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International mixed methods study protocol to develop a patient-reported outcome measure for all types of chronic wounds (the WOUND-Q)

Por: Klassen · A. · van Haren · E. L. · Cross · K. · Fan · K. L. · Gibbons · C. · Hoogbergen · M. M. · Longmire · N. M. · Poulsen · L. · Sorensen · J. A. · Squitieri · L. · Tsangaris · E. · van Alphen · T. C. · van Dishoeck · A.-M. · Vasilic · D. · Pusic · A. L.
Introduction

Most patient-reported outcome measures (PROM) for chronic wounds are specific to a single wound type (eg, pressure ulcer) or part of the body. A barrier to outcome assessment in wound care and research is the lack of a rigorously designed PROM that can be used across wound types and locations. This mixed method study describes the protocol for an international collaboration to develop and validate a new PROM called the WOUND-Q for adults with chronic wounds.

Methods and analysis

In phase I, the qualitative approach of interpretive description is used to elicit concepts important to people with wounds regarding outcome. Participants from Canada, Denmark, the Netherlands, and the USA are aged 18 years and older and have a wound that has lasted 3 months or longer. Interviews are digitally recorded, transcribed and coded. A conceptual framework and preliminary item pool are developed from the qualitative dataset. Draft scales are formed to cover important themes in the conceptual framework. These scales are refined using feedback from people with chronic wounds and wound care experts. After refinement, the scales are translated into Danish and Dutch, following rigorous methods, to prepare for an international field-test study. In phase II, data are collected in Canada, Denmark, the Netherlands, and the USA. An international sample of people with a large variety of chronic wounds complete the WOUND-Q. Rasch Measurement Theory analysis is used to identify the best subset of items to retain for each scale and to examine reliability and validity.

Ethics and dissemination

This study is coordinated at Brigham and Women’s Hospital (Boston, USA). Ethics board approval was received at each participating site for both study phases. Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.

Study protocol for SFX-01 after subarachnoid haemorrhage (SAS): a multicentre randomised double-blinded, placebo controlled trial

Por: Zolnourian · A. H. · Franklin · S. · Galea · I. · Bulters · D. O.
Introduction

Subarachnoid haemorrhage (SAH) from a ruptured cerebral aneurysm carries high morbidity and mortality. Despite huge advances in techniques to secure the aneurysm, there has been little progress in the treatment of the deleterious effects of the haemorrhage.

Sulforaphane is an Nrf2 inducer with anti-oxidant and anti-inflammatory properties. It has been shown to improve clinical outcome in experimental models of SAH, but is unstable. SFX-01 (Evgen Pharma) is a novel composition comprised of synthetic sulforaphane stabilised within an α-cyclodextrin complex. On ingestion, the complex releases sulforaphane making SFX-01 an ideal vehicle for delivery of sulforaphane.

Methods and analysis

The objective of the study is to assess the safety, pharmacokinetics and efficacy of SFX-01. This is a prospective, multicentre, randomised, double-blind placebo-controlled trial in patients aged 18–80 years with aneurysmal subarachnoid haemorrhage in the previous 48 hours. 90 patients will be randomised to receive SFX-01 (300 mg) or placebo two times per day for up to 28 days.

Safety will be assessed using blood tests and adverse event reporting.

Pharmacokinetics will be assessed based on paired blood and cerebrospinal fluid (CSF) sulforaphane levels on day 7. A subgroup will have hourly samples taken during 6 hours post-dosing on days 1 and 7. Pharmacodynamics will be assessed by haptoglobin and malondialdehyde levels, and maximum flow velocity of middle cerebral artery will be measured by transcranial Doppler ultrasound.

Clinical outcomes will be assessed at days 28, 90 and 180 with modified Rankin Scale, Glasgow Outcome Score, SAH Outcome Tool, Short Form-36, Brain Injury Community Rehabilitation Outcome Scales and Check List for Cognitive and Emotional consequences following stroke. MRI at 6 months including quantitative susceptibility mapping and volumetric T1 will measure iron deposition and cortical volume.

Safety, CSF sulforaphane concentration and middle cerebral artery flow velocity will be primary outcomes and all others secondary.

Ethics and dissemination

Ethical approval was obtained from South Central Hampshire A committee. Outcomes of the trial will be submitted for publication in a peer-reviewed journal.

