Laparoscopic Colorectal Surgery Outcomes Improved After National Training Program (LAPCO) for Specialists in England.

OBJECTIVE: To examine the impact of The National Training Program for Lapco on the rate of laparoscopic surgery and clinical outcomes of cases performed by Lapco surgeons after completion of training. SUMMARY OF BACKGROUND DATA: Lapco provided competency-based supervised clinical training for specialist colorectal surgeons in England. METHODS: We compared the rate of laparoscopic surgery, mortality, and morbidity for colorectal cancer resections by Lapco delegates and non-Lapco surgeons in 3-year periods preceding and following Lapco using difference in differences analysis. The changes in the rate of post-Lapco laparoscopic surgery with the Lapco sign-off competency assessment and in-training global assessment scores were examined using risk-adjusted cumulative sum to determine their predictive clinical validity with predefined competent scores of 3 and 5 respectively. RESULTS: One hundred eight Lapco delegates performed 4586 elective colo-rectal resections pre-Lapco and 5115 post-Lapco while non-Lapco surgeons performed 72,930 matched cases. Lapco delegates had a 37.8% increase in laparoscopic surgery which was greater than non-Lapco surgeons by 20.9% [95% confidence interval (CI), 18.5-23.3, P < 0.001) with a relative decrease in 30-day mortality by -1.6% (95% CI, -3.4 to -0.2, P = 0.039) and 90-day mortality by -2.3% (95% CI, -4.3 to -0.4, P = 0.018). The change point of risk-adjusted cumulative sum was 3.12 for competency assessment tool and 4.74 for global assessment score whereas laparoscopic rate increased from 44% to 66% and 40% to 56%, respectively. CONCLUSIONS: Lapco increased the rate of laparoscopic colorectal cancer surgery and reduced mortality and morbidity in England. In-training competency assessment tools predicted clinical performance after training.

Benchmarks in colorectal surgery: multinational study to define quality thresholds in high and low anterior resection.

BACKGROUND: Benchmark comparisons in surgery allow identification of gaps in the quality of care provided. The aim of this study was to determine quality thresholds for high (HAR) and low (LAR) anterior resections in colorectal cancer surgery by applying the concept of benchmarking. METHODS: This 5-year multinational retrospective study included patients who underwent anterior resection for cancer in 19 high-volume centres on five continents. Benchmarks were defined for 11 relevant postoperative variables at discharge, 3 months, and 6 months (for LAR). Benchmarks were calculated for two separate cohorts: patients without (ideal) and those with (non-ideal) outcome-relevant co-morbidities. Benchmark cut-offs were defined as the 75th percentile of each centre's median value. RESULTS: A total of 3903 patients who underwent HAR and 3726 who had LAR for cancer were analysed. After 3 months' follow-up, the mortality benchmark in HAR for ideal and non-ideal patients was 0.0 versus 3.0 per cent, and in LAR it was 0.0 versus 2.2 per cent. Benchmark results for anastomotic leakage were 5.0 versus 6.9 per cent for HAR, and 13.6 versus 11.8 per cent for LAR. The overall morbidity benchmark in HAR was a Comprehensive Complication Index (CCI®) score of 8.6 versus 14.7, and that for LAR was CCI® score 11.9 versus 18.3. CONCLUSION: Regular comparison of individual-surgeon or -unit outcome data against benchmark thresholds may identify gaps in care quality that can improve patient outcome.

Perioperative risk prediction in the era of enhanced recovery: a comparison of POSSUM, ACPGBI, and E-PASS scoring systems in major surgical procedures of the colorectal surgeon.

