Patient and multidisciplinary team perspectives on watch and wait in rectal cancer.

This article adopts a multidisciplinary approach, including surgery, oncology, radiology and patient perspectives, to discuss the key points of debate surrounding a watch and wait approach. In an era of shared decision-making, discussion of watch and wait as an option in the context of complete clinical response is appropriate, although it is not the gold standard treatment. Key challenges are the difficulty in assessing for a complete clinical response, prediction of recurrence and access to timely diagnostics for surveillance. Salvage surgery has good results if regrowth is detected early but does have imperfect outcomes, with only a 90% salvage rate. Good communication with patients about the risks and alternatives is essential. Patients undergoing watch and wait should ideally be enrolled in prospective registries or clinical trials.

Development and validation of a patient reported outcome measure for health-related quality of life for locally recurrent rectal cancer: a multicentre, three-phase, mixed-methods, cohort study.

Background: Locally recurrent rectal cancer (LRRC) occurs in 5-10% of patients following previous treatment of rectal cancer. It has a significant impact on patients' overall health-related quality of life (HrQoL). Major advances in surgical treatments have led to improved survival outcomes. However, due to the lack of disease-specific, validated patient-reported outcome measure (PROM), HrQoL, is variably assessed. The aim of this study is to develop a disease-specific, psychometrically robust, and validated PROM for use in LRRC. Methods: A multicentre, three phase, mixed-methods, observational study was performed across five centres in the UK and Australia. Adult patients (>18 years old) with an existing or previously treated LRRC within the last 2 years were eligible to participate. Patients completed the proposed LRRC-QoL, EORTC QLQ-CR29, and FACT-C questionnaires. Scale structure was analysed using multi-trait scaling analysis and exploratory factor analysis, reliability was assessed using Cronbach's and the intra-class coefficient, convergent validity was assessed using Pearson's correlation, and known-groups comparison was assessed using the student t-test or ANOVA. Findings: Between 01/03/2015 and 31/12/2019, 117 patients with a diagnosis of LRRC were recruited. The final scale structure of the LRRC-QoL consisted of nine multi-item scales (healthcare services, psychological impact, pain, urostomy-related symptoms, lower limb symptoms, stoma, sexual function, sexual interest, and urinary symptoms) and three single items. Cronbach's Alpha and Intraclass correlation values of >0.7 across the majority of scales supported overall reliability. Convergent validity was demonstrated between LRRC-QoL Pain Scale and FACT-C Physical Well Being scale (r = 0.528, p < 0.001), LRRC-QoL Psychological Impact scale with EORTC QLQ CR29 Body Image (r = 0.680, p < 0.001) and the FACT-C Emotional Well Being scale (r = 0.326, p < 0.001), and LRRC-QoL Urinary Symptoms scale with EORTC QLQ-CR29 Urinary Frequency scale (r = 0.310, p < 0.001). Known-groups validity was demonstrated for gender, disease location, treatment intent, and re-recurrent disease. Interpretation: The LRRC-QoL has demonstrated robust psychometric properties and can be used in clinical and academic practice. Funding: None.

Short-term outcomes of health-related quality of life in patients with locally recurrent rectal cancer: multicentre, international, cross-sectional cohort study.

BACKGROUND: Overall survival rates for locally recurrent rectal cancer (LRRC) continue to improve but the evidence concerning health-related quality of life (HrQoL) remains limited. The aim of this study was to describe the short-term HrQoL differences between patients undergoing surgical and palliative treatments for LRRC. METHODS: An international, cross-sectional, observational study was undertaken at five centres across the UK and Australia. HrQoL in LRRC patients was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29 and functional assessment of cancer therapy - colorectal (FACT-C) questionnaires and subgroups (curative versus palliative) were compared. Secondary analyses included the comparison of HrQoL according to the margin status, location of disease and type of treatment. Scores were interpreted using minimal clinically important differences (MCID) and Cohen effect size (ES). RESULTS: Out of 350 eligible patients, a total of 95 patients participated, 74.0 (78.0 per cent) treated with curative intent and 21.0 (22.0 per cent) with palliative intent. Median time between LRRC diagnosis and HrQoL assessments was 4 months. Higher overall FACT-C scores denoting better HrQoL were observed in patients undergoing curative treatment, demonstrating a MCID with a mean difference of 18.5 (P < 0.001) and an ES of 0.6. Patients undergoing surgery had higher scores denoting a higher burden of symptoms for the EORTC CR29 domains of urinary frequency (P < 0.001, ES 0.3) and frequency of defaecation (P < 0.001, ES 0.4). Higher overall FACT-C scores were observed in patients who underwent an R0 resection versus an R1 resection (P = 0.051, ES 0.6). EORTC CR29 scores identified worse body image in patients with posterior/central disease (P = 0.021). Patients undergoing palliative chemoradiation reported worse HrQoL scores with a higher symptom burden on the frequency of defaecation scale compared with palliative chemotherapy (P = 0.041). CONCLUSION: Several differences in short-term HrQoL outcomes between patients undergoing curative and palliative treatment for LRRC were documented. Patients undergoing curative surgery reported better overall HrQoL and a higher burden of pelvic symptoms.

