by 2 independent assessors using CAT. CONCLUSION: We described an iterative approach to develop an objective SQA within multicenter RCT. This approach provided standardization, the development of reliable and valid CAT, and the criteria for trial entry and monitoring surgical performance during the trial.
Subject(s)
Endoscopic Mucosal Resection/methods , Proctectomy/methods , Quality Assurance, Health Care , Rectal Neoplasms/surgery , Transanal Endoscopic Surgery/methods , Aged , Delphi Technique , Disease-Free Survival , Endoscopic Mucosal Resection/adverse effects , Female , Follow-Up Studies , Humans , Internationality , Male , Middle Aged , Neoplasm Invasiveness/pathology , Neoplasm Staging , Observer Variation , Postoperative Complications/epidemiology , Postoperative Complications/physiopathology , Proctectomy/mortality , Rectal Neoplasms/mortality , Rectal Neoplasms/pathology , Survival Analysis , Transanal Endoscopic Surgery/adverse effects , Treatment OutcomeABSTRACT
BACKGROUND: Transanal total mesorectal excision (TaTME) is a safe alternative to laparoscopic TME for mid and low rectal cancer. TaTME allows improved visualization of the surgical planes and margins, and may potentially improve oncological outcomes. However, functional results after total mesorectal excision (TME) are variable and there are currently only a few published studies that include functional data related to the outcomes of TaTME. METHODS: Fifty-four consecutive patients were included in this study: one group included 27 patients who underwent laparoscopic low anterior and the other included 27 patients who underwent TaTME. All patients were asked to complete five questionnaires related to quality of life (QOL) and function [EQ-5D-3L, EORTC-QLQ C30, EORTC-QLQ C29, Low Anterior Resection Syndrome score (LARS), and International Prostate Symptom Score IPSS]. All TaTME patients were operated on at The Gelderse Vallei Hospital by a single surgeon and had a follow-up of at least 6.6 months. RESULTS: The EORTC-QLQ C30 and EQ-5D-3L questionnaires showed comparable outcomes in terms of QOL between the two groups. Almost all items evaluated by the EORTC-QLQ C29, including sexual outcomes, were similar between the two groups. One item concerning fecal incontinence, however, was scored worse for TaTME. There were no significant differences between the groups in terms of LARS symptoms or urinary function. CONCLUSIONS: Patients undergoing laparoscopic or transanal TME showed comparable functional and QOL outcomes. Although the TaTME technique is still evolving, this study indicates that this technique is a safe alternative to laparoscopic surgery in terms of functional outcomes for mid and low rectal cancers.
Subject(s)
Laparoscopy/methods , Quality of Life , Rectal Neoplasms/psychology , Rectal Neoplasms/surgery , Transanal Endoscopic Surgery/methods , Aged , Female , Humans , Male , Margins of Excision , Middle Aged , Postoperative Complications/etiology , Rectum/surgeryABSTRACT
BACKGROUND: Debate persists on the optimal management of incisional hernias due to paucity of accurate recurrence rates. Reoperation rates implicate a severe underestimation of the risk of a recurrence. Therefore, long-term postoperative clinic visits allowing physical examination of the abdomen are deemed necessary. However, these are time and costs consuming. Aim of this study was to develop and evaluate a new screenings method for recurrent hernias, the 'PINCH-Phone' (Post-INCisional-Hernia repair-Phone). METHODS: The PINCH-Phone is a telephone questionnaire. In this multicenter prospective study, the PINCH-Phone was answered by patients after incisional hernia repair. Afterwards the patients were seen at the clinic and physical examination was done to detect any recurrences. RESULTS: The PINCH-Phone questions were answered by 210 patients with a median postoperative follow-up of 36 months. Fifty-six patients were seen after multiple incisional hernia repairs. In 137 patients who had replied positively to one or more questions, 28 recurrent incisional hernias were detected at physical examination. Six recurrences were noted in 73 patients who had replied negatively to all questions. The overall sensitivity and specificity of the PINCH-Phone were 82% and 38%, respectively. CONCLUSION: The PINCH-Phone appears a simple and valuable screenings method for recurrences after incisional hernia repair and, hence, is recommended for implementation.
Subject(s)
Aftercare/methods , Hernia, Ventral/surgery , Incisional Hernia/diagnosis , Interviews as Topic/methods , Postoperative Complications/diagnosis , Surveys and Questionnaires , Female , Humans , Incisional Hernia/etiology , Male , Middle Aged , Reoperation/adverse effects , Reoperation/methods , Reproducibility of Results , Secondary PreventionABSTRACT
BACKGROUND: Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal area (locoregional recurrence) and survival after laparoscopic and open resection of rectal cancer. METHODS: In this international trial conducted in 30 hospitals, we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, and without distant metastases to undergo either laparoscopic or open surgery in a 2:1 ratio. The primary end point was locoregional recurrence 3 years after the index surgery. Secondary end points included disease-free and overall survival. RESULTS: A total of 1044 patients were included (699 in the laparoscopic-surgery group and 345 in the open-surgery group). At 3 years, the locoregional recurrence rate was 5.0% in the two groups (difference, 0 percentage points; 90% confidence interval [CI], -2.6 to 2.6). Disease-free survival rates were 74.8% in the laparoscopic-surgery group and 70.8% in the open-surgery group (difference, 4.0 percentage points; 95% CI, -1.9 to 9.9). Overall survival rates were 86.7% in the laparoscopic-surgery group and 83.6% in the open-surgery group (difference, 3.1 percentage points; 95% CI, -1.6 to 7.8). CONCLUSIONS: Laparoscopic surgery in patients with rectal cancer was associated with rates of locoregional recurrence and disease-free and overall survival similar to those for open surgery. (Funded by Ethicon Endo-Surgery Europe and others; COLOR II ClinicalTrials.gov number, NCT00297791.).