International Journal of Surgery Protocols最新文献

Background: Well-designed surgical registries are essential for high-quality patient centred evaluation of implantable devices and surgical procedures. The importance of registries was highlighted in the recent Cumberlege report that detailed important innovation failures such as the use of vaginal mesh. Many surgical registries exist, but it is currently unclear how different registries are funded, governed, designed, and how their databases are hosted and utilised. There is therefore a need to understand the variation and characteristics of existing surgical registries to identify limitations and make recommendations for improvement. This work aims to understand the characteristics and heterogeneity in the design, governance, and function of existing surgical registries in the United Kingdom (UK).

Methods: Existing surgical registries will be identified using multiple data sources including surgical society websites; search engine review; a targeted search of the Medline and Embase databases and expert knowledge. The data identified were reviewed following the synthesis without meta-analysis (SWiM) methodology. This information will be gathered from sources in the public domain only to fully understand registry transparency for professionals and the public. Details of each registry including disease area/condition/device evaluated; types of outcomes collected; governance, consent, and oversight; linkage to other datasets and funding will be extracted using a standardised data extraction tool. Characteristics of identified registries will be summarised into a narrative review.

Dissemination: Findings will be presented at national and international conferences and published in peer-reviewed journals. Results will be presented to key stakeholders including surgeons, methodologists, trialists, regulators, data managers and patients to provide an up-to-date description of the current state of surgical registries in the UK. This work will inform a consensus process to agree how the design of new and existing registries can be optimised to support high quality research to benefit patients and the NHS.

Highlights: Well-designed surgical registries are essential for high-quality patient centred evaluation of implantable devices and surgical proceduresPresently there is limited understanding on how these registries are designed, governed, what data they collect and how this data is utilised for research.This review aims to map the landscape of surgical registries in the UK, and understand how they are optimised for research.

Introduction: Innovation in surgery drives improvements to patient care. New surgical procedures and devices typically undergo a series of modifications as they are developed and refined during their introduction into clinical practice. These changes should ideally be reported and shared between surgeon-innovators to promote efficient, safe and transparent innovation. Currently, agreement on how modifications should be defined, conceptualised and classified, so they can be reported and shared efficiently and transparently, is lacking. The aim of this review is to examine and summarise existing literature on definitions, perceptions and classifications of modifications to surgical procedures/devices, including views on how to measure and report them. The findings will inform future work to standardise reporting and sharing of modifications in surgical innovation.

Materials and methods: A systematic scoping review will be conducted adhering to PRISMA-ScR guidelines. Included articles will focus on review articles and opinion pieces relevant to modifications to new surgical procedures or devices introduced to clinical practice. Methods to identify relevant literature will include systematic searches in MEDLINE (Ovid version), targeted internet searches (Google Scholar) and snowball searches. A two-stage screening process (titles/abstracts/keywords and full-texts) will use specified exclusion/inclusion criteria to identify eligible articles. Data on how modifications are i) defined, ii) perceived, and iii) classified, and iv) views on how modifications should be measured and reported, will be extracted verbatim. Inductive thematic analysis will be applied to extracted data where appropriate. Results will be presented as a narrative summary including descriptive characteristics of included articles. Findings will inform a preliminary conceptual framework to facilitate the systematic reporting and sharing of modifications to novel procedures and devices.

Highlights: This work will generate an in-depth understanding of how modifications are currently defined, perceived and classified, and views on how they may be reported, in the context of surgical innovation.Rigorous and comprehensive search methods will be applied to identify a wide range of diverse data sources for inclusion in the review.A summary of existing relevant literature on modifications is a necessary step to inform development of a framework for transparent, real-time reporting and sharing of modifications in future studies of innovative invasive procedures/devices.

Background: A significant proportion of the public rely on the internet for their health information, and social media has emerged as the principal information source. YouTube is the world's largest and most popular video library, and it has emerged as a primary health information source because it offers animated and interactive content. However, little is known of its usefulness of neurosurgery videos to African YouTube users. We aim with this study to evaluate the usefulness of YouTube as a source of patient information for neurosurgical care in Africa.

