International Journal of Surgery Protocols最新文献

Introduction

Traumatic brain injury (TBI) accounts for a significant amount of death and disability worldwide and the majority of this burden affects individuals in low-and-middle income countries. Despite this, considerable geographical differences have been reported in the care of TBI patients. On this background, we aim to provide a comprehensive international picture of the epidemiological characteristics, management and outcomes of patients undergoing emergency surgery for traumatic brain injury (TBI) worldwide.

Methods and analysis

The Global Neurotrauma Outcomes Study (GNOS) is a multi-centre, international, prospective observational cohort study. Any unit performing emergency surgery for TBI worldwide will be eligible to participate. All TBI patients who receive emergency surgery in any given consecutive 30-day period beginning between 1st of November 2018 and 31st of December 2019 in a given participating unit will be included. Data will be collected via a secure online platform in anonymised form. The primary outcome measures for the study will be 14-day mortality (or survival to hospital discharge, whichever comes first). Final day of data collection for the primary outcome measure is February 13th. Secondary outcome measures include return to theatre and surgical site infection.

Ethics and dissemination

This project will not affect clinical practice and has been classified as clinical audit following research ethics review. Access to source data will be made available to collaborators through national or international anonymised datasets on request and after review of the scientific validity of the proposed analysis by the central study team.

Introduction

Considerably large numbers of bariatric surgery (BS) procedures are undertaken globally, and are projected to increase with the obesity epidemic. Venous thromboembolic events (VTE) comprise an important cause of postoperative morbidity and mortality after BS and an important issue with wide clinical and financial repercussions. Yet, a precise extent of the prevalence of VTE after BS for obesity and its mortality remains uncertain.

Methods and analysis

In order to respond to this knowledge gap, we will conduct a systematic review and meta-analysis of the prevalence of and mortality associated with VTE after BS. This protocol outlines the methodology that will be used and the search strategies and eligibility criteria that will be utilized to identify and select studies, as well as the method 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 1990 through 10th April 2020, for original studies written in English that provided prevalence estimates of VTE after BS. Articles will also be searched for mortality estimates of VTE after BS. STROCSS (Strengthening the Reporting of Cohort Studies in Surgery) criteria will evaluate the methodological quality of the selected studies. The use of fixed effect or random effects model will be subject to the findings of the statistical tests for heterogeneity. Publication bias will be visually estimated by inspecting the funnel plots. Pooled estimates will be computed. Th current protocol conforms to the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines and has been submitted to the PROSPERO International Prospective Register of systematic reviews. No ethical clearance is required for this study. This systematic review and meta-analysis will be published in a peer-reviewed journal and presented at national and international conferences.

Introduction

Oral cancer is a significant health problem in India. Diagnosis is often delayed. The effectiveness of conventional oral screening has been shown in the Trivandrum oral cancer screening study. The present study will be a step forward to test a mobile phone-based (the mHealth approach) comparing it with the conventional approach. The purpose of this paper is to report the protocol for this study. The primary objective will be to compare both methods in diagnosing oral potentially malignant disorders and cancers. The secondary objective would be to study the cost-effectiveness.

Methods and analysis

This will be a cluster-randomized clinical trial of the population in Ernakulam district of Kerala state in India. They will undergo oral cancer screening by community health workers, who will be pre-assigned to the randomly allotted intervention (mHealth) or control (conventional method) clusters. We will enrol a minimum of 9696 subjects from all 6 clusters over 18 months. The cost-effectiveness of the two strategies for oral screening will be determined using data from this randomized controlled trial. The incremental cost per oral cancer/high-risk dysplasia detected, and the incremental cost per life saved will be reported. We will conduct sensitivity and scenario analysis to evaluate the robustness of the findings.

Ethics and dissemination

When completed, this will be the first cluster randomized population-based study to test the technology-based approach in India. The knowledge from this study will indicate whether specialists can make a remote diagnosis of oral lesions accurately based on the information gathered using a mobile phone health application and whether the mHealth strategy will be cost-effective in Oral cancer screening. The study will follow the ethical guidelines and will be published in an indexed journal.

Introduction

In recent times, ‘early osteoarthritis’ (EOA) has achieved recognition as a disease entity. The importance of defining EOA is in the fact that a variety of joint preservation treatments are available. Development of the sense of proprioception is a known vital element of most exercise rehabilitation programmes. Postural sways have been found to be prevalent in arthritic patients. It follows therefore that correction of early postural aberrations should help patients with EOA. The current study aims to determine the effectiveness of such proprioceptive training versus conventional exercises in patients with EOA.

