Bowel preparation for elective colorectal resection: multi-treatment machine learning analysis on 6241 cases from a prospective Italian cohort.

BACKGROUND: Current evidence concerning bowel preparation before elective colorectal surgery is still controversial. This study aimed to compare the incidence of anastomotic leakage (AL), surgical site infections (SSIs), and overall morbidity (any adverse event, OM) after elective colorectal surgery using four different types of bowel preparation. METHODS: A prospective database gathered among 78 Italian surgical centers in two prospective studies, including 6241 patients who underwent elective colorectal resection with anastomosis for malignant or benign disease, was re-analyzed through a multi-treatment machine-learning model considering no bowel preparation (NBP; No. = 3742; 60.0%) as the reference treatment arm, compared to oral antibiotics alone (oA; No. = 406; 6.5%), mechanical bowel preparation alone (MBP; No. = 1486; 23.8%), or in combination with oAB (MoABP; No. = 607; 9.7%). Twenty covariates related to biometric data, surgical procedures, perioperative management, and hospital/center data potentially affecting outcomes were included and balanced into the model. The primary endpoints were AL, SSIs, and OM. All the results were reported as odds ratio (OR) with 95% confidence intervals (95% CI). RESULTS: Compared to NBP, MBP showed significantly higher AL risk (OR 1.82; 95% CI 1.23-2.71; p = .003) and OM risk (OR 1.38; 95% CI 1.10-1.72; p = .005), no significant differences for all the endpoints were recorded in the oA group, whereas MoABP showed a significantly reduced SSI risk (OR 0.45; 95% CI 0.25-0.79; p = .008). CONCLUSIONS: MoABP significantly reduced the SSI risk after elective colorectal surgery, therefore representing a valid alternative to NBP.

Surgical Techniques and Related Perioperative Outcomes After Robot-assisted Minimally Invasive Gastrectomy (RAMIG): Results From the Prospective Multicenter International Ugira Gastric Registry.

OBJECTIVE: To gain insight in global practice of RAMIG and evaluated perioperative outcomes using an international registry. BACKGROUND: The techniques and perioperative outcomes of robot-assisted minimally invasive gastrectomy (RAMIG) for gastric cancer vary substantially in literature. METHODS: Prospectively registered RAMIG-cases for gastric cancer (≥10 per center) were extracted from 25 centers in Europe, Asia and South-America. Techniques for the resection, reconstruction, anastomosis and lymphadenectomy were analyzed, and related to perioperative surgical and oncological outcomes. Complications were uniformly defined by the Gastrectomy Complications Consensus Group. RESULTS: Between 2020-2023, 759 patients underwent total (n=272), distal (n=465) or proximal (n=22) gastrectomy (RAMIG). After total gastrectomy with Roux-en-Y-reconstruction, anastomotic leakage rates were 8% with hand-sewn (n=9/111) and 6% with linear stapled anastomoses (n=6/100). After distal gastrectomy with Roux-en-Y (67%) or Billroth-II-reconstruction (31%), anastomotic leakage rates were 3% with linear stapled (n=11/433) and 0% with hand-sewn anastomoses (n=0/26). Extent of lymphadenectomy consisted of D1+ (28%), D2 (59%) or D2+ (12%). Median nodal harvest yielded 31 nodes [IQR 21-47] after total and 34 nodes [IQR 24-47] after distal gastrectomy. R0-resection rates were 93% after total and 96% distal gastrectomy. Hospital stay was 9 days after total and distal gastrectomy, and was 3 days shorter without perianastomotic drains versus routine drain placement. Postoperative 30-day mortality was 1%. CONCLUSIONS: This large multicenter study provided a worldwide overview of current RAMIG-techniques with their respective perioperative outcomes. These outcomes demonstrated high surgical quality, set a quality standard for RAMIG and can be considered an international reference for surgical standardization.

Open vs robotic gastrectomy with D2 lymphadenectomy: a propensity score-matched analysis on 1469 patients from the IMIGASTRIC prospective database.

