Publications
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PelvEx Collaborative, 2024, Beating the empty pelvis syndrome: the PelvEx Collaborative core outcome set study protocol, BMJ Open, Vol: 14, ISSN: 2044-6055
INTRODUCTION: The empty pelvis syndrome is a significant source of morbidity following pelvic exenteration surgery. It remains poorly defined with research in this field being heterogeneous and of low quality. Furthermore, there has been minimal engagement with patient representatives following pelvic exenteration with respect to the empty pelvic syndrome. 'PelvEx-Beating the empty pelvis syndrome' aims to engage both patient representatives and healthcare professionals to achieve an international consensus on a core outcome set, pathophysiology and mitigation of the empty pelvis syndrome. METHODS AND ANALYSIS: A modified-Delphi approach will be followed with a three-stage study design. First, statements will be longlisted using a recent systematic review, healthcare professional event, patient and public engagement, and Delphi piloting. Second, statements will be shortlisted using up to three rounds of online modified Delphi. Third, statements will be confirmed and instruments for measurable statements selected using a virtual patient-representative consensus meeting, and finally a face-to-face healthcare professional consensus meeting. ETHICS AND DISSEMINATION: The University of Southampton Faculty of Medicine ethics committee has approved this protocol, which is registered as a study with the Core Outcome Measures in Effectiveness Trials Initiative. Publication of this study will increase the potential for comparative research to further understanding and prevent the empty pelvis syndrome. TRIAL REGISTRATION NUMBER: NCT05683795.
Bennett H, Rao C, Batten L, et al., 2024, Low energy contact X-ray brachytherapy for treatment of rectal cancer: a health technology appraisal by Health Technology Wales, Colorectal Disease, Pages: 1-6, ISSN: 1462-8910
AimHealth Technology Wales sought to evaluate the clinical and cost-effectiveness of contact X-ray brachytherapy (CXB) for early-stage rectal cancer.MethodsRelevant studies were identified through systematic searches of MEDLINE, Embase, Cochrane Library and Scopus. A cost-utility model was developed to estimate the cost-effectiveness of CXB in National Health Service Wales, using results of the Organ Preservation in Early Rectal Adenocarcinoma (OPERA) trial. Patient perspectives were obtained through the Papillon Patient Support group and All-Wales Cancer Network.ResultsThe OPERA randomized controlled trial showed that CXB improved complete response and organ preservation rates compared with external-beam boost for people with T2–3b, N0–1, M0 rectal cancer who are fit for surgery. Managing more of this population non-operatively after CXB was estimated to provide 0.2 quality-adjusted life years at an additional cost of £887 per person. CXB was cost effective compared with external-beam boost at a cost of £4463 per quality-adjusted life year gained. This conclusion did not change in scenario analysis and CXB was cost effective in 91% of probabilistic sensitivity analyses. Patients valued receiving clear information on all available options to support their individual treatment choices. The detrimental impact of a stoma on quality of life led some patients to reject the idea that surgery was their only option.ConclusionThis evidence review and cost-utility analysis indicates that CXB is likely to be clinically and cost effective, as part of a watch and wait strategy for adults fit for surgery. Wider access to CXB is supported by patient testimonies.
PelvEx Collaborative, 2024, The empty pelvis syndrome: a core data set from the PelvEx collaborative, British Journal of Surgery, Vol: 111, ISSN: 0007-1323
BACKGROUND: Empty pelvis syndrome (EPS) is a significant source of morbidity following pelvic exenteration (PE), but is undefined. EPS outcome reporting and descriptors of radicality of PE are inconsistent; therefore, the best approaches for prevention are unknown. To facilitate future research into EPS, the aim of this study is to define a measurable core outcome set, core descriptor set and written definition for EPS. Consensus on strategies to mitigate EPS was also explored. METHOD: Three-stage consensus methodology was used: longlisting with systematic review, healthcare professional event, patient engagement, and Delphi-piloting; shortlisting with two rounds of modified Delphi; and a confirmatory stage using a modified nominal group technique. This included a selection of measurement instruments, and iterative generation of a written EPS definition. RESULTS: One hundred and three and 119 participants took part in the modified Delphi and consensus meetings, respectively. This encompassed international patient and healthcare professional representation with multidisciplinary input. Seventy statements were longlisted, seven core outcomes (bowel obstruction, enteroperineal fistula, chronic perineal sinus, infected pelvic collection, bowel obstruction, morbidity from reconstruction, re-intervention, and quality of life), and four core descriptors (magnitude of surgery, radiotherapy-induced damage, methods of reconstruction, and changes in volume of pelvic dead space) reached consensus-where applicable, measurement of these outcomes and descriptors was defined. A written definition for EPS was agreed. CONCLUSIONS: EPS is an area of unmet research and clinical need. This study provides an agreed definition and core data set for EPS to facilitate further research.
