Search

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. [ABSTRACT FROM AUTHOR]

Background: With limitations of conventional imaging and biopsy, accurate, non-invasive techniques to detect clear-cell renal cell carcinoma in patients with renal masses remain an unmet need. 89 Zr-labelled monoclonal antibody ([ 89 Zr]Zr-girentuximab) has high affinity for carbonic anhydrase 9, a tumour antigen highly expressed in clear-cell renal cell carcinoma. We aimed to evaluate [ 89 Zr]Zr-girentuximab PET-CT imaging for detection and characterisation of clear-cell renal cell carcinoma., Methods: ZIRCON was a prospective, open-label, multicentre, phase 3 trial conducted at 36 research hospitals and practices across nine countries (the USA, Australia, Canada, the UK, Türkiye, Belgium, the Netherlands, Spain, and France). Patients aged 18 years or older with an indeterminate renal mass 7 cm or smaller (cT1) suspicious for clear-cell renal cell carcinoma and scheduled for nephrectomy received a single dose of [ 89 Zr]Zr-girentuximab (37 MBq ±10%; 10 mg girentuximab) intravenously followed by abdominal PET-CT imaging 5 days (±2 days) later. Surgery was performed no later than 90 days after administration of [ 89 Zr]Zr-girentuximab. Blinded central review, conducted by three independent readers, determined the histology from surgical samples. The coprimary endpoints, determined for each individual reader, were the sensitivity and specificity of [ 89 Zr]Zr-girentuximab PET-CT imaging to detect clear-cell renal cell carcinoma, with histopathological confirmation as standard of truth. Analyses were on the full analysis set of patients, defined as patients who had evaluable PET-CT imaging and a confirmed histopathological diagnosis. The trial is registered with ClinicalTrials.gov, NCT03849118, and EUDRA Clinical Trials Register, 2018-002773-21, and is closed to enrolment., Findings: Between Aug 14, 2019, and July 8, 2022, 371 patients were screened for eligibility, 332 of whom were enrolled. 300 patients received [ 89 Zr]Zr-girentuximab (214 [71%] male and 86 [29%] female). 284 (95%) evaluable patients were included in the primary analysis. The mean sensitivity was 85·5% (95% CI 81·5-89·6) and mean specificity was 87·0% (81·0-93·1). No safety signals were observed. Most adverse events were not or were unlikely to be related to [ 89 Zr]Zr-girentuximab, with most (193 [74%] of 261 events) occurring during or after surgery. The most common grade 3 or worse adverse events were post-procedural haemorrhage (in six [2%] of 261 patients), urinary retention (three [1%]), and hypertension (three [1%]). In 25 (8%) of 300 patients, 52 serious adverse events were reported, of which 51 (98%) occurred after surgery. There were no treatment-related deaths., Interpretation: Our results suggest that [ 89 Zr]Zr-girentuximab PET-CT has a favourable safety profile and is a highly accurate, non-invasive imaging modality for the detection and characterisation of clear-cell renal cell carcinoma, which has the potential to be practice changing., Funding: Telix Pharmaceuticals., Competing Interests: Declaration of interests BS has served as a consultant for Telix Pharmaceuticals, Veracyte, Merck, and Johnson & Johnson; has served as a speaker for Merck; and received travel support from Histosonics. AJP has received institutional funding and medical writing support from Telix Pharmaceuticals for this trial. J-CB has served as a consultant or advisor, and received honoraria and research funding from Bristol Myers Squibb, Conmed, Ipsen Pharmaceuticals, Merck Sharp and Dohme, Pfizer, and Intuitive Surgical. MAM has received institutional funding from Telix Pharmaceuticals; served as a board member for Oranomed, RayzeBio, Fusion, Advanced Molecular Imaging and Therapy, American College of Nuclear Medicine, and Society for Nuclear Medicine and Molecular Imaging; and holds stock or stock options from Advanced Molecular Imaging and Therapy, Gentem Health, and SoftThread. VM has received honoraria from Ethicon and Exelixis. AMS has received institutional research funding from Telix Pharmaceuticals, National Health and Medical Research Council, National Imaging Facility, National Breast Cancer Foundation, Medical Research Future Fund, Australian Cancer Research Foundation, and Victorian Cancer Agency; holds intellectual property licensing with Humanigen, AbbVie, and Life Science Pharmaceuticals; served as an advisory board member and consultant for ImmunOs and Imagion Bio; served as a board