PURPOSE: This study aims to determine whether traditional risk models can accurately predict morbidity and mortality in patients undergoing major surgery by colorectal surgeons within an enhanced recovery program. METHODS: One thousand three hundred eighty patients undergoing surgery performed by colorectal surgeons in a single UK hospital (2008-2013) were included. Six risk models were evaluated: (1) Physiology and Operative Severity Score for the enumeration of Mortality and Morbidity (POSSUM), (2) Portsmouth POSSUM (P-POSSUM), (3) ColoRectal (CR-POSSUM), (4) Elderly POSSUM (E-POSSUM), (5) the Association of Great Britain and Ireland (ACPGBI) score, and (6) modified Estimation of Physiologic Ability and Surgical Stress Score (E-PASS). Model accuracy was assessed by observed to expected (O:E) ratios and area under Receiver Operating Characteristic curve (AUC). RESULTS: Eleven patients (0.8%) died and 143 patients (10.4%) had a major complication within 30 days of surgery. All models overpredicted mortality and had poor discrimination: POSSUM 8.5% (O:E 0.09, AUC 0.56), P-POSSUM 2.2% (O:E 0.37, AUC 0.56), CR-POSSUM 7.1% (O:E 0.11, AUC 0.61), and E-PASS 3.0% (O:E 0.27, AUC 0.46). ACPGBI overestimated mortality in patients undergoing surgery for cancer 4.4% (O:E = 0.28, AUC = 0.41). Predicted morbidity was also overestimated by POSSUM 32.7% (O:E = 0.32, AUC = 0.51). E-POSSUM overestimated mortality (3.25%, O:E 0.57 AUC = 0.54) and morbidity (37.4%, O:E 0.30 AUC = 0.53) in patients aged ≥ 70 years and over. CONCLUSION: All models overestimated mortality and morbidity. New models are required to accurately predict the risk of adverse outcome in patients undergoing major abdominal surgery taking into account the reduced physiological and operative insult of laparoscopic surgery and enhanced recovery care.

A prospective case control study of functional outcomes and related quality of life after colectomy for neoplasia.

AIM: Our aim was to assess bowel function and its effect on overall quality of life (QOL) when compared to healthy controls after colectomy. METHODS: Patients undergoing resection of colorectal neoplasia were recruited pre-operatively and followed up at 6 and 12 months, to assess 'early' bowel function. Patients who underwent surgery 2 to 4 years previously were recruited for assessment of 'intermediate' bowel function. Healthy relatives were recruited as controls. The Memorial Sloan-Kettering Cancer Centre and EQ-5D questionnaires were used to assess bowel function and QOL, respectively. Statistical assessment included regression analyses, parametric and non-parametric tests. The association between QOL and Memorial Sloan-Kettering Cancer Centre (MSKCC) scores was evaluated using Spearman's rank correlation. RESULTS: Ninety-one patients were recruited for assessment of 'early' and 85 for 'intermediate' bowel function. There were 85 controls. Patients had a significantly higher number of bowel movements at each follow-up (p < 0.001). At 12 months after surgery, patients reported difficulty with gas-stool discrimination. The 'intermediate' group were found to have lower scores for flatus control (<0.001) and total frequency score (p 0.03), indicating worse function. Patients with higher total MSKCC scores, no symptoms of urgency and those able to control flatus reported better QOL (p 0.006, 0.007 and 0.005, respectively) at 6 and 12 months. Gas-stool differentiation and complete evacuation correlated with better QOL in the 'intermediate' bowel function group (p 0.02 and 0.02, respectively). CONCLUSION: Colonic resection adversely affects elements of bowel function up to 4 years after surgery. Good colonic function, represented by higher MSKCC scores, correlates with better QOL.

Low Muscularity and Myosteatosis Is Related to the Host Systemic Inflammatory Response in Patients Undergoing Surgery for Colorectal Cancer.

OBJECTIVE: We examined the relationships between computed tomography (CT)-defined skeletal muscle parameters and the systemic inflammatory response (SIR) in patients with operable primary colorectal cancer (CRC). BACKGROUND: Muscle depletion is characterized by a reduced muscle mass (myopenia) and increased infiltration by inter- and intramuscular fat (myosteatosis). It is recognized as a poor prognostic indicator in patients with cancer, but the underlying factors remain unclear. METHODS: A total of 763 patients diagnosed with CRC undergoing elective surgical resection between 2006 and 2013 were included. Image analysis of CT scans was used to calculate Lumbar skeletal muscle index (LSMI), and mean muscle attenuation (MA). The SIR was quantified by the preoperative neutrophil to lymphocyte ratio (NLR) and albumin levels. Correlation and multivariate regression analysis was performed to identify independent relationships between patient SIR and muscle characteristics. RESULTS: Patients with NLR > 3 had significantly lower LSMI and lower MA than those with NLR < 3 [LSMI = 42.07 cmm vs 44.27 cmm (P = 0.002) and MA = 30.04 Hounsfield unit (HU) vs 28.36 HU (P = 0.016)]. Multivariate logistic regression analysis showed that high NLR [odds ratio (OR) = 1.78 (95% confidence interval [CI]: 1.29-2.45), P < 0.001] and low albumin [OR = 1.80 (95% CI: 1.17-2.74), P = 0.007] were independent predictors of reduced muscle mass. High NLR was significantly related with a low mean MA and hence myosteatosis [OR = 1.60 (95% CI: 1.03-2.49), P = 0.038]. CONCLUSIONS: These results highlight a direct association between myopenia, myosteatosis, and the host SIR in patients with operable CRC. A better understanding of factors that regulate muscle changes such as myopenia and myosteatosis may lead to the development of novel therapies that influence a more metabolically "healthy" skeletal muscle and potentially alter cancer outcomes.

