ImportancePatients undergoing unplanned abdominal surgical procedures are at increased risk of surgical site infection (SSI). It is not known if incisional negative pressure wound therapy (iNPWT) can reduce SSI rates in this setting.ObjectiveTo evaluate the effectiveness of iNPWT in reducing the rate of SSI in adults undergoing emergency laparotomy with primary skin closure.Design, Setting, and ParticipantsSUNRRISE was an assessor-masked, pragmatic, phase 3, individual-participant, randomized clinical trial. Adult patients undergoing emergency laparotomy in 22 hospitals in the UK and 12 hospitals in Australia between December 18, 2018, and May 25, 2021, were recruited. Patients were followed up for 30 days postprocedure; database closure was on August 25, 2021.InterventionsParticipants were randomized 1:1 to receive iNPWT (n = 411), which involved a specialized dressing used to create negative pressure over the closed wound vs the surgeon’s choice of wound dressing (n = 410). Randomization and dressing application occurred in the operating room at the end of the surgical procedure.Main Outcomes and MeasuresThe primary outcome measure was SSI up to 30 days postprocedure, evaluated by an assessor masked to the randomized allocation and using criteria from the US Centers for Disease Control and Prevention. There were 7 secondary outcomes, including length of hospital stay, postoperative complications up to 30 days, hospital readmission for wound-related complications within 30 days, wound pain, and quality of life.ResultsA total of 840 patients were randomized (536 from the UK; 304 from Australia). Overall, 52% were female; the mean age was 63.8 (range, 18.8 to 95.3) years. After postrandomization exclusions (N = 52), 394 participants per group were included in the primary analysis. The number of participants who had an SSI in the iNPWT group was 112 of 394 (28.4%), compared with 108 of 394 (27.4%) in the surgeon’s preference group (relative risk, 1.03 [95% CI, 0.83-1.28]; P = .78). This finding was consistent across the preplanned subgroup analyses, including degree of contamination, presence of a stoma, participant body mass index, and skin preparation used, and across all preplanned sensitivity analyses. Of 7 secondary outcomes, 6 showed no significant difference, including hospital readmission, quality of life, and hospital stay (median [IQR], 8 [6-14] days in the iNPWT group and 9 [6-14.5] days in the surgeon’s preference group [ratio of geometric means, 0.96 (95% CI, 0.88-1.06); P = .21]).Conclusions and RelevanceRoutine application of iNPWT to the closed surgical wound after emergency laparotomy did not prevent SSI more than other dressings.Trial Registrationisrctn.com Identifier: ISRCTN17599457; anzctr.org.au Identifier: ACTRN12619000496112
BACKGROUND:Perforated peptic ulcer remains a common contributor to morbidity and mortality rates worldwide. In common with other emergency surgery conditions, there is a trend towards minimally invasive surgery. This review aims to describe current evidence comparing open and laparoscopic management strategies for perforated peptic ulcers, by summarizing patients, intervention, comparator, outcomes, describing intervention components and delivery, outcomes reported and assessing study pragmatism (applicability) using PRagmatic Explanatory Continuum Indicator Summary-2. METHODS:Systematic searches of published literature were performed using Ovid MEDLINE and Embase online databases, as well as clinical trial databases. Randomized trials comparing laparoscopic and open repair of peptic ulcer were included. Data extracted included study metadata, patients, intervention, comparator, outcomes elements, technical aspects of interventions and use of co-interventions, and surgeon learning curves/experience. Applicability was assessed using the PRagmatic Explanatory Continuum Indicator Summary-2 tool, to explore whether trials were predominantly pragmatic or explanatory, and study validity assessed using the Cochrane Risk-of-Bias 2 tool. RESULTS:A total of 408 studies were screened for eligibility, with nine finally included (880 patients). Incision, ulcer closure details and lavage were the most frequently reported aspects of laparoscopic repair. Co-interventions such as antibiotic use and analgesia were reported in most articles, whilst nutrition and Helicobacter pylori eradication were not reported. Interventions were generally delivered by high-volume laparoscopic surgeons. Studies were considered at high Risk-of-Bias. PRagmatic Explanatory Continuum Indicator Summary-2 assessment found studies were neither fully pragmatic nor explanatory. CONCLUSION:Laparoscopic repair of perforated peptic ulcer is a variably defined intervention. Consideration of how intervention components and co-interventions should be optimally delivered is required to facilitate a well designed randomized trial.
