International Journal of Surgery Protocols最新文献

Background: Trauma accounts for 10% of global mortality, with increasing rates disproportionally affecting low- and middle-income countries. In an attempt to improve clinical outcomes after injury, trauma systems have been implemented in multiple countries over recent years. However, whilst many studies have subsequently demonstrated improvements in overall mortality outcomes, less is known about the impact trauma systems have on morbidity, quality of life, and economic burden. This systematic review seeks to assess the existing evidence base for trauma systems with these outcome measures.

Methods: This review will include any study that assesses the impact implementation of a trauma system has on patient morbidity, quality of life, or economic burden. Any comparator study, including cohort, case-control, and randomised controlled studies, will be included, both retrospective or prospective in nature. Studies conducted from any region in the world and involving any age of patient will be included. We will collect data on any morbidity outcomes, health-related quality of life measures, or health economic assessments reported. We predict a high heterogeneity in these outcomes used and will therefore keep inclusion criteria broad.

Discussion: Previous reviews have shown the significant improvements that can be achieved in mortality outcomes with the implementation of an organised trauma system, however the wider impact they can have on morbidity outcomes, quality of life measures, and the economic burden of trauma, is less well described. This systematic review will present all available data on these outcomes, helping to better characterise both the societal and economic impact of trauma system implementation.

Highlights: Trauma systems are known to improve mortality rates, however less in known on the impact they have on morbidity outcomes, quality of life, and economic burdenWe aim to perform a systematic review to identify any comparator study that assesses the impact implementation of a trauma system on these outcomesUnderstanding the impact trauma systems can have on wider parameters, such as economic and quality of life outcomes, is crucial to allow governments globally to appropriately allocate often limited healthcare resources.PROSPERO registration number: CRD42022348529.

Background: Prolonged post-operative ileus is associated with increased risk of other complications, length of hospital stays and health care related costs. Chewing gum has been shown to reduce duration of ileus in many elective surgeries, but there is a paucity of randomised controlled trials (RCTs) on its effect on duration of ileus among patients undergoing emergency surgery, specifically patients with peritonitis. The aim of this study is to determine the effect of chewing gum on duration of postoperative ileus following laparotomy for gastroduodenal perforations.

Methods: This will be a randomised controlled trial done in 3 hospitals. Fifty-two patients will be randomised to 2 groups. Group A will receive chewing gum in addition to routine care, whereas group B will receive routine care only. The duration of post-operative ileus in the two groups which is the primary outcome, will be compared using the independent samples t-test in SPSS version 22. The length of hospital stay, in-hospital morbidity and mortality will be the secondary outcomes. This trial has been approved by Kampala International University research and Ethics committee (Ref No. KIU-2021-60) and Uganda national council of science and technology (Ref No. HS1665ES). Retrospective registration with the research registry has also been done (UIN: researchregistry8565).

Highlights: Prolonged post-operative ileus significantly contributes to adverse surgical outcomesChewing gum has been shown to reduce duration of ileus in many elective surgeriesThere is paucity of RCTs on role of chewing gum following surgery for peritonitis.

Introduction: Digestive surgical emergencies remains one of the main general surgery activities. Despite the associated mortality rate in low income countries, epidemiologic data about this subject is rare and multicenter studies are even more. We aimed to study an epidemiology of digestive surgical emergencies in Senegal by multicenter protocol.

Methods and analysis: it will a prospective multicenter pilot study from May to July 2022. The patients were from General surgery departments of these teaching hospital in Senegal: Dakar Principal Hospital, Aristide le Dantec Hospital, Dalal Jamm hospital and Saint-Louis Regional Hospital. The Schwartz formula was used. We used a proportion of abdominal surgical emergency of 20%. We had a sample size of 246 patients.

Ethics and dissemination: this research protocol will be submitted to Ethics committee of four hospital that included. The results of this study can help to get better the management of our digestives emergencies and at the same time improve mortality rate.

