International Journal of Surgery Protocols最新文献

Introduction

‘Personalised medicine’ aims to tailor interventions to the individual, and has become one of the fastest growing areas of cancer research. One of these approaches is to harvest cancer cells from patients and grow them in the laboratory, which can then be subjected to treatments and the response assessed. We have developed a 3D tumour model with a complex protein matrix that mimics the tumour stroma, cell to cell and cell-matrix interactions seen in vivo, called a tumouroid. In this study, we test the acceptability and feasibility of using this model to establish patient-derived tumouroids.

Methods and analysis

This is a first in-human study using prospective tissue and data collection of adult participants with confirmed or suspected renal cell carcinoma. The goals of the study are to assess patient acceptability to the use of patient-derived tumour models for future treatment decisions, and to assess the feasibility of generating patient-specific renal cancer tumouroids that can be challenged with drugs. These goals will be realised through the collection of tumour samples (expected n = 10), participant-completed questionnaires (expected n = 10), and in-depth semi-structured interviews with patients (expected n = 5). Collected multiregional tumour samples will be dissociated to isolate primary cells which are then expanded in vitro and incorporated into tumouroids. Drug challenge will ensue and the response will be categorised into “responder”, “weak responder”, and “non-responder”. Statistical analysis will be descriptive.

Ethics and dissemination

The study has ethical approval (REC reference 17/LO/1744). Findings will be made available to patients, clinicians, funders, and the National Health Service (NHS) through presentations at national and international meetings, peer-reviewed publications, social media and patient support groups.

Trial registration

Registered on ClinicalTrials.gov (NCT03300102).

Introduction

There is little evidence-based guidance on the use of prophylactic antibiotics in skin surgery; whilst antibiotics may protect against surgical site infections (SSI), they have associated side effects, increase the risk of adverse events, and can propagate antibiotic resistance. We present a protocol for a systematic review to establish whether the benefit of prophylactic antibiotics overrides the risk, for patients undergoing autograft surgery.

Methods

The systematic review will be registered a priori on researchregistry.com and will be conducted in line with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). A search strategy will be devised to investigate ‘skin graft surgery and use of antibiotics’. The following electronic databases will be searched, 1979–2018: 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. All comparative study designs reporting on the use of antibiotics in skin graft surgery will be considered for inclusion, namely randomized controlled trials (RCTs). Two trained independent teams will screen all titles and abstracts, followed by relevant full texts, for eligibility. Data will be extracted under standardized extraction fields into a preformatted database. Note will be made of the indication for skin graft surgery (traumatic, congenital, malignant, benign), the graft site (head & neck, trunk, upper extremities, lower extremities), type of skin graft (split thickness, full-thickness). The primary outcome will be occurrence of SSI at the donor and/or recipient sites. Secondary outcomes, if reported, will include: length of hospital stay, revision surgery required, cost of medical care, time to wound healing and cosmetic outcome.

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. 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.

Introduction

Neoadjuvant systemic therapy (NST) has several potential advantages in the treatment of breast cancer. However, there is currently considerable variation in NST use across the UK. The NeST study is a national, prospective, multicentre cohort study that will investigate current patterns of care with respect to NST in the UK.

Methods and analysis

Phase 1 – a national practice questionnaire (NPQ) to survey current practice.

Phase 2 – a multi-centre prospective cohort study of breast cancer patients, undergoing NST.

Women undergoing NST as their MDT recommended primary breast cancer treatment between December 2017 and May 2018 will be included. The breast surgery and oncological professional associations and the trainee research collaborative networks will encourage participation by all breast cancer centres.

Patient demographics, radiological, oncological, surgical and pathological data will be collected, including complications and the need for further intervention/treatment. Data will be collated to establish current practice in the UK, regarding NST usage and variability of access and provision of these therapies. Prospective data on 600 patients from ~50 centres are anticipated.

Trial registration: ISRCTN11160072.

Ethics and dissemination

Research ethics approval is not required for this study, as per the online Health Research Authority decision tool. The information obtained will provide valuable insights to help patients make informed decisions about their treatment. These data should establish current practice in the UK concerning NST, inform future service delivery as well as identifying further research questions.