Skeletal Muscle Changes After Elective Colorectal Cancer Resection: A Longitudinal Study.

BACKGROUND: Muscle depletion is a poor prognostic indicator in colorectal cancer (CRC) patients, but there were no data assessing comparative temporal body composition changes following elective CRC surgery. We examined patient skeletal muscle index trajectories over time after surgery and determined factors that may contribute to those alterations. METHODS: Patients diagnosed with CRC undergoing elective surgical resection between 2006 and 2013 were included in this study. Image analysis of serial computed tomography (CT) scans was used to calculate lumbar skeletal muscle index (LSMI). A multilevel mixed-effect linear regression model was applied using STATA (version 12.0) using the xtmixed command to fit growth curve models (GCM) for LSMI and time. RESULTS: In 856 patients, a total of 2136 CT images were analyzed; 856 (38.2 %) were preoperative. A quadratic GCM with random intercept and random slope for patients' LSMI was identified that demonstrated laparoscopy produces a positive change on the LSMI curve [estimate = 0.17 cm(2)/m(2), standard error (SE) 0.06 cm(2)/m(2); p = 0.03], whereas Union for International Cancer Control (UICC) stage III + IV disease contributed to a negative curve change (estimate = -0.19 cm(2)/m(2), SE 0.09 cm(2)/m(2); p = 0.03). Older age (p < 0.01), female gender (p < 0.01), higher American Society of Anesthesiologists (ASA) score (p < 0.01), and altered systemic inflammatory response [SIR] (p = 0.03) were factors significantly associated with lower values of LSMI over time. CONCLUSION: In patients undergoing CRC surgery, laparoscopy and the absence of a significantly elevated SIR favored preservation and restoration of skeletal muscle, postoperatively. These emerging data may permit the development of new treatment protocols whereby monitoring and modification of body composition has therapeutic potential.

Body composition of the host influences dendritic cell phenotype in patients treated for colorectal cancer.

Dendritic cells (DCs) are antigen-presenting cells that can acquire tumour antigens and initiate cytotoxic T cell reactions. Obesity has been proposed as a cause for tumours escaping immune surveillance, but few studies investigate the impact of other body composition parameters. We examined the relationship of DC phenotype with computer tomography (CT)-defined parameters in patients with colorectal cancer (CRC). DCs were identified within peripheral blood mononuclear cells by flow cytometry as HLA-DR positive and negative for markers of other cell lineages in 21 patients. Analysis of CT scans was used to calculate lumbar skeletal muscle index (LSMI) and mean muscle attenuation (MA). Positive correlation between the LSMI and expression of CD40 in all DCs (r = 0.45; p = 0.04) was demonstrated. The MA was positively correlated with scavenger receptor CD36 [all DCs (r = 0.60; p = 0.01) and myeloid DCs (r = 0.63; p < 0.01)]. However, the MA was negatively correlated with CCR7 expression in all DCs (r = -0.46, p = 0.03.) and with CD83 [all DCs (r = -0.63; p = 0.01) and myeloid DCs (r = -0.75; p < 0.01)]. There were no relationships between the fat indexes and the DC phenotype. These results highlight a direct relationship between muscle depletion and changes in stimulatory, migratory and fatty acid-processing potential of DC in patients with CRC.

The potential impact of local excision for T1 colonic cancer in elderly and comorbid populations: a decision analysis.