Designing and evaluating a patient decision aid for patients with locally advanced or locally recurrent rectal cancer: a national multicentre mixed methods study protocol.

INTRODUCTION: Approximately 5%-10% of new rectal cancers are locally advanced (locally advanced rectal cancer (LARC)) at presentation with 4%-8% recurring (locally recurrent rectal cancer (LRRC)) after initial treatment. Patients with potentially curable disease have to consider many trade-offs when considering major exenterative surgery. There are no decision tools for these patients and current resources have found to not meet minimum international standards. The overall aim of this study is to produce a validated patient decision aid (PtDA) to assist patients considering radical pelvic exenteration for LARC and LRRC created in line with international minimum standards. METHODS AND ANALYSIS: This study is a national, multicentre mixed methods project and has been designed in keeping with guidance from the International Patient Decision Aids Standard.This study is in four stages. In stage 1, we will develop the PtDA and its content using agile developmental methodology. In stage 2, we will assess the content and face validity of the PtDA using mixed-methods with key stakeholders. In stage 3, we will assess the feasibility and efficacy of the PtDA. In stage 4, we will establish the barriers and facilitators to the use of a PtDA in the outpatient setting. Questionnaires including the QQ-10, EORTC PATSAT-C33, Preparation for Decision-Making Scale and the NoMAD survey will be analysed during the study. Interviews will be analysed using thematic analysis. ETHICS AND DISSEMINATION: Research ethics approval from North of Scotland Research Ethics Service 19/NS/0056 (IRAS 257890) has been granted. Results will be published in open access peer-reviewed journals, presented in conferences and distributed through bowel research UK charity. External endorsement will be sought from the International Patient Decision Standards Collaboration inventory of PtDAs. PROSPERO REGISTRATION NUMBER: CRD42019122933.

Outcomes Following Immediate Vertical Rectus Abdominis Myocutaneous (VRAM) Flap-Based Perineal Reconstruction Following Resectional Surgery For Pelvic Malignancies.

BACKGROUND: Increasingly radical surgery combined with neo-adjuvant radiotherapy present a challenge for the reconstructive surgeon. The study objective was to review outcomes of Vertical Rectus Abdominis Myocutaneous (VRAM) flap-based perineal reconstruction following resectional surgery for pelvic malignancies. METHODS: Single-centre retrospective analysis of patients undergoing immediate VRAM flap reconstruction of a perineal/pelvic defect for pelvic malignancy between July 2009 and November 2017. Primary outcome was perineal morbidity (surgical site infection (SSI), flap loss or dehiscence and perineal hernia). Secondary outcomes were length of stay and donor site morbidity (SSI, full-thickness dehiscence and incisional hernia). RESULTS: A total of 178 patients (96 females) were included. Median age was 67 years (range 28-88). The majority were performed for locally advanced rectal adenocarcinoma (n = 122; 68.5%) and 136 (76.4%) patients had received neoadjuvant radiotherapy. Four patients had complete flap loss (2.3%), and 40 had perineal dehiscence (22.5%); however, only, 18 patients required a return to theatre during the admission for perineal-related complications (10.1%). Abdominal dehiscence occurred in six patients (3.4%). Median length of post-operative stay was 15 days (6-131). Sixty-day mortality rate was 1.1%. SSI at the midline and perineum occurred in 34 (19.1%) and 38 patients (21.3%), respectively. At 90-day post-operatively, 75.6% of perineal wounds were healed. During a median follow-up of 44.5 months, twelve, eleven and 39 patients were diagnosed with perineal, midline and parastomal hernias, respectively (6.9%, 6.2% and 21.9%). CONCLUSIONS: It is important to have accurate knowledge of perineal and donor-site morbidity rates to allow an informed consent process.

