International Journal of Surgery Protocols最新文献

Oxygen free radicals have been implicated as the deleterious agent in a variety of organ systems undergoing ischemia and subsequent reperfusion. Hemorrhagic shock represents a clinical situation that carries a high rate of morbidity and mortality despite adequate fluid resuscitation. Since this entity represents, in its most simplified sense, total body ischemia followed by reperfusion, it is likely that the generation of oxygen free radicals has some significance in the pathophysiology of this delayed morbidity. This is a research protocol, where rabbits will be subjected to severe hemorrhagic shock followed by adequate fluid resuscitation. In the first part of the experiment, free radical generation will be measured directly by Electron Paramagnetic Resonance (EPR) spectroscopy in various organ systems in rabbits before and during shock, and following resuscitation. In the second part, free radical scavengers will be introduced as an adjunct to fluid resuscitation in a group of rabbits subjected to hemorrhagic shock to see if mortality rates are affected. By acquiring a better understanding of the molecular mechanisms that may be responsible for the delayed morbidity in reperfusion injury in general, and hemorrhagic shock in particular, we will be able to better address the long-standing problem of multi system organ failure (MSOF) that often follows a successful resuscitation.

Introduction

Osteoarthritis (OA) is the most prevalent disorder of articulating joints in humans. As one of the steps of advanced pharmacological management, intra-articular treatment is applied in knee OA. However, there is no clinical practice guideline (CPG) involving intra-articular injection for knee OA. Here, we will develop a CPG according to a recognized methodology.

Methods and analysis

We will develop the new CPG according to the Institute of Medicine, the Appraisal of Guidelines for Research & Evaluation Ⅱ (AGREE Ⅱ), and WHO guideline handbook and make recommendations based on systematic reviews. We will establish a Guideline Working Group (including a Guideline Steering Subgroup, a Guideline Development Subgroup, and a Guideline Secretary Subgroup); formulate clinical questions in the form of Population, Intervention, Comparison, Outcomes (PICO); and complete a literature search. The consensus will be developed through evidence syntheses and the Delphi method. We will also consider patients’ values or preferences, peer review results, and declaration of interests in developing CPG. The present CPG was registered on the International Practice Guidelines Registry Platform (http://www.guidelines-registry.org/), and the registration number is IPGRP-2016CN004.

Ethics and dissemination

The protocol will provide us a roadmap to systematically develop evidence-based CPG for intra-articular injection for knee OA. The work will be disseminated electronically and in print. The guideline would be the first CPG that is developed primarily by orthopedic specialists in China and strictly based on systematic methodology.

Introduction

Following Abdominal Wall Reconstruction (AWR) wound infections occur in over one third of patients and rates can be even higher in entero-cutaneous fistula repair. A novel antimicrobial gel has been engineered by microbiologists called Surgihoney Reactive Oxygen (SHRO). SHRO gel will be applied to a group of patients. We aim to conduct a pilot case series with the hope to show a reduction in local wound complications after SHRO application.

Methods and analysis

A single arm pilot study of AWR patients will be carried out on patients with grade 3 and 4 (VHWG grade) ventral hernias. Patients’ pre-operative wounds will be graded according to the CDC classification scale. Post operatively the wounds will be classified according to the Wilson surgical site infection classification. Intervention: SHRO will be applied after abdominal fascial closure and before skin closure through a standardised method. Our results from the series will be compared to our retrospective standard wound care results. Data will be collected from 01.03.2017 to 01.11.2017. Primary outcome: Surgical site infection within 30 days of surgery, assessed by clinicians at 5, 15 and 30 days and by patient’s self-report for the intervening period. Secondary outcomes include other SSOs (haematoma, seroma, wound dehiscence, skin necrosis), duration of stay in hospital, reported side effects from local treatment and other systemic postoperative complications. We will aim for a cohort of 40 patients.

Conclusions

This study will provide an assessment of methods and feasibility of recruiting and following up patients who are treated with SHRO. On the basis of this pilot trial, a full trial may be proposed in the future which will provide additional, robust evidence on the clinical and cost effectiveness of SHRO in wound management following AWR. This may act as a model for the management of wounds in complex patients undergoing AWR.

