Early outcomes from the Minimally Invasive Right Colectomy Anastomosis study (MIRCAST).

BACKGROUND: The impact of method of anastomosis and minimally invasive surgical technique on surgical and clinical outcomes after right hemicolectomy is uncertain. The aim of the MIRCAST study was to compare intracorporeal and extracorporeal anastomosis (ICA and ECA respectively), each using either a laparoscopic approach or robot-assisted surgery during right hemicolectomies for benign or malignant tumours. METHODS: This was an international, multicentre, prospective, observational, monitored, non-randomized, parallel, four-cohort study (laparoscopic ECA; laparoscopic ICA; robot-assisted ECA; robot-assisted ICA). High-volume surgeons (at least 30 minimally invasive right colectomy procedures/year) from 59 hospitals across 12 European countries treated patients over a 3-year interval The primary composite endpoint was 30-day success, defined by two measures of efficacy-absence of surgical wound infection and of any major complication within the first 30 days after surgery. Secondary outcomes were: overall complications, conversion rate, duration of operation, and number of lymph nodes harvested. Propensity score analysis was used for comparison of ICA with ECA, and robot-assisted surgery with laparoscopy. RESULTS: Some 1320 patients were included in an intention-to-treat analysis (laparoscopic ECA, 555; laparoscopic ICA, 356; robot-assisted ECA, 88; robot-assisted ICA, 321). No differences in the co-primary endpoint at 30 days after surgery were observed between cohorts (7.2 and 7.6 per cent in ECA and ICA groups respectively; 7.8 and 6.6 per cent in laparoscopic and robot-assisted groups). Lower overall complication rates were observed after ICA, specifically less ileus, and nausea and vomiting after robot-assisted procedures. CONCLUSION: No difference in the composite outcome of surgical wound infections and severe postoperative complications was found between intracorporeal versus extracorporeal anastomosis or laparoscopy versus robot-assisted surgery.

Development of a procedure-specific tool for skill assessment in left- and right-sided laparoscopic complete mesocolic excision.

AIM: To (1) develop an assessment tool for laparoscopic complete mesocolic excision (LCME) and (2) report evidence of its content validity. METHOD: Assessment statements were revealed through (1) semi-structured expert interviews and (2) consensus by the Delphi method, both involving an expert panel of five LCME surgeons. All experts were interviewed and then asked to rate LCME describing statements from 1 (strongly disagree) to 5 (strongly agree). Responses were returned anonymously to the panel until consensus was reached. Statements were directly included as content in the assessment tool if ≥60% of the experts responded "agree" or "strongly agree" (ratings 4 and 5), with the remaining responses being "neither agree nor disagree" (rating 3). Interclass correlation coefficient (ICC) was calculated for expert agreement evaluation. All included statements were subsequently reformulated as tool items and approved by the experts. RESULTS: Four Delphi rounds were performed to reach consensus. Disagreement was reported for statements describing instrument handling around pancreas; visualisation of landmarks before inferior mesenteric artery ligation; lymphadenectomy around the inferior mesenteric artery, and division of the terminal ileum and transverse colon. ICC in the last Delphi-round was 0.84. The final tool content included 73 statements, converted to 48 right- and 40 left-sided items for LCME assessment. CONCLUSION: A procedure-specific, video-based tool, named complete mesocolic excision competency assessment tool (CMECAT), has been developed for LCME skill assessment. In the future, we hope it can facilitate assessment of LCME surgeons, resulting in improved patient outcome after colon cancer surgery.

Technical assessment in minimally invasive complete mesocolic excision: Is the complete mesocolic excision competency assessment tool valid and reliable?