This protocol will be disseminated through the Mammary Fold Academic Research Collaborative (MFAC), the Reconstructive Surgery Trials Network and the Association of Breast Surgery. Participating units will have access to their own data and collective results will be presented at relevant conferences and published in appropriate peer-reviewed journals, as well as being made accessible to relevant patient groups.

Background

New surgical procedures, devices and other complex interventions need robust evaluation for safety, efficacy and effectiveness. The IDEAL Framework and Recommendations lay out a pathway to achieve this and offer general guidance on how studies at each stage should be reported. However, researchers require some assistance in translating theory into practice. We will develop a set of reporting guidelines for each IDEAL stage where deemed necessary through Delphi consensus methodology.

Methods

For each IDEAL stage requiring a new set of reporting guidelines, we will use the following process. We will search for the relevant reporting guidelines already in existence and use principles developed by the IDEAL Collaboration to compile the initial long list of potential checklist items. In each round, the participants will rate the importance of reporting each element on a nine-point Likert scale as proposed by the GRADE group. Sequential rounds and questionnaire administration and completion will take place until a final set of items is produced. There will then be a final consensus meeting of a working group to condense and refine the final recommendations for the reporting guidelines.

Introduction

Gastrointestinal stromal tumour is a pathology that originates from the interstitial cells of Cajal and differentiates from other mesenchymal neoplasm by expression of CD117 oncogene on Immunohistochemistry test. Colon and Rectal GISTs constitutes of approximately 5% of all gastrointestinal GISTs. The past decade has witnessed a dramatic change in the treatment of rectal cancer. Preoperative, perioperative and postoperative, management has changed thanks to new chemotherapy regimens and emergence of novel surgical techniques. Our aim is to investigate if same change can be implemented for rectal GISTs management.

Methods and analysis

This protocol is compliant with the Preferred Reporting Items for Systematic Review and Meta-Analysis protocols (PRISMA-P) guidelines. Exclusion and inclusion criteria are outlined within this protocol. Points of interest and objectives are described within this protocol. The search strategy, aims to identify all articles on “Rectal GISTs”.

Discussion

The choice of resection type surgery depends upon the location and size of rectal GIST. Neoadjuvant Imatinib therapy yields tumour shrinkage in at least 50% and is associated with a prolonged disease-free survival for intermediate and high-risk patients. This review will also allow a summary clinicopathological features and prognostic factors of rectal GISTs.

Ethics and dissemination

The Centre for Reviews and Dissemination, University of York acknowledged that this systematic review is within the register scope. This review will be published in a peer-reviewed journal and will be presented at various national and international conferences.

Introduction

The “traditional approach” to resect synchronous colorectal cancer with liver metastases (CRLM) is to perform staged resections. Many institutions perform simultaneous resection. Disadvantages to the simultaneous approach include longer operating room times, which may increase major postoperative complication rates. Data supporting simultaneous resection are limited to retrospective studies that are subject to selection bias. Therefore, we have proposed a single-arm prospective cohort pilot study to evaluate the postoperative complications following simultaneous resection of synchronous CRLM.

Methods and analysis

This single-arm study will be performed in five high-volume hepatobiliary centres to prospectively evaluate the following objectives: (1) To determine the 90-day postoperative complication rate of patients diagnosed with synchronous CRLM undergoing a simultaneous colorectal and liver resection, including major liver resections; (2) To determine the postoperative mortality rate at 90 days following index surgery; (3) To determine change in global health-related Quality of Life (QoL) following simultaneous resection at three months compared to baseline; and (4) To build a costing model for simultaneous resection, We will also evaluate the feasibility of performing combined resection in these patients by evaluating the number of eligible patients enrolled in the study and determining the reasons eligible patients were not enrolled. This protocol has been registered with ClinicalTrials.gov (NCT02954913).

Ethics and dissemination

This study has been provincially approved by the central research ethics board. Study results will inform the design a randomized controlled trial by providing information about the comprehensive complication index in this patient population used to calculate the sample size for the trial.

Background

Patients undergoing relaparotomies are underrepresented in clinical trials. Standard of care, relative outcomes compared to primary laparotomy, and the ideal fascial closure technique are unknown.