BACKGROUND: Population-based bowel cancer screening has resulted in increasing numbers of patients with T1 colonic cancer. The need for colectomy in this group is questioned due to the low risk of lymphatic spread and increased treatment morbidity, particularly for elderly, comorbid patients. This study examined the quality-of-life benefits and risks of endoscopic resection compared with results after colectomy, for low-risk and high-risk T1 colonic cancer. METHODS: Decision analysis using a Markov simulation model was performed; patients were managed with either endoscopic resection (advanced therapeutic endoscopy) or colectomy. Lesions were considered high risk according to accepted national guidelines. Probabilities and utilities (perception of quality of life) were derived from published data. Hypothetical cohorts of 65- and 80-year-old, fit and unfit patients with low-risk or high-risk T1 colonic cancer were studied. The primary outcome was quality-adjusted life expectancy (QALE) in life-years (QALYs). RESULTS: In low-risk T1 colonic neoplasia, endoscopic resection increases QALE by 0.09 QALYS for fit 65-year-olds and by 0.67 for unfit 80-year-olds. For high-risk T1 cancers, the QALE benefit for surgical resection is 0.24 QALYs for fit 65-year-olds and the endoscopic QALE benefit is 0.47 for unfit 80-year-olds. The model findings only favored surgery with high local recurrence rates and when quality of life under surveillance was perceived poorly. CONCLUSIONS: Under broad assumptions, endoscopic resection is a reasonable treatment option for both low-risk and high-risk T1 colonic cancer, particularly in elderly, comorbid patients. Exploration of methods to facilitate endoscopic resection of T1 colonic neoplasia appears warranted.

A multi-modal approach to training in laparoscopic colorectal surgery accelerates proficiency gain.

BACKGROUND: How to efficiently train and transfer skills in laparoscopic colorectal surgery is unclear. Errors are rarely avoidable during learning but may incur patient morbidity. Multi-modality training with a modular operative approach provides proficiency-based structured task-specific training in a sequential manner, fragmenting complex laparoscopic colorectal procedures by difficulty allowing more than one trainee to gain experience irrespective of prior experience. This study assessed multi-modality training and its effect on proficiency gain in laparoscopic colorectal fellows. METHODS: A prospective study of 750 consecutive laparoscopic colon and rectal resection training cases assessing proficiency gain using a modified direct observation of procedural skills (DOPS) (behaviors-assessment) and weighted global modular attainment score (GMAS) (maneuvers-assessment) was carried out. Two mentors delivered training in a standardized format from 2008. Consequential intra-operative errors (requiring a corrective maneuver to permit further progression of the operation) were recorded. Eight Laparoscopic Fellows were assessed in six-month periods over 4 years. Primary outcome was proficiency gain measured by cumulative sum (CUSUM) analysis with boot-strapping comparing weighted GMAS and modified DOPS assessment. Morbidity (Clavien-Dindo classification), and consequential errors were submitted to similar analysis to assess significant variations during the training period. RESULTS: Fellows were trained on over 100 laparoscopic colorectal resections in a six Fellowship month period. Proficiency gain was identifiable in the DOPS and GMAS with 32 (99 % CI 25-37) and 39 (99 % CI 32-44) cases, respectively. Two- versus single-mentor training improved proficiency gain 35 (99 % CI 30-43) versus 55 (99 % CI 50-60). Overall consequential error rate and major morbidity rate (CD III-IV) were stable over time at 25 and 8.7 %, respectively. CONCLUSIONS: Multi-modality training with modular operative training and technique standardization shortens the time to proficiency gain with low morbidity accepting an intra-operative consequential error rate of 25 %.

International expert consensus on endpoints for full-thickness laparoendoscopic colonic excision.

BACKGROUND: Full-thickness laparoendoscopic excision has been reported for complex endoscopically unresectable colonic polyps. However, the endpoints used in these studies vary significantly and therefore making definitive conclusions regarding the novel procedure would be improved if a common data set were adopted. This study sought to define most appropriate endpoints that should be measured and reported for research on full-thickness laparoendoscopic excision of colonic polyps. METHODS: A Web-based Delphi Questionnaire was developed using a systematic literature review of reported endpoints. Outcomes were grouped into general, complication, technical and histopathology endpoints. International specialists in laparoscopic surgery, endoscopy and transanal endoscopic microsurgery were invited to participate. The questionnaire required prioritization of outcomes on a 5-point Likert scale. Respondents were then sent a second questionnaire containing feedback on scores from round 1 and asked to re-prioritize outcomes based on the feedback received to identify a final core outcome set. RESULTS: A total of 33 (75% response rate) participants from 11 countries completed the round 1 Delphi of 28 proposed endpoints, and all completed the second round. Eight endpoints were rated the most important to stakeholders within the four domains--reoperation (general); anastomotic leak, mortality (complications); secure closure of the excision site, macroscopic completeness of excision (technical); presence of cancer, clearance of resected margins and en bloc specimen production (histopathology). CONCLUSIONS: This study has developed a provisional consensus on a minimum number of feasible and clinically meaningful outcome measures to use in studies of full-thickness laparoendoscopic excision of colonic polyps. Widespread adoption will allow better reporting of the technique and more efficient development in clinical practice.