AIM: The complete mesocolic excision competency assessment tool (CMECAT) is a novel tool designed to assess technical skills in minimally invasive complete mesocolic excision (CME) surgery. The aim of this study was to assess construct validity and reliability of CMECAT in a clinical context. METHOD: Colorectal surgeons were asked to submit video recorded laparoscopic CME resections for independent assessment of their technical abilities. The videos were grouped by surgeons' training level, and four established CME experts were recruited as CMECAT assessors. Extended reliability analysis (G-theory) was applied to describe assessor agreement. RESULTS: A total of 19 videos and 72 assessments were included in the analysis. Overall, technical skills assessed by CMECAT improved with increased training level: the experts scored significantly better than the untrained surgeons (3.3 vs. 2.5 points; p < 0.01). On right-sided resections, significantly higher scores were reported with increased training level for all categories and sections, while for left-sided resections, the variance across groups was smaller and significantly higher scores were only reported for oncological safety describing items. Overall, assessor agreement was high (G-coefficient: 0.81). CONCLUSION: This study confirms that CMECAT can be applied to video recorded CME cases for technical skill assessment. Further, it can reliably assess technical performance in right sided CME surgery, where construct validity has now been established. More videos are required to evaluate its validity on left colonic CME. In the future, we hope CMECAT can improve feedback during CME training, serve as a tool in certification processes and contribute to distinguishing CME from conventional surgery in future research.

Protective ileostomy creation after anterior resection of the rectum: Shared decision-making or still subjective?

AIM: The choice of whether to perform protective ileostomy (PI) after anterior resection (AR) is mainly guided by risk factors (RFs) responsible for the development of anastomotic leakage (AL). However, clear guidelines about PI creation are still lacking in the literature and this is often decided according to the surgeon's preferences, experiences or feelings. This qualitative study aims to investigate, by an open-ended question survey, the individual surgeon's decision-making process regarding PI creation after elective AR. METHOD: Fifty four colorectal surgeons took part in an electronic survey to answer the questions and describe what usually led their decision to perform PI. A content analysis was used to code the answers. To classify answers, five dichotomous categories (In favour/Against PI, Listed/Unlisted RFs, Typical/Atypical, Emotions/Non-emotions, Personal experience/No personal experience) have been developed. RESULTS: Overall, 76% of surgeons were in favour of PI creation and 88% considered listed RFs in the question of whether to perform PI. Atypical answers were reported in 10% of cases. Emotions and personal experience influenced surgeons' decision-making process in 22% and 49% of cases, respectively. The most frequently considered RFs were the distance of the anastomosis from the anal verge (96%), neoadjuvant chemoradiotherapy (88%), a positive intraoperative leak test (65%), blood loss (37%) and immunosuppression therapy (35%). CONCLUSION: The indications to perform PI following rectal cancer surgery lack standardization and evidence-based guidelines are required to inform practice. Until then, expert opinion can be helpful to assist the decision-making process in patients who have undergone AR for adenocarcinoma.

A probabilistic model for the prediction of intra-abdominal infection after colorectal surgery.

AIM: Predicting intra-abdominal infections (IAI) after colorectal surgery by means of clinical signs is challenging. A naïve logistic regression modeling approach has some limitations, for which reason we study two potential alternatives: the use of Bayesian networks, and that of logistic regression model. METHODS: Data from patients that had undergone colorectal procedures between 2010 and 2017 were used. The dataset was split into two subsets: (i) that for training the models and (ii) that for testing them. The predictive ability of the models proposed was tested (i) by comparing the ROC curves from days 1 and 3 with all the subjects in the test set and (ii) by studying the evolution of the abovementioned predictive ability from day 1 to day 5. RESULTS: In day 3, the predictive ability of the logistic regression model achieved an AUC of 0.812, 95% CI = (0.746, 0.877), whereas that of the Bayesian network was 0.768, 95% CI = (0.695, 0.840), with a p-value for their comparison of 0.097. The ability of the Bayesian network model to predict IAI does present significant difference in predictive ability from days 3 to 5: AUC(Day 3) = 0.761, 95% CI = (0.680, 0.841) and AUC(Day 5) = 0.837, 95% CI = (0.769, 0.904), with a p-value for their comparison of 0.006. CONCLUSIONS: Whereas at postoperative day 3, a logistic regression model with imputed data should be used to predict IAI; at day 5, when the predictive ability is almost identical, the Bayesian network model should be used.

