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The Pre-BRA (pre-pectoral Breast Reconstruction EvAluation) feasibility study: protocol for a mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of prepectoral implant-based breast reconstruction

Por: Harvey · K. L. · Mills · N. · White · P. · Holcombe · C. · Potter · S. · on behalf of The Pre-BRA Feasibility Study Steering Group · Barry · Cawthorn · Gardiner · Irwin · Kirwan · McKenzie · McKenzie · OConnell · Oni · Rattay · Roy · Skillman · Soumian · Vidya · Whisker · William
Introduction

Implant-based breast reconstruction is the most commonly performed reconstructive technique worldwide. Subpectoral reconstruction with mesh is the current standard of care but new prepectoral techniques have recently been introduced. Prepectoral breast reconstruction (PPBR) may improve outcomes for patients but robust evaluation is required. Randomised clinical trials (RCTs) are ideally needed but the short-term safety of PPBR is yet to be established; the technique and its indications are evolving and it has yet to be adopted by a sufficient number of surgeons for an RCT to be feasible.

The Pre-BRA study aims to determine the feasibility of using mixed-methods within an IDEAL 2a/2b (IDEAL, Idea-Development-Exploration-Assessment-Long-term) study to explore the short-term safety of PPBR and determine when the technique is sufficiently stable for evaluation in a pragmatic RCT.

Methods and analysis

Pre-BRA is an IDEAL stage 2a/2b prospective multicentre cohort study with embedded qualitative research.

Consecutive patients electing to undergo immediate PPBR at participating centres will be invited to participate. Demographic, operative, oncology and complication data will be collected and patient-reported outcomes will be assessed at baseline, 3 and 18 months postoperatively. The primary safety endpoint will be implant loss at 3 months.

Surgeons performing PPBR will be asked to complete questionnaires regarding their practice and report any modifications made to the procedure or learning arising from complications via free-text response fields on electronic case-report forms. Semistructured will explore surgeons’ experiences in detail to identify emerging best practice. This will be fed back to participating surgeons to promote shared learning.

The Pre-BRA study will aim to recruit 341 patients from 30 to 40 UK centres over a 12-month period. Recruitment will commence Spring 2019.

Ethics and dissemination

The study has full ethical approval from OXFORD-B South Central Committee Ref:19/SC/0129. Results will be presented at national and international meetings and published in peer-reviewed journals.

Trial registration number

ISRCTN11898000; Pre-results.

Circular pOlyethylene drape in preVEntion of suRgical site infection (COVER trial): study protocol for a randomised controlled trial

Por: Yoo · R. N. · Kim · H. J. · Lee · J. I. · Kang · W.-K. · Kye · B.-H. · Kim · C. W. · Bae · S. U. · Nam · S. · Kang · B. M.
Introduction

Surgical site infection (SSI) after abdominal surgery remains a significant cause of morbidity and is associated with an increased socioeconomic burden and a reduced quality of life. Circular wound protectors have been expected to reduce the risk of SSI, but previous studies reported conflicting results on their protective effects. The purpose of this study was to evaluate the efficacy of circular wound protectors in reducing SSI in open abdominal surgery.

Methods and analysis

The circular pOlyethylen drape in preVEntion of suRgical site infection (COVER) trial investigates whether the application of a dual-ring circular plastic wound protector reduces the rate of SSI in patients undergoing elective or emergent open abdominal surgery related to the gastrointestinal tract, regardless of the type of wound classified by the Centers for Disease Control. The COVER trial is a multicentre, randomised controlled clinical trial with two parallel arms—one using a dual-ring wound protector with circular polyethylene drape and the other using conventional surgical dressing gauze. The primary outcome will measure the rate of SSI within 30 days after surgery in two groups. Statistical analysis of the primary end point will be based on the intention-to-treat population. The sample size was determined to achieve a study power of 80% with 95% two-sided confidence limits. Considering a dropout rate of up to 5%, a total of 458 patients, 229 patients in each group, will be enrolled in this study.

Ethics and dissemination

The trial protocol and informed consent document have been reviewed and approved by the institutional review board at each participating centre. Written informed consent will be obtained from each study participant. The clinical outcomes of this trial will be submitted to an international peer-reviewed journal and presented at international conferences.

Trial registration number

NCT 03170843.

What are patients preferences for revision surgery after periprosthetic joint infection? A discrete choice experiment

Por: Carroll · F. E. · Gooberman-Hill · R. · Strange · S. · Blom · A. W. · Moore · A. J.
Objectives

Understanding patients’ preferences for treatment is crucial to provision of good care and shared decisions, especially when more than one treatment option exists for a given condition. One such condition is infection of the area around the prosthesis after hip replacement, which affects between 0.4% and 3% of patients. There is more than one treatment option for this major complication, and our study aimed to assess the value that patients place on aspects of revision surgery for periprosthetic hip infection.

Design

We identified four attributes of revision surgery for periprosthetic hip infection. Using a discrete choice experiment (DCE), we measured the value placed on each attribute by 57 people who had undergone either one-stage or two-stage revision surgery for infection.