Background

Malnutrition is commonly known as a risk factor in surgical procedures. The nutritional status seems particularly relevant to the clinical outcome of patients undergoing hepatic resection. Thus, identifying affected individuals and taking preventive therapeutic actions before surgery is an important task. However, there are only very few studies, that investigate which existing nutritional assessment score (NAS) is suited best to predict the postoperative outcome in liver surgery.

Objective

Nutritional Risk in Major Abdominal Surgery (NURIMAS) Liver is a prospective observational trial that analyses the predictive value of 12 different NAS for postoperative morbidity and mortality after liver resection.

Methods

After admission to the surgical department of the University Hospital in Heidelberg or the municipal hospital of Karlsruhe, all patients scheduled for elective liver resection will be screened for eligibility. Participants will fill in a questionnaire and undergo a physical examination in order to evaluate nutritional status according to Nutritional Risk Index, Nutritional Risk Screening Score, Subjective Global Assessment, Malnutrition Universal Screening Tool, Mini Nutritional Assessment, Short Nutritional Assessment Questionnaire, Imperial Nutritional Screening System, Imperial Nutritional Screening System II, Nutritional Risk Classification and the ESPEN malnutrition criteria. Postoperative morbidity and mortality will be tracked prospectively throughout the postoperative course. The association of malnutrition according to each score and occurrence of at least one major complication will be analysed using both chi-squared tests and a multivariable logistic regression analysis. Already established risk factors in liver surgery will be added as covariates.

Discussion

NURIMAS Liver is a bicentric, prospective observational trial. The aim of this study is to investigate the predictive value of clinical nutritional assessment scores on postoperative morbidity and mortality after hepatic resection. This is necessary, as only a validated identification of malnourished patients at high risk for postoperative complications, enables targeted preventive action.

Background

Surgical proficiency is highly dependent on continuous and efficient training. However, efficacy of training hinges on questions such as accessibility and how intuitively the training can be translated into reality. Minimally invasive surgery (MIS) in particular relies on adequate training modalities in order to compensate for its additional psychomotor and visuospatial challenges. The increasing demand for MIS procedures longs for further enhancement of training and steep learning curves. We are investigating a nouveau training concept that continuously utilizes the first person view as addendum to laparoscopic view. We hypothesize this approach to be more intuitive thus faster and more naturally to apprehend than a laparoscopic view only and aim to establish a new standard to implement into training curricula.

Methods and analysis

The present study is conducted as a monocentric, two-arm randomized trial. Participants undergo a training curriculum in laparoscopic suturing and knot tying, using e-learning video material with either the first-person perspective of the surgeon or the laparoscopic view only. Primary endpoint is the total training time needed to reach a predefined proficiency level. Participants are evaluated by blinded raters using validated checklists. Number of attempts, procedure and knot quality subscore difference as well as metric parameter analysis from the first and last knots analyzed as secondary endpoints. Furthermore, trainees are assessed with regard to surgical background, basic skills level and spatial awareness. A total sample size of 80 participants for the analysis of the primary endpoint was determined, which will be performed as a two-sided t-test.

Ethics and dissemination

Ethical approval was obtained from the Ethics Committee of the Medical Faculty at Heidelberg University (Code S-334/2011). This trial was registered with the German Clinical Trials Register (DRKS) in Freiburg, Germany, on May 6th (DRKS00009997). The results will be published and presented at appropriate conferences.

Background

In 2013, the Declaration of Helsinki was updated and required the registration of all research studies involving human participants. Prior registries focussed on the registration of clinical trials and systematic reviews, and we estimate that only 10% of observational research is registered in a publically accessible registry. The Research Registry® was established to provide a venue of registration for any study, prospectively or retrospectively, involving human participants. This protocol describes the analysis for the first 2000 registrations received to the Research Registry®.

Methods and analysis

Data for each registration to the Research Registry® (www.researchregistry.com), adapted from the World Health Organisation minimum data set, has been collected since the launch of the registry in 2015. A weekly curation process ensures that inappropriate registrations, such as duplicate studies or those not involving human participants, are removed from the registry. We will present the characteristics of the first 2000 registrations and how they have changed overtime. A quality score will be calculated for each registration by two independent teams, and inter-rater reliability will be calculated. Funding sources of work registered will also be presented. This process will also be performed for the systematic review portion of the registry (‘The Review Registry’), which will be considered separately.

Ethics and dissemination

Ethical approval is not required for this study as it involves no human participants. The findings will be presented at international conferences and published in a peer reviewed journal.