Trial registration number

NCT02614742.

PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study

Por: Sohn · M. · Agha · A. · Iesalnieks · I. · Bremer · S. · Trum · S. · Di Cerbo · F. · Nerlich · A. · Lotz · N. · Klieser · E. · Hochrein · A. · Schredl · P. · Kalcheva · D. · Emmanuel · K. · Presl · J.
Introduction

Diverticulitis is among the most common abdominal disorders. The best treatment strategy for this complicated disease as well as for recurrent stages is still under debate. Moreover, little knowledge exists regarding the effect of different therapeutic strategies on the health-related quality of life (HrQoL). Therefore, the PREDIC-DIV (PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease) study aims to assess predictors of a change in HrQoL in patients after elective sigmoidectomy for diverticular disease.

Methods and analysis

A prospective multicentre transnational observational study was started in November 2017. Patients undergoing elective sigmoid resection for diverticular disease were included. Primary outcome includes HrQoL 6 months postoperatively, staged by the Gastrointestinal Quality of Life Index (GIQLI). Secondary outcomes include HrQoL 6 months after sigmoidectomy, assessed using the Short Form 36 Questionnaire and a custom-made Visual Analogue Scale-based inventory; HrQoL after 12 and 24 months; postoperative morbidity; mortality; influence of surgical technique (conventional laparoscopic multiport operation vs robotic approach); histological grading of inflammation and morphological characteristics of the bowel wall in the resected specimen; postoperative functional changes (faecal incontinence, faecal urge, completeness of emptying, urinary incontinence, sexual function); disease-specific healthcare costs; and changes in economic productivity, measured by the iMTA Productivity Cost Questionnaire. The total follow-up will be 2 years.

Ethics and dissemination

The protocol was approved by the medical ethical committee of the Bavarian Medical Council (report identification number: 2017-177). The study was conducted in accordance with the Declaration of Helsinki. The findings of this study will be submitted to a peer-reviewed journal (BMJ Open, Annals of Surgery, British Journal of Surgery, Diseases of the Colon and the Rectum). Abstracts will be submitted to relevant national and international conferences.

Trial registration number

The study is registered with the ClinicalTrials.gov register as NCT03527706; Pre-results.

Long-term patient satisfaction and durability of laparoscopic anti-reflux surgery in a large Danish cohort: study protocol for a retrospective cohort study with development of a novel scoring system for patient selection

Por: Sanberg Ljungdalh · J. · Rubin · K. H. · Durup · J. · Houlind · K. C.
Introduction

Laparoscopic anti-reflux surgery is standard of care in surgical treatment of gastro-oesophageal reflux disease and is not without risks of adverse effects, including disruption of the fundoplication and postfundoplication dysphagia, in some cases leading to reoperation. Non-surgical factors such as pre-existing anxiety or depression influence postoperative satisfaction and symptom relief. Previous studies have focused on a short-term follow-up or only certain aspects of disease, such as reoperation or postoperative quality of life. The aim of this study is to evaluate long-term patient-satisfaction and durability of laparoscopic anti-reflux surgery in a large Danish cohort using a comprehensive multimodal follow-up, and to develop a clinically applicable scoring system usable in selecting patients for anti-reflux surgery.

Methods and analysis

The study is a retrospective cohort study utilising data from patient records and follow-up with patient-reported quality of life as well as registry-based data. The study population consists of all adult patients having undergone laparoscopic anti-reflux surgery at The Department of Surgery, Kolding Hospital, a part of Lillebaelt Hospital Denmark in an 11-year period. From electronic records; patient characteristics, preoperative endoscopic findings, reflux disease characteristics and details on type of surgery, will be identified. Disease-specific quality of life and dysphagia will be collected from a patient-reported follow-up. From Danish national registries, data on comorbidity, reoperative surgery, use of pharmacological anti-reflux treatment, mortality and socioeconomic factors will be included. Primary outcome of this study is treatment success at follow-up.

Ethics and dissemination

Study approval has been obtained from The Danish Patient Safety Agency, The Danish Health Data Authority and Statistics Denmark, complying to Danish and EU legislation. Inclusion in the study will require informed consent from participating subjects. The results of the study will be published in peer-reviewed medical journals regardless of whether these are positive, negative or inconclusive.

Trial registration number

Clinicaltrials.gov (NCT03959020).