Setting

The DCE was conducted with participants from nine National Health Service hospitals in the UK.

Participants

Adults who had undergone revision surgery for periprosthetic hip infection (N=57).

Results

Overall, the strongest preference was for a surgical option that resulted in no restrictions on engaging in valued activities after a new hip is fitted (β=0.7). Less valued but still important attributes included a shorter time taken from the start of treatment to return to normal activities (6 months; β=0.3), few or no side effects from antibiotics (β=0.2), and having only one operation (β=0.2).

Conclusions

The results highlight that people who have had revision surgery for periprosthetic hip infection most value aspects of care that affect their ability to engage in normal everyday activities. These were the most important characteristics in decisions about revision surgery.

International development and implementation of a core measurement set for research and audit studies in implant-based breast reconstruction: a study protocol

Por: Potter · S. · Davies · C. · Holcombe · C. · Weiler-Mithoff · E. · Skillman · J. · Vidya · R. · Masannat · Y. · Weber · W. · Heil · J. · Wilson · S. · Thrush · S. · Whisker · L. · Blazeby · J. · Metcalfe · C. · Avery · K.
Introduction

Outcome reporting in research studies of breast reconstruction is inconsistent and lacks standardisation. The results of individual studies therefore cannot be meaningfully compared or combined limiting their value. A core outcome set (COS) has been developed to address these issues and identified 11 key outcomes to be measured and reported in all future research and audit studies in reconstructive breast surgery (RBS). A COS represents what key outcomes should be measured. The next step is to determine how and when this should be done. The aim of this study is to develop a core measurement set (CMS) for use in research and audit studies in implant-based breast reconstruction.

Methods and analysis

The CMS will be developed in accordance with the guidance developed by the Core Outcome Measures in Effectiveness Trials initiative (COMET) and COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) group for the selection of outcome measurement instruments (OMIs) for relevant outcome domains included in the RBS COS. This will involve three phases with strategies to promote implementation as a final additional phase. The phases are (1) conceptual considerations in which the target population, procedures and settings are defined; (2) systematic reviews to identify existing clinical, patient-reported and cosmetic OMIs and, if appropriate, assess their quality using COSMIN methodology; (3) a modified Delphi process including sequential Delphi surveys involving approximately 100 healthcare professionals and a face to face consensus meeting to agree and ratify which outcome definitions and OMIs should be used and standardised time points for assessment; (4) strategies to promote dissemination and adoption of the CMS.

Ethics and dissemination

Ethical approval has been granted by University of Bristol Faculty Research Ethics Committee FREC ID 60221. Dissemination strategies will include scientific meeting presentations and peer-reviewed journal publications. Implementation activities will include engagement with journal editors and funders to promote uptake and use of the CMS.

Effects of presurgical interventions on chronic pain after total knee replacement: a systematic review and meta-analysis of randomised controlled trials

Por: Dennis · J. · Wylde · V. · Gooberman-Hill · R. · Blom · A. · Beswick · A. D.
Objective

Nearly 100 000 primary total knee replacements (TKR) are performed in the UK annually. The primary aim of TKR is pain relief, but 10%–34% of patients report chronic pain. The aim of this systematic review was to evaluate the effectiveness of presurgical interventions in preventing chronic pain after TKR.

Design

MEDLINE, Embase, CINAHL, The Cochrane Library and PsycINFO were searched from inception to December 2018. Screening and data extraction were performed by two authors. Meta-analysis was conducted using a random effects model. Risk of bias was assessed using the Cochrane tool and quality of evidence was assessed by Grading of Recommendations Assessment, Development and Evaluation.

Primary and secondary outcomes

Pain at 6 months or longer; adverse events.

Interventions

Presurgical interventions aimed at improving TKR outcomes.

Results

Eight randomised controlled trials (RCTs) with data from 960 participants were included. The studies involved nine eligible comparisons. We found moderate-quality evidence of no effect of exercise programmes on chronic pain after TKR, based on a meta-analysis of 6 interventions with 229 participants (standardised mean difference 0.20, 95% CI –0.06 to 0.47, I2=0%). Sensitivity analysis restricted to studies at overall low risk of bias confirmed findings. Another RCT of exercise with no data available for meta-analysis showed no benefit. Studies evaluating combined exercise and education intervention (n=1) and education alone (n=1) suggested similar findings. Adverse event data were reported by most studies, but events were too few to draw conclusions.

Conclusions

We found low to moderate-quality evidence to suggest that neither preoperative exercise, education nor a combination of both is effective in preventing chronic pain after TKR. This review also identified a lack of evaluations of other preoperative interventions, such as multimodal pain management, which may improve long-term pain outcomes after TKR.

PROSPERO registration number

CRD42017041382.