Methodology: This observational study will be conducted using YouTube. A search will be carried out to identify neurosurgery videos suggested to African YouTube viewers from inception to September 2021. An internet browser (Google Chrome, Google Inc., CA, USA) with its cache cleared will be used to execute the search. The default YouTube search setting of "relevance" will be used to replicate what a search attempt performed by a patient would be. The first 50 results from each keyword search will be registered in a Microsoft Excel spreadsheet (Microsoft, WA, USA). The primary outcome measure is the reliability of the videos. Data will be analyzed using SPSS version 26 (IBM, WA, USA). Odds ratios and their 95% confidence intervals will be calculated. The statistically significant level will be set at 0.05. Also, a linear regression analysis will be performed to examine the effects of independent variables on continuous dependent variables.

Dissemination: The study findings will be published in an academic peer-reviewed journal, and the abstract will be presented at an international conference. English and French visual and video abstracts of the methods and key findings will be designed and disseminated widely on social media.

Highlights: A significant proportion of the public rely on the internet and social media for health information.YouTube has emerged as the world's largest video library, and has emerged as a primary health information source.There are few safeguards to avoid dissemination of false or biased information on the platform this could negatively influence health seeking behaviorWe aim to evaluate the usefulness of YouTube as a source of patient information for neurosurgical care in Africa.The findings of this study will help evaluate the volume and quantity of African neurosurgical video content and identify best practices.

Objectives: The current Indian scenario follows the western cardiac rehabilitation protocol; hence the primary aim of the study is to develop a cardiac rehabilitation phase 1 protocol for the Indian scenario. The protocol will be used in the study as standard rehabilitation protocol for the intervention groups. The literature suggests the use of Pranayama and chair aerobics to improve the anxiety in CABG patients. This study also aims to provide the answer for the effect of Pranayama and chair aerobics on anxiety and exercise tolerance in CABG patients. And also try to find out which among the two intervention is superior among one another.

Methods: The cardiac rehabilitation protocol will be validated by experts in the field and applied in the patients and the results will be analysed. Then the protocol will be used as the standard rehabilitation protocol in both the groups. 100 patients will be randomised and allocated into 2 groups. Group 1 will receive Nadi Sodhana Chair aerobics for 15 minutes along with phase I cardiac rehabilitation. The group 2 will receive Chair aerobics for 15 minutes along with phase I cardiac rehabilitation. The outcome measures will be taken before the surgery and on the post-operative day 7. The primary outcome measures are Hospital anxiety and depression scale (HADS) and Heart rate and the secondary outcome measure is 6-minute walk test. The intention to treat analysis will be done after the data collection.

Results: The data will be analysed using unpaired t test, p value <0.05 will be considered significant.

Conclusion: The result will give a new insight into the field of cardiac surgery, where the effect of pranayama and chair aerobics on anxiety and functional outcome will be proved.

Ctri registration: This trial is prospectively registered in CTRI, the registration number of the trial is CTRI/2021/09/037008.

Highlights: What is already known about this subject? The effect of Pranayama and chair aerobics on various components like pain, peak expiratory flow after CABG is proven in different studies. The phase 1 cardiac rehabilitation is practiced and adopted from western protocol.What does this study add? The study will give a new insight into the field of cardiac rehabilitation. Definite phase I cardiac rehabilitation protocol for Indian population is not exist in the literature. The Indian set up is using the western protocol, which is not suitable for the Indian population hence could not achieve the expected outcome on discharge. We believe that this study will provide a definite phase I cardiac rehabilitation protocol for the Indian population. This can be followed in the community. Also, this study aims to explore the unexplored area of anxiety after CABG. Where the effect of the Pranayama and chair aerobics will be identified. And also give idea about

Introduction: Ageing of the general population has led to an increase in the use of suboptimal kidneys from expanded criteria donation after brain death (ECD-DBD) and donation after circulatory death (DCD) donors. However, these kidneys have inferior graft outcomes and lower rates of immediate function. Normothermic machine perfusion (NMP) may improve outcomes of these suboptimal donor kidneys. Previous non-randomized studies have shown the safety of this technique and suggested its efficacy in improving the proportion of immediate functioning kidneys compared to static cold storage (SCS). However, its additional value to hypothermic machine perfusion (HMP), which has already been proved superior to SCS, has not yet been established.

Methods and analysis: This single-center, open-label, randomized controlled trial aims to assess immediate kidney function after 120 minutes additional, end-ischemic NMP compared to HMP alone. Immediate kidney function is defined as no dialysis treatment in the first week after transplant. Eighty recipients on dialysis at the time of transplant who receive an ECD-DBD or DCD kidney graft are eligible for inclusion. In the NMP group, the donor kidney is taken of HMP upon arrival in the recipient hospital and thereafter put on NMP for 120 minutes at 37 degrees Celsius followed by transplantation. In the control group, donor kidneys stay on HMP until transplantation. The primary outcome is immediate kidney function.