Evans A, Jarrom D, Hasler E, et al., 2023, Low energy contact x-ray brachytherapy (CXB) for the treatment of early-stage rectal cancer, Low energy contact x-ray brachytherapy (CXB) for the treatment of early-stage rectal cancer, Cardiff, Publisher: Health Technology Wales (HTW), EAR053
Why did Health Technology Wales (HTW) appraise this topic?Colorectal cancer is one of the most common cancers in Wales. Rectal cancer accounts for about a third of colorectal cancers, being diagnosed in over 600 people per year in Wales. Rectal cancer is usually treated with surgery and chemoradiotherapy either before or after surgery, or both. This surgery can result in the need for a stoma, which has a significant long-term impact on patients. Interest in non-operative management of early stage rectal cancer is increasing, and one option being explored is contact x-ray brachytherapy (CXB).CXB is a form of radiotherapy which is administered via a tube inserted into the rectum. It is being tested as a method of radiotherapy boost, to be given alongside standard chemoradiotherapy. It is hoped that the use of CXB in early-stage rectal cancer in this way would improve the efficacy of non-operative cancer management, reducing the need for surgery and its associated adverse effects, and also reducing the adverse effects associated with external beam boost. If introduced in Wales, this could improve quality of life for patients, reduce costs of surgical interventions and long term care for patients who require stomas. It could also reduce the need for patients to travel, as CXB in the UK is currently only available in a select few hospitals in England.The topic was proposed by NHS lower gastrointestinal oncologists.What evidence did HTW find?The evidence identified included one randomised controlled trial (OPERA) comparing CXB and external beam boost in operable patients. There was no evidence identified for the use of CXB in inoperable patients or those unwilling to undergo surgery. The OPERA study was run across several European countries, in people with T2–3, N0–1, M0 rectal cancer. The rates of clinical complete response by 24 weeks and organ preservation at three years favoured CXB. Rates of surgery overall were reduced with CXB, and there was no differen
Wong R, Hussain MI, Toh S, et al., 2023, Digital and paper consent errors, BRITISH JOURNAL OF SURGERY, ISSN: 0007-1323
SunMyint A, Rao C, Barbet N, et al., 2023, The safety and efficacy of total mesorectal excision (TME) surgery following dose‐escalation: Surgical outcomes from the organ preservation in early rectal adenocarcinoma (OPERA) trial, a European multicentre phase 3 randomised trial (NCT02505750), Colorectal Disease, ISSN: 1462-8910
<jats:title>Abstract</jats:title><jats:sec><jats:title>Aim</jats:title><jats:p>Nonsurgical treatment with chemoradiotherapy for rectal cancer is gaining interest as it avoids total mesorectal excision (TME) surgery and stoma. The OPERA trial aims to evaluate whether dose escalation with contact X‐ray brachytherapy (CXB) boost improves organ preservation compared to external beam radiotherapy (EBRT) boost. It has been suggested that dose escalation adversely affects surgical outcomes and therefore we report outcomes following TME in OPERA at 36 months.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>OPERA is a European multicentre phase 3 trial (NCT02505750) which randomises patients with cT2‐3a‐b, cN0‐1, M0 to EBCRT (45 Gy in 25 fractions over 5 weeks with oral capecitabine 825 mg/m<jats:sup>2</jats:sup>) followed by EBRT boost (9 Gy in 5 fractions over 5 days) versus EBCRT followed by CXB boost (90 Gy in 3 fractions over 4 weeks). Patients were assessed at 14, 20 and 24 weeks from the start of treatment. Watch and wait management was adopted for patients who achieved a clinical complete response (cCR) at 24 weeks following treatment. Either local excision (LE) or TME surgery was offered for residual disease or local regrowth, according to patient and surgeon preference. Surgical morbidity and mortality were recorded prospectively.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Between July 2015 and June 2020, 148 patients were randomised of which 141 were evaluable in March 2022. At median follow‐up of 38.2 months (range: 34.2–42.5), surgery was performed for 66 (47%) patients. A total of 27 (20%) patients had local excision and 39 (29%) had TME surgery, 22/39 (56%) underwent anterior resection and 17/39 (44%) underwent abd