Improving the quality of life of patients with breast cancer-related lymphoedema by lymphaticovenous anastomosis (LVA): study protocol of a multicentre randomised controlled trial

Por: Wolfs · J. · Beugels · J. · Kimman · M. · Piatkowski de Grzymala · A. A. · Heuts · E. · Keuter · X. · Tielemans · H. · Ulrich · D. · van der Hulst · R. · Qiu · S. S.
Introduction

Early breast cancer detection and advancements in treatment options have resulted in an increase of breast cancer survivors. An increasing number of women are living with the long-term effects of breast cancer treatment, making the quality of survivorship an increasingly important goal. Breast cancer-related lymphoedema (BCRL) is one of the most underestimated complications of breast cancer treatment with a reported incidence of 20%. A microsurgical technique called lymphaticovenous anastomosis (LVA) might be a promising treatment modality for patients with BCRL. The main objective is to assess whether LVA is more effective than the current standard therapy (conservative treatment) in terms of improvement in quality of life and weather it is cost-effective.

Methods and analysis

A multicentre, randomised controlled trial, carried out in two academic and two community hospitals in the Netherlands. The study population includes 120 women over the age of 18 who have undergone treatment for breast cancer including axillary treatment (sentinel lymph node biopsy or axillary lymph node dissection) and/or axillary radiotherapy, presenting with an early stage lymphoedema of the arm, viable lymphatic vessels and received at least 3 months conservative treatment. Sixty participants will undergo the LVA operation and the other sixty will continue their regular conservative treatment, both with a follow-up of 24 months. The primary outcome is the health-related quality of life. Secondary outcomes are societal costs, quality adjusted life years, cost-effectiveness ratio, discontinuation rate of conservative treatment and excess limb volume.

Ethics and dissemination

The study was approved by the Ethics Committee of Maastricht University Medical Center (METC) on 19 December 2018 (NL67059.068.18). The results of this study will be disseminated in presentations at academic conferences, publications in peer-reviewed journals and other news media.

Trial registration number

NCT02790021; Pre-results.

Cost-effectiveness of total knee replacement in addition to non-surgical treatment: a 2-year outcome from a randomised trial in secondary care in Denmark

Por: Skou · S. T. · Roos · E. · Laursen · M. · Arendt-Nielsen · L. · Rasmussen · S. · Simonsen · O. · Ibsen · R. · Larsen · A. T. · Kjellberg · J.
Objective

To assess the 24-month cost-effectiveness of total knee replacement (TKR) plus non-surgical treatment compared with non-surgical treatment with the option of later TKR if needed.

Methods

100 adults with moderate-to-severe knee osteoarthritis found eligible for TKR by an orthopaedic surgeon in secondary care were randomised to TKR plus 12 weeks of supervised non-surgical treatment (exercise, education, diet, insoles and pain medication) or to supervised non-surgical treatment alone. Including quality-adjusted life years (QALYs) data from baseline, 3, 6, 12 and 24 months, effectiveness was measured as change at 24 months. Healthcare costs and transfer payments were derived from national registries. Incremental healthcare costs, and incremental cost-effectiveness ratios (ICERs) were calculated. A probabilistic sensitivity analysis was conducted and the probability of cost-effectiveness was estimated at the 22 665 Euros/QALY threshold defined by the National Institute for Health and Care Excellence.

Results

TKR plus non-surgical treatment was more expensive (mean of 23 076 vs 14 514 Euros) but also more effective than non-surgical treatment (mean 24-month improvement in QALY of 0.195 vs 0.056). While cost-effective in the unadjusted scenario (ICER of 18 497 Euros/QALY), TKR plus non-surgical treatment was not cost-effective compared with non-surgical treatment with the option of later TKR if needed in the adjusted (age, sex and baseline values), base-case scenario (ICER of 32 611 Euros/QALY) with a probability of cost-effectiveness of 23.2%. Including deaths, TKR plus non-surgical treatment was still not cost-effective (ICERs of 46 277 to 64 208 Euros/QALY).

Conclusions

From a 24-month perspective, TKR plus non-surgical treatment does not appear to be cost-effective compared with non-surgical treatment with the option of later TKR if needed in patients with moderate-to-severe knee osteoarthritis and moderate intensity pain in secondary care in Denmark. Results were sensitive to changes, highlighting the need for further confirmatory research also assessing the long-term cost-effectiveness of TKR.

Trial registration number

ClinicalTrials.gov (NCT01410409).

Development and evaluation of a patient decision aid for patients considering ongoing medical or surgical treatment options for ulcerative colitis using a mixed-methods approach: protocol for DISCUSS study

Por: Baker · D. M. · Lee · M. J. · Folan · A.-M. · Blackwell · S. · Robinson · K. · Wootton · R. · Sebastian · S. · Brown · S. R. · Jones · G. L. · Lobo · A. J.
Introduction

Approximately 20%–30% of patients with ulcerative colitis (UC) require surgery, the majority of these being elective due to chronic symptoms refractory to medical treatment. The decision for surgery is difficult and dependent on patient preferences. Current resources for patients considering surgery have been found not to meet minimum international standards. The overall aim of the ‘DISCUSS’ study is to develop and evaluate a new patient decision aid (PtDA) for patients considering surgery for UC created in line with international minimum standards.