Vertical rectus abdominis flap (VRAM) for perineal reconstruction following pelvic surgery: A systematic review.

BACKGROUND: The vertical rectus abdominis myocutaneous (VRAM) flap is an established technique employed to reconstruct pelvic and perineal defects not amenable to primary closure. The aim of this study was to systematically review the morbidity of VRAM flap reconstruction following exenterative pelvic surgery. MATERIALS AND METHODS: A systematic literature search was conducted by using Medline, EMBASE, and Cochrane databases. Abstracts of all studies published from inception to November 2019 were identified. Search terms used included 'vertical rectus abdominis myocutaneous', 'vertical rectus abdominis musculocutaneous' and 'VRAM'. Only studies that described outcomes when a VRAM flap was used during exenterative pelvic surgery were included; case reports were excluded. The primary outcome measure was VRAM flap morbidity. Secondary outcome measures included donor site morbidity and hospital length of stay. RESULTS: Sixty-five studies with a total of 1827 patients were identified and included. Perineal reconstruction was most commonly performed following abdominal perineal excision of the rectum (APER) (n = 636 and 34.8%). Median patient age at surgery ranged from 38 to 78 years. Mean perineal flap morbidity was 27%, with a complete flap loss rate of 1.8% and a perineal hernia rate of 0.2%. Mean donor site morbidity was 15%, with an abdominal dehiscence rate of 5.5% and an incisional hernia rate of 3.3%. CONCLUSIONS: While overall morbidity after VRAM flap reconstruction in pelvic visceral surgery is high; the risk of major complications remains low. These data are important when counselling patients for surgery.

Clinicopathological characteristics of colorectal cancer presenting under the age of 50.

OBJECTIVE: Previous studies suggest that colorectal cancer (CRC) presenting at a young age tends to be advanced, proximally located and associated with a poor outcome. The aim of this study was to analyse characteristics of CRC in a cohort under the age of 50. METHOD: A single centre retrospective cohort study of consecutive patients under the age of 50 receiving potentially curative resection was performed. Clinical and pathological data was collected from a prospectively maintained cancer registry database. Of 2799 patients having CRC resections between 2002 and 2013, 103 patients (3.6%) were under 50, with full survival data available on 98 (3.5%). An additional 7 patients under 50 had inoperable disease. The proportion of patients under 50 was constant throughout the study period. A group of 98 consecutive patients over the age of 50 undergoing surgery for colorectal cancer in the same centre was used for comparison. Just 7 patients (7%) had pathologically verified FAP or Lynch syndrome, although there was a high suspicion of Lynch syndrome in further 3 patients. CONCLUSION: There was a higher proportion of rectal cancer in the under 50s (p < 0.0001), although there was no significant difference in the staging of the disease or lymph node positivity. There was a greater incidence of poor differentiation in the younger patients, but there was no effect on 5-year overall survival (71.4%) which is much higher than in the reported literature. The majority of colorectal cancers presenting under the age of 50 were sporadic, and a higher proportion of rectal cancer was observed compared with the older patients, and as compared to the published literature on younger CRC patients. This paper adds to the literature by demonstrating that despite advanced stage at presentation of colorectal cancer requiring extended surgery and multimodal treatment, this young age group experienced good overall survival.

Paradigm shift in the management of rectal cancer.

Surgery for rectal cancer in the pre-Total Mesorectal Excision (TME) era was associated with high local recurrence rates. The widespread adoption of the TME technique together with the addition of neoadjuvant oncological therapies have reduced local failure rates and improved survival for patients with rectal cancer. Advances in our knowledge, better understanding of tumour biology and refinement in minimal access techniques and equipment have significantly changed the management of rectal cancer. This paper reviews these changes and proposes a paradigm shift in how rectal cancer management is conceptualised and treated, such that the treatment of rectal cancer is separated into early tumours (potentially suitable for local excison), TME tumours (optimally managed by TME) and beyond TME tumours (optimally managed by multivisceral resection outside the TME plane).

An asymptomatic case of peritoneal encapsulation: case report and review of the literature.

Peritoneal encapsulation is a rare congenital anomaly characterised by a thin membrane of peritoneum encasing the small bowel to form an accessory peritoneal sac. We present a case of peritoneal encapsulation diagnosed incidentally in an 82 year old man undergoing laparotomy for colonic cancer. The sac was easily excised and surgery was otherwise uneventful. A discussion of the case and a review of the literature are presented.