Factors Implicated for Delay of Adjuvant Chemotherapy in Colorectal Cancer: A Meta-analysis of Observational Studies.

BACKGROUND: The survival benefit of administering adjuvant chemotherapy (AC) in colorectal cancer is well established, as is the impact of its timing. Although various factors have been associated with treatment delay, their implications remain controversial. We determined clinicopathological factors associated with delay in transition to AC via systematic review and meta-analysis. METHODS: Studies assessing factors for delay in initiating AC were identified from MEDLINE, EMBASE, and Cochrane Databases. Studies were included only if relevant clinicopathological factors were adequately described and appropriate comparative groups were balanced. For each study, the odds ratio (OR) and 95 % confidence interval (CI) were estimated, regarding response to early versus delayed AC initiation. RESULTS: We identified 15 eligible studies involving 67,537 patients. Twelve studies were multicentre studies and three were single-center cohort studies. Meta-analysis demonstrated age >75 years [4 studies, OR = 1.44 (95 % CI 1.32-1.58)], marital status-single [3 studies, OR = 1.32 (95 % CI 1.20-1.44)], low socioeconomic status (SES) [7 studies, OR = 1.67 (95 % CI 1.32-2.12)], worse comorbidity status [5 studies, OR = 1.47 (95 % CI 1.14-1.90)], low tumour grade [7 studies, OR = 1.06 (95 % CI 1.02-1.11)], prolonged length of stay [3 studies, OR 2.37 (95 % CI 2.10-2.68)], and readmission [3 studies, OR = 3.23 (95 % CI 1.66-6.26)] were significant predictors of delayed initiation of AC. Laparoscopy compared to an open surgical approach was a significant predictor of earlier AC initiation [5 studies, OR = 0.70 (95 % CI 0.51-0.97)]. CONCLUSIONS: Laparoscopy is associated with earlier initiation of AC, encouraging its increased adoption. Social isolation and low SES merit consideration of approaches that counter the lack of social support and deprivation to improve cancer outcomes.

The impact of anastomotic leak and its treatment on cancer recurrence and survival following elective colorectal cancer resection.

AIM: Anastomotic leakage is a serious complication in restorative colorectal surgery. Anastomotic leakage and its subsequent management may have long-term impact on survival. This study aims to assess the impact of colorectal anastomotic leak (AL) on overall survival (OS) and disease-free survival (DFS). METHODS: A prospective database of 1,048 patients undergoing restorative colorectal cancer resections at St Mark's hospital between October 2004 and October 2013 was examined. RESULTS: The overall leak rate was 99/1,048 (9.4%). 43 ALs were managed conservatively with antibiotics or radiological drainage and 56 with reoperations. OS was significantly reduced in the AL group treated with a reoperation (HR 2.74, 95% CI 1.67-4.52, p < 0.001). AL was not significantly associated with worse DFS [conservatively managed AL's vs. no AL-HR 2.07 (95% CI 1.05-4.10); reoperated AL's vs. no AL-HR 1.56 (95% CI 0.81-2.99), overall p value = 0.058]. CONCLUSION: Patients who suffer anastomotic leaks requiring reoperations have worse OS compared to patients who do not leak, but there were no significant differences in DFS between patients who leaked and those who did not.

A preoperative neutrophil to lymphocyte ratio of 3 predicts disease-free survival after curative elective colorectal cancer surgery.

OBJECTIVE: This study aims to determine the role of the neutrophil to lymphocyte ratio (NLR) as a prognostic marker for patients with nonmetastatic colorectal cancer undergoing curative resection. BACKGROUND: An NLR reflects a systematic inflammatory response, with some evidence suggesting that an elevated preoperative NLR of more than 5.0 is associated with poorer survival in patients with colorectal cancer. METHODS: Data from 506 consecutive patients with a diagnosis of nonmetastatic colorectal adenocarcinoma undergoing surgical resection between 2006 and 2011 were included. Receiver operating characteristic curve analysis was used to identify the optimal value for NLR in relation to disease-free and overall survival. Univariate and multivariate Cox regression models were used to determine the role of NLR after stratification by several clinicopathological factors. Patients were followed by a standardized protocol until February 2013. RESULTS: Median follow-up was 45 months [interquartile range, 21-65]. Multivariate Cox regression analysis identified an NLR of more than 3 as an independent prognostic factor for disease-free survival (odds ratio = 2.41; 95% confidence interval = 1.12-5.15; P = 0.024) but not for overall survival (odds ratio = 1.23; 95% confidence interval = 0.80-1.90; P = 0.347). A high NLR was significantly associated with older age, higher T and N stages, the presence of microvascular invasion, low preoperative albumin levels, and higher ASA (American Society of Anesthesiologists) status of the patient. CONCLUSIONS: For patients with colorectal cancer, a preoperative NLR of more than 3.0 may be an independent prognostic factor for disease-free survival. Considering this in addition to well-established prognostic variables may improve the processes of identifying patients at higher risk of recurrence who would benefit from adjuvant therapies or more frequent surveillance, thereby providing more personalized cancer care.