Methods and analysis

This is a prospective mixed-methods study of adults (18+ years) who are considering surgical intervention for UC across two regional centres in Yorkshire, UK. This study is in three stages. In stage 1 we will develop the PtDA and its content via systematic reviews and a patient questionnaire. In stage 2 we will assess the face validity of the PtDA using mixed-methods on key stakeholders using both semistructured interviews and questionnaires, following which the PtDA will be refined. In stage 3 we will assess the acceptability of using the PtDA in clinical practice. This will use a mixed-methods approach on clinicians and patients who are considering undergoing elective surgery. Questionnaires including the Preparation for Decision-Making Scale, a measure of anxiety and decisional conflict will be analysed at two timepoints using paired sample t-tests and CIs. Interviews with patients and clinicians will be analysed using thematic analysis.

Ethics and dissemination

Research ethics approval from North East–Tyne & Wear South Research Ethics Committee (Ref: 19/NE/0073) and Health Research Authority approval (Ref: 257044) have been granted. Results will be published in open access peer-reviewed journals, presented in conferences and distributed through the Crohn’s and Colitis UK charity. External endorsement will be sought from the International Patient Decision Aid Standards Collaboration inventory of PtDAs.

PROSPERO registration number

CRD42018115513, CRD42019126186, CRD42019125193.

Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds

Objective

Surgical site infection (SSI) affects up to 25% of primary surgical wounds. Dressing strategies may influence SSI risk. The Bluebelle study assessed the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI in primary surgical wounds.

Design

A pilot, factorial RCT.

Setting

Five UK hospitals.

Participants

Adults undergoing abdominal surgery with a primary surgical wound.

Interventions

Participants were randomised to ‘simple dressing’, ‘glue-as-a-dressing’ or ‘no dressing’, and to the time at which the treatment allocation was disclosed to the surgeon (disclosure time, before or after wound closure).

Primary and secondary outcome measures

Feasibility outcomes focused on recruitment, adherence to randomised allocations, reference assessment of SSI and response rates to participant-completed and observer-completed questionnaires to assess SSI (proposed primary outcome for main trial), wound experience and symptoms, and quality of life (EQ-5D-5L).

Results

Between March and November 2016, 1115 patients were screened; 699 (73.4%) were eligible and approached, 415 (59.4%) consented and 394 (35.3%) were randomised (simple dressing=133, glue=129 and ‘no dressing’=132). Non-adherence to dressing allocation was 2% (3/133), 6% (8/129) and 15% (20/132), respectively. Adherence to disclosure time was 99% and 86% before and after wound closure, respectively. The overall rate of SSI (reference assessment) was 18.1% (51/281). Response rates to the Wound Healing Questionnaire and other questionnaires ranged from >90% at 4 days to 68% at 4–8 weeks.

Conclusions

A definitive RCT of dressing strategies including ‘no dressing’ is feasible. Further work is needed to optimise questionnaire response rates.

Trial registration number

49328913; Pre-results.

Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial

Por: Zhuang · Q. · Tao · L. · Lin · J. · Jin · J. · Qian · W. · Bian · Y. · Li · Y. · Dong · Y. · Peng · H. · Li · Y. · Fan · Y. · Wang · W. · Feng · B. · Gao · N. · Sun · T. · Lin · J. · Zhang · M. · Yan · S. · Shen · B. · Pei · F. · Weng · X.
Objectives

To evaluate the morphine-sparing effects of the sequential treatment versus placebo in subjects undergoing total knee arthroplasty (TKA), the effects on pain relief, inflammation control and functional rehabilitation after TKA and safety.

Design

Double-blind, pragmatic, randomised, placebo-controlled trial.

Setting

Four tertiary hospitals in China.

Participants

246 consecutive patients who underwent elective unilateral TKA because of osteoarthritis (OA).

Interventions

Patients were randomised 1:1 to the parecoxib/celecoxib group or the control group. The patients in the parecoxib/celecoxib group were supplied sequential treatment with intravenous parecoxib 40 mg (every 12 hours) for the first 3 days after surgery, followed by oral celecoxib 200 mg (every 12 hours) for up to 6 weeks. The patients in the control group were supplied with the corresponding placebo under the same instructions.

Primary and secondary outcome measures

The primary endpoint was the cumulative opioid consumption at 2 weeks post operation (intention-to-treat analysis). Secondary endpoints included the Knee Society Score, patient-reported outcomes and the cumulative opioid consumption.

Results

The cumulative opioid consumption at 2 weeks was significantly smaller in the parecoxib/celecoxib group than in the control group (median difference, 57.31 (95% CI 34.66 to 110.33)). The parecoxib/celecoxib group achieving superior Knee Society Scores and EQ-5D scores and greater Visual Analogue Scale score reduction during 6 weeks. Interleukin 6, erythrocyte sedation rate and C-reactive protein levels were reduced at 72 hours, 2 weeks and 4 weeks and prostaglandin E2 levels were reduced at 48 hours and 72 hours in the parecoxib/celecoxib group compared with the placebo group. The occurrence of adverse events (AEs) was significantly lower in the parecoxib/celecoxib group.

Conclusions

The sequential intravenous parecoxib followed by oral celecoxib regimen reduces morphine consumption, achieves better pain control and functional recovery and leads to less AEs than placebo after TKA for OA.