BACKGROUND: Comparative data on D2-robotic gastrectomy (RG) vs D2-open gastrectomy (OG) are lacking in the Literature. Aim of this paper is to compare RG to OG with a focus on D2-lymphadenectomy. STUDY DESIGN: Data of patients undergoing D2-OG or RG for gastric cancer were retrieved from the international IMIGASTRIC prospective database and compared. RESULTS: A total of 1469 patients were selected for inclusion in the study. After 1:1 propensity score matching, a total of 580 patients were matched and included in the final analysis, 290 in each group, RG vs OG. RG had longer operation time (210 vs 330 min, p < 0.0001), reduced intraoperative blood loss (155 vs 119.7 ml, p < 0.0001), time to liquid diet (4.4 vs 3 days, p < 0.0001) and to peristalsis (2.4 vs 2 days, p < 0.0001), and length of postoperative stay (11 vs 8 days, p < 0.0001). Morbidity rate was higher in OG (24.1% vs 16.2%, p = 0.017). CONCLUSION: RG significantly expedites recovery and reduces the risk of complications compared to OG. However, long-term survival is similar.

Risk factors for anastomotic leakage after anterior resection for rectal cancer (RALAR study): A nationwide retrospective study of the Italian Society of Surgical Oncology Colorectal Cancer Network Collaborative Group.

AIM: Anastomotic leakage after restorative surgery for rectal cancer shows high morbidity and related mortality. Identification of risk factors could change operative planning, with indications for stoma construction. This retrospective multicentre study aims to assess the anastomotic leak rate, identify the independent risk factors and develop a clinical prediction model to calculate the probability of leakage. METHODS: The study used data from 24 Italian referral centres of the Colorectal Cancer Network of the Italian Society of Surgical Oncology. Patients were classified into two groups, AL (anastomotic leak) or NoAL (no anastomotic leak). The effect of patient-, disease-, treatment- and postoperative outcome-related factors on anastomotic leak after univariable and multivariable analysis was measured. RESULTS: A total of 5398 patients were included, 552 in group AL and 4846 in group NoAL. The overall incidence of leaks was 10.2%, with a mean time interval of 6.8 days. The 30-day leak-related mortality was 2.6%. Sex, body mass index, tumour location, type of approach, number of cartridges employed, weight loss, clinical T stage and combined multiorgan resection were identified as independent risk factors. The stoma did not reduce the leak rate but significantly decreased leak severity and reoperation rate. A nomogram with a risk score (RALAR score) was developed to predict anastomotic leak risk at the end of resection. CONCLUSIONS: While a defunctioning stoma did not affect the leak risk, it significantly reduced its severity. Surgeons should recognize independent risk factors for leaks at the end of rectal resection and could calculate a risk score to select high-risk patients eligible for protective stoma construction.

ERAS program adherence-institutionalization, major morbidity and anastomotic leakage after elective colorectal surgery: the iCral2 multicenter prospective study.

BACKGROUND: Enhanced recovery after surgery (ERAS) programs influence morbidity rates and length of stay after colorectal surgery (CRS), and may also impact major complications and anastomotic leakage rates. A prospective multicenter observational study to investigate the interactions between ERAS program adherence and early outcomes after elective CRS was carried out. METHODS: Prospective enrolment of patients submitted to elective CRS with anastomosis in 18 months. Adherence to 21 items of ERAS program was measured upon explicit criteria in every case. After univariate analysis, independent predictors of primary endpoints [major morbidity (MM) and anastomotic leakage (AL) rates] were identified through logistic regression analyses including all significant variables, presenting odds ratios (OR). RESULTS: Institutional ERAS protocol was declared by 27 out of 38 (71.0%) participating centers. Median overall adherence to ERAS program items was 71.4%. Among 3830 patients included in the study, MM and AL rates were 4.7% and 4.2%, respectively. MM rates were independently influenced by intra- and/or postoperative blood transfusions (OR 7.79, 95% CI 5.46-11.10; p < 0.0001) and standard anesthesia protocol (OR 0.68, 95% CI 0.48-0.96; p = 0.028). AL rates were independently influenced by male gender (OR 1.48, 95% CI 1.06-2.07; p = 0.021), intra- and/or postoperative blood transfusions (OR 4.29, 95% CI 2.93-6.50; p < 0.0001) and non-standard resections (OR 1.49, 95% CI 1.01-2.22; p = 0.049). CONCLUSIONS: This study disclosed wide room for improvement in compliance to several ERAS program items. It failed to detect any significant association between institutionalization and/or adherence rates to ERAS program with primary endpoints. These outcomes were independently influenced by gender, intra- and postoperative blood transfusions, non-standard resections, and standard anesthesia protocol.

Management and 1-year outcomes of anastomotic leakage after elective colorectal surgery.