'French LARS score: validation of the French version of the low anterior resection syndrome (LARS) score for measuring bowel dysfunction after sphincter-preserving surgery among rectal cancer patients: a study protocol

Por: Eid · Y. · Bouvier · V. · Dejardin · O. · Menahem · B. · Chaillot · F. · Chene · Y. · Dutheil · J. J. · Juul · T. · Morello · R. · Alves · A.
Introduction

Many bowel problems following low anterior resection (LAR) for rectal cancer considerably impair the quality of life (QoL) of patients. The LAR syndrome (LARS) scale is a self-report questionnaire to identify and assess bowel dysfunction after rectal cancer surgery. It has been translated and validated in several languages but not in French (metropolitan French). The primary objective is to adapt the LARS scale to the French language (called French-LARS score) and to assess its psychometric properties. Secondary objectives are to assess both the prevalence and severity of LARS and to measure their impact on QoL.

Methods and analysis

A French multicentre observational cohort study has been designed. The validation study will include translation of the LARS scale following the current international recommendations, assessment of its reliability, convergent and discriminant validities, sensitivity, internal consistency, internal validity and confirmatory analyses. One thousand patients will be enrolled for the analyses. The questionnaire will be initially administered to the first 100 patients to verify the adequacy and degree of comprehension of the questions. Then reproducibility will be investigated by a test–retest procedure in the following 400 patients.

An analysis will be conducted to determine the correlation between the LARS score and the Quality of Life Questionnaire (QLQ; European Organization for Treatment and Research of Cancer’s QLQ-C30, QLQ-CR29). Risk factors linked to QoL deterioration will be identified and their impact will be measured. This study will meet the need for a validated tool to improve patient care and QoL.

Ethics and dissemination

The institutional review board of the University Hospital of Caen and the ethics committee (CPP Nord Ouest I, 25 January 2019) approved the study.

Trial registration number

NCT03569488.

Arthroscopic meniscectomy versus non-surgical or sham treatment in patients with MRI confirmed degenerative meniscus lesions: a protocol for an individual participant data meta-analysis

Por: Wijn · S. R. W. · Rovers · M. M. · Rongen · J. J. · Osteras · H. · Risberg · M. A. · Roos · E. M. · Hare · K. B. · van de Graaf · V. A. · Poolman · R. W. · Englund · M. · Hannink · G.
Introduction

Arthroscopic partial meniscectomy (APM) after degenerative meniscus tears is one of the most frequently performed surgeries in orthopaedics. Although several randomised controlled trials (RCTs) have been published that showed no clear benefit compared with sham treatment or non-surgical treatment, the incidence of APM remains high. The common perception by most orthopaedic surgeons is that there are subgroups of patients that do need APM to improve, and they argue that each study sample of the existing trials is not representative for the day-to-day patients in the clinic. Therefore, the objective of this individual participant data meta-analysis (IPDMA) is to assess whether there are subgroups of patients with degenerative meniscus lesions who benefit from APM in comparison with non-surgical or sham treatment.

Methods and analysis

An existing systematic review will be updated to identify all RCTs worldwide that evaluated APM compared with sham treatment or non-surgical treatment in patients with knee symptoms and degenerative meniscus tears. Time and effort will be spent in contacting principal investigators of the original trials and encourage them to collaborate in this project by sharing their trial data. All individual participant data will be validated for missing data, internal data consistency, randomisation integrity and censoring patterns. After validation, all datasets will be combined and analysed using a one-staged and two-staged approach. The RCTs’ characteristics will be used for the assessment of clinical homogeneity and generalisability of the findings. The most important outcome will be the difference between APM and control groups in knee pain, function and quality of life 2 years after the intervention. Other outcomes of interest will include the difference in adverse events and mental health.

Ethics and dissemination

All trial data will be anonymised before it is shared with the authors. The data will be encrypted and stored on a secure server located in the Netherlands. No major ethical concerns remain. This IPDMA will provide the evidence base to update and tailor diagnostic and treatment protocols as well as (international) guidelines for patients for whom orthopaedic surgeons consider APM. The results will be submitted for publication in a peer-reviewed journal.

PROSPERO registration number

CRD42017067240.