BACKGROUND:Inconsistent reporting of patient characteristics in clinical research hampers reproducibility and limits analysis opportunities. This paper proposes condition-specific 'Core Descriptor Sets' comprising key factors like demographics, disease severity, comorbidities, and prognosis to standardize Table 1 reporting. METHODS:Development entails stakeholder involvement, systematic identification of descriptors, value rating, and consensus-building using multiple Delphi rounds. Final agreement comes at an expert meeting. CONCLUSION:Benefits include easier cross-study comparison, for example, through individual patient meta-analysis, facilitated by comparison of consistently reported individual data rather than group-level analysis. This may also support routine data analyses, subgroup and risk identification, and reduced research waste. Core Descriptor Sets describe cohorts thoroughly while minimizing research burden. They are intended to enable improved clinical characterization, personalization, reproducibility, data sharing, and knowledge building.
Abstract Background Endoscopic resection (ER) is a therapeutic option for early oesophago-gastric (OG) cancer. It is recommended as primary treatment for T1a cancers and as an option in T1b cancers. Following ER, surgery is recommended if high-risk features are identified on post-operative pathology. The aim of this retrospective audit is to evaluate the outcomes of patients who underwent curative intent surgery following ER in a tertiary centre in the United Kingdom, to inform patient selection. Methods Data were retrospectively collected from 2015-2020 at one large tertiary referral centre. Patients were included if they underwent EMR for T1 oesophageal or gastric cancer. Patient demographics, information regarding referral and diagnosis, histology, staging, treatment and outcomes were recorded. Patients were offered surgical resection after EMR after discussion at a multidisciplinary team meeting. Data were analysed descriptively. Results 186 patients underwent ER. Seventeen subsequently underwent curative surgery (Females, n=4), see Table 1 for further details. 41% experienced Clavien-Dindo complications Grade I-V. Final histology were: 24% no residual cancer, 35% T1a, 24% T1b, 18% T2. The final stage was upgraded in 29%, 47% had the same grade or downgraded. Lymph node metastases were found in 24% of cases. In patients with no residual cancer after oesophagectomy: two had malignant deep margins on ER histology (T1b), one was recommended surgery, and one underwent chemo-radiation. Two patients had clear margins on ER (T1a m1), one had poorly differentiated histology and proceeded to surgery, the other underwent surveillance. Both patients who did not initially undergo surgery had recurrence (8 and 48 months). Conclusion Almost 10% of patients underwent surgery following ER. Despite selection criteria following international guidelines, 25% of those who underwent major surgery had no residual cancer following ER although a similar portion had positive lymph nodes. Morbidity and mortality following OG cancer remains significant and further work is required to better identify patients for surveillance following ER.