PURPOSE: To analyze different types of management and one-year outcomes of anastomotic leakage (AL) after elective colorectal resection. METHODS: All patients with anastomotic leakage after elective colorectal surgery with anastomosis (76/1,546; 4.9%), with the exclusion of cases with proximal diverting stoma, were followed-up for at least one year. Primary endpoints were as follows: composite outcome of one-year mortality and/or unplanned intensive care unit (ICU) admission and additional morbidity rates. Secondary endpoints were as follows: length of stay (LOS), one-year persistent stoma rate, and rate of return to intended oncologic therapy (RIOT). RESULTS: One-year mortality rate was 10.5% and unplanned ICU admission rate was 30.3%. Risk factors of the composite outcome included age (aOR = 1.08 per 1-year increase, p = 0.002) and anastomotic breakdown with end stoma at reoperation (aOR = 2.77, p = 0.007). Additional morbidity rate was 52.6%: risk factors included open versus laparoscopic reoperation (aOR = 4.38, p = 0.03) and ICU admission (aOR = 3.63, p = 0.05). Median (IQR) overall LOS was 20 days (14-26), higher in the subgroup of patients reoperated without stoma. At 1 year, a stoma persisted in 32.0% of patients, higher in the open (41.2%) versus laparoscopic (12.5%) reoperation group (p = 0.04). Only 4 out of 18 patients (22.2%) were able to RIOT. CONCLUSION: Mortality and/or unplanned ICU admission rates after AL are influenced by increasing age and by anastomotic breakdown at reoperation; additional morbidity rates are influenced by unplanned ICU admission and by laparoscopic approach to reoperation, the latter also reducing permanent stoma and failure to RIOT rates. TRIAL REGISTRATION: ClinicalTrials.gov # NCT03560180.

Impact of COVID-19 outbreak on esophageal cancer surgery in Northern Italy: lessons learned from a multicentric snapshot.

Coronavirus Disease-19 (COVID-19) outbreak has significantly burdened healthcare systems worldwide, leading to reorganization of healthcare services and reallocation of resources. The Italian Society for Study of Esophageal Diseases (SISME) conducted a national survey to evaluate changes in esophageal cancer management in a region severely struck by COVID-19 pandemic. A web-based questionnaire (26 items) was sent to 12 SISME units. Short-term outcomes of esophageal resections performed during the lockdown were compared with those achieved in the same period of 2019. Six (50%) centers had significant restrictions in their activity. However, overall number of resections did not decrease compared to 2019, while a higher rate of open esophageal resections was observed (40 vs. 21.7%; P = 0.034). Surgery was delayed in 24 (36.9%) patients in 6 (50%) centers, mostly due to shortage of anesthesiologists, and occupation of intensive care unit beds from intubated COVID-19 patients. Indications for neoadjuvant chemo (radio) therapy were extended in 14% of patients. Separate COVID-19 hospital pathways were active in 11 (91.7%) units. COVID-19 screening protocols included nasopharyngeal swab in 91.7%, chest computed tomography scan in 8.3% and selective use of lung ultrasound in 75% of units. Postoperative interstitial pneumonia occurred in 1 (1.5%) patient. Recovery from COVID-19 pandemic was characterized by screening of patients in all units, and follow-up outpatient visits in only 33% of units. This survey shows that clinical strategies differed considerably among the 12 SISME centers. Evidence-based guidelines are needed to support the surgical esophageal community and to standardize clinical practice in case of further pandemics.

ICG fluorescence imaging in colorectal surgery: a snapshot from the ICRAL study group.

BACKGROUND: Fluorescence-guided visualization is a recently proposed technology in colorectal surgery. Possible uses include evaluating perfusion, navigating lymph nodes and searching for hepatic metastases and peritoneal spread. Despite the absence of high-level evidence, this technique has gained considerable popularity among colorectal surgeons due to its significant reliability, safety, ease of use and relatively low cost. However, the actual use of this technique in daily clinical practice has not been reported to date. METHODS: This survey was conducted on April 2020 among 44 centers dealing with colorectal diseases and participating in the Italian ColoRectal Anastomotic Leakage (iCral) study group. Surgeons were approximately equally divided based on geographical criteria from multiple Italian regions, with a large proportion based in public (89.1%) and nonacademic (75.7%) centers. They were invited to answer an online survey to snapshot their current behaviors regarding the use of fluorescence-guided visualization in colorectal surgery. Questions regarding technological availability, indications and techniques, personal approaches and feelings were collected in a 23-item questionnaire. RESULTS: Questionnaire replies were received from 37 institutions and partially answered by 8, as this latter group of centers do not implement fluorescence technology (21.6%). Out of the remaining 29 centers (78,4%), fluorescence is utilized in all laparoscopic colorectal resections by 72.4% of surgeons and only for selected cases by the remaining 27.6%, while 62.1% of respondents do not use fluorescence in open surgery (unless the perfusion is macroscopically uncertain with the naked eye, in which case 41.4% of them do). The survey also suggests that there is no agreement on dilution, dosing and timing, as many different practices are adopted based on personal judgment. Only approximately half of the surgeons reported a reduced leak rate with fluorescence perfusion assessment, but 65.5% of them strongly believe that this technique will become a minimum requirement for colorectal surgery in the future. CONCLUSION: The survey confirms that fluorescence is becoming a widely used technique in colorectal surgery. However, both the indications and methods still vary considerably; furthermore, the surgeons' perceptions of the results are insufficient to consider this technology essential. This survey emphasizes the need for further research to reach recommendations based on solid scientific evidence.

Long-term Oncologic Results After Stenting as a Bridge to Surgery Versus Emergency Surgery for Malignant Left-sided Colonic Obstruction: A Multicenter Randomized Controlled Trial (ESCO Trial).

OBJECTIVE: To assess overall (OS), time to progression (TTP), and disease-free survival (DFS) at 3 years after treatment, comparing stenting as bridge-to-surgery (SBTS) versus emergency surgery (ES) in neoplastic left colon obstruction, secondary endpoints of the previously published randomized controlled trial. BACKGROUND: While SBTS in neoplastic colon obstruction may reduce morbidity and need for a stoma compared with ES, concern has been raised, about long-term survival. METHODS: Individuals affected by left-sided malignant large-bowel obstruction were enrolled from 5 European hospitals and randomly assigned (1:1 ratio) to receive SBTS or ES. The computer-generated randomization sequence was stratified by center on cT and concealed by the use of a web-based application. Investigators and participants were unmasked to treatment assignment. The secondary outcomes analyzed here were OS, TTP, and DFS. Analysis was by intention to treat. This study is registered, ID-code NCT00591695. RESULTS: Between March 2008 and November 2015, 144 patients were randomly assigned to undergo either SBTS or ES; 115 (SBTS n = 56, ES n = 59) were eligible for analysis, while 20 participants were excluded for a benign disease, 1 for unavailability of the endoscopist while 8 withdrew from the trial. With a median follow-up of 37 months (range 1-62), no difference was observed in the SBTS group compared with ES in terms of OS (HR 0.93 (95% CI 0.49-1.76), P = 0.822), TTP (HR 0.81 (95% CI 0.42-1.54), P = 0.512), and DFS (HR 1.01 (95% CI 0.56-1.81), P = 0.972). Planned subgroup analysis showed no difference in respect to age, sex, American Society for Anesthesiology score, body mass index, and pT between SBTS and ES groups. Those participants randomized for the SBTS group whose obstruction was located in the descending colon had a better TTP compared with ES group (HR 0.44 (95% CI 0.20-0.97), P = 0.042), but no difference was observed in terms of OS (HR 0.73 (95% CI 0.33-1.63), P = 0.442) and DFS (HR 0.68 (95% CI 0.34-1.34), P = 0.261) in the same individuals. CONCLUSIONS: This randomized controlled trial shows that, although not powered for these seconday outcomes, OS, TTP, and DFS did not differ between groups at a minimum follow-up of 36 months.

Robotic Treatment for Large Duodenal Gastrointestinal Stromal Tumor.

BACKGROUND: Duodenal gastrointestinal stromal tumors (D-GISTs) represent a rare entity.1 Surgery is the primary treatment choice for localized or potentially resectable D-GISTs. The main principle is the complete excision of the lesion with microscopically negative margins, without performing lymph node dissection.2 Nevertheless, the best surgical choice is still controversial since the strategy depends not only on the tumor size but also on its anatomic location.3,4 As a result, surgical management ranges from a major resection such as pancreaticoduodenectomy to more conservative procedures.5-8 This video presents a duodenal sparing robotic resection of a large GIST of the second-third duodenal portion. METHODS: A 49-year-old healthy female complained episodes of melena. Endoscopy with endoscopic ultrasound identified a 6-cm lesion of the second-third portion of the duodenum with recent bleeding, arising from muscolaris propria. A computed tomography scan confirmed a large mass suspected to be a GIST without metastases or involvement of the ampulla of Vater. On the basis of these findings, after a multidisciplinary consultation, she was offered robotic surgery with a radical intent. RESULTS: A duodenal-sparing da Vinci®Si™ resection with robot-sewn primary duodenal closure was performed. After an uneventful postoperative course, the patient was discharged on post-operative day 7. Final pathology revealed a high-grade risk D-GIST with free margins: adjuvant Imatinib was recommended.9 At 4 years follow-up, no recurrence has been detected. CONCLUSIONS: A robotic approach might be considered in cases of large D-GISTs amenable to a conservative R0 surgery. This system provides several technical advantages that facilitate otherwise complex resection and reconstruction.10.

Impact of laparoscopy on adherence to an enhanced recovery pathway and readiness for discharge in elective colorectal surgery: Results from the PeriOperative Italian Society registry.

INTRODUCTION: Previous studies reported that laparoscopic surgery (LPS) improved postoperative outcomes in patients undergoing colorectal surgery within an enhanced recovery program (ERP). However, the effect of minimally invasive surgery on each ERP item has not been clarified, yet. The aim of this study is to assess the impact of LPS on adherence to ERP items and recovery as measured by time to readiness for discharge (TRD). METHODS: Prospectively collected data entered in an electronic Italian registry specifically designed for ERP were reviewed. Patients undergoing elective colorectal surgery were divided into three groups: successful laparoscopy, conversion to open surgery, primary open surgery. Adherence to 19 ERP elements and postoperative outcomes were compared among groups. Multivariate regression analysis was used to identify whether LPS had an independent role to improve ERP adherence and postoperative outcomes. RESULTS: 714 patients (successful LPS 531, converted 42, open 141) underwent elective colorectal surgery within an ERP. Epidural analgesia was used in the 75.1% of open group patients versus 49.9% of LPS group patients (p = 0.012). After surgery, oral feeding recovery, i.v. fluids suspension, removal of both urinary and epidural catheters occurred earlier in the LPS group both in the overall series and in uneventful patients only. Mean TRD and length of hospital stay were significantly shorter in the LPS group (p < 0.001 for both). Overall morbidity rate was 18.7% in the LPS group versus 32.6% in the open group (p = 0.001). At multivariate analysis, LPS was significantly associated to an increased adherence to postoperative ERP items, a shorter TRD, and a reduced overall morbidity, whereas rectal surgery and new stoma formation impaired postoperative recovery. CONCLUSIONS: The present study showed that a successful laparoscopic procedure had an independent role to increase the adherence to postoperative ERP and to improve short-term postoperative outcome.

Colonic stenting as a bridge to surgery versus emergency surgery for malignant colonic obstruction: results of a multicentre randomised controlled trial (ESCO trial).

BACKGROUND: The aim of colonic stenting with self-expandable metallic stents in neoplastic colon obstruction is to avoid emergency surgery and thus potentially reduce morbidity, mortality, and need for a stoma. Concern has been raised, however, about the effect of colonic stenting on short-term complications and long-term survival. We compared morbidity rates after colonic stenting as a bridge to surgery (SBTS) versus emergency surgery (ES) in the management of left-sided malignant large-bowel obstruction. METHODS: This multicentre randomised controlled trial was designed with the endorsement of the European Association for Endoscopic Surgery. The study population was consecutive patients with acute, symptomatic malignant left-sided large-bowel obstruction localised between the splenic flexure and 15 cm from the anal margin. The primary outcome was overall morbidity within 60 days after surgery. RESULTS: Between March 2008 and November 2015, 144 patients were randomly assigned to undergo either SBTS or ES; 29/144 (13.9%) were excluded post-randomisation mainly because of wrong diagnosis at computed tomography examination. The remaining 115 patients (SBTS n = 56, ES n = 59) were deemed eligible for analysis. The complications rate within 60 days was 51.8% in the SBTS group and 57.6% in the ES group (p = 0.529). Although long-term follow-up is still ongoing, no statistically significant difference in 3-year overall survival (p = 0.998) and progression-free survival rates between the groups has been observed (p = 0.893). Eleven patients in the SBTS group and 23 in the ES group received a stoma (p = 0.031), with a reversal rate of 30% so far. CONCLUSIONS: Our findings indicate that the two treatment strategies are equivalent. No difference in oncologic outcome was found at a median follow-up of 36 months. The significantly lower stoma rate noted in the SBTS group argues in favour of the SBTS procedure when performed in expert hands.

Enhanced Recovery Program in High-Risk Patients Undergoing Colorectal Surgery: Results from the PeriOperative Italian Society Registry.