Method

This study is a randomized controlled trial. A total of 100 participants between the age of 20–45 years will be recruited. Participants will be randomly assigned to conventional or interventional group. Participants in both the groups will receive 12 session of treatment over a period of four weeks. Outcome measure considered are center of pressure excursion, joint position sense, hand held dynamometer, visual analog scale and knee injury and osteoarthritis Outcome Score for functional outcome.

Results

Data collected will be analyzed by mean, SD and 2 factor ANOVA for repeated measure, followed by Bonferroni post hoc analysis. Data will be analyzed using SPSS package version 17.0, p < 0.05 will be considered as significant.

Conclusion

The authors hope to determine whether proprioceptive training improves outcome better than conventional exercise therapy and hope to contribute to an improved targeted treatment for patients with Early osteoarthritis.

Background

Minimally invasive surgery (MIS) procedures require special psychomotoric skills. Learning of these MIS basic skills is often performed in the operating room (OR). This is economically inefficient and could be improved in terms of patient safety. Against the background of this problem, various MIS simulators have been developed to train MIS basic skills outside the OR. Aim of this study is to evaluate to what extent MIS training programs and simulators improve the residents’ skills in performing their first MIS procedures on patients.

Method

The current multicentric RCT will be performed with surgical residents without prior active experience in MIS (n = 14). After the participants have completed their first laparoscopic cholecystectomy as baseline evaluation (CHE I), they will be randomized into two groups: 1) The intervention group will perform the Lübeck Toolbox curriculum, whereas 2) the control group will not undergo any MIS training. After 6 weeks, both groups will perform the second laparoscopic CHE (CHE II). Changes or improvements in operative performance (between CHE I and CHE II) will be analyzed and evaluated according to the Global Operative Assessment of Laparoscopic Skill (GOALS) Score (primary endpoint).

Discussion

The multicentric randomized controlled trial will help to determine the value of MIS training outside the operation room. Proof of effectiveness in practice transfer could be of considerable relevance with regard to an integration of MIS training programs into surgical education.

Introduction

Blood loss is an important consideration in all types of shoulder surgery. Excessive bleeding is associated with increased morbidity. Tranexamic acid (TXA) is an antifibrinolytic agent. It has been demonstrated to be effective in reducing blood loss across multiple surgical specialties. The aim of this systematic review and meta-analysis is to review the literature evaluating clinical outcomes associated with the use of TXA in shoulder surgery.

Methods

The study protocol was designed and registered prospectively on PROSPERO (International prospective register for systematic reviews). Literature search will include the MEDLINE, EMBASE, PsycINFO, and Cochrane Library databases. Randomised controlled trials (RCTs) evaluating the use of TXA against placebo, in all types of shoulder surgery, will be included. Our primary outcome is total blood loss (ml). Secondary outcomes include patient-reported outcome measures (PROMs), adverse events, and number of blood transfusions required. Risk of bias will be assessed within each study using The Cochrane Risk of Bias Tool 2.0 and the Jadad score. Inconsistency and bias across included studies will be assessed statistically. Data from comparable outcomes will be pooled and analysed quantitatively or descriptively as appropriate.

Ethics and dissemination

No ethical clearances required for this study. This systematic review and meta-analysis will be published in a peer-reviewed journal. It will be presented a various national and international conferences.

Background

The objective of the present study is to compare the outcomes open PVHR and robotic PVHR.

Methods/Design

The present study will be a randomized single-blinded controlled trial with intention-to-treat analysis comparing robotic PVHR to open PVHR in adult patients undergoing elective PVHR with a defect ranging between 1–5 cm. Patient refusing to participate, not able to give informed consent, with history of intra-abdominal surgery contraindicating a robotic surgical approach will be excluded. The intervention will consist in laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical PVHR with closure of fascial defect and non-adsorbable mesh reinforcement. The control will be open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-absorbable mesh reinforcement. The primary outcome will be the incidence of wound-related complication within 1 month. The secondary outcomes will be esthetic satisfaction, pain, pain-killers consumption, general complications, costs, operative time and early hernia recurrence.

Discussion

Open PVHR is potentially associated to more wound-related complications, but has the advantages of cost-effectiveness, short operative time and totally extra-peritoneal repair. Laparoscopic PVHR has lower wound-related complications but implies placing the mesh in intra-peritoneal position, requires advanced laparoscopic skills, usually does not allow the closure of the defect, and can lead to excessive pain and pain-killers consumption. Robotic PVHR uses the same laparoscopic access as laparoscopic PVHR, but thanks to the extended range of motion given by the robotic system, allows defect closure, pre-peritoneal placement of the mesh and requires less technical skills.