The impact of SARS-CoV-2 infection on the surgical management of colorectal cancer: lessons learned from a multicenter study in Spain.

OBJECTIVE: the aim of the study was to analyze the management of colorectal cancer (CRC) patients diagnosed with CRC or undergoing elective surgery during the period of the SARS-CoV-2 pandemic. MATERIAL AND METHODS: a multicenter ambispective analysis was performed in nine centers in Spain during a four-month period. Data were collected from every patient, including changes in treatments, referrals or delays in surgeries, changes in surgical approaches, postoperative outcomes and perioperative SARS-CoV-2 status. The hospital's response to the outbreak and available resources were categorized, and outcomes were divided into periods based on the timeline of the pandemic. RESULTS: a total of 301 patients were included by the study centers and 259 (86 %) underwent surgery. Five hospitals went into phase III during the peak of incidence period, one remained in phase II and three in phase I. More than 60 % of patients suffered some form of change: 48 % referrals, 39 % delays, 4 % of rectal cancer patients had a prolonged interval to surgery and 5 % underwent neoadjuvant treatment. At the time of study closure, 3 % did not undergo surgery. More than 85 % of the patients were tested preoperatively for SARS-CoV-2. A total of nine patients (3 %) developed postoperative pneumonia; three of them had confirmed SARS-CoV-2. The observed surgical complications and mortality rates were similar as expected in a usual situation. CONCLUSIONS: the present multicenter study shows different patterns of response to the SARS-CoV-2 pandemic and collateral effects in managing CRC patients. Knowing these patterns could be useful for planning future changes in surgical departments in preparation for new outbreaks.

Robotic-Assisted versus Laparoscopic Distal Pancreatectomy: The Results of a Case-Matched Analysis from a Tertiary Care Center.

BACKGROUND: Laparoscopic distal pancreatectomy (LDP) has been adopted relatively slowly despite the benefits of minimally invasive approach. The robotic approach can overcome the limitations of LDP, thus increasing the acceptance of minimally invasive distal pancreatectomy. METHODS: We performed a 1:1 retrospective case-matched comparison among 2 groups of 35 patients who underwent robotic-assisted distal pancreatectomy (RDP) or LDP from August 2014 to April 2017. RESULTS: The operative time was similar in both groups (230 RDP vs. 205 LDP min, p = 0.382). The robotic group had a lower estimated blood loss (95 vs. 275 mL, p = 0.035). The spleen preservation rate was higher in the RDP group (100 vs. 66.7%, p = 0.027), while the conversion rate to open surgery was higher in the laparoscopic group (14.3 vs. 2.9%, p = 0.048). The overall complication rate was lower in the robotic group (25.7 vs. 37.1%, p = 0.044). There was no statistically significant difference in oncologic outcomes between the groups in terms of R0 resection rate (100% RDP vs. 85% LDP, p = 0.233) and number of harvested lymph nodes (14.4 RDP vs. 10.8 LDP, p = 0.678). CONCLUSIONS: The RDP showed a lower estimated blood loss, conversion, and morbidity rate. It offered a higher spleen preservation rate in comparison to LDP while maintaining comparable oncologic outcomes.

Minimally invasive right colectomy anastomosis study (MIRCAST): protocol for an observational cohort study of surgical complications using four surgical techniques for anastomosis in patients with a right colon tumor.