Outcomes of resection and non-resection strategies in management of patients with advanced colorectal cancer.

BACKGROUND: The management of patients with surgically incurable bowel cancer at presentation is controversial. The aims of treatment are to optimise quality of life and prolong survival. It has been believed that the most effective palliation is achieved by resection of the primary cancer in order to pre-empt future complications. This study reviews and compares the outcomes of patients with incurable bowel cancer managed by resection and non-resection strategies over a 7-year period in a single District General Hospital. PATIENTS AND METHODS: All patients with surgically incurable bowel cancer at presentation were identified from the prospectively collected local ACPGBI database. Survival, using Kaplan-Meier method and log-rank test, was compared between patients managed by resection of the primary, non-resectional intervention (surgery, stent & oncological treatments) and those managed with supportive care only. The primary endpoint of the study was survival on an intention to treat basis, compared using Kaplan-Meier and log-rank tests. RESULTS: Of 646 consecutive newly diagnosed bowel cancer patients over a 7 year period 154 cases (24%) were deemed surgically incurable at presentation. Of these surgical resection was carried out in 45 patients (29%), non-resectional intervention was followed in 52 patients (34%) and supportive treatment alone in 57 patients (37%). Median survival of each group was as follows: resected patients 11 months (I.Q range 3-18 months), non-resectional intervention 7 months (I.Q range 2-15 months) and supportive care alone 2 months (I.Q range 1-8 months). Only one patient (2%) managed by non-resectional intervention required later surgery to treat primary tumour related complications. Survival was not significantly different between resection and non-resection treatments. The overall operative mortality for the resection group was 16% (7/45 cases), with an elective mortality of 14% (4/28 cases) and emergency mortality 18% (3/17 cases). CONCLUSION: In an unselected bowel cancer population surgical resection of the primary tumour in patients presenting with incurable disease does not improve survival and is associated with a high risk of post-operative mortality.

Impact of methicillin-resistant Staphylococcus aureus infection on outcome after esophagectomy.

BACKGROUND: Infection with methicillin-resistant Staphylococcus aureus (MRSA) has reached endemic proportions in the United Kingdom. The aim of the present study was to determine the frequency of MRSA infection in patients undergoing esophagectomy and to report its impact on patient outcome. PATIENTS AND METHODS: The study population was 98 patients undergoing esophagectomy for carcinoma during the years 1998-2004. Patient information was collected prospectively and entered into a computerized database and analyzed retrospectively by univariate and multivariate analysis. RESULTS: Overall, 20 of the 98 patients (20%) developed infection with MRSA after esophagectomy. Patients who developed MRSA infection had greater levels of postoperative morbidity, longer intensive care unit (ICU) stays (median 2 days versus 1 day, P = 0.005) and hospital stays (21 days versus 16 days, P < 0.001) compared to those who did not develop infection. Multivariate analysis identified preoperative chemotherapy (P = 0.006) and readmission to the ICU (P = 0.007) as significant risk factors with MRSA infection. Overall, 17 of 46 patients (37%) who received neoadjuvant chemotherapy developed MRSA infection, compared to 3 of 52 (6%) who did not receive this treatment (P = 0.0001). CONCLUSIONS: Overall, one in five patients undergoing esophagectomy developed MRSA infection, with those patients who received neoadjuvant chemotherapy identified as being at greatest risk of this complication. This is an alarming finding, as neoadjuvant chemotherapy is the standard of care for patients with esophageal carcinoma in the United Kingdom.

Estimated radiation dose to breast feeding infant following maternal administration of 57Co labelled to vitamin B12.

Administration of a radiopharmaceutical may result in a radiation dose to an infant due to ingestion of the radiopharmaceutical secreted in the breast milk. Following a maternal administration of Co labelled to vitamin B12 (cyanocobalamin) as part of a Schilling test an estimate of the absorbed dose to a breast feeding infant was calculated. Milk samples were collected from every feed in the first 24 h, and at approximately 48 and 72 h post-administration. The absorbed dose to the infant's liver (the organ receiving the highest dose) was calculated to be 0.23 mGy. The effective dose to the infant was calculated to be 0.025 mSv, which is considerably lower than the current regulatory limit of 1 mSv. The Administration of Radioactive Substances Advisory Committee advise that the first feed, at approximately 4 h after administration, be discarded. The data show that this was unwarranted, and that the peak concentration of Co in the breast milk occurred at around 24 h.