Ethics and dissemination: The protocol has been approved by the Medical Ethical Committee of Erasmus Medical Center (2020-0366). Results of this study will be submitted to peer-reviewed journals.

Registration: registered in clinicaltrials.gov (NCT04882254).

Highlights: This is the first RCT to compare additional NMP to HMP alone.Extensive sampling will offer in-depth analysis of kidney physiology during NMP.This RCT may help identify biomarkers to predict clinical outcomes during NMP.Biomarkers can help develop NMP as assessment tool for declined kidneys.

Background: Surgical site infections (SSIs) remain a relevant problem in colorectal surgery. The aim of this study is to implement a bundle of care in order to reduce SSIs in colorectal surgery.

Methods: All patients undergoing colorectal surgery between October 2018 and December 2021 will be included in a prospective observational study. Since our colorectal bundle has been established gradually, patients will be grouped in a pre-implementation (2018-2019), implementation (2019-2020) and post implementation phase (2021), in order to assess the effectiveness of the actions undertaken. Primary endpoint of this study will be surgical site infection (SSI) rate, while secondary endpoints encompass potential risk factors for SSIs. We assume that obesity, age, diabetes, alcoholism and smoking may lead to a higher risk for SSIs.

Discussion: This study aims to determine whether the colorectal bundle designed and implemented at Cantonal Hospital Lucerne, will lead to a significant reduction of SSIs. The impact of potential risk factors for SSIs will additionally be evaluated.

Trial registration: ClinicalTrials.gov, ID: NCT04677686. Registered retrospectively 18 December 2020.

Highlights: A bundle of care might reduce the occurence of surgical site infections after colorectal surgery.Analysis of risk factors may detect patient's with high probability of developing surgical site infections.

Background: Various sites are used for specimen extraction in oncological minimally invasive colorectal surgery. The objective is to determine if the choice of extraction site modulates the incidence of incisional hernia (IH).

Methods/design: A systematic review will be performed in accordance to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. MEDLINE, Embase and CENTRAL will be searched to look for original studies reporting the incidence of IH after minimally invasive colorectal surgery. Studies will be excluded from the analysis if: 1) they do not report original data, 2) the outcome of interest (incidence of incisional hernia) is not clearly reported and does not allow to extrapolate and/or calculate the required data for network meta-analysis, 3) they include pediatric patients, 4) they include a patients' population with a conversion rate to laparotomy >10%, 5) they do not compare at least two different extraction sites for the operative specimen, 6) they report patients who underwent pure (and not hybrid) natural orifice transluminal endoscopic surgery (NOTES). Network meta-analysis will be performed to determine the incidence of IH per extraction site.

Discussion: By determining which specimen extraction site leads to reduced rate of IH, this systematic review and network meta-analysis will help colorectal surgeons to choose their extraction site and reduce the morbidity and costs associated with IH.

Registration: The systematic review and meta-analysis protocol is registered in the International Prospective Register of Ongoing Systematic Reviews (PROSPERO) with number CRD42021272226.

Highlights: Various sites are used for specimen extraction in oncological minimally invasive colorectal surgery, and the choice of the site may probably modulate the incidence of incisional hernia.The present protocol aims to design a systematic review which will identify original studies comparing two extraction sites during minimally invasive colorectal surgery in terms of incidence of incisional hernia.Network meta-analysis will be performed to determine the incidence of IH per extraction site.

Introduction: Percutaneous thermal ablation is widely adopted as a curative treatment approach for unresectable liver neoplasms. Accurate immediate assessment of therapeutic response post-ablation is critical to achieve favourable outcomes. The conventional technique of side-by-side comparison of pre- and post-ablation scans is challenging and hence there is a need for improved methods, which will accurately evaluate the immediate post-therapeutic response.

Objectives and significance: This review summarizes the findings of studies investigating the feasibility and efficacy of the fusion imaging systems in the immediate post-operative assessment of the therapeutic response to thermal ablation in liver neoplasms. The findings could potentially empower the clinicians with updated knowledge of the state-of-the-art in the assessment of treatment response for unresectable liver neoplasms.

Methods and analysis: A rapid review will be performed on publicly available major electronic databases to identify articles reporting the feasibility and efficacy of the fusion imaging systems in the immediate assessment of the therapeutic response to thermal ablation in liver neoplasms. The risk of bias and quality of articles will be assessed using the Cochrane risk of bias tool 2.0 and Newcastle Ottawa tool.