Trial registration number

ClinicalTrials.gov (ID: NCT02198924).

Protocol for the derivation and external validation of a 30-day mortality risk prediction model for older patients having emergency general surgery (PAUSE score--Probability of mortality Associated with Urgent/emergent general Surgery in oldEr patients sc

Por: Feng · S. · Van Walraven · C. · Lalu · M. · Moloo · H. · Musselman · R. · McIsaac · D. I.
Introduction

People 65 years and older represent the fastest growing segment of the surgical population. Older age is associated with doubling of risk when undergoing emergency general surgery (EGS) procedures and often coexists with medical complexity and considerations of end-of-life care, creating prognostic and decisional uncertainty. Combined with the time-sensitive nature of EGS, it is challenging to gauge perioperative risk and ensure that clinical decisions are aligned with the patient values. Current preoperative risk prediction models for older EGS patients have major limitations regarding derivation and validation, and do not address the specific risk profile of older patients. Accurate and externally validated models specific to older patients are needed to inform care and decision making.

Methods and analysis

We will derive, internally and externally validate a multivariable model to predict 30-day mortality in EGS patients >65 years old. Our derivation sample will be individuals enrolled in the National Surgical Quality Improvement Program (NSQIP) database between 2012 and 2016 having 1 of 7 core EGS procedures. Postulated predictor variables have been identified based on previous research, clinical and epidemiological knowledge. Our model will be derived using logistic regression penalised with elastic net regularisation and ensembled using bootstrap aggregation. The resulting model will be internally validated using k-fold cross-validation and bootstrap validation techniques and externally validated using population-based health administrative data. Discrimination and calibration will be reported at each step.

Ethics and dissemination

Ethics for NSQIP data use was obtained from the Ottawa Hospital Research Ethics Board; external validation will use routinely collected anonymised data legally exempt from research ethics review. The final risk score will be published in a peer-reviewed journal. We plan to further disseminate the model as an online calculator or application for clinical use. Future research will be required to test the clinical application of the final model.

NINJA trial: should the nail plate be replaced or discarded after nail bed repair in children? Protocol for a multicentre randomised control trial

Por: Jain · A. · Jones · A. · Gardiner · M. D. · Cooper · C. · Sierakowski · A. · Dritsaki · M. · Png · M. E. · Stokes · J. R. · Shirkey · B. · Cook · J. · Beard · D. · Greig · A. V. H.
Introduction

Trauma to the nail bed is the most common surgically treated paediatric hand injury. The majority of surgeons replace the nail plate after repairing the nail bed despite a lack of evidence to do so. Replacing the nail plate may be associated with increased postoperative infection. We will investigate the impact of replacing or discarding the nail plate on infection, cosmetic appearance, pain and subsequent healthcare use. The Nail bed INJury Analysis trial (NINJA) aims to answer the question of whether the nail plate should be replaced or discarded after surgical nail bed repair in children.

Methods and analysis

A two-arm parallel group open multicentre randomised control trial of replacing the nail plate or not, as part of a nail bed repair, will be undertaken in children presenting within 48 hours of a nail bed injury requiring surgical repair. The coprimary outcomes are: cosmetic appearance summary score at a minimum of 4 months and surgical site infection at around 7 days following surgery. Secondary outcomes are EuroQol EQ-5D-(Y); the pain intensity experienced at first dressing change; child/parent satisfaction with nail healing and healthcare resource use. We will recruit a minimum of 416 patients (208 in each group) over 3 years. Children and their parents/carers will be reviewed in clinic around 7 days after their operation and will be assessed for surgical site infection or other problems. The children, or depending on age, their parents/carers, will also be asked to complete a questionnaire and send in photos of their fingernail at a minimum of 4 months postsurgery to assess cosmetic appearance.

Ethics and dissemination

The South Central Research Ethics Committee approved this study on 4 June 2019 (18/SC/0024). A manuscript to a peer-reviewed journal will be submitted on completion of the trial as per National Institute for Health Research publication policy. The results of this trial will substantially inform clinical practice and provide evidence on whether the practice of replacing the nail plate should continue at the time of nail bed repair.

Trial registration number

ISRCTN44551796.

Effectiveness and reporting standards of psychological interventions for improving short-term and long-term pain outcomes after total knee replacement: a systematic review

Por: Whale · K. · Wylde · V. · Beswick · A. · Rathbone · J. · Vedhara · K. · Gooberman-Hill · R.
Objectives

To assess the effectiveness and reporting standards of psychological interventions for improving outcomes after total knee replacement (TKR).

Design

Medline, Embase, and PsycINFO were searched from inception to up to 9 May 2019 with no language restrictions applied. Randomised controlled trials (RCTs) assessing the effectiveness of psychological interventions for short-term and long-term postoperative pain after TKR were included. Screening, data extraction, and assessment of methodological quality were performed in duplicate by two reviewers. The primary effectiveness outcome was postoperative pain severity and the primary harm outcome was serious adverse events. Secondary outcomes included function, quality of life, and psychological well-being. Reporting standards were assessed using the Template for Intervention Description and Replication (TIDieR) checklist for intervention reporting.

