Development and external validation of a nomogram and online tool to predict bowel dysfunction following restorative rectal cancer resection: the POLARS score.

OBJECTIVE: Bowel dysfunction is common following a restorative rectal cancer resection, but symptom severity and the degree of quality of life impairment is highly variable. An internationally validated patient-reported outcome measure, Low Anterior Resection Syndrome (LARS) score, now enables these symptoms to be measured. The study purpose was: (1) to develop a model that predicts postoperative bowel function; (2) externally validate the model and (3) incorporate these findings into a nomogram and online tool in order to individualise patient counselling and aid preoperative consent. DESIGN: Patients more than 1 year after curative restorative anterior resection (UK, median 54 months; Denmark (DK), 56 months since surgery) were invited to complete The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version3 (EORTC QLQ-C30 v3), LARS and Wexner incontinence scores. Demographics, tumour characteristics, preoperative/postoperative treatment and surgical procedures were recorded. Using transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) guidelines, risk factors for bowel dysfunction were independently assessed by advanced linear regression shrinkage techniques for each dataset (UK:DK). RESULTS: Patients in the development (UK, n=463) and validation (DK, n=938) datasets reported mean (SD) LARS scores of 26 (11) and 24 (11), respectively. Key predictive factors for LARS were: age (at surgery); tumour height, total versus partial mesorectal excision, stoma and preoperative radiotherapy, with satisfactory model calibration and a Mallow's Cp of 7.5 and 5.5, respectively. CONCLUSIONS: The Pre-Operative LARS score (POLARS) is the first nomogram and online tool to predict bowel dysfunction severity prior to anterior resection. Colorectal surgeons, gastroenterologist and nurse specialists may use POLARS to help patients understand their risk of bowel dysfunction and to preoperatively highlight patients who may require additional postoperative support.

LAP-VEGaS Practice Guidelines for Reporting of Educational Videos in Laparoscopic Surgery: A Joint Trainers and Trainees Consensus Statement.

OBJECTIVE: Consensus statement by an international multispecialty trainers and trainees expert committee on guidelines for reporting of educational videos in laparoscopic surgery. SUMMARY OF BACKGROUND DATA: Instructive laparoscopy videos with appropriate exposition could be ideal for initial training in laparoscopic surgery, but there are no guidelines for video annotation or procedural educational and safety evaluation. METHODS: Delphi questionnaire of 45 statements prepared by a steering group and voted on over 2 rounds by committee members using an electronic survey tool. Committee selection design included representative surgical training experts worldwide across different laparoscopic specialties, including general surgery, lower and upper gastrointestinal surgery, gynecology and urology, and a proportion of aligned surgical trainees. RESULTS: All 33 committee members completed both the first and the second round of the Delphi questionnaire related to 7 major domains: Video Introduction/Authors' information; Patient Details; Procedure Description; Procedure Outcome; Associated Educational Content; Peer Review; and Use in Educational Curriculae. The 17 statements that did not reach at least 80% agreement after the first round were revised and returned into the second round. The committee consensus approved 37 statements to at least an 82% agreement. CONCLUSION: Consensus guidelines on how to report laparoscopic surgery videos for educational purposes have been developed. We anticipate that following our guidelines could help to improve video quality.These reporting guidelines may be useful as a standard for reviewing videos submitted for publication or conference presentation.

Predicting the Risk of Bowel-Related Quality-of-Life Impairment After Restorative Resection for Rectal Cancer: A Multicenter Cross-Sectional Study.

BACKGROUND: Restorative anterior resection is considered the optimal procedure for most patients with rectal cancer and is frequently preceded by radiotherapy. Both surgery and preoperative radiotherapy impair bowel function, which adversely affects quality of life. OBJECTIVE: This study aimed to report symptoms associated with and key predictors for bowel-related quality-of-life impairment. DESIGN: The study included a cross-sectional cohort. SETTINGS: This was a multicenter study from 12 United Kingdom centers. PATIENTS: A total of 578 patients with rectal cancer underwent curative restorative anterior resection between 2001 and 2012 (median, 5.25 years postsurgery). MAIN OUTCOME MEASURES: Patients completed outcome measures that assessed bowel dysfunction (low anterior resection syndrome score), incontinence (Wexner score), and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30), plus an anchor question: "Overall how does bowel function affect your quality of life?" RESULTS: The response rate was 80% (462/578). Overall, 85% (391/462) of patients reported bowel-related quality-of-life impairment, with 40% (187/462) reporting major impairment. A large difference in global quality of life (22 points; p < 0.001) was reported for "none" versus "major" impairment, with greatest symptom severity being diarrhea (25 points; p < 0.001), insomnia (24 points; p < 0.001), and fatigue (20 points; p < 0.001). Regression analysis identified major impairment in 60% and 45% of patients with low rectal cancer treated with and without preoperative radiotherapy compared with 47% and 33% of middle/upper rectal cancers with and without preoperative radiotherapy. LIMITATIONS: Advances in radiotherapy delivery and improvements in posttreatment symptom control, although currently of limited efficacy, imply that the content of this consent aid should be re-evaluated in 5 to 10 years. CONCLUSIONS: Before a restorative anterior resection, patients with rectal cancer should be informed that bowel-related quality-of-life impairment is common. The key risk factors are neoadjuvant therapy and a low tumor height. This study presents quality-of-life and functional outcome data, along with a consent aid, that will enhance this preoperative patient discussion.