Journal Article Definition and management of intra-abdominal metachronous oligometastatic pancreatic cancer: a systematic review Get access Katie F Boag, Katie F Boag Department of Abdominal Medicine and Surgery, Leeds Teaching Hospitals Trust, Leeds, UK https://orcid.org/0000-0001-6729-0696 Search for other works by this author on: Oxford Academic Google Scholar Emily Britton, Emily Britton Bristol Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Bristol, UK https://orcid.org/0000-0001-9001-1739 Search for other works by this author on: Oxford Academic Google Scholar Stephen R Knight, Stephen R Knight Centre for Medical Informatics, Usher Institute, University of Edinburgh, Edinburgh, UK https://orcid.org/0000-0003-0448-3719 Search for other works by this author on: Oxford Academic Google Scholar Peter O Coe, Peter O Coe Department of Abdominal Medicine and Surgery, Leeds Teaching Hospitals Trust, Leeds, UK https://orcid.org/0000-0002-5943-6728 Search for other works by this author on: Oxford Academic Google Scholar Benjamin Chan, Benjamin Chan Department of Hepatobiliary Surgery, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UKDepartment of Pharmacology & Therapeutics, University of Liverpool, Liverpool, UK https://orcid.org/0000-0001-9500-2380 Search for other works by this author on: Oxford Academic Google Scholar Natalie S Blencowe, Natalie S Blencowe Department of Abdominal Medicine and Surgery, Leeds Teaching Hospitals Trust, Leeds, UKBristol Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Bristol, UK Search for other works by this author on: Oxford Academic Google Scholar Samir Pathak Samir Pathak Department of Abdominal Medicine and Surgery, Leeds Teaching Hospitals Trust, Leeds, UK Correspondence to: S. Pathak, Department of Abdominal Medicine and Surgery, St James University Hospital, Beckett Street, Leeds LS9 7TF, UK (E-mail: drsamirpathak@gmail.com) Search for other works by this author on: Oxford Academic Google Scholar British Journal of Surgery, znad338, https://doi.org/10.1093/bjs/znad338 Published: 31 October 2023 Article history Received: 12 May 2023 Revision received: 10 August 2023 Accepted: 15 September 2023 Published: 31 October 2023
Introduction Choledocholithiasis is common, with patients usually treated with endoscopic retrograde cholangiopancreatography (ERCP) and subsequent cholecystectomy to remove the presumed source of common bile duct (CBD) stones. However, previous investigations into the management of patients following ERCP have focused on recurrent CBD stones, negating the risks of cholecystectomy. This article appraises the role of cholecystectomy following successful endoscopic clearance of bile duct stones. Methods Patients undergoing ERCP and CBD clearance for choledocholithiasis at St James's University Hospital January 2015-December 2018 were included. Patients were divided into those who received cholecystectomy and those managed non-operatively. Readmissions, operative morbidity, mortality and treatment costs were investigated. Results Eight hundred and forty-four patients received ERCP and CBD clearance with 3.9 years follow-up. Two hundred and nine patients underwent cholecystectomy with 15% requiring complex surgery. Three hundred and seventy-three patients were non-operatively managed. Unplanned readmissions occurred in 15% following ERCP, mostly within two years. There was no difference in readmissions between the two groups. Accounting for the entire patient pathway, non-operative management was less expensive. Conclusions The majority of patients do not require readmission following ERCP for CBD stones, and cholecystectomy did not reduce the risk of readmission. Few patients have recurrent CBD stones, but complex biliary surgery is frequently required. Routine cholecystectomy following ERCP needs to be re-evaluated and a more stratified approach to future risk developed.
Aim: Crohn's anal fistula (CAF) is a complex condition, with no agreement on which patient characteristics should be routinely reported in studies. The aim of this study was to develop a core descriptor set of key patient characteristics for reporting in all CAF research.Method: Candidate descriptors were generated from published literature and stakeholder suggestions. Colorectal surgeons, gastroenterologists and specialist nurses in inflammatory bowel disease took part in three rounds of an international modified Delphi process using nine-point Likert scales to rank the importance of descriptors. Feedback was provided between rounds to allow refinement of the next ratings. Patterns in descriptor voting were assessed using principal component analysis (PCA). Resulting PCA groups were used to organize items in rounds two and three. Consensus descriptors were submitted to a patient panel for feedback. Items meeting predetermined thresholds were included in the final set and ratified at the consensus meeting.Results: One hundred and thirty three respondents from 22 countries completed round one, of whom 67.0% completed round three. Ninety seven descriptors were rated across three rounds in 11 PCA-based groups. Forty descriptors were shortlisted. The consensus meeting ratified a core descriptor set of 37 descriptors within six domains: fistula anatomy, current disease activity and phenotype, risk factors, medical interventions for CAF, surgical interventions for CAF, and patient symptoms and impact on quality of life.Conclusion: The core descriptor set proposed for all future CAF research reflects characteristics important to gastroenterologists and surgeons. This might aid transparent reporting in future studies.