Development of screening tools to predict the risk of recurrence and related complications following anal fistula surgery: protocol for a prospective cohort study

Por: Mei · Z. · Li · Y. · Zhang · Z. · Zhou · H. · Liu · S. · Han · Y. · Du · P. · Qin · X. · Shao · Z. · Ge · M. · Wang · Q. · Yang · W.
Introduction

Postoperative recurrence and related complications are common and related to poor outcomes in patients with anal fistula (AF). Due to being associated with short-term and long-term cure rates, perioperative complications have received widespread attention following AF surgery. This study aims to identify a set of predictive factors to develop risk prediction models for recurrence and related complications following AF surgery. We plan to develop and validate risk prediction models, using information collected through a WeChat patient-reported questionnaire system combined with clinical, laboratory and imaging findings from the perioperative period until 3–6 months following AF surgery.

Methods and analysis

This is a prospective hospital-based cohort study using a linked database of collected health data as well as the follow-up outcomes for all adult patients who suffered from AF at a tertiary referral hospital in Shanghai, China. We will perform logistic regression models to predict anal fistula recurrence (AFR) as well as related complications (eg, wound haemorrhage, faecal impaction, urinary retention, delayed wound healing and unplanned hospitalisation) during and after AF surgery, and machine learning approaches will also be applied to develop risk prediction models. This prospective study aims to develop the first risk prediction models for AFR and related complications using multidimensional variables. These tools can be used to warn, motivate and empower patients to avoid some modifiable risk factors to prevent postoperative complications early. This study will also provide alternative tools for the early screening of high-risk patients with AFR and related complications, helping surgeons better understand the aetiology and outcomes of AF in an earlier stage.

Ethics and dissemination

The study was approved by the Institutional Review Board of Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine (approval number: 2019-699-54-01). The results of this study will be submitted to international scientific peer-reviewed journals or conferences in surgery, anorectal surgery or anorectal diseases.

Trial registration number

ChiCTR1900025069; Pre-results.

Global incidence of surgical site infection after appendectomy: a systematic review and meta-analysis

Por: Danwang · C. · Bigna · J. J. · Tochie · J. N. · Mbonda · A. · Mbanga · C. M. · Nzalie · R. N. T. · Guifo · M. L. · Essomba · A.
Background

Although surgical site infection (SSI) is one of the most studied healthcare-associated infections, the global burden of SSI after appendectomy remains unknown.

Objective

We estimated the incidence of SSI after appendectomy at global and regional levels.

Design

Systematic review and meta-analysis.

Participants

Appendectomy patients.

Data sources

EMBASE, PubMed and Web of Science were searched, with no language restrictions, to identify observational studies and clinical trials published between 1 January 2000 and 30 December 2018 and reporting on the incidence of SSI after appendectomy. A random-effect model meta-analysis served to obtain the pooled incidence of SSI after appendectomy.

Results

In total, 226 studies (729 434 participants from 49 countries) were included in the meta-analysis. With regard to methodological quality, 59 (26.1%) studies had low risk of bias, 147 (65.0%) had moderate risk of bias and 20 (8.8%) had high risk of bias. We found an overall incidence of SSI of 7.0 per 100 appendectomies (95% prediction interval: 1.0–17.6), varying from 0 to 37.4 per 100 appendectomies. A subgroup analysis to identify sources of heterogeneity showed that the incidence varied from 5.8 in Europe to 12.6 per 100 appendectomies in Africa (p

Conclusion

This study suggests a high burden of SSI after appendectomy in some regions (especially Africa) and in low-income countries. Strategies are needed to implement and disseminate the WHO guidelines to decrease the burden of SSI after appendectomy in these regions.

Prospero registration number

CRD42017075257.

Postoperative surveillance and long-term outcome after endovascular aortic aneurysm repair in the Netherlands: study protocol for the retrospective ODYSSEUS study

Por: Geraedts · A. C. M. · de Mik · S. · Ubbink · D. · Koelemay · M. · Balm · R. · on behalf of the ODYSSEUS study group · Elshof · Elsman · Hamming · van Herwaarden · Kropman · Lensvelt · Poyck · Schurink · Smet · van Sterkenburg · Ünlü · Vahl · Verhagen · Vriens · Vries · Wever
Introduction

Strict imaging surveillance protocols to detect complications following endovascular aneurysm repair (EVAR) are common practice. However, controversy exists as to whether all EVAR patients need intense surveillance. The 2019 European Society for Vascular Surgery guidelines for management of abdominal aortic aneurysm (AAA) suggest that patients may be considered for limited follow-up with imaging if classified as ‘low risk’ for complications based on their initial postoperative imaging. The current study aims to investigate the intervention-free survival and overall survival stratified for patients with and without yearly imaging surveillance.

