scholarly journals A Study Protocol for a Randomised Controlled Trial Evaluating the Effects of Intraoperative Computed Tomography on the Outcomes of Zygomatic Fractures

2019 ◽  
Author(s):  
Andrew Michael Higgins ◽  
Michael James Leslie Hurrell ◽  
Richard Ian Harris ◽  
Geoffrey James Findlay ◽  
Michael C David ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Randomised Controlled Trial ◽  
Surgical Management ◽  
Controlled Trial ◽  
The Body ◽  
Fracture Reduction ◽  
Facial Trauma ◽  
Facial Profile ◽  
Post Surgery ◽  
Randomised Controlled

Abstract Background Zygomaticomaxillary complex (ZMC) and zygomatic arch (ZA) fractures are common injuries resulting from facial trauma and frequently require surgical management.1 A substantial number of post-operative functional and cosmetic complications can arise from the surgical management of these fractures. These include scarring, inadequate facial profile restoration, facial asymmetries and diplopia.2-4 Intuitively, most of these aforementioned complications arise as a result of inadequate fracture reduction, however current standard practice is to assess reduction post-operatively through plain radiographs or computed tomography (CT) scans. The role of intra-operative computed tomography (CT) scanning to assess the reduction of ZMC/ZA fractures and the potential impact on complications, has thus far not been established. Methods This is a prospective randomised controlled trial currently being undertaken at the Royal Brisbane and Women’s Hospital. All patients who require operative management of their ZMC or ZA fractures are offered enrollment in the trial. The patients are randomised into two groups: interventional (intra-operative CT) and control (no intra-operative CT). All patients from both groups will have post-operative radiographs taken. From these radiographs, the reduction of the ZMC and/or ZA fracture is graded by a blinded assessor. Patients will be reviewed in clinic at one and six weeks post-surgery. During these consultations, all patients will be assessed for scarring, diplopia, facial profile restoration and need for revision surgery. Discussion Many complications associated with surgical management of ZMC and ZA fractures involve poor aesthetic results as a direct consequence of inadequate fracture reduction. Inadequate fracture reduction is predictable given that small incisions are used and only limited visualisation of the fractures is possible during the procedure. This is due to a desire to limit scarring and reduce the risk of damage to vital structures in an aesthetically sensitive region of the body. It follows that an intraoperative adjunctive tool such as a CT scan, which can assist in visualisation of the fractures and the subsequent reduction, could potentially improve reduction and reduce complications.

scholarly journals A Study Protocol for a Randomised Controlled Trial Evaluating the Effects of Intraoperative Computed Tomography on the Outcomes of Zygomatic Fractures

2019 ◽  
Author(s):  
Andrew Michael Higgins ◽  
Michael James Leslie Hurrell ◽  
Richard Ian Harris ◽  
Geoffrey James Findlay ◽  
Michael C David ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Randomised Controlled Trial ◽  
Surgical Management ◽  
Controlled Trial ◽  
The Body ◽  
Fracture Reduction ◽  
Facial Trauma ◽  
Facial Profile ◽  
Post Surgery ◽  
Randomised Controlled

Abstract Background Zygomaticomaxillary complex (ZMC) and zygomatic arch (ZA) fractures are common injuries resulting from facial trauma and frequently require surgical management.1 A substantial number of post-operative functional and cosmetic complications can arise from the surgical management of these fractures. These include scarring, inadequate facial profile restoration, facial asymmetries and diplopia.2-4 Intuitively, most of these aforementioned complications arise as a result of inadequate fracture reduction, however current standard practice is to assess reduction post-operatively through plain radiographs or computed tomography (CT) scans. The role of intra-operative computed tomography (CT) scanning to assess the reduction of ZMC/ZA fractures and the potential impact on complications, has thus far not been established. Methods This is a prospective randomised controlled trial currently being undertaken at the Royal Brisbane and Women’s Hospital. All patients who require operative management of their ZMC or ZA fractures are offered enrollment in the trial. The patients are randomised into two groups: interventional (intra-operative CT) and control (no intra-operative CT). All patients from both groups will have post-operative radiographs taken. From these radiographs, the reduction of the ZMC and/or ZA fracture is graded by a blinded assessor. Patients will be reviewed in clinic at one and six weeks post-surgery. During these consultations, all patients will be assessed for scarring, diplopia, facial profile restoration and need for revision surgery. Discussion Many complications associated with surgical management of ZMC and ZA fractures involve poor aesthetic results as a direct consequence of inadequate fracture reduction. Inadequate fracture reduction is predictable given that small incisions are used and only limited visualisation of the fractures is possible during the procedure. This is due to a desire to limit scarring and reduce the risk of damage to vital structures in an aesthetically sensitive region of the body. It follows that an intraoperative adjunctive tool such as a CT scan, which can assist in visualisation of the fractures and the subsequent reduction, could potentially improve reduction and reduce complications.