This study defines core patient descriptors in perforated peptic ulcer research. Background Perforated peptic ulcer (PPU) remains a common condition globally with significant morbidity and mortality. Previous work has demonstrated variation in reporting of patient characteristics in PPU studies, making comparison of studies and outcomes difficult. The aim of this study was to standardize the reporting of patient characteristics, by creating a core descriptor set (CDS) of important descriptors that should be consistently reported in PPU research. Methods Candidate descriptors were identified through systematic review and stakeholder proposals. An international Delphi exercise involving three survey rounds was undertaken to obtain consensus on key patient characteristics for future research. Participants rated items on a scale of 1-9 with respect to their importance. Items meeting a predetermined threshold (rated 7-9 by over 70 per cent of stakeholders) were included in the final set and ratified at a consensus meeting. Feedback was provided between rounds to allow refinement of ratings. Results Some 116 clinicians were recruited from 29 countries. A total of 63 descriptors were longlisted from the literature, and 27 were proposed by stakeholders. After three survey rounds and a consensus meeting, 27 descriptors were included in the CDS. These covered demographic variables and co-morbidities, risk factors for PPU, presentation and pathway factors, need for organ support, biochemical parameters, prognostic tools, perforation details, and surgical history. Conclusion This study defines the core descriptive items for PPU research, which will allow more robust synthesis of studies.
Background The ability to compare findings across surgical research is important. Inadequate description of participants, interventions or outcomes could lead to bias and inaccurate assessment of findings. The aim of this study was to assess consistency of description of participants using studies comparing laparoscopic and open repair of peptic ulcer as an example. Methods This systematic review is reported in line with the PRISMA checklist. Searches of MEDLINE and Embase databases were performed to identify studies comparing laparoscopic and open repair of perforated peptic ulcer in adults, published in the English language. Manuscripts were dual-screened for eligibility. Full texts were retrieved and dual-screened for inclusion. Data extracted from studies included descriptors of participants in studies from tables and text. Descriptors were categorized into conceptual domains by the research team, and coverage of each domain by study was tabulated. Results Searches identified 2018 studies. After screening, 37 full texts were retrieved and 23 studies were included in the final synthesis. A total of 76 unique descriptors were identified. These were classified into demographics (11 descriptors), vital signs (9 descriptors), disease-specific characteristics (10 descriptors), presentation and pathway factors (4 descriptors), risk factors (8 descriptors), laboratory tests (14 descriptors) and baseline health (28 descriptors). The number of descriptors in a single study ranged from three to 31. All studies reported at least one demographic descriptor. Laboratory tests was the least frequently described domain. Conclusion Study participants are described inconsistently in studies of a single example surgical condition.
Editor We read with interest the COVIDSurg Collaborative article, ‘Global Guidance for surgical care during the COVID19 pandemic’1 and eagerly await the collaboratives initial report. It is clear, the SARS-CoV-2 pandemic has had a significant impact on emergency and elective surgical services. Concerns about surgical outcomes in COVID-19 positive patients and intra-operative transmission to healthcare workers meant that initial guidance from multiple surgical bodies recommended non-operative management options where possible. Specifically, for the management of acute biliary disease, the Intercollegiate General Surgery Guidance on COVID-192 recommended either non-surgical management or the utilisation of a cholecystostomy tube. This represents a major deviation from prior best practice where definitive treatment with early laparoscopic cholecystectomy was recommended within one week of index admission3,4 and the use of cholecystostomy drains reserved only for patients considered too high risk for surgery5. The White Rose Surgical Collaborative (WRSC) (UK) is undertaking a multicentre, retrospective cohort study to examine commonly utilised management strategies for acute cholecystitis in the UK. One of the primary objectives is to examine the use of cholecystostomy drains, their associated management and morbidity. Data collection is ongoing, but interim analysis of results may provide guidance on what we might expect with the increased use of this strategy throughout the pandemic. To date, 864 patients with a coded diagnosis of acute cholecystitis during the study period were submitted from five hospital trusts in the United Kingdom. Of these 63 (7⋅2%) had a cholecystostomy drain placed. This typically represented those with more comorbidities (Charlson comorbidity index median