Laparoscopic Complete Mesocolic Excision Without Routine Gastro-Pancreatico-Colic Trunk Dissection: Survival Outcomes and Morbidity for 567 Cases.

Purpose: It is unclear whether the principles of open complete mesocolic excision (CME) can be safely applied to laparoscopic surgery. Furthermore, definitions vary over how radical optimal CME surgery should be. We report morbidity and oncological outcomes for laparoscopic CME without routine gastro-pancreatico-colic trunk (GPCT) dissection. Materials and Methods: An observational study with consecutive data for patients with Union for International Cancer Control (UICC) stage I-III colon adenocarcinoma who underwent elective laparoscopic resection between 2006 and 2015. Data were retrieved for demographics, tumor characteristics, treatment, and histology from prospectively maintained databases. Standardized, routinely video recorded, laparoscopic resections were performed in two United Kingdom centers from The National Training Programme for Laparoscopic Colorectal Surgery. Overall survival and disease-free survival (DFS) were reported using Kaplan-Meier curves and Cox regression. Results: Laparoscopic CME was performed in 567 patients, 52.7% (288/546) women, median (interquartile range [IQR]) age 73 (65-80) years. Median (IQR) length of stay was 4 (3-5) days with 4.0 (2.2-5.7)-year follow-up. Significant DFS predictors (hazard ratio [HR]) by multivariable Cox regression were age >80 years (1.9), American Society of Anesthesiologists (ASA) 3 and 4 (HR = 1.1), right colon cancer (1.7), UICC stage III (3.4), and intramesocolic grade (2.2). Overall 4-year DFS (95% confidence interval) was 81.3% (77-85). Four-year DFS by UICC grades I, II, and III was 94.6% (89-99), 83.4% (77-88), and 72.2% (66-78), respectively (log-rank P = .001). Morbidity by Clavien-Dindo grade was III 18 (3.2%), IV 4 (0.7%) and V 7 (1.2%). Conclusion: This large series suggests standardized laparoscopic CME without routine GPCT dissection has a low morbidity and achieves equivalent outcomes to the most radical open CME techniques.

A rectal cancer feasibility study with an embedded phase III trial design assessing magnetic resonance tumour regression grade (mrTRG) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (TRIGGER): study protocol for a randomised controlled trial.

BACKGROUND: Pre-operative chemoradiotherapy (CRT) for MRI-defined, locally advanced rectal cancer is primarily intended to reduce local recurrence rates by downstaging tumours, enabling an improved likelihood of curative resection. However, in a subset of patients complete tumour regression occurs implying that no viable tumour is present within the surgical specimen. This raises the possibility that surgery may have been avoided. It is also recognised that response to CRT is a key determinant of prognosis. Recent radiological advances enable this response to be assessed pre-operatively using the MRI tumour regression grade (mrTRG). Potentially, this allows modification of the baseline MRI-derived treatment strategy. Hence, in a 'good' mrTRG responder, with little or no evidence of tumour, surgery may be deferred. Conversely, a 'poor response' identifies an adverse prognostic group which may benefit from additional pre-operative therapy. METHODS/DESIGN: TRIGGER is a multicentre, open, interventional, randomised control feasibility study with an embedded phase III design. Patients with MRI-defined, locally advanced rectal adenocarcinoma deemed to require CRT will be eligible for recruitment. During CRT, patients will be randomised (1:2) between conventional management, according to baseline MRI, versus mrTRG-directed management. The primary endpoint of the feasibility phase is to assess the rate of patient recruitment and randomisation. Secondary endpoints include the rate of unit recruitment, acute drug toxicity, reproducibility of mrTRG reporting, surgical morbidity, pathological circumferential resection margin involvement, pathology regression grade, residual tumour cell density and surgical/specimen quality rates. The phase III trial will focus on long-term safety, regrowth rates, oncological survival analysis, quality of life and health economics analysis. DISCUSSION: The TRIGGER trial aims to determine whether patients with locally advanced rectal cancer can be recruited and subsequently randomised into a control trial that offers MRI-directed patient management according to radiological response to CRT (mrTRG). The feasibility study will inform a phase III trial design investigating stratified treatment of good and poor responders according to 3-year disease-free survival, colostomy-free survival as well as an increase in cases managed without a major resection. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02704520 . Registered on 5 February 2016.

MR imaging for rectal cancer: the role in staging the primary and response to neoadjuvant therapy.

Pre-operative staging is an essential aspect of modern rectal cancer management and radiological assessment is central to this process. An ideal radiological assessment should provide sufficient information to reliably guide pre-operative decision-making. Technical advances allow high-resolution imaging to not only provide prognostic information but to define the anatomy, helping the surgeon to anticipate potential pitfalls during the operation. The main imaging modality for local staging of rectal cancer is Magnetic Resonance Imaging (MRI), as it defines the tumour and relevant anatomy providing the most detail on the important prognostic factors that influence treatment choice. In addition, there is an emerging role for MRI in the assessment of the response to neoadjuvant therapy. This article is an evidence-based review of rectal cancer staging focusing on post-treatment assessment of response using MRI. The discussion extends into the implications for reliably assessing response and how this may influence future rectal cancer management.