West CT, West MA, Mirnezami AH, et al., 2023, Empty pelvis syndrome: PelvEx Collaborative guideline proposal, BRITISH JOURNAL OF SURGERY, ISSN: 0007-1323
Rao C, 2023, Appeal Panel Decision: Molnupiravir, remdesivir and tixagevimab plus cilgavimab for treating COVID-19 [ID6261], Appeal Panel Decision: Molnupiravir, remdesivir and tixagevimab plus cilgavimab for treating COVID-19, London, Publisher: National Institute of Health and Care Excellence (NICE), ID6261
Rahman F, Trivedy M, Rao C, et al., 2023, Faecal immunochemical testing to detect colorectal cancer in symptomatic patients: a diagnostic accuracy study, Diagnostics, Vol: 13, ISSN: 2075-4418
(1) Background: NHS England recommended faecal immunochemical testing (FIT) for symptomatic patients in June 2020 to rationalise limited diagnostic services during COVID-19. (2) Aim: to investigate the diagnostic performance of FIT, analysing the proportion of FIT-negative colorectal cancers (CRC) missed in symptomatic patients and how this risk could be mitigated. (3) Design and Setting: a retrospective study of biochemistry and cancer databases involving patients referred from primary healthcare with suspected CRC to a single secondary care trust in North East London. (4) Methods: a retrospective cohort diagnostic accuracy study was undertaken to determine the performance of FIT for detecting CRC at 10 µgHb/g. (5) Results: between January and December 2020, 7653 patients provided a stool sample for FIT analysis; 1679 (22%) samples were excluded due to inadequate or incorrect specimens; 48% of suspected CRC referrals completed FIT before evaluation; 86 FIT tested patients were diagnosed with histologically proven CRC. At 10 µgHb/g, FIT performance was comparable with the existing literature with a sensitivity of 0.8140 (95% CI 0.7189–0.8821), a specificity of 0.7704 (95% CI 0.7595–0.7809), a positive predictive value (PPV) of 0.04923 (95% CI 0.03915–0.06174), a negative predictive value (NPV) of 0.9965 (95% CI 0.9943–0.9978), and a likelihood ratio (LR) of 3.545; 16 patients with CRC had an FIT of ≤10 µgHb/g (18.6% 95% CI 11.0–28.4%). (6) Conclusions: this study raises concerns about compliance with FIT testing and the incidence of FIT-negative CRC at the NICE recommended threshold and how this risk can be mitigated without colonic imaging. Whilst FIT may have facilitated prioritisation during COVID-19, we must be cautious about using FIT alone to determine which patients are referred to secondary care or receive further investigation.
Umeojiako W, Hurndall KH, Mansuri A, et al., 2023, The Role of Patient Reported Outcomes Measures (PROMS) and Health-Related Quality-of-Life (HRQoL) in Economic Analysis, Patient Reported Outcomes and Quality of Life in Surgery, Editors: Patel, Athanasiou, Darzi, Publisher: Springer, ISBN: 9783031275968
In this chapter the importance of quality-of-life estimates in the prevailing paradigm for economic evaluation is discussed. Empirical methods for measuring quality-of-life are described. Finally, the generic and disease-specific PROMS used to derive estimates of quality-of-life in economic evaluation are discussed.
Shamsiddinova A, Deputy M, Worley G, et al., 2023, Systematic review: oncological outcomes of patients with inflammatory bowel disease undergoing segmental colonic resections for colorectal cancer and dysplasia, Publisher: BMJ PUBLISHING GROUP, Pages: A108-A108, ISSN: 0017-5749
Ainsworth N, Hussain MI, Houten R, et al., 2023, Informed consent failures: National Health Service Resolution data, BRITISH JOURNAL OF SURGERY, ISSN: 0007-1323
Shamsiddinova A, Deputy M, Worley G, et al., 2023, Systematic review: Oncological outcomes of patients with Inflammatory Bowel Disease undergoing segmental colonic resections for colorectal cancer and dysplasia, Publisher: OXFORD UNIV PRESS, Pages: 494-495, ISSN: 1873-9946