score 2 vs 4 for no drain and drained respectively, p< 0⋅001), and those with a greater inflammatory response at admission (mean admission CRP 87⋅5 vs 169 mg/L, p< 0⋅01). Of those receiving a cholecystostomy, 22 (35⋅2%) patients experienced a complication. Of these 3 (4⋅7%) were immediate (e.g. bleeding) and 19 were late; Complications were reported as wrong site placement in 2 (10⋅5%) patients, displacement of drain in 12 (63⋅2%) patients and chronic fistula formation was seen in 1 (5⋅3%) individual. Other non-specific complications were seen in 4 (21⋅1%) patients undergoing intervention. Following insertion of a cholecystostomy drain, 21 (41⋅4%) patients underwent a check tubogram before discharge. Interestingly, 42⋅9% of those patients post cholecystostomy drain required readmission to hospital, re-presenting acutely for admission mean of 0⋅55 times (Range 1 to 4 times each). With the anticipated move towards radiological drainage for a wider population group resulting from COVID-19 protocols, the burden of complications and readmissions can be expected to increase6. As the peri-operative risks of Covid-19 become clearer we must remember that whatever strategy we adopt now will have ramifications for patients. Avoiding repeated admissions to hospital through the provision of definitive treatment pathways should be a consideration in planning services. Where laparoscopic surgery in the acute setting can be safely delivered for patients with acute cholecystitis this should be considered given the morbidity associated with non-operative strategies. Avoiding unintended consequences and balancing the associated risks of any proposed strategy remain difficult goals to achieve. We are working to expedite the completion and analysis of the dataset to further contribute to the discussion. A. Peckham-Cooper1 , P. O. Coe1 , R. W. Clarke2, J. Burke1 and M. J. Lee3
Objective: The aim of this study was to compare open surgery (OS) with laparoscopic surgery (LS) for perforated peptic ulcer (PPU) disease using a National dataset. Background: PPU disease is typically treated surgically with an omental patch. This can be performed through OS or a LS. Current evidence in OS versus LS suggests equivalence in mortality and postoperative complications, but a decrease in pain and wound infections with LS. Methods: A one-to-one propensity score-matched analysis of patients who underwent PPU repair from December 2013 to December 2017 using data from the National Emergency Laparotomy Audit was performed. Patients with an initially laparoscopic approach were classed as LS even if converted to OS. The primary end-point was 90-day mortality; secondary endpoints were length of stay (LOS), re-operation, and re-admission to critical care. Multivariable logistic and linear models were created to compare the effect of operative approach on binary and continuous outcomes with log-rank tests for time-to-event data. Results: A total of 5253 patients underwent surgery in the study period. After propensity-matching, 2 groups of 1158 patients were created. Overall 90-day mortality was 7.5%. There was no difference between the LA and OA for 90-day mortality (7.2% vs 8.5%, OR 0.80, 95% CI 0.56- 1.15, P = 0.23), median LOS (equivalent at 7 days, P = 0.09), reoperation (3.6% vs 4.0%, P = 0.74), or re-admission to critical care (2.8% vs 2.9%, P = 0.92). Across the 4-year study period LS use increased from 20% to 26% and the conversion rate decreased from 40% to 31%. Conclusions: Short outcomes from laparoscopic PPU repair appear equivalent to open repair. There is increasing adoption of LS with decreasing conversion rates. LS for PPU appears to be an acceptable approach in this setting.
The prevalence of elevated intra-hepatic fat (IHF) is increasing in the Western world, either alone as hepatic steatosis (HS) or in conjunction with inflammation (steatohepatitis). These changes to the hepatic parenchyma are an independent risk factor for post-operative morbidity following liver resection for colorectal liver metastases (CRLM). As elevated IHF and colorectal malignancy share similar risk factors for development it is unsurprisingly frequent in this cohort. In patients undergoing resection IHF may be elevated due to excess adiposity or its elevation may be induced by neoadjuvant chemotherapy, termed chemotherapy associated steatosis (CAS). Additionally, chemotherapy is implicated in the development of inflammation termed chemotherapy associated steatohepatitis (CASH). Following cessation of chemotherapy, patients awaiting resection have a 4–6 week washout period prior to resection that is a window for prehabilitation prior to surgery. In patients with NAFLD dietary and pharmacological interventions can reduce IHF within this timeframe but this approach to modifying IHF is untested in this population. In this review, the aetiology of CAS and CASH is reviewed with recommendations to identify those at risk. We also focus on the post-chemotherapy washout period, reviewing dietary interventions applied to the metabolic population and suggest this window may be used as an opportunity to optimise IHF with such a regime as part of a pre-operative prehabilitation programme to produce improved patient outcomes.