Highlights: Digestive surgical emergencies is a public health issueBecause of high mortality rate in poorest countries, epidemiological data in Senegal must be knownThese information can help to lower associated mortality.

Introduction and objectives: Mandible reconstruction with vascularized fibula flap is the standard treatment for segmental mandibulectomy in patients with tumor or trauma. But the height of the fibula graft is insufficient for dental implant placement and prosthetic rehabilitation to replace the missing teeth, which in turn will compromise the functional efficiency and aesthetics of the patient. Although the bone height can be augmented through onlay grafting with iliac crest, it is associated with limitations like donor site morbidity and fast resorbability. This suggests the need for a synthetic biomaterial for vertical bone augmentation in implant dentistry.We have developed a biomimetic, porous, mechanically stable, and biodegradable nanocomposite named "NANOTEX BONE Graft" and its bone regeneration potential was evaluated in pre-clinical animal models. In this clinical trial, the safety as well as the efficacy of NANOTEX to augment new bone over fibula and further its ability to integrate with dental implants will be studied. The study has received the approval of the Ethics Committee of Amrita Institute of Medical Sciences and Central Drugs Standard Control Organization (CDSCO), India.

Methods: We have designed a prospective, single-center, non-randomized pilot clinical study. Patients with benign tumor or trauma indicated for mandibular reconstruction followed by implant rehabilitation will be included in the study. Eligible patients will be enrolled after obtaining informed consent. The study will be initiated and followed up as per defined timelines.

Highlights: Resection of benign mandibular tumours necessitates surgical removal of jaw bone and adjacent affected areas.The segmental mandibulectomy leaves the patient with functional impairments and aesthetic defects which in turn affect the quality of life.The standard treatment of reconstruction with vascularized fibula flap has challenge in achieving sufficient vertical bone height for implant placement and prosthetic rehabilitation.Alternate surgical techniques cause donor site morbidity and surgical complications.There is need for a synthetic biomaterial to be grafted over fibula for vertical bone augmentation.NANOTEX BONE Graft, a nanofibrous composite scaffold that mimics native bone, promote cell infiltration, neo-angiogenesis and new bone formation.Preclinical studies of NANOTEX in animal models showed bone tissue regeneration, better biodegradation in critical sized defects and efficient integration with dental implants.This clinical study propose to evaluate the safety and efficacy of NANOTEX bone graft augmented over fibula in bone regeneration and Titanium dental implant integration.

Introduction: Intraoperative adverse events (iAEs) occur and have the potential to impact the postoperative course. However, iAEs are underreported and are not routinely collected in the contemporary surgical literature. There is no widely utilized system for the collection of essential aspects of iAEs, and there is no established database for the standardization and dissemination of this data that likely have implications for outcomes and patient safety. The Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) Global Surgical Collaboration initiated a global effort to address these shortcomings, and the establishment of an adverse event data collection system is an essential step. In this study, we present the core-set variables for collecting iAEs that were based on the globally validated ICARUS criteria for surgical/interventional and anesthesiologic intraoperative adverse event collection and reporting.

Material and methods: This article includes three tools to capture the essential aspects of iAEs. The core-set variables were developed from the globally validated ICARUS criteria for reporting iAEs (item 1). Next, the summary table was developed to guide researchers in summarizing the accumulated iAE data in item 1 (item 2). Finally, this article includes examples of the method and results sections to include in a manuscript reporting iAE data (item 3). Then, 5 scenarios demonstrating best practices for completing items 1-3 were presented both in prose and in a video produced by the ICARUS collaboration.

Dissemination: This article provides the surgical community with the tools for collecting essential iAE data. The ICARUS collaboration has already published the 13 criteria for reporting surgical adverse events, but this article is unique and essential as it actually provides the tools for iAE collection. The study team plans to collect feedback for future directions of adverse event collection and reporting.