BACKGROUND: Enhanced recovery after surgery (ERAS) pathways represent the optimal approach for patients undergoing colorectal surgery. Elderly or low physical status patients have been often excluded from ERAS pathways because considered at high risk. The aim of this study is to assess the adherence to ERAS protocol and its impact on short-term postoperative outcome in patients with different surgical risk undergoing elective colorectal resection. METHODS: Prospectively collected data entered in an electronic Italian registry specifically designed for ERAS were reviewed. Patients were divided into four groups according to age (70-year-old cutoff) and preoperative physical status as measured by the ASA grade (I-II vs. III-IV). Adherence to 18 ERAS elements and postoperative outcomes were compared between groups. Regression analysis was used to identify independent factors associated with improved outcomes. RESULTS: Eleven Italian hospitals reported data on 706 patients undergoing elective colorectal surgery within an ERAS protocol. Patients with low physical status had reduced adherence to preoperative carbohydrate loading, epidural analgesia, PONV prophylaxis, and early urinary catheter removal. No difference was found between groups for adherence to other perioperative elements. Major complications occurred in 37 (5.2 %) patients without significant differences among groups (p = 0.384). Median (IQR) time to readiness for discharge (TRD) was 4 (3-6) days, length of hospital stay (LOS) was 6 (4-7) days, and both were significantly shorter by only 1 day in the groups of younger patients (p < 0.001). At multivariate analysis, laparoscopy increased adherence to ERAS items and reduced TRD, LOS, and morbidity. A high ASA grade was significantly associated with lower adherence, whereas older age significantly prolonged TRD and LOS. CONCLUSION: ERAS pathway can be safely applied in elderly and low physical status patients yielding slight differences in postoperative morbidity and time to recover. Laparoscopy was independently associated with increased adherence to ERAS protocol and improved short-term postoperative outcome.

Oral Antibiotics Alone versus Oral Antibiotics Combined with Mechanical Bowel Preparation for Elective Colorectal Surgery: A Propensity Score-Matching Re-Analysis of the iCral 2 and 3 Prospective Cohorts.

The evidence regarding the role of oral antibiotics alone (oA) or combined with mechanical bowel preparation (MoABP) for elective colorectal surgery remains controversial. A prospective database of 8359 colorectal resections gathered over a 32-month period from 78 Italian surgical units (the iCral 2 and 3 studies), reporting patient-, disease-, and procedure-related variables together with 60-day adverse events, was re-analyzed to identify a subgroup of 1013 cases (12.1%) that received either oA or MoABP. This dataset was analyzed using a 1:1 propensity score-matching model including 20 covariates. Two well-balanced groups of 243 patients each were obtained: group A (oA) and group B (MoABP). The primary endpoints were anastomotic leakage (AL) and surgical site infection (SSI) rates. Group A vs. group B showed a significantly higher AL risk [14 (5.8%) vs. 6 (2.5%) events; OR: 3.77; 95%CI: 1.22-11.67; p = 0.021], while no significant difference was recorded between the two groups regarding SSIs. These results strongly support the use of MoABP for elective colorectal resections.

Intraoperative left-sided colorectal anastomotic testing in clinical practice: a multi-treatment machine-learning analysis of the iCral3 prospective cohort.

BACKGROUND: Current evidence about intraoperative anastomotic testing after left-sided colorectal resections is still controversial. The aim of this study was to analyze the impact of Indocyanine Green fluorescent angiography (ICG-FA) and air-leak test (ALT) over standard assessment on anastomotic leakage (AL) rates according to surgeon's perception of anastomosis perfusion and/or integrity in clinical practice. METHODS: A database of 2061 patients who underwent left-sided colorectal resections was selected from patients enrolled in a prospective multicenter study. It was retrospectively analyzed through a multi-treatment machine-learning model considering standard visual assessment (NW; No. = 899; 43.6%) as the reference treatment arm, compared to ICG-FA alone (WP; No. = 409; 19.8%), ALT alone (WI; No. = 420; 20.4%) or both (WPI; No. = 333; 16.2%). Twenty-four covariates potentially affecting the outcomes were included and balanced into the model within the subgroups. The primary endpoint was AL, the secondary endpoints were overall morbidity (OM), major morbidity (MM), reoperation for AL, and mortality. All the results were reported as odds ratio (OR) with 95% confidence intervals (95%CI). RESULTS: The WPI subgroup showed significantly higher AL risk (OR 1.91; 95% CI 1.02-3.59; p 0.043), MM risk (OR 2.35; 95% CI 1.39-3.97; p 0.001), and reoperation for AL risk (OR 2.44; 95% CI 1.12-5.31; p 0.025). No other significant differences were recorded. CONCLUSIONS: This study showed that the surgeons' perception of both anastomotic perfusion and integrity (WPI subgroup) was associated to a significantly higher risk of AL and related morbidity, notwithstanding the extensive use of both ICG-FA and ALT testing.

Implementation of an enhanced recovery after surgery protocol for colorectal cancer in a regional hospital network supported by audit and feedback: a stepped wedge, cluster randomised trial.

BACKGROUND: Enhanced recovery after surgery (ERAS) protocols are known to potentially improve the management and outcomes of patients undergoing colorectal surgery, with limited evidence of their implementation in hospital networks and in a large population. We aimed to assess the impact of the implementation of an ERAS protocol in colorectal cancer surgery in the entire region of Piemonte, Italy, supported by an audit and feedback (A&F) intervention. METHODS: A large, stepped wedge, cluster randomised trial enrolled patients scheduled for elective surgery at 29 general surgery units (clusters). At baseline (first 3 months), standard care was continued in all units. Thereafter, four groups of clusters began to adopt the ERAS protocol successively. By the end of the study, each cluster had a period in which standard care was maintained (control) and a period in which the protocol was applied (experimental). ERAS implementation was supported by initial training and A&F initiatives. The primary endpoint was length of stay (LOS) without outliers (>94th percentile), and the secondary endpoints were outliers for LOS, postoperative medical and surgical complications, quality of recovery and compliance with ERAS items. RESULTS: Of 2626 randomised patients, 2397 were included in the LOS analysis (1060 in the control period and 1337 in the experimental period). The mean LOS without outliers was 8.5 days during the control period (SD 3.9) and 7.5 (SD 3.5) during the experimental one. The adjusted difference between the two periods was a reduction of -0.58 days (95% CI -1.07, -0.09; p=0.021). The compliance with ERAS items increased from 52.4% to 67.3% (estimated absolute difference +13%; 95% CI 11.4%, 14.7%). No difference in the occurrence of complications was evidenced (OR 1.22; 95% CI 0.89, 1.68). CONCLUSION: Implementation of the ERAS protocol for colorectal cancer, supported by A&F approach, led to a substantial improvement in compliance and a reduction in LOS, without meaningful effects on complications. Trial registration number NCT04037787.

Mechanical bowel preparation in elective colorectal surgery: a propensity score-matched analysis of the Italian colorectal anastomotic leakage (iCral) study group prospective cohorts.

Retrospective evaluation of the effects of mechanical bowel preparation (MBP) on data derived from two prospective open-label observational multicenter studies in Italy regarding elective colorectal surgery. MBP for elective colorectal surgery remains a controversial issue with contrasting recommendations in current guidelines. The Italian ColoRectal Anastomotic Leakage (iCral) study group, therefore, decided to estimate the effects of no MBP (treatment variable) versus MBP for elective colorectal surgery. A total of 8359 patients who underwent colorectal resection with anastomosis were enrolled in two consecutive prospective studies in 78 surgical centers in Italy from January 2019 to September 2021. A retrospective PSMA was performed on 5455 (65.3%) cases after the application of explicit exclusion criteria to eliminate confounders. The primary endpoints were anastomotic leakage (AL) and surgical site infections (SSI) rates; the secondary endpoints included SSI subgroups, overall and major morbidity, reoperation, and mortality rates. Overall length of postoperative hospital stay (LOS) was also considered. Two well-balanced groups of 1125 patients each were generated: group A (No MBP, true population of interest), and group B (MBP, control population), performing a PSMA considering 21 covariates. Group A vs. group B resulted significantly associated with a lower risk of AL [42 (3.5%) vs. 73 (6.0%) events; OR 0.57; 95% CI 0.38-0.84; p = 0.005]. No difference was recorded between the two groups for SSI [73 (6.0%) vs. 85 (7.0%) events; OR 0.88; 95% CI 0.63-1.22; p = 0.441]. Regarding the secondary endpoints, no MBP resulted significantly associated with a lower risk of reoperation and LOS > 6 days. This study confirms that no MBP before elective colorectal surgery is significantly associated with a lower risk of AL, reoperation rate, and LOS < 6 days when compared with MBP.

Abdominal drainage after elective colorectal surgery: propensity score-matched retrospective analysis of an Italian cohort.