Results

12 RCTs were included, with a total of 1299 participants. Psychological interventions comprised music therapy (five studies), guided imagery and music (one study), hypnosis (one study), progressive muscle relaxation with biofeedback (one study), pain coping skills programme (one study), cognitive–behavioural therapy (two studies), and a postoperative management programme (one study). Due to the high heterogeneity of interventions and poor reporting of harms data, it was not possible to make any definitive statements about the overall effectiveness or safety of psychology interventions for pain outcomes after TKR.

Conclusion

Further evidence about the effectiveness of psychological interventions for improving pain outcomes after TKR is needed. The reporting of harm outcomes and intervention fidelity is currently poor and could be improved. Future work exploring the impact of intervention timing on effectiveness and whether different psychological approaches are needed to address acute postoperative pain and chronic postoperative pain would be of benefit.

PROSPERO registration number

CRD42018095100.

Evaluation of titanium mesh cranioplasty and polyetheretherketone cranioplasty: protocol for a multicentre, assessor-blinded, randomised controlled trial

Por: Yang · J. · Sun · T. · Yuan · Y. · Li · X. · Yu · H. · Guan · J.
Introduction

Cranioplasty is a common surgery in neurosurgery department. However, restoring the integrity of skull brings many challenges to surgeons, and the selection of ideal implant materials is throughout the history of cranioplasty. Although titanium mesh was still preferred by many neurosurgeons in cranial reconstruction, the new polyetheretherketone (PEEK) material, for example, is gaining popularity for craniofacial reconstruction today. There remain limited data that compare the outcome of PEEK cranioplasty and titanium mesh cranioplasty. It is necessary to conduct a study to compare outcome of different materials for cranioplasty.

Methods/design

In this multicentre, assessor-blinded, randomised controlled study, we will randomise 140 patients in a 1:1 ratio to PEEK cranioplasty versus titanium cranioplasty. Eligible patients are adults who were diagnosed with cranial defect (due to severe traumatic brain injury, ischaemic stroke, haemorrhagic stroke, infiltrative tumour and so on), the defect size is over 25 cm2, and they need to agree to participate in this trial. Instead of standard examinations, the enrolled patients receive neurological, motor, cognitive function and cerebral hemodynamics examinations as well as cosmetic evaluation. The procedures are repeated 3, 6 months after cranioplasty. The primary outcome, defined as infection or implant exposure after surgery, is the implant failure rate within 6 months. Secondary outcomes include postoperative complication rates, neurological outcomes, motor function, cerebral hemodynamics, cosmetic outcome and the total cost over a 6-month period.

Ethics and dissemination

This trial protocol has been approved by Biomedical Research Ethics Committee of West China Hospital of Sichuan University. All patients will be fully informed the implant materials, potential complications after surgery, responsibilities during the trial, and they will sign the informed consent before joining in this trial. If the patient’s cognitive function is impaired, the patient’s next of kin would be carefully informed. The results will be disseminated through academic conferences, student theses and will be published in a peer-reviewed journal.

Trail registration number

ChiCTR1900024625; Pre-results.

Road to recovery: a study protocol quantifying neurological outcome in cardiac surgery patients and the role of cerebral oximetry

Por: Semrau · J. S. · Scott · S. H. · Hamilton · A. G. · Petsikas · D. · Payne · D. M. · Bisleri · G. · Saha · T. · Boyd · J. G.
Introduction

Patients undergoing cardiac surgery may experience both short-term and long-term postoperative neurological problems. However, the underlying cause of this impairment is unclear. Regional cerebral oxygen saturation (rSO2) levels may play a role in the development of acute dysfunction, known as postoperative delirium, in addition to longer term outcomes after cardiac surgery. Yet the degree of impairment has been difficult to define, partly due to subjective methods of assessments. This study aims to fill this knowledge gap by determining the relationship between rSO2, postoperative delirium and long-term neurological outcome after cardiac surgery using quantitative robotic technology.

Methods and analysis

95 patients scheduled for elective cardiac surgery will be recruited for this single-centre prospective observational study. Patients will be assessed before as well as 3 and 12 months after their surgery using the Kinarm End-Point Lab and standardised tasks. Intraoperatively, rSO2 and other haemodynamic data will be collected for the duration of the procedure. Following their operation, patients will also be screened daily for delirium during their hospital stay.

Ethics and dissemination

This study has been approved by the Health Sciences Research Ethics Board at Queen’s University (DMED-1672–14). The results of this study will be published in a peer-review journal and presented at international and/or national conferences as poster or oral presentations. Participants wishing to know the results of this study will be contacted directly on data publication.

Trial registration number

NCT04081649

Volume and in-hospital mortality after emergency abdominal surgery: a national population-based study

Por: Nally · D. M. · Sorensen · J. · Valentelyte · G. · Hammond · L. · McNamara · D. · Kavanagh · D. O. · Mealy · K.
Objectives

Emergency abdominal surgery (EAS) refers to high-risk intra-abdominal surgical procedures undertaken for acute gastrointestinal pathology. The relationship between hospital or surgeon volume and mortality of patients undergoing EAS is poorly understood. This study examined this relationship at the national level.