Highlights: This article represents a novel, fully-encompassing system for the data collection of intraoperative adverse events.The presented core-set variables for reporting intraoperative adverse events are not based solely on our opinion, but rather are synthesized from the globally validated ICARUS criteria for reporting intraoperative adverse events.Together, the included text, figures, and ICARUS collaboration-produced video should equip any surgeon, anesthesiologist, or nurse with the tools to properly collect intraoperative adverse event data.Future directions include translation of this article to allow for the widest possible adoption of this important collection system.

Introduction: The treatment of acute, peri-operative, and chronic pain by healthcare practitioners and health systems requires appropriate access to and availability of essential opioid medications. While opioids are often oversupplied and overprescribed in high-income countries, there are significant inequities as many low- and middle-income countries (LMICs) experience severe shortages. In fact, while the richest 10% in the world reside in countries receiving almost 90% of all available opioids, 50% of the poorest in the world reside in countries receiving just 1% of all available opioids.Understanding the social, economic, cultural, and regulatory barriers to access essential opioid analgesics in LMICs is critical in delineating and prioritizing appropriate interventions. We aim to conduct a scoping review on the availability and usage of essential opioid analgesics in LMICs, specifically in sub-Saharan Africa, to identify barriers, themes, and knowledge gaps.

Materials and methods: We will utilize the framework for conducting scoping reviews by Arksey and O'Malley. We will perform the search for articles in 3 electronic databases (i.e., SCOPUS, PubMed, Embase) and relevant gray literature. Only articles in English will be included. There will be no restriction on the publication period. All articles will directly involve either the availability and/or the use of essential opioid analgesics. Studies will be restricted to focus on sub-Saharan Africa. We will use a tailored extraction frame to extract relevant information from published articles that meet our inclusion criteria. We will analyze the data using both descriptive statistics and thematic analysis on the main study questions.

Ethics and dissemination: Since we will not be collecting primary data, formal ethical approval is not required.Our study findings will be disseminated through abstracts, conference presentations, and peer-reviewed publications.

Highlights: 50 percent of the poorest in the world reside in countries receiving just 1 percent of all available opioidsThere is a paucity of data analyzing the inequitable distribution of essential opioid analgesics worldwideOur scoping review will identify barriers, themes, and knowledge gaps on the availability and use of essential opioids in SSAIt will identify areas for further research and potential policy initiatives.

Background: The radioactive seed localization (RSL) is used in impalpable breast cancer conservative surgery to assist the surgeon in accurately locating and excising the lesion site. This study aims to present recommendations about the RSL program implementation in health institutions that perform breast cancer conservative surgery with intraoperative localization.

Methods: An extensive literature review was performed. It comprehends: the committee responsible for implementation of the program actions; description of the necessary multidisciplinary team; the radiological safety committee role; the facility licensing; professionals training; material and instrumentation associated with the technique; and seed tracking system.

Results: 13 topics are presented. The Program Implementation Committee must be formed by leaders from each department. The committee assumes responsibility for evaluating the necessary processes and presenting the schedule for program implementation. Since the procedure is classified as a nuclear medicine procedure it requires licensing. The Professional Team Formation, Education, and Training is a priority and simulation exercises are necessary. The Materials and Instrumentation Associated with the Technique must be well-know by the team and they should practice using radiation detectors. The seed must be always tracked, from moment they are received to discard. An Inventory for Tracking Seeds is provided. The Radiological Safety Aspects such as the ALARA principle are presented. A full description for the Radiological Procedure for Placing the seeds, the surgical removal and the Specimen Handling in Pathology focusing on how to locate the seed and retrieve them. After removed, the seeds can be placed in storage to wait for full radioactive decay or be returned to the manufacturer.