In the present randomized controlled trial, we expect to show that robotic PVHR leads to better wound-related outcomes than open PVHR.

Trial registration

The present randomized controlled trial was registered into clinicaltrials.gov under registration number NCT04171921.

Introduction

Pancreatoduodenectomy is the treatment of choice for a range of benign and malignant diseases. The pancreatic head must be separated from its supplying vessels, especially the gastroduodenal artery, during this operation. However, dissection of the gastroduodenal artery can disturb blood supply to the liver and result in liver ischemia. There is currently no well-established algorithm to evaluate and ensure sufficient blood flow in patients with altered hepatic artery blood flow. To address this important issue, this study aims to establish a basis for assessing liver blood supply during pancreatoduodenectomy. Furthermore, factors influencing arterial blood flow and related postoperative complications will be evaluated.

Methods and analysis

The HEPARFLOW study is a single institutional single-arm prospective exploratory observational clinical trial. All consecutive patients undergoing elective partial or total pancreatoduodenectomy will be screened for inclusion until 100 patients are enrolled. Blood flow in the proper hepatic artery, gastroduodenal artery, portal vein, and additional vessels supplying the liver will be measured during pancreatoduodenectomy using Doppler flowmetry. All patients will be followed up for 90 days after surgery. At each visit, standard clinical data, postoperative complications and mortality will be recorded.

Discussion

This will be the first study to prospectively assess intraoperative flow rates of the hepatic artery and portal vein to evaluate liver blood supply during pancreatoduodenectomy. The preoperative and intraoperative factors influencing blood flow in the hepatic arteries will be identified. This study may also reveal the hemodynamic and clinical relevance of a compression of the celiac axis during pancreatoduodenectomy.

Ethics and dissemination

This study was approved by the Ethics Committee of the University of Heidelberg (S-073/2018). The results will be published in a peer-reviewed journal and will be presented at medical meetings.

Introduction and objectives

Recurrence rates for patients presenting with non-muscle invasive bladder carcinoma (NMIBC) can be as high as 60% during the first year after a transurethral resection of bladder tumor (TURBT). Currently, an immediate postoperative instillation of chemotherapy (IPOIC) is recommended for the prevention of recurrences in patients with low to intermediate risk disease. Although in real clinical practice this specific instillation of chemotherapy has many difficulties to be standardized, including its contraindications (suspected or confirmed bladder perforation, wide or extensive resection and, continuous bladder irrigation requirement), which will only make it feasible for around 30% of patients.

We propose in this controlled study, to administer an immediate neoadjuvant instillation of chemotherapy (INAIC), which can be applied technically to all patients, no matter the surgical outcomes and compare it with a control group. We expect to find a reduction in the recurrence rate in the experimental group of at least 15%.

Methods

We designed a phase IV, randomized, controlled, open label clinical trial. Main inclusion criteria are: patients with a clinical diagnosis of localized, papillary-type bladder cancer (suspected low to intermediate risk) with a disease-free interval of at least 6 months. Eligible patients will be allocated into group A (INAIC plus TURBT) or group B (TURBT) using a computer-generated block randomization sequence/ratio 1:1. Time to recurrence of both groups will be analyzed and compared using Kaplan-Meier estimates, log-rank tests and, Cox-regression. Univariate and multivariate analyzes will be performed to determine factors which influence recurrence. The study has received the approval of the Ethics Committee for Drug Research (CEIm) of La Paz University Hospital and the Spanish Agency for Medicines and Health Products.

Background

The Vagi-Pipe® is a useful device for performing a total laparoscopic hysterectomy. The conventional model of the Vagi-Pipe® is unable to grasp the uterus during colpotomy for recovery of the resected uterus. However, the modified C-Type Vagi-Pipe® model has a shape that allows insertion into the vagina without removing the uterus manipulator. In this study, we will prospectively investigate the safety and efficacy of the C-Type Vagi-Pipe® in total laparoscopic hysterectomies.

Materials and methods

In total, 25 female subjects aged between 20 and 60 years with uterine fibroids or adenomyosis will be included. Patients with complications regarded as unsuitable for this study by the investigators will be excluded. The C-Type Vagi-Pipe® will be used rather than the conventional Vagi-Pipe® when performing a total laparoscopic hysterectomy. The primary endpoint will be safety and the secondary endpoints will be operation time, bleeding volume, and presence of complications.

Ethics and dissemination

The protocol was approved by the institutional review boards. Written informed consent will be obtained from all patients before registration in accordance with the Declaration of Helsinki. Results of the study will be disseminated via publications in peer-reviewed journals.