Design

This is a national population-based study using a full administrative inpatient dataset (National Quality Assurance Improvement System) from publicly funded hospitals in Ireland.

Setting

24 public hospitals providing EAS services.

Participants and Interventions

Patients undergoing EAS as identified by primary procedure codes during the period 2014–2018.

Main outcome measures

The main outcome measure was adjusted in-hospital mortality following EAS in publicly funded Irish hospitals. Mortality rates were adjusted for sex, age, admission source, Charlson Comorbidity Index, procedure complexity, organ system and primary diagnosis. Differences in overall, 7-day and 30-day in-hospital mortality for hospitals with low (

Results

The study included 10 344 EAS episodes. 798 in-hospital deaths occurred, giving an overall in-hospital mortality rate of 77 per 1000 episodes. There was no statistically significant difference in adjusted mortality rate between low and high volume hospitals. Low volume surgical teams had a higher adjusted mortality rate (85.4 deaths/1000 episodes) compared with high volume teams (54.7 deaths/1000 episodes), a difference that persisted among low volume surgeons practising in high volume hospitals.

Conclusion

Patients undergoing EAS managed by high volume surgeons have better survival outcomes. These findings contribute to the ongoing discussion regarding configuration of emergency surgery services and emphasise the need for effective clinical governance regarding observed variation in outcomes within and between institutions.

What is the evidence for efficacy, effectiveness and safety of surgical interventions for plantar fasciopathy? Protocol for a systematic review

Por: MacRae · C. S. · Roche · A. J. · Sinnett · T. J. · O'Connell · N. E.
Introduction

Plantar fasciopathy (PF) is a degenerative condition of the plantar fascia, secondary to repetitive overloading. For the majority, PF is self-limiting with greater than 80% of those affected gaining complete resolution within 1 year. However, persistent symptoms develop in approximately 10% of cases. Clinical practice guidelines for first-line treatment of PF recommend conservative management. For people with persistent symptoms that have not resolved following a trial of 6–12 months of conservative management, surgery may be offered. However, to date there are no systematic reviews of the effectiveness of the various surgical procedures for PF. We aim to systematically review quantitative studies assessing the effectiveness of surgical interventions in the management of PF.

Methods and analysis

We will search for all published and unpublished randomised clinical trials evaluating surgical interventions in the management of PF. Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE (OVID), EMBASE (OVID), Web of Science (ISI) and Google Scholar will be searched without restrictions on date or language of publication. Inclusion criteria will include people over 18 years, diagnosed by clinical examination with PF, or with an alternative diagnostic label (eg, plantar fasciitis, plantar heel pain, plantar fasciosis). The primary outcomes are changes in pain severity/intensity for first-step pain, and incidence and nature of adverse events. Secondary outcomes include foot and ankle-related disability/function, health-related quality of life, cost-effectiveness, changes in other reported measures of pain (eg, overall pain) and medication use. Outcomes will be assessed (1) short term (≤3 months after intervention), (2) medium term (>3 months to ≤6 months after intervention) or (3) long term (>6 months to ≤2 years after treatment). All data extraction will be performed by at least two independent reviewers on the basis of a priori developed extraction form. Where adequate data are found meta-analysis will be used to combine the results of studies for all core comparisons and outcomes using random effects models. Overall certainty of the evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.

Ethics and dissemination

This systematic review does not require ethical approval as primary data will not be collected. The results of the study will be published in a peer-reviewed journal and presented at appropriate conferences.

PROSPERO registration number

CRD42019133563.

Study protocol for VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer, a UK multicentre randomised controlled trial with an internal pilot (the VIOLET study)

Por: Lim · E. · Batchelor · T. · Shackcloth · M. · Dunning · J. · McGonigle · N. · Brush · T. · Dabner · L. · Harris · R. · Mckeon · H. E. · Paramasivan · S. · Elliott · D. · Stokes · E. A. · Wordsworth · S. · Blazeby · J. · Rogers · C. A. · on behalf of The VIOLET Trialists · Lim · Rogers
Introduction

Lung cancer is a leading cause of cancer deaths worldwide and surgery remains the main treatment for early stage disease. Prior to the introduction of video-assisted thoracoscopic surgery (VATS), lung resection for cancer was undertaken through an open thoracotomy. To date, the evidence base supporting the different surgical approaches is based on non-randomised studies, small randomised trials and is focused mainly on short-term in-hospital outcomes.

Methods and analysis

The VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer study is a UK multicentre parallel group randomised controlled trial (RCT) with blinding of outcome assessors and participants (to hospital discharge) comparing the effectiveness, cost-effectiveness and acceptability of VATS lobectomy versus open lobectomy for treatment of lung cancer. We will test the hypothesis that VATS lobectomy is superior to open lobectomy with respect to self-reported physical function 5 weeks after randomisation (approximately 1 month after surgery). Secondary outcomes include assessment of efficacy (hospital stay, pain, proportion and time to uptake of chemotherapy), measures of safety (adverse health events), oncological outcomes (proportion of patients upstaged to pathologic N2 (pN2) disease and disease-free survival), overall survival and health related quality of life to 1 year. The QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.