scholarly journals Physical activity and health promotion for nursing staff in elderly care: a study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e038202
Author(s):  
Ann-Kathrin Otto ◽  
Juliane Pietschmann ◽  
Luisa-Marie Appelles ◽  
Michael Bebenek ◽  
Laura L Bischoff ◽  
...  
Keyword(s):  
Health Promotion ◽  
Nursing Home ◽  
Randomised Controlled Trial ◽  
Nursing Staff ◽  
Controlled Trial ◽  
The Body ◽  
Work Related ◽  
Post Test ◽  
Fitness Training ◽  
Randomised Controlled

IntroductionNursing staff is burdened by high workload and stress. Furthermore, heavy lifting, as well as transferring nursing home residents, cause lumbar tissue damage and back pain. Exercise intervention studies to reduce work-related problems are rare and the evidence for efficacy of studies among nurses is limited. Studies including targeted analysis of requirements are necessary to generate effective recommendations and tailored interventions for health promotion programmes. The purpose of this multicentred intervention study is to identify work-related problems, to implement health promotion programmes and to evaluate their effectiveness.Methods and analysisA randomised controlled trial will be conducted, including a total of 48 nursing home facilities in eight regions of Germany with an estimated sample size of 700 nurses. Standardised ergonomics and posture training (10 weeks, once a week for 20–30 min) and subsequently, back-fitness training (12 weeks, once a week for 45–60 min) will be administered. Following the implementation of standardised health promotion programmes, further demand-oriented interventions can be implemented. The perceived exposure to work-related demands, work-related pain in different parts of the body, health-related quality of life, perceived stress, work-related patterns of behaviour and experience, presentism behaviour, work environment as well as general needs and barriers to health promotion, will be assessed at baseline (pre-test), at 10 weeks (post-test, after ergonomics training), at 22 weeks (post-test, after back-fitness training) and at 34 weeks of the programme (follow-up).Ethics and disseminationThe study was reviewed and approved by the local ethics committee of the University of Hamburg (AZ: 2018_168). The results of the study will be published in open-access and international journals. Furthermore, the results will be presented in the participating nursing homes and at national and international conferences.Trial registration numberDRKS.de (DRKS00015241).

Preoperative MRI and surgical management in patients with nonpalpable breast cancer: The MONET – Randomised controlled trial

2011 ◽  
Vol 47 (6) ◽  
pp. 879-886 ◽  
Author(s):  
N.H.G.M. Peters ◽  
S. van Esser ◽  
M.A.A.J. van den Bosch ◽  
R.K. Storm ◽  
P.W. Plaisier ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomised Controlled Trial ◽  
Surgical Management ◽  
Controlled Trial ◽  
Nonpalpable Breast Cancer ◽  
Randomised Controlled

Post-surgery adjuvant therapy with intermediate doses of interferon alfa 2b versus observation in patients with stage IIb/III melanoma (EORTC 18952): randomised controlled trial

The Lancet ◽  
2005 ◽  
Vol 366 (9492) ◽  
pp. 1189-1196 ◽  
Author(s):  
Alexander MM Eggermont ◽  
Stefan Suciu ◽  
Rona MacKie ◽  
Wlodzimierz Ruka ◽  
Alessandro Testori ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Adjuvant Therapy ◽  
Controlled Trial ◽  
Interferon Alfa ◽  
Post Surgery ◽  
Randomised Controlled

scholarly journals A feasibility randomised controlled trial to evaluate the role of computed tomography in adults with atypical right iliac fossa pain

2019 ◽  
Vol 101 (8) ◽  
pp. 546-551
Author(s):  
R Jones ