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.

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.

Blood Transfusions and Adverse Events after Colorectal Surgery: A Propensity-Score-Matched Analysis of a Hen-Egg Issue.

Blood transfusions are considered a risk factor for adverse outcomes after colorectal surgery. However, it is still unclear if they are the cause (the hen) or the consequence (the egg) of adverse events. A prospective database of 4529 colorectal resections gathered over a 12-month period in 76 Italian surgical units (the iCral3 study), reporting patient-, disease-, and procedure-related variables, together with 60-day adverse events, was retrospectively analyzed identifying a subgroup of 304 cases (6.7%) that received intra- and/or postoperative blood transfusions (IPBTs). The endpoints considered were overall and major morbidity (OM and MM, respectively), anastomotic leakage (AL), and mortality (M) rates. After the exclusion of 336 patients who underwent neo-adjuvant treatments, 4193 (92.6%) cases were analyzed through a 1:1 propensity score matching model including 22 covariates. Two well-balanced groups of 275 patients each were obtained: group A, presence of IPBT, and group B, absence of IPBT. Group A vs. group B showed a significantly higher risk of overall morbidity (154 (56%) vs. 84 (31%) events; OR 3.07; 95%CI 2.13-4.43; p = 0.001), major morbidity (59 (21%) vs. 13 (4.7%) events; OR 6.06; 95%CI 3.17-11.6; p = 0.001), and anastomotic leakage (31 (11.3%) vs. 8 (2.9%) events; OR 4.72; 95%CI 2.09-10.66; p = 0.0002). No significant difference was recorded between the two groups concerning the risk of mortality. The original subpopulation of 304 patients that received IPBT was further analyzed considering three variables: appropriateness of BT according to liberal transfusion thresholds, BT following any hemorrhagic and/or major adverse event, and major adverse event following BT without any previous hemorrhagic adverse event. Inappropriate BT was administered in more than a quarter of cases, without any significant influence on any endpoint. The majority of BT was administered after a hemorrhagic or a major adverse event, with significantly higher rates of MM and AL. Finally, a major adverse event followed BT in a minority (4.3%) of cases, with significantly higher MM, AL, and M rates. In conclusion, although the majority of IPBT was administered with the consequence of hemorrhage and/or major adverse events (the egg), after adjustment accounting for 22 covariates, IPBT still resulted in a definite source of a higher risk of major morbidity and anastomotic leakage rates after colorectal surgery (the hen), calling urgent attention to the implementation of patient blood management programs.

Long-term results of tailored D(2) lymph node dissection after R(0) surgery for gastric cancer.

Implementation of extended lymph node dissection for gastric cancer in western non-specialized centers through tailoring its extent upon disease stage and patient comorbidities was suggested as a wise policy to reduce morbidity and mortality rates, albeit with a potential for undertreatment in elderly and/or comorbid patients. Current definition of R(0) resection for gastric cancer lacks consideration of treatment-related variables such as extended lymph node dissection. Few studies to date have tried to fill this gap in such a clinical context. A retrospective evaluation of factors influencing long-term results after R(0) surgery was done in a prospective series of a non-specialized western surgical unit during the implementation of D(2) lymphadenectomy. Univariate and multivariate analysis of 22 variables were performed on a prospective database of 233 consecutive R(0) resections performed by ten different surgeons in 10 years. Endpoint was disease-free survival calculated at 5 and at 10 years. Disease-free survival rates were independently influenced by age, American Society of Anesthesiologists (ASA) status and lymph node ratio. Subset analysis of the status at censor stratified for age and ASA status failed to identify any significant difference in disease recurrence rates. Lymph node ratio was the only treatment-related independent prognostic factor for long-term results after R(0) surgery for gastric cancer in the setting of a non-specialized western unit, where the extent of lymph node dissection needs to be tailored on the presence of comorbidities (ASA status).

Lymph node retrieval and examination during the implementation of extended lymph node dissection for gastric cancer in a non-specialized western institution.

The optimal degree of lymph node dissection for gastric cancer is still matter of debate. Particularly, there are serious doubts about the reproducibility of extended lymph node dissection in western surgical units, and no studies to date have investigated factors influencing lymph node retrieval and examination during the learning curve. Univariate and multivariate retrospective analysis of 21 variables were carried out on a prospective series of 313 consecutive resections for gastric cancer performed by ten different surgeons, with lymph node retrieval and analysis performed by ten different pathologists. Endpoints were number of examined lymph nodes per patient, number of cases with inadequate nodal staging (<15 examined lymph nodes) and lymph node ratio (calculated as the absolute ratio between the number of metastatic and the number of examined lymph nodes). The number of examined lymph nodes per patient (mean ± SD 28.3 ± 14.1, median 26, range 2-78) was independently influenced by age, pN status, the type of gastric resection, the degree of lymph node dissection and single pathologist. There were 47 cases (15.0%) with incomplete nodal staging that was independently determined by the degree of lymph node dissection and by the pathologist. Lymph node ratio was independently influenced by the number of metastatic lymph nodes, the disease stage and by the histological subtype of the tumor. The role of an experienced or dedicated pathologist should not be underevaluated in western series when dealing with lymph node retrieval and examination. Lymph node ratio appeared not to be significantly influenced by the number of examined lymph nodes, being independently influenced only by the number of metastatic lymph nodes, the disease stage and by the histological subtype of the tumor. It could be therefore tested as a prognostic factor limiting the stage-migration phenomenon induced by extended lymph node dissection.

[Colorectal cancer surgery. Analysis of risk factors in relation to incidence of morbidity and mortality]. / Chirurgia oncologica colo-rettale. Analisi dei fattori di rischio nell'incidenza di morbi-mortalità.

The aim of the study was to investigate risk factors in relation to the incidence of morbidity and mortality in surgery for colorectal cancer. Between 1986-2005, 328 patients underwent colorectal cancer surgery, 308 of whom (93.9%) in elective and 20 (6.1%) in emergency surgery. Radical resection was performed in 276 (84.2%) and palliative surgery in 52 (15.8%) patients. Bivariate statistical analysis was used for morbidity and mortality factors and multivariate analysis was performed in order to find independent variables (age, gender, ASA grade, elective or emergency surgery, tumour excision, cancer stage according to Dukes) associated with dependent variable interactions. Differences were considered statistically significant for p values < 0.05. The incidences of mortality and morbidity were 0.91% and 20.1%, respectively. In our study we observed a leakage incidence of 2.74% (9/328). In emergency surgery we found morbidity and mortality rates of 20% and 10%, respectively. Age and advanced cancer stage influenced results but were not found to be statistically significant. 18.3% of patients (60/328) were ASA I, 32% (105/328) ASA II, 39.6% (130/328) ASA III and 10.1% (33/328) ASA IV. Among the independent variables observed in the multivariate analysis, ASA grade was found to be the only positive predictive factor correlated with morbidity. Logistic regression showed an exponential increase in operative risk: odds ratio (OR) 2.9 in ASA I vs ASA II, OR 4.2 in ASA I vs ASA Ill, OR 10.3 in ASA I vs ASA IV (95% confidence interval). As regards the mortality rate, none of the independent variables were found to be statistically significant risk factors (p < 0.05).