Methods and analysis

The Observing a Decade of Yearly Standardised Surveillance in EVAR patients with Ultrasound or CT Scan study comprises a national multicentre retrospective cohort study in 17 medical centres. Consecutive patients with an asymptomatic or symptomatic infrarenal AAA who underwent EVAR between January 2007 and January 2012 will be included in this study with follow-up until December 2018. Clinical variables and all follow-up information will be retrieved in extensive data collection from the patient’s medical records. In addition, an e-survey was sent to vascular surgeons at the 17 participating centres to gauge their opinions regarding the possibility of safely reducing the frequency of imaging surveillance. Primary endpoints are intervention after EVAR and aneurysm-related mortality. The initial estimated sample size is 1997 patients.

Ethics and dissemination

The study has been approved by the Medical Ethics Review Committee of the Amsterdam UMC, location Academic Medical Centre, Amsterdam, the Netherlands. Study findings will be disseminated via presentations at conferences and publications in peer-reviewed journal.

Trial registration number

The Netherlands Trial Registry, NL6953 (old: NTR28773).

Does breast reduction surgery improve health-related quality of life? A prospective cohort study in Australian women

Objectives

To assess the health burden of breast hypertrophy and the comparative effectiveness of breast reduction surgery in improving health-related quality of life.

Design

Prospective cohort study.

Setting

A major public tertiary care hospital in Australia.

Participants

Women with symptomatic breast hypertrophy who underwent breast reduction surgery were followed for 12 months. A comparison control cohort comprised women with breast hypertrophy who did not undergo surgery.

Interventions

Bilateral breast reduction surgery for women in the surgical cohort.

Main outcome measures

The primary outcome measure was health-related quality of life measured preoperatively and at 3, 6 and 12 months postoperatively using the Short Form-36 (SF-36) questionnaire. Secondary outcome measures included post-surgical complications.

Results

209 patients in the surgical cohort completed questionnaires before and after surgery. 124 patients in the control hypertrophy cohort completed baseline and 12-month follow-up questionnaires. At baseline, both groups had significantly lower scores compared with population norms across all scales (p

Conclusion

Breast reduction significantly improved quality of life in women with breast hypertrophy. This increase was most pronounced within 3 months of surgery and sustained at 12-month follow-up. This improvement in quality of life is comparable to other widely accepted surgical procedures. Furthermore, women benefit from surgery regardless of factors including body mass index and resection weight.

Laparoendoscopic single-site surgery compared with conventional laparoscopic surgery for benign ovarian masses: a systematic review and meta-analysis

Por: Lin · Y. · Liu · M. · Ye · H. · He · J. · Chen · J.
Objective

We aimed to evaluate the safety, efficiency and preferred indication for laparoendoscopic single-site surgery (LESS) compared with conventional laparoscopic (CL) surgery for benign ovarian masses.

Design

A systemic review and cumulative meta-analysis were performed in line with the criteria of Grading of Recommendations Assessment, Development and Evaluation: levels of evidence and grades of recommendation.

Data sources

We comprehensively searched the electronic databases including PubMed, Medline, Embase and the Cochrane Library in November 2018.

Eligibility criteria for selecting studies

We included all randomised controlled trials (RCTs) and retrospective studies published in recent 10 years, which investigated the performance of LESS versus CL in patients at all ages with benign ovarian masses.

Results

Four RCTs and nine retrospective studies published in recent decade including 1542 cases (744 cases for LESS and 798 cases for CL) were identified. Perioperative complication was consisted of intraoperative and postoperative complications, including ileus, wound infection or dehiscence and incisional hernia. Although LESS has less postoperative analgesic consumption (46.78% and 79.25%; OR: 0.49; 95% CI: 0.33 to 0.74, p

Conclusions

The indications of LESS for benign ovarian masses are similar to CL and it has better postoperative recovery. However, with less perioperative complications, CL surgery is safer than LESS.