Ethics and dissemination: Being a review, we do not anticipate the need for any approval from the Institutional Review Board. The outcomes of this study will be published in a peer-reviewed journal.

Highlights: Evaluation of the therapeutic response in liver neoplasms immediately post-ablation is critical to achieve favourable patient outcomes. We will examine the feasibility and technical efficacy of different fusion imaging systems in assessing the immediate treatment response post-ablation. The findings are expected to guide the clinicians with updated knowledge on the state-of-the-art when assessing the immediate treatment response for unresectable liver neoplasms.

Diverticular disease is an increasingly common issue, with a variety of clinical presentations and treatment options. However, very few prospective cohort studies explore outcomes between the different presentations and treatments. The Diverticular Disease Registry (DDR Trial) is a multicenter, prospective, observational cohort study on behalf of the Advanced International Mini-Invasive Surgery (AIMS) academy clinical research network. The DDR Trial aims to investigate the short-term postoperative and long-term quality of life outcomes in patients undergoing surgery or medical treatments for diverticular disease. DDR Trial is open to participation by all tertiary-care hospitals. DDR Trial has been registered at ClinicalTrials.gov (NCT04907383). Data collection will be recorded on Research Electronic Data Capture (REDCap) starting on June 1^st, 2021 and will end after 5 years of recruitment. All adult patients with imaging-proven colonic diverticular disease (i.e., symptomatic colonic diverticulosis including diverticular bleeding, diverticulitis, and Symptomatic Uncomplicated Diverticular Disease) will be included. The primary outcome of DDR Trial is quality of life assessment at 12-month according to the Gastrointestinal Quality of Life Index (GIQLI). The secondary outcome is 30-day postoperative outcomes according to the Clavien-Dindo classification. DDR Trial will significantly advance in identifying the optimal care for patients with diverticular disease by exploring outcomes of different presentations and treatments.

Highlights: Diverticular disease (i.e., diverticulitis, bleeding) has different treatments.This is a clinical protocol for the Diverticular Disease Registry (DDR Trial).DDR Trial is a multicenter, prospective, observational cohort study open to participation.DDR Trial will study short-term postoperative and long-term quality of life outcomes.Medical treatments, interventional radiology and surgery will be explored.

Introduction: Although single-incision laparoscopic appendectomy (SILA) was introduced decades ago, it is still considered a difficult technique to perform compared to conventional laparoscopic appendectomy (CLA). In addition, controversy about the benefits of SILA compared to CLA abound and no definite criteria for choosing SILA over CLA in patients with appendicitis currently exist. Therefore, we have planned a multi-center randomized controlled trial to compare SILA with CLA in terms of cosmetic satisfaction and pain reduction.

Methods and analysis: Patients diagnosed with appendicitis at the participating centers will be recruited and allocated into either a CLA or an SILA groups using a 1:1 randomization. Patients in the CLA group will receive a conventional 3-port laparoscopic appendectomy and patients in the SILA group will receive a laparoscopic appendectomy using a single-incision at the umbilicus. The primary trial endpoint is cosmetic satisfaction assessed using the Patients and Observer Scar Assessment Scale (POSAS) administered 6 weeks post-surgery. Secondary trial endpoints include cosmetic satisfaction assessed via the Body Image Questionnaire, pain levels assessed via the Visual Analog Scale and International Pain Outcomes questionnaire, and the presence of postoperative complications. The target sample size of this superiority trial is 120 patients, as this will provide 80% power at the 2.5% level of significance to detect a 3-point difference in POSAS.

Discussion: The results of this planned multi-center randomized controlled trial will provide substantive evidence to help surgeons choose when to use SILA over CLA in patients with appendicitis.

Ethics and dissemination: This trial was approved by the institutional review board at Daegu joint on February 27, 2020 (No: 19-12-001-001) and registered with the clinical research information service (CRIS) (KCT0005048). The results of the study will be published and presented at appropriate conferences.

Highlights: To investigate the clinical benefits comparing between single incision laparoscopic appendectomy and conventional laparoscopic appendectomyTo assess the pain and cosmetic satisfaction through quantitative scales, Patient-Reported Outcomes Measures (PROMs), International Pain Outcome (IPO) Questionnaire, the Patient and Observer Scar Assessment Scale (POSAS), and the Body Image Questionnaire (BIQ)To help surgeons choose when to use single incision laparoscopic appendectomy in patients with appendicitis.