BACKGROUND: In Italy, surgeons continue to drain the abdominal cavity in more than 50 per cent of patients after colorectal resection. The aim of this study was to evaluate the impact of abdominal drain placement on early adverse events in patients undergoing elective colorectal surgery. METHODS: A database was retrospectively analysed through a 1:1 propensity score-matching model including 21 covariates. The primary endpoint was the postoperative duration of stay, and the secondary endpoints were surgical site infections, infectious morbidity rate defined as surgical site infections plus pulmonary infections plus urinary infections, anastomotic leakage, overall morbidity rate, major morbidity rate, reoperation and mortality rates. The results of multiple logistic regression analyses were presented as odds ratios (OR) and 95 per cent c.i. RESULTS: A total of 6157 patients were analysed to produce two well-balanced groups of 1802 patients: group (A), no abdominal drain(s) and group (B), abdominal drain(s). Group A versus group B showed a significantly lower risk of postoperative duration of stay >6 days (OR 0.60; 95 per cent c.i. 0.51-0.70; P < 0.001). A mean postoperative duration of stay difference of 0.86 days was detected between groups. No difference was recorded between the two groups for all the other endpoints. CONCLUSION: This study confirms that placement of abdominal drain(s) after elective colorectal surgery is associated with a non-clinically significant longer (0.86 days) postoperative duration of stay but has no impact on any other secondary outcomes, confirming that abdominal drains should not be used routinely in colorectal surgery.

Prompt or delayed appendectomy? Influence of timing of surgery for acute appendicitis.

PURPOSE: The aim of the study was to compare the clinical outcomes and histological findings in prompt and delayed appendectomy for acute appendicitis. METHODS: All patients who underwent appendectomy for histologically confirmed acute appendicitis from 2003 to 2009 were included in this study. Patients were divided into three groups according to the time of surgery after hospital admission: The early appendectomy (EA) group underwent surgery within 12 h, the early-delayed appendectomy (EDA) group between 12 and 24 h and the delayed appendectomy (DA) group more than 24 h. The perioperative data and pathological state of the appendix were evaluated and compared. RESULTS: A total of 723 patients, with histologically confirmed acute appendicitis, were included in the study: There were 518 patients in the EA group, 140 patients in the EDA group and 65 patients in the DA group. The operative times were similar in each group. Postoperative complications occurred in 49 patients (6.8 %) and were significantly higher in the DA group in comparison to the EA group (p = 0.0012) and EDA group (p = 0.003). Two patients (3 %) in the DA group died. There were no differences in the length of the hospital stay. The gangrenous appendicitis rate was significantly higher in the DA group (p < 0.05) in comparison to the EA and EDA groups. CONCLUSIONS: Performing appendectomy within 24 h from presentation does not increase the length of hospital stay or rate of complications. However, delayed appendectomy after 24 h from onset increases the rate of complications.

Robot-assisted esophagectomy with robot-sewn intrathoracic anastomosis (Ivor Lewis): surgical technique and early results.

Esophagectomy is the selected treatment for nonmetastatic esophageal and esophagogastric junction cancer, although high perioperative morbidity and mortality incur. Robot-assisted minimally invasive esophagectomy (RAMIE) effectively reduces cardiopulmonary complications compared to open esophagectomy and offers a technical advantage, especially for lymph node dissection and intrathoracic anastomosis. This article aims at describing our initial experience of Ivor Lewis RAMIE, focusing on the technique's main steps and robotic-sewn esophagogastrostomy. Prospectively collected data from all consecutive patients who underwent Ivor Lewis RAMIE for cancer was reviewed. Reconstruction was performed with a gastric conduit pull-up and a robotic-sewn intrathoracic anastomosis. Intraoperative and postoperative complications were recorded as prescribed by the Esophagectomy Complications Consensus Group (ECCG). Thirty patients underwent Ivor Lewis RAMIE with complete mediastinal lymph node dissection and robot-sewn anastomosis. No intraoperative complications nor conversion occurred. Pulmonary complications totaled 26.7%. Anastomotic leakage (ECCG, type III) and conduit necrosis (ECCG, type III) both occurred in one patient (3.3%). Chylothorax appeared in 2 patients (6.7%) (ECCG, Type IIA). Anastomotic stricture, successfully treated with endoscopic dilatations, occurred in 8 cases (26.7%). Median overall postoperative stay was 11 days (range, 6-51 days). 30 day and 90 day mortality was 0%. R0 resection was performed in 96.7% of patients with a median number of 47 retrieved lymph nodes. RAMIE with robot-sewn intrathoracic anastomosis appears to be feasible, safe and effective, with favorable perioperative results. Nevertheless, further high-quality studies are needed to define the best anastomotic technique for Ivor Lewis RAMIE.