Patient priorities in relation to surgery for gastric cancer: qualitative interviews with gastric cancer surgery patients to inform the development of a core outcome set

Por: Alkhaffaf · B. · Blazeby · J. M. · Bruce · I. A. · Morris · R. L.
Objective

The reporting of outcomes in surgical trials for gastric cancer is inconsistent. The GASTROS study (GAstric Cancer Surgery TRials Reported Outcome Standardisation) aims to address this by developing a core outcome set (COS) for use in all future trials within this field. A COS should reflect the views of all stakeholders, including patients. We undertook a series of interviews to identify outcomes important to patients which would be considered for inclusion in a COS.

Setting

All interviews took place within the UK. Interviews were carried out face-to-face at hospitals and cancer support centres or via the telephone.

Participants

Twenty participants at varying stages of recovery following surgery for gastric cancer with curative intent.

Design

Qualitative design using semistructured interviews, supported by an interview guide which was iteratively modified; thematic analysis was used to explore patient priorities.

Results

Six themes enveloping 38 outcomes were identified; surviving and controlling cancer, technical aspects of surgery, adverse events from surgery, recovering from surgery, long-term problems following surgery and long-term life impact of surgery. The ‘most important’ patient priority was to be ‘cured of cancer’.

Conclusion

Surgical trials for gastric cancer should consider broader priorities of patients when choosing which outcomes to report. This study highlighted the importance of longer-term outcomes such as cancer survival. Outcomes identified in this study will be used to inform an international Delphi survey to develop a COS in this field.

TULIP: a randomised controlled trial of surgical versus non-surgical treatment of lateral compression injuries of the pelvis with complete sacral fractures (LC1) in the non-fragility fracture patient--a feasibility study protocol

Por: Barnfield · S. · Ingram · J. · Halliday · R. · Griffin · X. · Greenwood · R. · Kandiyali · R. · Thompson · J. · Glynn · J. · Beasant · L. · McArthur · J. · Bates · P. · Acharya · M.
Introduction

Lateral compression type 1 (LC1) pelvic fractures are the most common type of pelvic fracture. The majority of LC1 fractures are considered stable. Fractures where a complete sacral fracture is present increases the degree of potential instability and have the potential to displace over time. Non-operative management of these unstable fractures may involve restricted weight bearing and significant rehabilitation. Frequent monitoring with X-rays is also necessary for displacement of the fracture. Operative stabilisation of these fractures may be appropriate to prevent displacement of the fracture. This may allow patients to mobilise pain-free, quicker.

Methods and analysis

The study is a feasibility study to inform the design of a full definitive randomised controlled trial to guide the most appropriate management of these injuries. Participants will be recruited from major trauma centres and randomly allocated to either operative or non-operative management of their injuries. A variety of outcome instruments, measuring health-related quality of life, functional outcome and pain, will be completed at several time points up to 12 months post injury. Qualitative interviews will be undertaken with participants to explore their views of the treatments under investigation and trial processes.

Eligibility and recruitment to the study will be analysed to inform the feasibility of a definitive trial. Completion rates of the measurement instruments will be assessed, as well as their sensitivity to change and the presence of floor or ceiling effects in this population, to inform the choice of the primary outcome for a definitive trial.

Ethics and dissemination

Ethical approval for the study was given by the South West—Central Bristol NHS Research Ethics Committee on 2nd July 2018 (Ref; 18/SW/0135). The study will be reported in relevant specialist journals and through presentation at specialist conferences.

Trial registration number

ISRCTN10649958

Proximal Femoral Nail Unlocked versus Locked (ProFNUL): a protocol for a multicentre, parallel-armed randomised controlled trial for the effect of femoral nail mode of lag screw locking and screw configuration in the treatment of intertrochanteric femur f

Por: Sivakumar · A. · Thewlis · D. · Ladurner · A. · Edwards · S. · Rickman · M.
Introduction

Intertrochanteric fractures are common fragility injuries in the elderly. Surgical fixation using intramedullary devices are one of the widely used management options. To date, evidence demonstrating the effects of lag screw configuration and the mode of lag screw locking in these devices is lacking. The purpose of this study is to investigate whether the lag screw configuration (single vs integrated dual interlocking screw) and the mode of lag screw locking (static vs dynamic) of a femoral nail device result in differences in clinical and functional outcomes.