The emerging role of neutrophil to lymphocyte ratio in determining colorectal cancer treatment outcomes: a systematic review and meta-analysis.

BACKGROUND: There is growing evidence suggesting that the neutrophil to lymphocyte ratio (NLR) can act as an independent predictor of long-term outcomes in patients undergoing treatment for colorectal cancer (CRC). This study aims to systematically review the role of NLR in predicting survival for patients with CRC undergoing treatments, and to evaluate its utility within a CRC surveillance program. METHODS: This meta-analysis was performed according to PRISMA guidelines. Outcomes of interest included disease-free survival (DFS) for patients undergoing treatment with curative intent and progression-free survival (PFS) in patients undergoing treatments with palliative intent. RESULTS: Thirteen observational cohort studies published from 2007 to 2013 evaluated the role of NLR as a predictor of outcome following treatment for CRC. These included (i) patients undergoing surgery to resect the primary cancer (seven studies); (ii) those undergoing palliative chemotherapy (three studies); and (iii) patients undergoing potentially curative treatments for CRC liver metastases (three studies). When all studies were considered, a high pretreatment NLR independently predicted survival (HR 2.08; 95 % CI 1.64-2.64). A high NLR also predicted significantly poorer survival in each of the three groups. Finally, over a 3-year follow-up period, high NLR became a significant predictor of poor outcome at year 2 (HR 2.76; 95 % CI 2.06-3.69; p < 0.00001) and 3 (HR 2.03; 95 % CI 1.48-2.78; p < 0.0001), but not in the first year of follow-up (HR 1.47; 95 % CI 0.89-2.41; p = 0.13). CONCLUSIONS: Elevated preoperative NLR is associated with poorer survival in CRC patients undergoing treatment and may have a role in CRC surveillance programs as a means of delivering more personalized cancer care.

Intraoperative assessment of colorectal anastomotic integrity: a systematic review.

BACKGROUND: Surgeons have attempted to minimize postoperative anastomotic complications by employing intraoperative tests and manoeuvres to assess colorectal anastomotic integrity. These have evolved over time with improvement in operative technology and techniques. This systematic review aims to examine the impact of such intraoperative assessments. METHODS: A systematic review of studies assessing intraoperative anastomotic assessments and their impact on postoperative anastomotic complications was performed. Intraoperative measures undertaken as a result of intraoperative assessments and postoperative anastomotic complications were analysed. RESULTS: 37 Studies were identified. 13 studies evaluated basic mechanical patency tests, ten studies evaluated endoscopic visualisation techniques and 14 studies evaluated microperfusion techniques. Postoperative anastomotic complications were significantly lower in patients tested with basic mechanical patency tests compared to those untested (non-RCT: 4.1 vs. 8.1 %, p = 0.03, RCTs: 5.8 vs. 16.0 %, p = 0.024). There were no differences in postoperative anastomotic complications between tested and non-tested cohorts in non-randomised cohort studies evaluating endoscopic visualisation techniques. However, intraoperative measures taken after abnormal intraoperative tests may have reduced the number of postoperative complications. Perfusion analysis techniques are not in routine widespread clinical practice as yet, but newer techniques such as fluorescent dyes and imaging under near infrared light show technical feasibility. CONCLUSIONS: Intraoperative colorectal anastomotic assessment has evolved together with advancement of technology in the surgical setting. Moderate benefit in terms of lower postoperative anastomotic complications has been shown with basic mechanical patency testing and more recently with intraoperative endoscopic visualisation of colorectal anastomoses. The next advance and possible introduction into routine practice may include the use of microperfusion techniques. The latest in this group of techniques, which utilise autofluorescent dyes such as Indocyanine green, hold great potential. Well-planned controlled studies or ideally, randomised controlled trials need to be conducted to further assess the benefit of these latest techniques.