member, committee member, or chair for Fusion, Telix Pharmaceuticals, Australian and New Zealand Society of Nuclear Medicine, Australian and New Zealand Urogenital and Prostate Cancer trials group, Cooperative Trials Group for Neuro-Oncology, National Imaging Facility Molecular Imaging Theme, Australian Academy of Health and Medical Sciences, Melbourne Academic Centre for Health Molecular Imaging Theme, World Federation of Nuclear Medicine and Biology, Victorian Comprehensive Cancer Centre, Australian Nuclear Science and Technology Organisation External Advisory Board, and International Centers for Precision Oncology Foundation. CvP has served as consultant or advisor for Astellas and Merck; received honoraria from Astellas; and received travel funding from Ipsen. CBa has served as a data safety monitoring board or advisory board member for Telix Pharmaceuticals. BO has received research funding from Telix Pharmaceuticals. TA has received honoraria and research funding from Telix Pharmaceuticals. RM has received research funding from Telix Pharmaceuticals. DMS has received institutional research funding from Telix Pharmaceuticals; served as a consultant for Global Medical Solutions Taiwan, Progenics Pharmaceuticals, Heidelberg University, and DuChemBio; received payments or honoraria from the School of Breast Oncology, PrecisCa, and US Department of Justice; and served as an associate chair of Society for Nuclear Medicine and Molecular Imaging Scientific Program Committee. STL has received research funding from Telix Pharmaceuticals. NP-T has received honoraria from Actinium Pharmaceuticals; served as a consultant and advisor for Illumina, Imaginab, Actinium, and Progenics/Lantheus; a speaker for Actinium Pharmaceuticals and Telix Pharmaceuticals; and received institutional research funding from Actinium Pharmaceuticals, Imaginab, Regeneron Pharmaceuticals, Bristol Myers Squibb, Janssen, Clarity, Bayer Health, Telix Pharmaceuticals, and Ymabs. ACF is a board member of Molecular Decisions; a consultant or advisor for Verily; has received research funding from Earli, Filtricine, MagARRAY, and Calithera; and holds founders stock at Molecular Decisions, ACF's spouse is an employee or owner of Silverado Hospice and Antelope Valley Hospice. PA is an employee of Premier Research, and a consultant for Premier Research. KS is an employee of ABX-CRO advanced pharmaceutical services Forschungsgesellschaft. LT is an employee of Telix Pharmaceuticals and holds stock from Novartis. MW is an employee and holds patents and stock from Telix Pharmaceuticals. CBe is an employee of Telix Pharmaceuticals. CRWH was an employee of Telix Pharmaceuticals at the time of the trial. PM has received research funding from Telix Pharmaceuticals., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Reversal of ileostomy is associated with morbidity including wound infection and prolonged wound healing. Negative pressure wound therapy (NPWT) has been shown to reduce time to wound healing by secondary intention. The aim of this study was to determine whether NPWT improved wound healing rates, compared with simple wound dressings, in patients undergoing reversal of ileostomy where the skin wound is closed with a purse-string suture., Methods: This was a dual-centre, open-label, randomized controlled trial with two parallel intervention arms. Patients undergoing elective loop ileostomy reversal were randomized 1:1 to receive NPWT or simple wound dressings. The primary endpoint of the study was assessment of complete wound healing at day 42 post reversal of ileostomy and the secondary endpoints were patient-reported wound cosmesis using a visual analogue scale and rates of surgical site infection (SSI)., Results: The study was conducted from June 2018 to December 2021. The trial was approved by the local ethics committee. We enrolled 40 patients, 20 in each arm. One patient in each arm was lost to follow up. Nine patients (9/19, 47.36%) in the simple dressing group had wound healing vs. 13 patients (13/19, 68.42%) in the NPWT group (P = 0.188). There was no significant difference in patient- reported wound cosmesis or SSI., Conclusion: There was no difference in wound healing rates when comparing NPWT to simple wound dressings at early and late time points post reversal of ileostomy, where the skin wound was closed with a purse-string suture., (© 2024 The Authors. ANZ Journal of Surgery published by John Wiley & Sons Australia, Ltd on behalf of Royal Australasian College of Surgeons.)