Background

Although minimally invasive surgery (MIS) has replaced many open procedures in visceral surgery, technical and psychomotor obstacles remain a constant challenge for surgeons and trainees. However, there are various training curricula enabling surgeons to acquire the visuospatial and psychomotor abilities additionally required when performing MIS. Currently accepted training modalities include box-trainers, organ and animal models as well as completely simulated training environments, realized in virtual reality (VR) trainers. All of these methods facilitate an adequate training prior to patient contact, so patient safety can benefit as well. This study aims to evaluate the benefit of a structured multi-modality laparoscopy training curriculum.

Methods

Junior and senior surgical residents are included (n = 60). Groups are stratified with concern to previous experience and training of participants. The training curriculum consists of a standardized sequence of available modalities and exercises on box- and VR-trainers. Specific consideration applies to the training effect during the repeated performance of a laparoscopic cholecystectomy (LC) between intervention (training in between LCs) and control group (no training in between LCs). Analysis of training effects is performed using a cadaveric model for LC and objectified using the validated scoring system Global Operative Assessment of Laparoscopic Skills (GOALS).

Discussion

This study assesses the value of a multimodal training platform in medical education and postgraduate training and aims at illustrating possible guidelines when establishing such a curriculum. Possible factors of influence, such as varying backgrounds, learning motivation and –success among participants are explored in the data analysis and add beneficially to further evaluating the efficacy of such training to more heterogeneous participant groups like medical students and other professionals.

Introduction

Use of autologous fat grafting (AFG) for breast reconstructive surgery is gaining acceptance, but concerns regarding its efficacy and safety remain. We present a protocol for a systematic review that aims to update the findings since our previous systematic review on a number of outcomes of AFG.

Methods

The systematic review has been registered a priori (UIN: reviewregistry308). All study designs, including randomised controlled trials, cohort studies, case-controlled studies and case reports/series, reporting original data, on women undergoing AFG for breast reconstruction following mastectomy or breast conserving surgery, will be included. Six categorical outcomes will be assessed: oncological; clinical; aesthetic/functional; patient-reported; process; and radiological.

The search strategy will be devised to investigate ‘fat grafting and breast reconstruction’. Electronic databases will be searched, 01 April 2014 to 21 August 2017: PubMed, MEDLINE®, EMBASE, SCOPUS, CINAHL, PsychINFO, SciELO, The Cochrane Library, including the Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effect (DARE), the Cochrane Methodology Register, Health Technology Assessment Database, the NHS Economic Evaluation Databases and Cochrane Groups, ClinicalTrials.gov, Current Controlled Trials Database, the World Health Organisation (WHO) International Clinical Trials Registry Platform, UpToDate.com, NHS Evidence and the York Centre for Reviews and Dissemination. Grey literature will be searched. Two trained, independent teams will screen all titles and abstracts, and relevant full texts, for eligibility. Data will be extracted under standardised extraction fields into a preformatted database.

Ethics and dissemination

The systematic review will be published in a peer-reviewed journal and presented at national and international meetings within fields of plastic, reconstructive and aesthetic surgery, and surgical oncology. The work will be disseminated electronically and in print. Brief reports of the review and findings will be disseminated to interested parties through email and direct communication. The review aims to guide healthcare practice and policy.

Background

The main treatment of lung cancer (stage 1 and 2) is lung resection surgery. The risk of postoperative pulmonary complications is high and therefore standard postoperative care involves respiratory physiotherapy. The purpose of this systematic review is to create an overview of the evidence on respiratory physiotherapy after lung resection surgery on mortality rate (within 30 days) and postoperative pulmonary complications.

Methods and analysis

The review will include randomized or quasi-randomized controlled studies investigating the effect of all types of respiratory physiotherapy on mortality and postoperative pulmonary complications after lung resection surgery. Furthermore, the effect of respiratory physiotherapy is evaluated on secondary outcomes such as length of hospital stay, lung volumes and function, and adverse events. The method of the planned review is described in this paper. The literature search will include the databases PubMed, Cochrane (Central), Embase, Cinahl and PEDro. The literature search is being performed in 2017. If meta-analyses are not undertaken, a narrative synthesis of the available data will be provided. The protocol was registered in PROSPERO on the 10th of October 2016 (registration number CRD42016048956).

Ethics and dissemination

Conclusion of this systematic review is expected available in the second half of 2017.