Is competency assessment at the specialist level achievable? A study for the national training programme in laparoscopic colorectal surgery in England.

OBJECTIVES: To develop, validate, and implement a competency assessment tool (CAT) for technical surgical performance in the context of a summative assessment process for the National Training Programme in Laparoscopic Colorectal Surgery (NTP). BACKGROUND: The NTP is an educational initiative by the National Cancer Action Team in England to safely increase the uptake of laparoscopic colorectal surgery. It is the first competency-based national educational initiative for specialist surgeons (consultants), and performance assessment is an integral part of the program. METHODS: Content validity was sought using expert opinion by semistructured interviews and the Delphi method. For validity and reliability studies, NTP apprentices and experts were asked to submit video-recorded cases. Construct validity was established between delegates who passed the assessment and those who failed. Concurrent validity was tested by comparing scores with error counts as identified by observational clinical human reliability analysis. A fully crossed design, using generalizability theory methods and D-studies, was used for reliability. FINDINGS: Interviews and the Delphi method revealed a list of characteristics for assessment. A hybrid structure combining task-specific and generic items was used to include important characteristics into the assessment format. Fifty-four cases were submitted. Overall reliability reached G(ACI) = 0.803 when using 2 cases and 2 assessors. Experts scored significantly better than apprentices (3.19 vs 2.60; P = 0.004), and apprentices who passed had better scores than those who failed (2.95 vs 2.28; P < 0.001). There was an inverse correlation between CAT scores and observational clinical human reliability analysis error counts (ρ = -0.520, P < 0.001). The combination of both methods reached overall sensitivity of 100%, specificity of 83.3%, a positive predictive value of 93.8%, and a negative predictive value of 100%. CONCLUSIONS: The CAT can reliably assess technical performance in laparoscopic colorectal surgery. The use of CATs to judge specialist technical performance before embarking on independent practice of new procedures is achievable on a national scale and can be adapted by other specialties.

A systematic review regarding the feasibility and safety of endoscopic full thickness resection (EFTR) for colonic lesions.

PURPOSE: This review summarizes the published methods of colonic EFTR, examining data on feasibility and safety. Due to the introduction of bowel cancer screening programs, there is an increasing incidence of complex colonic polyps and early colonic cancer that requires segmental colectomy. Traditional radical surgery is associated with significant morbidity, and there is a need for alternative treatments. METHODS: Systematic literature search identified articles describing EFTR techniques of colon, published between 1990 and 2012. Complication rates, anastomotic bursting pressures, procedure duration, specimen size and quality, and postmortem findings were analyzed. RESULTS: Five research groups reported four EFTR techniques using endoscopic stapling devices, T-tags, compression closure, or laparoscopic assistance for defect closure before or after specimen resection. A total of 113 procedures were performed in 99 porcine models, with an overall success rate of 89 and 4 % mortality. The intraoperative complication rate was 22 % (0-67 %). Post-resection closure methods more commonly resulted in failure to close the defect (5-55 %) and a high incidence of abnormal findings at postmortem examination (84 %). Significant heterogeneity was observed in procedure duration (median or mean 3-233 min) and size of the excised specimen (median or mean 1.7-3.6 cm). Anastomotic bursting pressures and specimen quality were poorly documented. CONCLUSIONS: The technique of EFTR is developing, but the inability to close the resection defect reliably is a major obstacle. The review highlights the challenges that need to be addressed in future preclinical studies.

EnROL: a multicentre randomised trial of conventional versus laparoscopic surgery for colorectal cancer within an enhanced recovery programme.