Objective

The ReLap study has three objectives: First, to determine standard of care and gain evidence of intra-/postoperative outcomes for patients undergoing relaparotomy compared to patients undergoing primary laparotomy. Second, to gain evidence of an association between biomarkers and adhesion grade in a clinical-translational approach in patients undergoing relaparotomy or primary laparotomy. Third, to gain evidence of the feasibility and comparative effectiveness of fascial closure after relaparotomy using the small stitches technique with Monomax 2–0 versus the large stitches technique with PDS 1 loop.

Methods

The ReLap study is a monocentric, prospective, mixed-methods, exploratory study with three steps: health care research, translational research, and randomized controlled trial. All patients scheduled for elective laparotomies or relaparotomies at the University of Heidelberg will be screened for eligibility. There will be five study visits during the hospital stay and one study visit one year after surgery. The clinical course will be followed and outcomes necessary to answer the study objectives will be captured prospectively. Relaparotomy patients eligible for closure with the small and large stitches technique will be randomized intraoperatively to one technique.

Discussion

The ReLap study will bridge a significant knowledge gap regarding patients undergoing relaparotomy. Differences in the standard of care between relaparotomies and primary laparotomies will be determined. The relation between biomarkers and manifestation of adhesions will be explored and evidence for the comparative effectiveness of fascial closure after relaparotomy will be gained.

Introduction

Systematic reviews and meta-analyses are methodologically rigorous studies that are said to form the reference standard for summarising evidence to guide health care. Reporting quality of reviews is of critical importance in order to judge the quality and risk of bias in a review to ensure sound healthcare decisions are made. This is particularly important in the field of dermatology due to the growing number of systematic reviews and their key role in informing healthcare decision within dermatology. A contemporary and comprehensive review of the compliance of dermatology systematic reviews and meta-analyses with the PRISMA checklist, in the highest impact factor dermatology journals, has not yet been assessed. To our knowledge, our review represents the most extensive study assessing reporting quality of systematic reviews and meta-analyses published within dermatology to date.

Methods and analysis

Our protocol is reported in line with the Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 guidelines. MEDLINE will be searched to look for systematic reviews and meta-analysis in selected years within the top four highest impact factor dermatology journals in 2017. Records and full texts will be screened independently by five researchers. Data will be extracted onto a standard data extraction database. A training session will take place to ensure accurate data extraction and scoring of studies with the PRISMA checklist. The data will be analysed and outcomes will be determined. Primary outcome will be the compliance of reviews with the PRISMA checklist.

Introduction

A scaphoid fracture is the most common carpal fracture. When healing of the fracture fails (nonunion), a specific pattern of osteoarthrosis occurs, resulting in pain, restricted wrist motion and disability. Scaphoid fracture classification systems recognize fragment displacement as an important cause of nonunion. The fracture is considered unstable if the fragments are displaced. However, whether and how displaced bone fragments move with respect to one another has not yet been investigated in vivo. With a four-dimensional (4D) computed tomographic (CT) imaging technique we aim to analyze the interfragmentary motion patterns of displaced and non-displaced scaphoid fragments. Furthermore, the correlation between fragment motion and the development of a scaphoid nonunion is investigated. We hypothesize that fragment displacement is not correlated to fragment instability; and concurrent nonunion is related to fragment instability and not to interfragmentary displacement.

Methods

In a prospective single-center cohort pilot study, patients with a one-sided acute scaphoid fracture and no history of trauma to the contralateral wrist are illegible for inclusion. Twelve patients with a non-displaced scaphoid fracture and 12 patients with a displaced scaphoid fracture are evaluated. Both wrists are scanned with 4D-CT imaging during active flexion–extension and radio-ulnar deviation motion. The contralateral wrist serves as kinematic reference. Relative displacement of the distal scaphoid fragment with respect to the proximal scaphoid fragment, is described by translations and rotations (the kinematic parameters), as a function of the position of the capitate. Non-displaced scaphoid fractures are treated conservatively, displaced scaphoid fractures receive intraoperative screw fixation. Follow-up with CT scans is conducted until consolidation at 1½, 3 and 6 months. This trial is registered in the Dutch Toetsingonline trial registration system, number: NL60680.018.17.

Ethics

This study is approved by the Medical Ethics Committee of the Academic Medical Center, Amsterdam.