TAilored SToma policY after TME for rectal cancer: The TASTY approach.

AIM: Diverting stomas are routinely used in restorative surgery following total mesorectal exicision (TME) for rectal cancer to mitigate the clinical risks of anastomotic leakage (AL). However, routine diverting stomas are associated with their own complication profile and may not be required in all patients. A tailored approach based on personalized risk of AL and selective use of diverting stoma may be more appropriate. The aim of the TAilored SToma policY (TASTY) project was to design and pilot a standardized, tailored approach to diverting stoma in low rectal cancer. METHOD: A mixed-methods approach was employed. Phase I externally validated the anastomotic failure observed risk score (AFORS). We compared the observed rate of AL in our cohort to the theoretical, predicted risk of the AFORS score. To identify the subset of patients who would benefit from early closure of the diverting stoma using C-reactive protein (CRP) we calculated the Youden index. Phase II designed the TASTY approach based on the results of Phase I. This was evaluated within a second prospective cohort study in patients undergoing TME for rectal cancer between April 2018 and April 2020. RESULTS: A total of 80 patients undergoing TME surgery for rectal cancer between 2016 and 2018 participated in the external validation of the AFORS score. The overall observed AL rate in this cohort of patients was 17.5% (n = 14). There was a positive correlation between the predicted and observed rates of AL using the AFORS score. Using ROC curves, we calculated a CRP cutoff value of 115 mg/L on postoperative day 2 for AL with a sensitivity of 86% and a negative predictive value of 96%. The TASTY approach was designed to allocate patients with a low risk AFORS score to primary anastomosis with no diverting stoma and high risk AFORS score patients to a diverting stoma, with early closure at 8-14 days, if CRP values and postoperative CT were satisfactory. The TASTY approach was piloted in 122 patients, 48 (39%) were identified as low risk (AFORS score 0-1) and 74 (61%) were considered as high risk (AFORS score 2-6). The AL rate was 10% in the low-risk cohort of patient compared to 23% in the high-risk cohort of patients, p = 0.078 The grade of Clavien-Dindo morbidity was equivalent. The incidence of major LARS was lowest in the no stoma cohort at 3 months (p = 0.014). CONCLUSION: This study demonstrates the feasibility and safety of employing a selective approach to diverting stoma in patients with a low anastomosis following TME surgery for rectal cancer.

IDEAL Stage 2a/b prospective cohort study of transanal transection and single-stapled anastomosis for rectal cancer.

AIM: There are several anastomotic techniques available to facilitate restorative rectal cancer surgery after total mesorectal excision (TME), including double-stapled anastomosis (DST) and handsewn coloanal anastomosis (CAA). However, to date no one technique is superior with regard to anastomotic leakage (AL) or functional outcomes. Transanal transection single-stapled anastomosis (TTSS) aims to overcome some of the technical challenges and offer comparable clinical and functional outcomes to traditional anastomotic techniques. The aim of this study was to explore the role of TTSS in modern rectal cancer surgery and to provide comparative clinical and functional outcome data with DST and CAA. METHOD: A prospective cohort study was undertaken to assess the safety and clinical and patient-reported outcomes associated with the TTSS procedure. All patients undergoing sphincter-preserving surgery for rectal cancer with an anastomosis performed within 6 cm of the anal verge between January 2016 and April 2021 were prospectively enrolled into this study. Clinical and patient-reported outcome data, including low anterior resection syndrome (LARS) assessment, were collected. The primary endpoint was anastomotic leakage within 30 days. RESULTS: A total of 275 patients participated in this study, with 70 (25%) patients undergoing a TTSS, 110 (40%) undergoing a DST and 95 (35%) undergoing a CAA. Patients undergoing a CAA had more distal tumours than those having a TTSS or DST, with a median tumour height of 5, 7 and 9 cm (p < 0.001), respectively. We observed a statistically significant reduction in AL in the TTSS group compared with the DST group, with rates of 8.6% versus 20.9% (p = 0.028). There was no difference in LARS scores between patients undergoing TTSS and DST (p = 0.228), while patients with a CAA had worse LARS scores than TTSS patients (p = 0.002). CONCLUSION: TTSS is a technically safe and feasible anastomotic technique in rectal cancer surgery as an alternative to DST and CAA. Its advantages over DST are a reduced AL rate and, over CAA, improved function. It should therefore be considered as an alternative technique to improve clinical and patient-reported outcomes in restorative rectal cancer surgery.

Integrating a tumour appropriate transanal or robotic assisted approach to total mesorectal excision in high-volume rectal cancer practice is safe and cost-effective.

