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The incidence of long-term complications after rectal surgery varies widely among studies, and data regarding functional sequelae after transanal surgery are lacking. The aim of this study is to describe the incidence and change over time of sexual, urinary, and intestinal dysfunction in a single-center cohort, identifying independent predictors of dysfunction. A retrospective analysis of all rectal resections performed between March 2016 and March 2020 at our institution was conducted. Validated questionnaires were administered to assess post-operative function. Predictors of dysfunction were assessed by univariate and multivariate analysis. Latent class analysis was used to distinguish different risk profile classes. One hundred and forty-five patients were included. Sexual dysfunction at 1 month rose to 37% for both sexes, whereas urinary dysfunction reached 34% in males only. A significant (p < 0.05) improvement in urogenital function was observed between 1 and 6 months only. Intestinal dysfunction increased at 1 month, with no significant improvement between 1 and 12 months. Independent predictors of genitourinary dysfunction were post-operative urinary retention, pelvic collection, and Clavien-Dindo score ≥ III (p < 0.05). Transanal surgery resulted an independent predictor of better function (p < 0.05). Transanal approach, Clavien-Dindo score ≥ III, and anastomotic stenosis were independent predictors of higher LARS scores (p < 0.05). Maximum dysfunction was found at 1 month after surgery. Improvement was earlier for sexual and urinary dysfunction, whereas intestinal dysfunction improved slower and depended on pelvic floor rehabilitation. Transanal approach was protective for urinary and sexual function, although associated with a higher LARS score. Prevention of anastomosis-related complications resulted protective of post-operative function., (© 2023. Italian Society of Surgery (SIC).)

Purpose: The potential role of neoadjuvant radiation dose intensification in locally advanced rectal cancer (LARC) is still largely debated. In the present study, a comparative analysis between radiation dose intensification and conventional fractionation was performed., Materials and Methods: In the current prospective observational study (protocol ID RT-03/2011), 56 patients diagnosed with LARC were enrolled between January 2013 and December 2016. More specifically, 25 patients underwent preoperative conventional radiation dose [i.e., 50.4 Gy in 28 fractions here defined as standard dose radiotherapy (SDR)-group 1], whereas 31 patients were candidate for radiation dose intensification (RDI) (i.e., 60 Gy in 30 fractions-group 2). The primary endpoint was the complete pathological response (pCR) rate. Secondary endpoints were postoperative complications and ChT-RT-related toxicity., Results: No statistical significance was observed in pCR rate (20.8% and 22.6% in SDR and RDI group, respectively, p = 0.342). Of contrast, the RDI group showed a significantly higher primary tumor downstaging in case of T3 tumor compared to SDR group (p = 0.049). Sphincter-preserving surgery was 84% and 93.5% in SDR and RDI groups, respectively (p = 0.25). All patients had R0 margins. No surgical-related death was recorded. No statistically significant difference was observed regarding surgical complications and incomplete mesorectal excision. Acute genitourinary toxicity was significantly higher in RDI group (p = 0.015)., Conclusions: The intensification of the neoadjuvant radiotherapy for LARC seems to produce a major pathological response in T3 tumors. The radiation dose intensification appears probably associated with a higher rate of genitourinary toxicity.

Background: Neoadjuvant chemoradiotherapy followed by surgery is the mainstay treatment for locally advanced rectal cancer, leading to significant decrease in tumor size (downsizing) and a shift towards earlier disease stage (downstaging). Extensive histopathological work-up of the tumor specimen after surgery including tumor regression grading and lymph node status helped to visualize individual tumor sensitivity to chemoradiotherapy, retrospectively. As the response to neoadjuvant chemoradiotherapy is heterogeneous, however, valid biomarkers are needed to monitor tumor response. A relevant number of studies aimed to identify molecular markers retrieved from tumor tissue while the relevance of blood-based biomarkers is less stringent assessed. MicroRNAs are currently under investigation to serve as blood-based biomarkers. To date, no screening approach to identify relevant miRNAs as biomarkers in blood of patients with rectal cancer was undertaken. The aim of the study is to investigate the role of circulating miRNAs as biomarkers in those patients included in the TiMiSNAR Trial (NCT03465982). This is a biomolecular substudy of TiMiSNAR Trial (NCT03962088)., Methods: All included patients in the TiMiSNAR Trial are supposed to undergo blood collection at the time of diagnosis, after neoadjuvant treatment, after 1 month from surgery, and after adjuvant chemotherapy whenever indicated., Discussion: TiMiSNAR-MIRNA will evaluate the association of variation between preneoadjuvant and postneoadjuvant expression levels of miRNA with pathological complete response. Moreover, the study will evaluate the role of liquid biopsies in the monitoring of treatment, correlate changes in expression levels of miRNA following complete surgical resection with disease-free survival, and evaluate the relation between changes in miRNA during surveillance and tumor relapse., Trial Registration: Clinicaltrials.gov NCT03962088 . Registered on 23 May 2019.

Background: The optimal timing of surgery in relation to chemoradiation is still controversial. Retrospective analysis has demonstrated in the recent decades that the regression of adenocarcinoma can be slow and not complete until after several months. More recently, increasing pathologic Complete Response rates have been demonstrated to be correlated with longer time interval. The purpose of the trial is to demonstrate if delayed timing of surgery after neoadjuvant chemoradiotherapy actually affects pathologic Complete Response and reflects on disease-free survival and overall survival rather than standard timing., Methods: The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and forty patients will be randomized on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks., Discussion: To date, it is well-know that pathologic Complete Response is associated with excellent prognosis and an overall survival of 90%. In the Lyon trial the rate of pCR or near pathologic Complete Response increased from 10.3 to 26% and in retrospective studies the increase rate was about 23-30%. These results may be explained on the relationship between radiation therapy and tumor regression: DNA damage occurs during irradiation, but cellular lysis occurs within the next weeks. Study results, whether confirmed that performing surgery after 12 weeks from neoadjuvant treatment is advantageous from a technical and oncological point of view, may change the current pathway of the treatment in those patient suffering from rectal cancer., Trial Registration: ClinicalTrials.gov NCT3465982.

The aim was to report our experience with delayed colo-anal anastomosis (DCA) to avoid permanent stoma for complex rectal cases evaluating short- and long-term outcomes. Nine patients who underwent DCA from 2011 to 2016 were collected and analysed case by case. We considered medical history and surgical outcomes. Long-term bowel function was evaluated using the Wexner and low anterior resection syndrome (LARS) score at 6, 12 and 24 months. The range from previous surgery and salvage procedure was 337 days. All cases were performed with a full laparoscopic approach. The median length of hospital stay was 15 days. The median follow-up was 970.5 days. There was no peri-operative mortality. Two patients developed a post-operative pelvic abscess that required redo surgery. Long-term post-operative complications were mucosal prolapsed, anastomosis retraction and anastomotic stricture. The average values of LARS and Wexner scores were, respectively, at 6 months 33.7 and 16.2, at 12 months 28.5 and 11.7, at 24 months 21.1 and 6.7. Colo-anal sleeve delayed anastomosis appears a real answer to avoid permanent stoma in selected patients. The laparoscopic procedure is safe and feasible for skilful mini-invasive surgeons. Our experience describes the complexity of clinical history of these patients underlying a slow, but progressive improvement in continence after restoration of bowel continuity.