Methods and analysis

A multicentre, pragmatic, single-blinded randomised controlled trial (RCT) with a three-arm parallel group design is proposed. Nine-hundred patients with intertrochanteric fractures (A1 and A2 AO/OTA) will be randomised to fracture treatment using a Gamma3 nail (Stryker; proximally dynamic) or a Trigen Intertan nail (Smith & Nephew) in a dynamic or static lag screw configuration. The primary outcome measure consists of radiological evidence of construct failure within 6 months following surgery, with failure being defined as breakage of the femoral nail or distal locking screw, a change in tip-apex distance of more than 10 mm or lag screw cut-out through the femoral head. Secondary outcomes include surgical data (operation time, fluoroscopy time), complications (surgical site infection, reoperation, patient death), return to mobility and home circumstances, functional independence, function and pain. Patients who are able to walk independently with or without a mobility aid and are able to answer simple questions and follow instructions will be asked to participate in three dimensional gait analysis at 6 weeks and 6 months to assess hip biomechanics from this cohort. Additional secondary measures of gait speed, hip range of motion, joint contact and muscle forces and gross activity monitoring patterns will be obtained in this subgroup.

Ethics and dissemination

The Central Adelaide Local Health Network Human Research Ethics Committee has approved the protocol for this RCT (HREC/17/RAH/433). The results will be disseminated via peer-reviewed publications and presentations at relevant conferences.

Trial registration number

ACTRN12618001431213.

Perceived barriers to multiprofessional team briefings in operating theatres: a qualitative study

Por: Fruhen · L. · Carpini · J. A. · Parker · S. K. · Leung · Y. · Flemming · A. F. S.
Objectives

This study investigates perceived barriers towards the implementation of multiprofessional team briefings (MPTB) in operating theatres, as well as ways to overcome these perceived barriers. Previous research shows that MPTB can enhance teamwork and communication, but are underused in operating theatres. By adopting a multilevel systems perspective, this study examines perceived barriers and solutions for MPTB implementation.

Design

Participants completed open-ended survey questions. Responses were coded via qualitative content analysis. The analysis focused on themes in the responses and the systems level at which each barrier and solution operates.

Setting

Four tertiary hospitals in Australia.

Participants

103 operating theatre staff, including nurses, surgeons, anaesthetists, technicians and administrators.

Results

Participants identified barriers and solutions at the organisational (15.81% of barriers; 74.10% of solutions), work group (61.39% of barriers; 25.09% of solutions) and individual level (22.33% of barriers; 0% of solutions). Of all the perceived barriers to MPTB occurrence, a key one is getting everyone into the room at the same time . Matching of perceived barriers and solutions shows that higher systems-level solutions can address lower level barriers, thereby showing the relevance of implementing such wider reaching solutions to MPTB occurrence (including work practices at occupational level and above) as well as addressing more local issues.

Conclusions

Successful MPTB implementation requires changes at various systems levels. Practitioners can strategically prepare and plan for systems-based strategies to overcome barriers to MPTB implementation. Future research can build on this study’s findings by directly examining higher systems-level barriers and solutions via detailed case analyses.

Multicentre randomised controlled trial of balloon pulmonary angioplasty and riociguat in patients with chronic thromboembolic pulmonary hypertension: protocol for the MR BPA study

Por: Kawakami · T. · Matsubara · H. · Abe · K. · Kataoka · M. · Kohsaka · S. · Sato · Y. · Shinke · T. · Fukuda · K.
Introduction

Management of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) remains a clinical challenge. Currently, medical treatment involving pulmonary vasodilators (such as soluble guanylate-cyclase stimulators) is recommended, primarily for ameliorating symptoms. More recently, balloon pulmonary angioplasty (BPA) has been developed as alternative treatment for inoperable CTEPH. This study aimed to compare the efficacy and safety of BPA and riociguat (a soluble guanylate-cyclase stimulator) as treatments for inoperable CTEPH.

Methods and analysis

This study is a multicentre randomised controlled trial. Subjects with inoperable CTEPH were randomised (1:1) into either a BPA or riociguat group, and observed for 12 months after initiation of treatment. The primary endpoint will be the change in mean pulmonary arterial pressure from baseline to 12 months after initiation of treatment. For primary analysis, we will estimate the least square means difference and 95% CI for the change of pulmonary arterial pressure between the groups at 12 months using the analysis of covariance adjusted for allocation factors.

