International Journal of Surgery Protocols最新文献

Introduction

Hip fractures are a major health problem globally and are associated with increased morbidity, mortality, and substantial economic costs. Successful operative treatment of hip fracture patients is necessary for the optimization of post-op mobility and functional recovery of the patient. Rehabilitation after surgical stabilization of a hip fracture is crucial in order to restore pre-fracture function and to avoid long-term institutionalization. In particular ongoing exercise which targets balance can prevent up to 40% of falls. Therefore, we have designed a post-discharge home-based physical rehabilitation intervention program to minimize disability and falls in this high-risk elderly population.

Methods and analysis

The study will be an open label, simple randomized controlled trial at a single hospital. The two arms will be equally allocated on a 1:1 ratio into intervention and control groups. The control arm will receive the usual standard postoperative rehabilitation. The intervention group will receive an extended home-based rehabilitation program twice a week continued for 3 months (12 weeks) after discharge. The Primary outcome of the study is occurrence of falls. Falls will be measured at 3, 6, 12, and 24 months by research-assistant follow-up telephone calls for both the groups. Mobility-related disability will be measured with a self-reported test at every routine follow-up for up to two years using a performance-based short battery tool. Negative binomial regression model will be used to compare number of falls in both the groups by computing incidence ratio rates.

Ethics and dissemination

Approval for the conduction of this study has been taken from the Ethical Review Committee (ERC) of the institution. Evidences which will be obtained from this study will facilitate to propose changes in existing guidelines and policies for treating fall and hip fracture patients.

Trial registration

This trial is registered on clinicaltrials.gov ID: NCT04108793.

Background

Randomized controlled trials (RCTs) are critical in developing new therapeutic approaches. Historically, in plastic surgery, RCTs are uncommon as they make up less than 2% of all publications. However there has recently been an increase in RCTs appearing in plastic surgery but the quality of these articles has yet to be assessed. We aim to determine the completeness of intervention reporting in plastic surgery RCTs using the TIDieR checklist.

Methods

A search of Pubmed for RCTs published in the top 10 plastic surgery journals as determined by the Google h5-index will be performed by two investigators. All identified articles will be isolated and a random selection of 300 articles will be screened for inclusion in the study by two different investigators. All types of RCTs will be included in this study. Articles will be excluded if they are nonrandomized, observational, follow-up studies, or secondary analyses. Full exclusion criteria can be found within this protocol. Extracted data includes all 12 points of the TIDieR checklist, journal, intervention type, sample size, and funding source. A complete list of what data will be extracted is listed within this protocol. All data extraction will be performed by two independent investigators. All work will be verified by the two investigators and any discrepancies will be resolved via consensus between investigators or with third party adjudication.

Dissemination

We plan to publish this review in a peer-reviewed journal. We may also present this review at local and/or national conferences.

Introduction

The complexities and risks inherent to the field of surgery and surgical interventions present unique challenges to the design and analysis of surgical randomized controlled trials (RCT). Prior studies have investigated the practical and methodologic challenges posed by surgical RCTs. To date, however, a comprehensive analysis of the contemporary literature across multiple surgical subspecialties does not exist. In this descriptive analysis, we set out to characterize surgical RCTs over the past 10 years across six major surgical specialties.

Methods and analysis

A literature search by a medical librarian will be performed to identify all surgical randomized clinical trials published between January 2009 and December 2019 in the two journals with the highest impact factor for six surgical specialties as well as two large general medicine journals. Two reviewers will independently screen the citations retrieved from the literature search and extract data according to a previously described protocol via a pre-defined data collection form. Categorical variables will be reported as counts and percentages. Following assessment of normality, continuous variables will be reported as mean (standard deviation) or median (inter-quartile range). Based on normality of data, independent t-test or the Mann-Whitney U test will be used to compare continuous variables and chi-square and Fisher’s exact tests to compare categorical variables. Comparisons across multiple sets will be performed using ANOVA or Kruskak-Wallis tests. Two-sided significance testing will be used and a p-value <0.05 will be considered significant without adjustment for multiple testing. All analyses will be performed using SPSS version 24 and R within RStudio. PROSPERO (ID number: 162797).

Ethics and dissemination

There are no ethical concerns directly pertinent to this systematic review. The retrieved data will be made available upon request. The study will be written in English and submitted for publication in a peer-reviewed journal.

Background

Incisional hernias (IH) occur in 4 to 20% of cases following abdominal surgeries, often after laparotomies. In the US, there are 4 to 5 million laparotomies performed per year, which could lead to 400.000 to 1.000.000 IHs. Therefore, this disease accounts as an important social-economic factor. Furthermore, these hernias can lead to bowel incarcerations, chronic pain, and a decrease in quality of life. To guarantee sufficient wound healing and decrease the recurrence rate, physical activity restrictions (PAR) are recommended. The standard recommendations for PAR seem to vary from 0 to 12 weeks, but the evidence remains low due to a lack of clinical trials. Conducting the study at hand, we aim to provide more evidence on this topic.