Total mesorectal excision (TME) is accepted as the gold standard for oncological resection in rectal cancer. The best approach to TME is debated and often surgeons will select a preferred approach. In this study, we aimed to describe how both robotic (R-TME) and transanal (TaTME) TME can be integrated into high-volume rectal cancer surgeon practice with a comparison of clinical and oncological outcomes and cost analysis. A prospective comparative cohort study was performed in a high-volume rectal cancer centre comparing the previous 50 R-TME and 50 TaTME performed by the same surgeon. A comparison of tumour characteristics was performed to highlight a specific role for each technique. Clinical outcomes (operative duration, length of stay (LOS) and perioperative morbidity), cancer quality indicators (resection margin and completeness of TME) and cost analysis were compared. Statistical analysis was performed using IBM SPSS, version 20. R-TME was preferred in mid-rectal cancer, compared to TaTME preferred in low rectal cancer (9 cm vs. 5 cm, p < 0.001). Operative duration was longer in R-TME compared to TaTME (265 vs. 179 min, p < 0.001). Major complications (CD III-IV complications) were experienced in 10% of R-TME and 14% of TaTME (p = 0.476). A 98% (n = 49) clear R0 resection margin was achieved with both R-TME and TaTME and mesorectum quality defined as 'complete' in 86% (n = 43) in R-TME and 82% (n = 41) in TaTME. Length of hospital stay was shorter in R-TME (5 vs. 7 days, p = 0.624). An overall difference of €131 was observed favouring TaTME. In high-volume rectal cancer surgery practice, both R-TME and TaTME can be practised and tailored according to patients and tumour characteristics, with comparable clinical and cancer outcomes and is cost-effective.

Utilising quality of life outcome trajectories to aid patient decision making in pelvic exenteration.

BACKGROUND: Shared decision-making in pelvic exenteration is a complex and detailed process, which must balance clinical, oncological and patient-reported outcomes (PROs), whilst addressing and valuing the patient priorities. Communicating patient-centred information on quality of life (QoL) and functional outcomes is an essential component of this. The aim of this systematic review was to understand the impact of pelvic exenteration on QoL PROs over a longitudinal period and to develop QoL trajectories to support decision-making in this context. METHODS: MEDLINE, Embase and Web of Science databases were searched between 1st January 2000 and 20th December 2021 Studies reporting on PROs, including QoL, in adults undergoing pelvic exenteration were included. Risk of bias was assessed using the ROBINS-I assessment tool. Data from studies reporting QoL using the same outcome measure at the same candidate timepoint were extracted and synthesised to develop a longitudinal QoL trajectory. RESULTS: Fourteen studies consisting of 1370 patients were included in this review. QoL trajectories were constructed in the domains of physical function, psychological function, role function, sexual function, body image and general and specific symptoms. Decision-making was only assessed by one study, with satisfaction with decision-making reported to be high. There is an initial decline in QoL scores in the domains of physical function, role function, sexual function, body image and general health and symptoms deteriorating during the first 3-6 months post-operatively. Psychological function is the only QoL domain that remains stable throughout the post-operative period. CONCLUSION: Mapping QoL trajectories provides a visual representation of post-operative progress, highlighting the enduring impact of pelvic exenteration on patients and can be used to inform pre-operative shared decision-making.

A novel bowel rehabilitation programme after total mesorectal excision for rectal cancer: the BOREAL pilot study.

AIM: Low anterior resection syndrome (LARS) following sphincter-preserving surgery for rectal cancer has a high prevalence, with an impact on long-term bowel dysfunction and quality of life. We designed the bowel rehabilitation programme (BOREAL) as a proactive strategy to assess and treat patients with LARS. The BOREAL programme consists of a stepwise approach of escalating treatments: medical management (steps 0-1), pelvic floor physiotherapy, biofeedback and transanal irrigation (step 2), sacral nerve neuromodulation (step 3), percutaneous endoscopic caecostomy and anterograde enema (step 4) and definitive colostomy (step 5). METHODS: A pilot study was undertaken to assess the feasibility of collecting LARS data routinely with the parallel implementation of the BOREAL programme. All patients who underwent total mesorectal excision for rectal cancer between February 2017 and March 2019 were included. LARS was assessed using the LARS score and the Wexner Faecal Incontinence score at 30 days and 3, 6, 9 and 12 months postoperatively. A good functional result was considered to be a combined LARS score <20 and/or a Wexner score <4. RESULTS: In all, 137 patients were included. Overall compliance with the BOREAL programme was 72.9%. Major LARS decreased from 48% at 30 days postoperatively to 12% at 12 months, with a concomitant improvement in overall good function from 33% to 77%, P < 0.001. The majority of patients (n = 106, 77%) required medical management of their LARS. CONCLUSION: The BOREAL programme demonstrates the acceptability, feasibility and effectiveness of implementing a responsive, stepwise programme for detecting and treating LARS.