Ethics and dissemination

This trial has been approved by the UK (Dulwich) National Research Ethics Service Committee London. Findings will be written-up as methodology papers for conference presentation, and publication in peer-reviewed journals. Many aspects of the feasibility work will inform surgical RCTs in general and these will be reported at methodology meetings. We will also link with lung cancer clinical studies groups. The patient and public involvement group that works with the Respiratory Biomedical Research Unit at the Brompton Hospital will help identify how we can best publicise the findings.

Trial registration number

ISRCTN13472721

Evaluation of the role of transhepatic flow in postoperative outcomes following major hepatectomy (THEFLOW): study protocol for a single-centre, non-interventional cohort study

Por: Golriz · M. · Lemekhova · A. · Khajeh · E. · Ghamarnejad · O. · Al-Saeedi · M. · Strobel · O. · Thilo · H. · Müller-Stich · B. · Schneider · M. · Berchtold · C. · Tinoush · P. · Mayer · P. · Chang · D.-H. · Weiss · K. H. · Hoffmann · K. · Mehrabi · A.
Introduction

Liver resection is the only curative treatment for primary and secondary hepatic tumours. Improvements in perioperative preparation of patients and new surgical developments have made complex liver resections possible. However, small for size and flow syndrome (SFSF) is still a challenging issue, rendering patients inoperable and causing postoperative morbidity and mortality. Although the role of transhepatic flow in the postoperative outcome has been shown in small partial liver transplantation and experimental studies of SFSF, this has never been studied in the clinical setting following liver resection. The aim of this study is to systematically evaluate transhepatic flow changes following major liver resection and its correlation with postoperative outcomes.

Methods and analysis

The TransHEpatic FLOW (THEFLOW) study is a single-centre, non-interventional cohort study, and aims to enrol 50 patients undergoing major hepatectomy (defined as hemihepatectomy or extended hepatectomy based on the Brisbane classification) with or without prior chemotherapy. The portal venous flow, hepatic artery flow and portal venous pressure are measured before and after each resection. All patients are followed-up for 3 months after the operation. During each evaluation, standard clinical data, posthepatectomy liver failure and overall morbidity and mortality will be recorded. THEFLOW study was initiated on 25 March 2018 and is expected to progress for 2 years.

Ethics and dissemination

This protocol study received approval from the Ethics Committee of the University of Heidelberg (registration number: S576/2017). The results of this study will be published in a peer-reviewed journal, and will also be presented at medical meetings.

Trial registration number

NCT03762876.

Ward-based Goal-Directed Fluid Therapy (GDFT) in Acute Pancreatitis (GAP) trial: study protocol for a feasibility randomised controlled trial

Por: Froghi · F. · Soggiu · F. · Ricciardi · F. · Gurusamy · K. · Martin · D. S. · Singh · J. · Siddique · S. · Eastgate · C. · Ciaponi · M. · McNeil · M. · Filipe · H. · Schwalowsky-Monks · O. · Asis · G. · Varcada · M. · Davidson · B. R.
Introduction

Acute pancreatitis is an inflammatory disease of the pancreas with high risk of developing multiorgan failure and death. There are no effective pharmacological interventions used in current clinical practice. Maintaining fluid and electrolyte balance is the mainstay of supportive management. Goal-directed fluid therapy (GDFT) has been shown to decrease morbidity and mortality in surgical conditions with systemic inflammatory response. There is currently no randomised controlled trial (RCT) investigating the role of GDFT based on cardiac output parameters in patients with acute pancreatitis in the ward setting. A feasibility trial was designed to determine patient and clinician support for recruitment into an RCT of ward-based GDFT in acute pancreatitis, adherence to a GDFT protocol, safety, participant withdrawal, and to determine appropriate endpoints for a subsequent larger trial to evaluate efficacy.

Methods and analysis

The GDFT in Acute Pancreatitis trial is a prospective two-centre feasibility RCT. Eligible adults admitted with new onset of acute pancreatitis will be enrolled and randomised into ward-based GDFT (n=25) or standard fluid therapy (n=25) within 6 hours from the diagnosis and continuing for the following 48 hours. Cardiac output parameters will be monitored with a non-invasive device (Cheetah NICOM; Cheetah Medical). The intervention group will consist of a protocolised GDFT approach consisting of stroke volume optimisation with crystalloid fluid boluses, while the control group will receive standard care fluid therapy as advised by the clinical team. The primary endpoint is feasibility. Secondary endpoints will include safety of the intervention, complications, mortality, admission to intensive care unit, cost and quality of life.

Ethics and dissemination

Ethics approval was granted by the London Central Research Ethics Committee (17/LO/1235, project ID: 221872). The results of this trial will be presented to international conference with interest in general surgery and acute care and published in a peer-reviewed journal.

Trial registration number

ISRCTN36077283.

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