Myint AS, Dhadda A, Stewart A, et al., 2023, The Role of Contact X-Ray Brachytherapy in Early Rectal Cancer- Who, when and How?, CLINICAL ONCOLOGY, Vol: 35, Pages: 87-96, ISSN: 0936-6555
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Bibi S, Edilbe MW, Rao C, 2023, The Cost-effectiveness of Watch and Wait for Rectal Cancer, CLINICAL ONCOLOGY, Vol: 35, Pages: 132-137, ISSN: 0936-6555
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Shamsiddinova A, Deputy M, Worley G, et al., 2023, P362 Systematic review: Oncological outcomes of patients with Inflammatory Bowel Disease undergoing segmental colonic resections for colorectal cancer and dysplasia, Publisher: Oxford University Press (OUP), Pages: i494-i495, ISSN: 1873-9946
<jats:title>Abstract</jats:title> <jats:sec> <jats:title>Background</jats:title> <jats:p>Current international guidelines recommend that patients with inflammatory bowel disease (IBD) diagnosed with high grade dysplasia (HGD), or colorectal cancer undergo a proctocolectomy, and that proctocolectomy is considered within a shared decision-making framework with the patient in cases of low grade (LGD) or indeterminate (IND) dysplasia. However, segmental colectomy (surgical resection leaving remaining colon or rectum) is considered by some as a valid alternative, with less physiological stress, stoma avoidance and thus acceptability to patients. This systematic review aims to assess oncological and post-operative outcomes in studies reporting on segmental colectomy or proctocolectomy for patients with IBD and colonic or rectal dysplasia and cancer.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>This systematic review was prospectively registered with PROSPERO (CRD42021292891) and carried out in line with the PRISMA guidelines. Studies published between 1990 and 2022 reporting on oncological and surgical outcomes of adult patients undergoing segmental resection and/or proctocolectomy that included at least three cases of neoplasia were included. Descriptive statistics were used in the context of significant heterogeneity. A meta-analysis was performed for outcomes with at least three results.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>The search returned 2178 results, and after screening 12 studies were included in the final analysis. A total 12,701 patients were included reporting on outcomes of 10,386 segmental resections and 2,315 proctoco
Rao C, 2023, Appeal Panel Decision: Tafasitamab with lenalidomide for treating relapsed or refractory diffuse large B-cell lymphoma [ID3795], Appeal Panel Decision: Tafasitamab with lenalidomide for treating relapsed or refractory diffuse large B-cell lymphoma, London, Publisher: National Institute of Health and Care Excellence, TA883
Ghanem K, Momotaz S, Banerjee S, et al., 2022, “Extensive Anal Cancer Resection Requiring Bilateral Subtotal Buttockectomy” - A case report, Annals of Oncology Case Reports, Vol: 1, Pages: 1-2
We report an aggressive case of anal cancer recurrences.This 38-year-old male presented with extensive verrucousanal carcinoma extending laterally across both buttocks. Hewas diagnosed in May 2019 with a T3N1cM0 anal SCC. Hisinitial treatment entailed four cycles of neoadjuvant chemotherapywith carboplatin and paclitaxel, completed inOctober 2019, preceded by a laparoscopic defunctioningloop colostomy. Subsequent radical chemo radiotherapy using53.2 Gy in 28 fractions with concurrent mitomycin C andcapecitabine was complete in January 2020. MRI pelvis andPET CT scan 5 months later demonstrated total resolution,supported by an equally promising clinical response. However,further follow-up imaging at ten months post completionof treatment, suggested local disease recurrence withprominent FDG avid internal iliac lymph node, correlatingwith clinical findings. He underwent an extended ELAPE followedby VRAM myo-cutaneous flap with unilateral V-Y advancementflap on right side and fascio-cutaneous rotationadvancement flap on left side. Recovery was complicatedby wound dehiscence, successfully managed by a negativepressure dressing. He remains well and disease free.