Conclusions: The procedure has the advantage to increase to 2 months the time between insertion of the seed and the surgical removal. Regular multidisciplinary team meetings during program development are important to create a realistic timeline, having briefing meetings after the first 1-5 RSL cases and having annual or biannual follow-up meetings to discuss any issues or incidents. Abstract Graphic ImageCreated by Macrovector, obtained in Freepik at https://br.freepik.com/fotos-vetores-gratis/oncologia.This graphical abstract shows everything that is necessary to implement the RSL technique and are discussed in this paper.

Highlights: This study present recommendations for RSL program implementation in hospitalsWas performed by an extensive descriptive and qualitative literature reviewTopics 1: Implementation Committee, Professional Team Training, InstrumentationTopics 2: Radiological Safety, Patient Consent, Radiological ProcessTopics 3: Surgical Procedure, Pathology, Seeds Disp

Background: Vaginal birth may have a negative impact on nerve structure and function, pelvic floor muscle structure, and function. Reducing the risk of pelvic floor injuries during vaginal birth is one of the most effective ways to prevent labor morbidity in women. There is a lack of tools developed based on this approach, especially in Indonesia. Therefore, we aimed to know the efficacy of a vaginal dilator called Divabirth based on labor outcomes.

Methods: This clinical study involved subjects who are randomly grouped in to the control and treatment groups. Subjects in the treatment group are told to utilize vaginal dilator devices for 20 minutes each session, a maximum of two sessions per day, lasting 5 minutes every cycle, from 35 weeks of gestation until delivery.

Discussions: The current research contributes valuable information to developing a vaginal dilator intervention program for pregnant women to reduce perineal laceration and improve labor outcomes. It may also help to lower their medical and treatment expenditures. We expect its success to be a step forward in improving reproductive health status.

Highlights: Vaginal birth may have negative impact on nerve and pelvic floor muscle structure and functionLack of tool has been developed to reduce the risk of pelvic floor injuries during vaginal birthA study protocol of vaginal dilator usage to know the efficacy based on labor outcomes.

This project is to develop a surgical error reduction system (SERS) for laparoscopic appendectomy by using observational Human Reliability Analysis (OCHRA) model and to analyse it impact on patient's outcome.

Introduction: Ductoscopy is a minimally invasive micro-endoscopic approach for direct visualization of intraductal lesions of the breast. Challenges of ductoscopy are low sensitivity for detecting malignancy, the lack of a proper intraductal biopsy device, and adequate treatment of intraductal lesions. This study will analyze three new approaches to enhance the effectiveness of interventional ductoscopy in patients with (premalignant) intraductal lesions: narrow-band imaging (NBI), new intraductal biopsy tools, and intraductal laser ablation. The main aims of the present study are to improve diagnostic accuracy and therapeutic efficacy of interventional ductoscopy in patients with pathological nipple discharge (PND) and to explore the feasibility of the new approaches in diagnosing and removing intraductal precursor lesions.

Methods and analysis: This prospective, single-center, diagnostic feasibility study will include two patient groups. Group A: women with PND with no radiological suspicion for malignancy. Group B: women undergoing mastectomy (preventive or therapeutic). The primary endpoints for both groups are the technical feasibility of NBI ductoscopy, intraductal biopsy, and laser ablation, and as secondary endpoint the number of diagnosed and successfully treated intraductal lesions.

Discussion: Enhanced ductoscopy with NBI, intraductal biopsy, and laser ablation could prevent unnecessary surgery in patients with PND.

Ethics and dissemination: This study was approved by the Medical Research Ethics Committee UMC Utrecht in The Netherlands (METC protocol number 21-688/H-D). The results of this study will be published in peer-reviewed journals and presented at national and international conferences.

Highlights: - Pathological nipple discharge (PND) is a common breast-related complaint in women.- Ductoscopy, a minimally invasive technique, is used in the treatment of PND.- This study will analyze three new approaches to enhance interventional ductoscopy of the breast: narrow-band imaging, new intraductal biopsy tools, and intraductal laser ablation in patients with (premalignant) intraductal lesions.