Background: Excess body adiposity is associated with increased risk of pancreatic cancer, and in animal models excess intra-pancreatic fat is a driver of pancreatic carcinogenesis. Within a programme to evaluate pancreatic fat and PC risk in humans, we assessed whether MR-quantified pancreatic fat fraction (PFF) was 'fit for purpose' as an imaging biomarker. Methods: We determined PFF using MR spectroscopy (MRS) and MR chemical shift imaging (CS-MR), in two groups. In Group I, we determined accuracy of MR-derived PFF with histological digital fat quantification in 12 patients undergoing pancreatic resection. In a second study, we assessed reproducibility in 15 volunteers (Group IIa), and extended to 43 volunteers (Group IIa & IIb) to relate PFF with MR-derived hepatic fat fraction (HFF), body mass index (BMI), and waist circumference (WC) using linear regression models. We assessed intra-and inter-observer, and between imaging modality levels of agreement using Bland-Altman plots. Results: In Group I patients, we found strong levels of agreement between MRS and CS-MR derived PFF and digitally quantified fat on histology (rho: 0.781 and 0.672 respectively). In Group IIa, there was poor reproducibility in initial assessments. We refined our protocols to account for 3D dimensionality of the pancreas, and found substantially improved intra-observer agreements. In Group II, HFF and WC were significantly correlated with PFF (p values < 0.05). Interpretation: Both CS-MR and MRS (after accounting for pancreatic 3D dimensionality) were 'fit for purpose' to determine PFF and might add information on cancer prediction independent from measures of general body adiposity. Crown Copyright (C) 2018 Published by Elsevier B.V. on behalf of IAP and EPC. All rights reserved.
Objectives To determine whether preoperative dexamethasone reduces postoperative vomiting in patients undergoing elective bowel surgery and whether it is associated with other measurable benefits during recovery from surgery, including quicker return to oral diet and reduced length of stay. Design Pragmatic two arm parallel group randomised trial with blinded postoperative care and outcome assessment. Setting 45 UK hospitals. Participants 1350 patients aged 18 or over undergoing elective open or laparoscopic bowel surgery for malignant or benign pathology. Interventions Addition of a single dose of 8 mg intravenous dexamethasone at induction of anaesthesia compared with standard care. Main outcome measures Primary outcome: reported vomiting within 24 hours reported by patient or clinician. Secondary outcomes: vomiting with 72 and 120 hours reported by patient or clinician; use of antiemetics and postoperative nausea and vomiting at 24, 72, and 120 hours rated by patient; fatigue and quality of life at 120 hours or discharge and at 30 days; time to return to fluid and food intake; length of hospital stay; adverse events. Results 1350 participants were recruited and randomly allocated to additional dexamethasone (n=674) or standard care (n=676) at induction of anaesthesia. Vomiting within 24 hours of surgery occurred in 172 (25.5%) participants in the dexamethasone arm and 223 (33.0%) allocated standard care (number needed to treat (NNT) 13, 95% confidence interval 5 to 22; P=0.003). Additional postoperative antiemetics were given (on demand) to 265 (39.3%) participants allocated dexamethasone and 351 (51.9%) allocated standard care (NNT 8, 5 to 11; P<0.001). Reduction in on demand antiemetics remained up to 72 hours. There was no increase in complications. Conclusions Addition of a single dose of 8 mg intravenous dexamethasone at induction of anaesthesia significantly reduces both the incidence of postoperative nausea and vomiting at 24 hours and the need for rescue antiemetics for up to 72 hours in patients undergoing large and small bowel surgery, with no increase in adverse events. Trial registration EudraCT (2010-022894-32) and ISRCTN (ISRCTN21973627).
The results of a Health Education England Better Training Better Care pilot.