Methods

The 3N6 trial will be conducted as a national multicenter prospective trial with two study groups (n = 90), where the goal is to find matched pairs within the two groups. Patients who underwent open incisional hernia repair (IHR) in sublay technique will be enrolled. A patient in the 3-week PAR group will be matched to a patient in the 6-week PAR group based on heavy lifting, male gender, BMI > 30, and large hernia >7 cm. The primary endpoint is the duration of sick leave that patients require to return to work, by comparing PAR of 6 weeks with PAR of 3 weeks. The secondary endpoints are the recurrence rate, seroma formation, and chronic pain one year after surgery and postoperative complications within 30 days using Clavien-Dindo-classification.

Dissemination

The findings will be published in a peer-reviewed journal. We may also present the findings at local and/or national conferences.

Background

Esophageal cancer, as one of the most unknown cancers, is largely preventable through lifestyle modifications. In this study, a theory-based intervention will be designed and evaluated on the knowledge and perceptions of relatives of patients with cancer to improve their self-care.

Methods

This research will be carried out in two phases in Golestan province, located in north of Iran. A researcher-made questionnaire will be designed based on the extended parallel process model using a detailed literature review and the panel of experts' opinions. This questionnaire will aim to investigate the levels of knowledge, perception, and practice of respondents regarding esophageal cancer. Later, a comprehensive program will be designed over esophageal cancer self-care based on the information collected from the questionnaire, the information obtained from detailed literature review, and the experts' opinions. The second phase of the study will include implementation of an educational intervention with pretest–posttest design using the intervention and control groups to measure the effectiveness of this educational program on the knowledge, perception, and practice of the patients' relatives.

Discussion

The findings will provide valuable evidences regarding the efficacy of the educational intervention and will help the participants to improve their self-care behaviours. Consequently, policy-makers and planners can use the results to set appropriate policies.

Background

Abdominal surgeries are performed for the treatment and diagnosis of many diseases. Smokers undergoing abdominal surgery, are high risk population, having underlying pathological changes in lung parenchyma due to inflammatory effect of smoking. Site of incision and history of smoking may significantly affect pulmonary function such as FVC and FEV1. Respiratory muscle training pre-operatively has shown significant improvement of pulmonary function compare to only conventional therapy and has led to reduction of PPCs, length of hospital stay and cost. This study aims to find effectiveness of IMT in chronic smokers undergoing abdominal surgery and its significance in reduction of PPC and in pulmonary function and functional capacity as compared to non-smokers.

Methodology

This study protocol is observational cohort study comparing smoker and non-smoker participants undergoing abdominal surgery. The participants will be assessed for pulmonary function test and functional capacity (6MWD); pre-operatively and post-operatively day 1 till the day of discharge. Both the groups will receive IMT and conventional chest Physiotherapy from POD1 and increment of IMT will be done by assessing MIP each day.

Dissemination

We plan to publish this review in a peer-reviewed journal. We may also present this review at local and/or national conferences.

Introduction

Wide Awake Local Anaesthetic No Tourniquet (WALANT) technique has been developed to eliminate tourniquet pain during upper limb and hand surgery whilst also improving utilisation of operating theatre time and inpatient stay, however inconclusive data still limits the techniques uptake. Here presents a protocol for a systematic review to collate findings to produce conclusive data on efficacy of WALANT.

Methods

This systematic review will be registered a priori. All study designs defined by the Oxford Centre for Evidence-Based Medicine will be included in the search. “WALANT” in “upper limb” and “hand” surgery will be investigated as per the devised search strategy. 18 electronic databases will be searched, including PubMed, Medline and Embase in addition to a Grey literature search. Two independent teams of 3 researchers will screen all relevant titles, abstracts and subsequent full texts for suitability. Data will be extrapolated and entered into a preformatted database for analysis.

Ethics and dissemination

This systematic review will be published in a peer-reviewed journal and presented at both national and international conferences within the field of plastic and orthopaedic surgery. This review aims to inform surgical practice and policy.

Introduction

Routine preoperative esophagogastroduodenscopy (p-EGD) prior to bariatric surgery (BS) is currently widely undertaken, and hence an important issue with many clinical and financial repercussions. Yet, the true extent of why p-EGD is routinely undertaken for all bariatric patients remains not well understood.

Methods and analysis

To address this, we will undertake a systematic review and meta-analysis of routine p-EGD prior to BS from around the world. This protocol describes the methodological approach to be adopted and outlines the search strategies and eligibility criteria that will be employed to identify and select studies, and the way by which data from the selected studies will be extracted for analysis. PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), WHO International Clinical Trials Registry Platform, Cochrane Library, MEDLINE, Scopus, clinicaltrials.gov and Google scholar will be searched from 01 January 2000 to 30 April 2019 for original studies written in English that provided prevalence estimates of the outcomes of routine p-EGD prior to BS. STROBE criteria will assess the methodological quality of the selected studies. The use of fixed or random effects model will depend on the results of statistical tests for heterogeneity. Publication bias will be visually estimated by assessing funnel plots. Pooled estimates will be calculated. This protocol conforms to the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines and has been submitted for registration at the PROSPERO International Prospective Register of systematic reviews. No ethical clearance is required for this study. This review will be published in a peer- reviewed journal and will be presented at various national and international conferences.