BACKGROUND: Right colectomy is the standard surgical treatment for tumors in the right colon and surgical complications are reduced with minimally-invasive laparoscopy compared with open surgery, with potential further benefits achieved with robotic assistance. The anastomotic technique used can also have an impact on patient outcomes. However, there are no large, prospective studies that have compared all techniques. METHODS/DESIGN: MIRCAST is the Minimally-Invasive Right Colectomy Anastomosis Study that will compare laparoscopy with robot-assisted surgery, using either intracorporeal or extracorporeal anastomosis, in a large prospective, observational, multicenter, parallel, four-cohort study in patients with a benign or malignant, non-metastatic tumor of the right colon. Over 2 years of follow-up, the study will prospectively evaluate peri- and postoperative complications, postoperative recovery, hospital stay, and mid-term results including survival, local recurrence, metastases rate, and conversion rate. The primary composite endpoint will be the efficacy of the surgical method regarding surgical wound infections and postoperative complications (Clavien-Dindo grade III-IV complications at 30 days post-surgery). Secondary endpoints include long-term oncologic results, conversion rate, operative time, length of stay, and quality of life. DISCUSSION: This will be the first large, international study to prospectively evaluate the use of minimally-invasive laparoscopy or robot-assisted surgery during right hemicolectomy and to control for the impact of the anastomotic technique. The research will contribute to current knowledge regarding the medical care of patients with malignant or benign tumors of the right colon, and enable physicians to determine which technique may be the most appropriate for their patients. TRIAL REGISTRATION: This study was registered on Clinicaltrials.gov (clinicaltrials.gov identifier: NCT03650517 ) on August 28th 2018 (study protocol version CI18/02 revision A, 21 February 2018).

A Multicenter Matched Comparison of Transanal and Robotic Total Mesorectal Excision for Mid and Low-rectal Adenocarcinoma.

OBJECTIVE: To compare the quality of surgical resection of transanal total mesorectal excision (TA-TME) and robotic total mesorectal excision (R-TME). BACKGROUND: Both TA-TME and R-TME have been advocated to improve the quality of surgery for rectal cancer below 10 cm from the anal verge, but there are little data comparing TA-TME and R-TME. METHODS: Data of patients undergoing TA-TME or R-TME for rectal cancer below 10 cm from the anal verge and a sphincter-saving procedure from 5 high-volume rectal cancer referral centers between 2011 and 2017 were obtained. Coarsened exact matching was used to create balanced cohorts of TA-TME and R-TME. The main outcome was the incidence of poor-quality surgical resection, defined as a composite measure including incomplete quality of TME, or positive circumferential resection margin (CRM) or distal resection margin (DRM). RESULTS: Out of a total of 730 patients (277 TA-TME, 453 R-TME), matched groups of 226 TA-TME and 370 R-TME patients were created. These groups were well-balanced. The mean tumor height from the anal verge was 5.6 cm (SD 2.5), and 70% received preoperative radiotherapy. The incidence of poor-quality resection was similar in both groups (TA-TME 6.9% vs R-TME 6.8%; P = 0.954). There were no differences in TME specimen quality (complete or near-complete TA-TME 99.1% vs R-TME 99.2%; P = 0.923) and CRM (5.6% vs 6.0%; P = 0.839). DRM involvement may be higher after TA-TME (1.8% vs 0.3%; P = 0.051). CONCLUSIONS: High-quality TME for patients with rectal adenocarcinoma of the mid and low rectum can be equally achieved by transanal or robotic approaches in skilled hands, but attention should be paid to the distal margin.

The Application of Indocyanine Green Fluorescence Imaging During Robotic Liver Resection: A Case-Matched Study.

BACKGROUND: The ICG fluorescence properties are progressively gaining momentum in the HPB surgery. However, the exact impact of ICG application on surgical outcomes is yet to be established. METHODS: Twenty-five patients who underwent ICG fluorescence-guided robotic liver resection were case-matched in a 1:1 ratio to a cohort who underwent standard robotic liver resection. RESULTS: In the ICG group, six additional lesions not diagnosed by preoperative workup and intraoperative ultrasound were identified and resected. Four of the lesions were proved to be malignant. Despite the similar operative time (288 vs. 272 min, p = 0.778), the risk of postoperative bile leakage (0% vs. 12%, p = 0.023), R1 resection (0% vs. 16%, p = 0.019) and readmission (p = 0.023) was reduced in the ICG group compared with the no-ICG group. CONCLUSIONS: The ICG fluorescence is a real-time navigation tool which enables surgeons to enhance visualization of anatomical structures and overcome the disadvantages of minimally invasive liver resection. The procedure is not time-consuming, and its applications can reduce the postoperative complication rate in robotic liver surgery.