Ethics and dissemination

This study and its protocols were approved by the institutional review board of Keio University School of Medicine and each participating institution. Written informed consent was obtained from all participants. Results will be disseminated at medical conferences and in journal publications.

Trial registration number

University Hospital Medical Information Network Clinical Trial Registry (UMIN000019549); Pre-results.

Trial protocol: preoperative administration of tranexamic acid in sleeve gastrectomy (PATAS) to reduce haemorrhage rates. A randomised controlled trial

Por: Leeman · M. · Huisbrink · J. · Wijnand · J. M. A. · Biter · L. U. · Verbrugge · S. J. C. · Dunkelgrun · M. · Apers · J. A.
Introduction

Fast-track protocols often include short-term thromboprophylaxis and short length of hospital stay. These treatment strategies may negatively affect the occurrence and diagnosis of postoperative haemorrhage. Over the years, the rates of venous thromboembolic events (VTEs) have decreased, while there seems to be an increase in the occurrence of postoperative haemorrhage. Tranexamic acid (TXA) can potentially lower the incidence of postoperative haemorrhage. This trial aims to investigate whether preoperative administration of TXA reduces the preoperative and postoperative haemorrhage rates in laparoscopic sleeve gastrectomy (LSG).

Methods and analysis

This is a single centre double-blind randomised placebo-controlled trial. Patients undergoing an LSG are included after obtaining informed consent. Patients are randomised between two groups: (1) administration of placebo infusion and (2) administration of 1500 mg TXA. In both groups, the infusions will be administered during the induction phase of the procedure. Primary outcome measures are preoperative use of haemostatic clips, postoperative haemoglobin decrease and postoperative haemorrhage. Secondary outcome measure is the rates of VTE.

Ethics and dissemination

The protocol version 3 was approved by the medical ethical committee Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 29 July 2019. The trial results will be submitted for publication in a peer-reviewed journal and at conference presentations.

Trial registration number

The Netherlands Trial Registry (NL8029); Pre-results.

Computerised cognitive training to improve cognition including delirium following coronary artery bypass grafting surgery: protocol for a blinded randomised controlled trial

Por: Greaves · D. · Psaltis · P. J. · Lampit · A. · Davis · D. H. J. · Smith · A. E. · Bourke · A. · Worthington · M. G. · Valenzuela · M. J. · Keage · H. A. D.
Introduction

Coronary artery bypass grafting (CABG) surgery is known to improve vascular function and cardiac-related mortality rates; however, it is associated with high rates of postoperative cognitive decline and delirium. Previous attempts to prevent post-CABG cognitive decline using pharmacological and surgical approaches have been largely unsuccessful. Cognitive prehabilitation and rehabilitation are a viable yet untested option for CABG patients. We aim to investigate the effects of preoperative cognitive training on delirium incidence, and preoperative and postoperative cognitive training on cognitive decline at 4 months post-CABG.

Methods and analysis

This study is a randomised, single-blinded, controlled trial investigating the use of computerised cognitive training (CCT) both pre-CABG and post-CABG (intervention group) compared with usual care (control group) in older adults undergoing CABG in Adelaide, South Australia. Those in the intervention group will complete 1–2 weeks of CCT preoperatively (45–60 min sessions, 3.5 sessions/week) and 12 weeks of CCT postoperatively (commencing 1 month following surgery, 45–60 min sessions, 3 sessions/week). All participants will undergo cognitive testing preoperatively, over their hospital stay including delirium, and postoperatively for up to 1 year. The primary delirium outcome variable will be delirium incidence (presence vs absence); the primary cognitive decline variable will be at 4 months (significant decline vs no significant decline/improvement from baseline). Logistic regression modelling will be used, with age and gender as covariates. Secondary outcomes include cognitive decline from baseline to discharge, and at 6 months and 1 year post-CABG.

Ethics and dissemination

Ethics approval was obtained from the Central Adelaide Local Health Network Human Research Ethics Committee (South Australia, Australia) and the University of South Australia Human Ethics Committee, with original approval obtained on 13 December 2017. It is anticipated that approximately two to four publications and multiple conference presentations (national and international) will result from this research.

Trial registration number

This clinical trial is registered with the Australian New Zealand Clinical Trials Registry and relates to the pre-results stage. Registration number: ACTRN12618000799257.

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.

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