BACKGROUND: During the last two decades the use of laparoscopic resection and a multimodal approach known as an enhanced recovery programme, have been major changes in colorectal perioperative care. Clinical outcome improves using laparoscopic surgery to resect colorectal cancer but until recently no multicentre trial evidence had been reported regarding whether the benefits of laparoscopy still exist when open surgery is optimized within an enhanced recovery programme. The EnROL trial (Enhanced Recovery Open versus Laparoscopic) examines the hypothesis that laparoscopic surgery within an enhanced recovery programme will provide superior postoperative outcomes when compared to conventional open resection of colorectal cancer within the same programme. METHODS/DESIGN: EnROL is a phase III, multicentre, randomised trial of laparoscopic versus open resection of colon and rectal cancer with blinding of patients and outcome observers to the treatment allocation for the first 7 days post-operatively, or until discharge if earlier. 202 patients will be recruited at approximately 12 UK hospitals and randomised using minimization at a central computer system in a 1:1 ratio. Recruiting surgeons will previously have performed >100 laparoscopic colorectal resections and >50 open total mesorectal excisions to minimize conversion. Eligible patients are those suitable for elective resection using either technique. Excluded patients include: those with acute intestinal obstruction and patients in whom conversion from laparoscopic to open procedure is likely. The primary outcome is physical fatigue as measured by the physical fatigue domain of the multidimensional fatigue inventory 20 (MFI-20) with secondary outcomes including postoperative hospital stay; complications; reoperation and readmission; quality of life indicators; cosmetic assessments; standardized performance indicators; health economic analysis; the other four domains of the MFI-20. Pathological assessment of surgical quality will also be undertaken and compliance with the enhanced recovery programme will be recorded for all patients. DISCUSSION: Should this trial demonstrate that laparoscopic surgery confers a significant clinical and/or health economic benefit this will further support the transition to this type of surgery, with implications for the training of surgeons and resource allocation. TRIAL REGISTRATION: ISRCTN48516968.

Full-thickness laparoendoscopic excision in the stomach: the FLEx technique.

BACKGROUND: The authors describe the initial validation of a novel full-thickness laparoendoscopic excision (FLEx) technique for the stomach. METHODS: The technique was studied in seven 50-kg pigs. Secure full-thickness excision was ensured by inversion excision target with a 1-cm circumferential margin using laparoendoscopically placed brace bars passed intraluminally from the outside of the stomach, laparoscopic oversewing of the site of inversion, and endoscopic full-thickness excision using a dual scope approach. Pigs were sacrificed either immediately (n = 3) or between 7 and 10 days after surgery (n = 4). RESULTS: The procedure achieved uncomplicated full-thickness excision in every case. Median procedure duration was 227 minutes (range = 210-245 minutes). Median specimen diameter was 5.5 cm (range = 2.5-8 cm). Investigative autopsy confirmed technical sufficiency in all animals. Median site bursting pressure was 130 mm Hg (range = 120-160 mm Hg). CONCLUSIONS: The FLEx technique proved useful for excision of small localized lesions of the stomach in this animal study.

The current status of robotic pelvic surgery: results of a multinational interdisciplinary consensus conference.

BACKGROUND: Despite the significant benefits of laparoscopic surgery, limitations still exist. One of these limitations is the loss of several degrees of freedom. Robotic surgery has allowed surgeons to regain the two lost degrees of freedom by introducing wristed laparoscopic instruments. METHODS: At the first Pelvic Surgery Meeting held in Brescia in June 2007, the participants focused on the role of robotic surgery in pelvic operations surgery for malignancy including prostate, rectal, uterine, and cervical carcinoma. All members of the interdisciplinary panel were asked to define the role of robotic surgery in prostate, rectal, and uterine carcinoma. All key statements were reformulated until a consensus within the group was achieved (Murphy et al., Health Technol Assess 2(i-v):1-88, 1998). For the systematic review, a comprehensive literature search was performed in Medline and the Cochrane Library from January 1997 to June 2007. The keywords used were Da Vinci, telemonitoring, laparoscopy, neoplasms for urology, colorectal, gynecology, visceral surgery, and minimally invasive surgery. The pelvic surgery meeting was supported by Olympus Medical Systems Europa. RESULTS: As of December 31, 2007, there were 795 unit shipments worldwide of the Da Vinci((R)): 595 in North America, 136 in Europe, and 64 in the rest of the world (http://investor.intuitivesurgical.com/phoenix.zhtml?c=122359&p=irol-faq#22324 ). It was estimated that, during 2007, approximately 50,000 radical prostatectomies were performed with the Da Vinci robot system in the USA, reflecting market penetration of 60% of radical prostatectomies in the USA. This utilization represents 50% growth as in 2006 only 42% of all radical prostatectomies performed in the USA employed robotics. CONCLUSION: While robotic prostatectomy has become the most widely accepted method of prostatectomy, robotic hysterectomy and proctectomy remain far less widely accepted. The theoretical benefits of the increased degrees of freedom and three-dimensional visualization may be outweighed in these areas by the loss of haptic feedback, increased operative times, and increased cost.