Robotic Assisted Transanal Polypectomies: Is There Any Indication? / Polipectomía transanal asistida por robot: ¿tiene alguna indicación?

OBJECTIVES: Robotic assisted transanal polipectomy may have advantages compared with the conventional transanal minimally invasive surgery technique. We evaluate the safety, feasibility and advantages of this technique. METHODS: Between February 2014 and October 2015, 9patients underwent robotic transanal polypectomy. We performed a retrospective study in which we analyse prospectively collected data regarding patient and tumor characteristics, perioperative outcomes, pathological report, morbidity and mortality. RESULTS: A total of 5 male and 4 female patients underwent robotic TAMIS. Lesions were 6,22cm from the anal verge. Mean size was 15,8cm2. All procedures were performed in the lithotomy position. Closure of the defect was performed in all cases. Mean blood loss was 39,8ml. Mean operative time was 71,9min. No severe postoperative complications or readmissions occured. Median hospital stay was 2,5 days. CONCLUSIONS: Robotic TAMIS is useful to treat complex rectal lesions. Our transanal platform allowed a wider range of movements of the robotic arms and to perform all procedures in the lithotomy position.

Robotic-assisted laparoscopic transanal total mesorectal excision for rectal cancer: a prospective pilot study.

BACKGROUND: We performed a prospective pilot study of robotic-assisted laparoscopic transanal proctectomy with total mesorectal excision for the surgical treatment of rectal cancer. This study was to assess the feasibility and safety of robotic-assisted laparoscopic transanal total mesorectal excision. TECHNIQUE: All patients underwent robotic-assisted laparoscopic left colon mobilization, robotic-assisted laparoscopic transanal total mesorectal excision, ultralow mechanical colorectal or handsewn coloanal anastomosis, and a diverting loop ileostomy. Four patients with stage III disease received long-course preoperative chemoradiation before surgery. MAIN OUTCOME MEASURES: Primary and secondary end points included the assessment of pathological examination and postoperative morbidity. RESULTS: Between August 2013 and January 2014, 4 men and 1 woman underwent robotic-assisted laparoscopic transanal total mesorectal excision. Patient age and BMI were 57 ± 13.9 years and 25.8 ± 2,7 kg/m. Tumors were located an average of 5 ± 1 cm from the anal verge and were preoperatively staged as T2N0M0 (1 patient) and T2N1M0 (4 patients). Mean operative time was 398 ± 88 minutes with no intraoperative complications. Mean length of hospital stay was 6 ± 1 days. A Clavien II, grade B anastomotic leakage developed in 1 patient postoperatively. In all cases, pathological examination of the total mesorectal excision specimens showed complete mesorectal excision with negative proximal, distal, and circumferential margins. All patients were disease-free at their initial 3-month follow-up. CONCLUSIONS: Robotic-assisted laparoscopic transanal total mesorectal excision is a feasible and safe option for the surgical management of early-stage rectal cancers. Robotic technology with endowristed instruments and 3-dimensional high-definition imaging are of great help in overcoming the limitations of traditional laparoscopic transanal surgery. Long-term functional and oncological assessments of outcome are needed.

Splenic rupture after colorectal cancer screening.

The number of colonoscopies performed in recent years is increasing dramatically, specially those related to colorectal cancer screening programmes. For this reason, there is a direct relationship with the number of exceptional complications such as splenic rupture. We describe a clinical case of a splenic rupture with hemodynamic instability. Consequently, an emergency splenectomy was performed 6 hours after the colonoscopy was finished. Health staff should be aware of its existence, as an early reaction will avoid more severe problems.