Fahy MR, Kelly ME, Aalbers AGJ, et al., 2022, Minimum standards of pelvic exenterative practice: PelvEx Collaborative guideline, BRITISH JOURNAL OF SURGERY, Vol: 109, Pages: 1251-1263, ISSN: 0007-1323
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Myint AS, Dhadda AS, Stewart A, et al., 2022, New hope from OPERA trial for surgically fit rectal cancer patients who wish to have organ preservation, Colorectal Disease, ISSN: 1462-8910
Logan R, Rao C, Hunt N, et al., 2022, DUPLICATE FIT TESTING AS A SAFETY NETTING STRATEGY FOR PATIENTS AT RISK OF COLORECTAL CANCER, Publisher: BMJ PUBLISHING GROUP, Pages: A5-A5, ISSN: 0017-5749
Hunt N, Rao C, Logan R, et al., 2022, A cohort study of duplicate faecal immunochemical testing in patients at risk of colorectal cancer from North-West England, BMJ Open, Vol: 12, Pages: 1-7, ISSN: 2044-6055
Objectives We sought to investigate if duplicate faecal immunochemical testing (FIT) sampling improves the negative and positive predictive value of patients thought to be at risk of colorectal cancer (CRC). Specifically, we aimed to investigate whether the proportion of FIT-negative CRC missed by a single FIT test in symptomatic patients could be reduced by duplicate FIT testing.Design A retrospective service evaluation cohort study of the diagnostic accuracy of duplicate FIT testing.Setting Patients referred from primary care with suspected CRC to four secondary care trusts in North-West England.Participants 28 622 patients over 18-years-old with lower gastrointestinal symptoms suggestive of CRC who completed two FIT samples.Primary and secondary outcome measures The performance of duplicate FIT for detecting CRC at a threshold of 10 µgHb/g.Results The sensitivity if either test was >10 µgHb/g was 0.978 (0.955–0.989), specificity was 0.662 (0.657–0.668), positive predictive value 0.031 (0.028–0.035) and negative predictive value 1.00 (0.999–1.00). Despite two-thirds of patients (18952) being negative following two tests, at this threshold only seven CRC were missed over a 26-month period. All seven patients had other high-risk features which should have prompted investigation.Conclusions This study suggests that in routine NHS practice, a duplicate FIT sample strategy together with clinical evaluation for evidence of anaemia and weight loss is superior to a single FIT sample alone and would allow sym
Kelly ME, 2022, Contemporary management of locally advanced and recurrent rectal cancer: views from the PelvEx collaborative, Cancers, Vol: 14, ISSN: 2072-6694
Pelvic exenteration is a complex operation performed for locally advanced and recurrent pelvic cancers. The goal of surgery is to achieve clear margins, therefore identifying adjacent or involved organs, bone, muscle, nerves and/or vascular structures that may need resection. While these extensive resections are potentially curative, they can be associated with substantial morbidity. Recently, there has been a move to centralize care to specialized units, as this facilitates better multidisciplinary care input. Advancements in pelvic oncology and surgical innovation have redefined the boundaries of pelvic exenterative surgery. Combined with improved neoadjuvant therapies, advances in diagnostics, and better reconstructive techniques have provided quicker recovery and better quality of life outcomes, with improved survival This article provides highlights of the current management of advanced pelvic cancers in terms of surgical strategy and potential future developments
Myint AS, Rao C, Dhadda AS, et al., 2022, Improved organ preservation with dose escalation using contact X-ray brachytherapy for good responders following external beam chemoradiotherapy: Long-term outcomes from a single institution, ASCO Gastrointestinal Cancers Symposium, Publisher: LIPPINCOTT WILLIAMS & WILKINS, ISSN: 0732-183X
Mansuri A, Tan KL, Kaul S, et al., 2022, Is management of rectal cancer using watch-and-wait approach feasible, safe, and effective in a publicly funded general hospital?, Publisher: Elsevier BV, Pages: e102-e103, ISSN: 0748-7983
Mansuri A, Dimitrios Z, Strano G, et al., 2022, IMPROVING PATIENT FLOW VIA SURGICAL HOT CLINIC, Publisher: Elsevier BV, Pages: e143-e143, ISSN: 0748-7983
Kaul S, Rao C, Mane R, et al., 2022, Is the Management of Rectal Cancer Using a Watch and Wait Approach Feasible, Safe and Effective in a Publicly Funded General Hospital?, CLINICAL ONCOLOGY, Vol: 34, Pages: E25-E34, ISSN: 0936-6555
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Rao C, 2021, Appeal Panel Decision: Avelumab for maintenance treatment of locally advanced or metastatic urothelial cancer after platinum-based chemotherapy [TA788], Appeal Panel Decision: Avelumab for maintenance treatment of locally advanced or metastatic urothelial cancer after platinum-based chemotherapy, London, Publisher: National Institute of Health and Care Excellence, TA788
Deputy M, Rao C, Worley G, et al., 2021, Effect of the SARS-CoV-2 pandemic on mortality related to high-risk emergency and major elective surgery, British Journal of Surgery, Vol: 108, Pages: 754-759, ISSN: 0007-1323
The coronavirus pandemic has had a significant impact on the provision of surgery globally. This research looked at how the pandemic has affected rates of surgery in England using administrative data. Specifically, it examined the characteristics of patients who were admitted and mortality when patients contracted coronavirus. It found that the overall risk of death did not change in 2020 compared with the same time period in 2019. It did find that the risk of death increased with coronavirus infection. The authors recommend preventive measures to ensure patient safety when restarting elective surgery during the pandemic.
Rao C, 2021, Appeal Panel Decision: Tafamidis for treating transthyretin amyloidosis with cardiomyopathy [TA696], Appeal Panel Decision: Tafamidis for treating transthyretin amyloidosis with cardiomyopathy, London, Publisher: National Institute of Health and Care Excellence, TA696
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