Background & Aims: Perianal fistulation is a challenging phenotype of Crohn's disease, with significant impact on quality of life. Historically, fistulae have been classified anatomically in relation to the sphincter complex, and management guidelines have been generalized, with lack of attention to the clinical heterogenicity seen. The recent 'TOpClass classification system' for perianal fistulizing Crohn's disease (PFCD) addresses this issue, and classifies patients into defined groups, which provide a focus for fistula management that aligns with disease characteristics and patient goals. In this article, we discuss the clinical applicability of the TOpClass model and provide direction on its use in clinical practice., Methods: An international group of perianal clinicians participated in an expert consensus to define how the TOpClass system can be incorporated into real-life practice. This included gastroenterologists, inflammatory bowel disease surgeons, and radiologists specialized in PFCD. The process was informed by the multi-disciplinary team management of 8 high-volume fistula centres in North America, Europe, and Australia., Results: The process produced position statements to accompany the classification system and guide PFCD management. The statements range from the management of patients with quiescent perianal disease to those with severe PFCD requiring diverting-ostomy and/or proctectomy. The optimization of medical therapies, as well as the use of surgery, in fistula closure and symptom management is explored across each classification group., Conclusion: This article provides an overview of the system's use in clinical practice. It aims to enable clinicians to have a pragmatic and patient goal-centered approach to medical and surgical management options for individual patients with PFCD., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background & Aims: Perianal fistulizing Crohn's disease (PFCD)-associated anorectal and fistula cancers are rare but often devastating diagnoses. However, given the low incidence and consequent lack of data and clinical trials in the field, there is little to no guidance on screening and management of these cancers. To inform clinical practice, we developed consensus guidelines on PFCD-associated anorectal and fistula cancers by multidisciplinary experts from the international TOpClass consortium., Methods: We conducted a systematic review by standard methodology, using the Newcastle-Ottawa Scale quality assessment tool. We subsequently developed consensus statements using a Delphi consensus approach., Results: Of 561 articles identified, 110 were eligible, and 76 articles were included. The overall quality of evidence was low. The TOpClass consortium reached consensus on 6 structured statements addressing screening, risk assessment, and management of PFCD-associated anorectal and fistula cancers. Patients with long-standing (>10 years) PFCD should be considered at small but increased risk of developing perianal cancer, including squamous cell carcinoma of the anus and anorectal carcinoma. Risk factors for squamous cell carcinoma of the anus, notably human papilloma virus, should be considered. New, refractory, or progressive perianal symptoms should prompt evaluation for fistula cancer. There was no consensus on timing or frequency of screening in patients with asymptomatic perianal fistula. Multiple modalities may be required for diagnosis, including an examination under anesthesia with biopsy. Multidisciplinary team efforts were deemed central to the management of fistula cancers., Conclusions: Inflammatory bowel disease clinicians should be aware of the risk of PFCD-associated anorectal and fistula cancers in all patients with PFCD. The TOpClass consortium consensus statements outlined herein offer guidance in managing this challenging scenario., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: The COVID-19 pandemic disrupted the provision of surgical services in Australia. To prepare for a surge of COVID-19 patients, elective surgery was mandatorily reduced or ceased at multiple timepoints in Australian states between 2020 and 2022. Operative exposure is a critical component of surgical training in general surgery, and readiness for practice is an ongoing priority. However, the impact of COVID-19 on operative exposure in Australian General Surgical Trainees (AGST) has not been quantified., Methods: This study was a retrospective longitudinal cohort study using de-identified operative logbook data for Australian General surgical Trainees (AGST) from the Royal Australasian College of Surgeons (RACS) Morbidity and Audit Logbook Tool (MALT) system between February 2019 and July 2021. Bivariate analysis was used to determine the impact of COVID-19 on general surgical trainees' exposure to operative surgery and trainees' operative autonomy., Results: Data from 1896 unique 6-month training terms and 543 285 surgical cases was included over the data collection period. There was no statistically significant impact of the COVID-19 pandemic on AGST operative exposure to major, minor operations, endoscopies, or operative autonomy., Conclusions: The impact of COVID-19 on surgical trainees globally has been significant. Although this study does not assess all aspects of surgical training, this data demonstrates that there has not been a significant impact of the pandemic on operative exposure or autonomy of AGST., (© 2024 Royal Australasian College of Surgeons.)

Pelvic exenteration (PE) is a technically challenging surgical procedure. More recently, quality of life and survivorship following PEs are being increasingly acknowledged as important patient outcomes. This includes evaluating major long-term complications such as hernias, defined as the protrusion of internal organs through a facial defect (The PelvEx Collaborative in Br J Surg 109:1251-1263, 2022), for which there is currently limited literature. The aim of this paper is to ascertain the incidence and risk factors for postoperative hernia formation among our PE cohort managed at a quaternary centre., Method: A retrospective cohort study examining hernia formation following PE for locally advanced rectal carcinoma and locally recurrent rectal carcinoma between June 2010 and August 2022 at a quaternary cancer centre was performed. Baseline data evaluating patient characteristics, surgical techniques and outcomes was collated among a PE cohort of 243 patients. Postoperative hernia incidence was evaluated via independent radiological screening and clinical examination., Results: A total of 79 patients (32.5%) were identified as having developed a hernia. Expectantly, those undergoing flap reconstruction had a lower incidence of postoperative hernias. Of the 79 patients who developed postoperative hernias, 16.5% reported symptoms with the most common symptom reported being pain. Reintervention was required in 18 patients (23%), all of which were operative., Conclusion: This study found over one-third of PE patients developed a hernia postoperatively. This paper highlights the importance of careful perioperative planning and optimization of patients to minimize morbidity., (© 2024. Crown.)