Stoma-free Survival After Rectal Cancer Resection With Anastomotic Leakage: Development and Validation of a Prediction Model in a Large International Cohort.

OBJECTIVE: To develop and validate a prediction model (STOMA score) for 1-year stoma-free survival in patients with rectal cancer (RC) with anastomotic leakage (AL). BACKGROUND: AL after RC resection often results in a permanent stoma. METHODS: This international retrospective cohort study (TENTACLE-Rectum) encompassed 216 participating centres and included patients who developed AL after RC surgery between 2014 and 2018. Clinically relevant predictors for 1-year stoma-free survival were included in uni and multivariable logistic regression models. The STOMA score was developed and internally validated in a cohort of patients operated between 2014 and 2017, with subsequent temporal validation in a 2018 cohort. The discriminative power and calibration of the models' performance were evaluated. RESULTS: This study included 2499 patients with AL, 1954 in the development cohort and 545 in the validation cohort. Baseline characteristics were comparable. One-year stoma-free survival was 45.0% in the development cohort and 43.7% in the validation cohort. The following predictors were included in the STOMA score: sex, age, American Society of Anestesiologist classification, body mass index, clinical M-disease, neoadjuvant therapy, abdominal and transanal approach, primary defunctioning stoma, multivisceral resection, clinical setting in which AL was diagnosed, postoperative day of AL diagnosis, abdominal contamination, anastomotic defect circumference, bowel wall ischemia, anastomotic fistula, retraction, and reactivation leakage. The STOMA score showed good discrimination and calibration (c-index: 0.71, 95% CI: 0.66-0.76). CONCLUSIONS: The STOMA score consists of 18 clinically relevant factors and estimates the individual risk for 1-year stoma-free survival in patients with AL after RC surgery, which may improve patient counseling and give guidance when analyzing the efficacy of different treatment strategies in future studies.

Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial.

BACKGROUND: More than 60% of patients who undergo surgery for colorectal cancer experience anxiety at some point during the perioperative period. In addition to the obvious impact on the experience of the therapeutic process, the presence of anxiety has also been associated with the appearance of complications. Virtual reality could reduce it by simulating the controlled exposure of the patient to the conscious part of the surgical process. METHODS: Single-center randomized clinical trial (NCT04058600) in which patients who were to undergo surgery for colorectal cancer and who had not previously undergone surgery as adults were exposed, prior to hospital admission, to virtual reality software in which all perioperative phases in which the patient is awake, from admission to discharge, were recreated. The main objective was to determine the presence of pre- and post-exposure anxiety using the validated State-Trait Anxiety Inventory Scale (STAI-S) and Hospital Anxiety and Depression Scale (HADS). RESULTS: A total of 126 patients were recruited (58 exposed, 68 unexposed). There were no differences between the groups in terms of age, gender, anesthetic risk, type of surgery. or levels of preoperative anxiety or depression. After exposure, all anxiety/depression rating scales decreased significantly. CONCLUSIONS: The use of simulation using virtual reality can reduce perioperative anxiety in patients undergoing surgery for colorectal cancer.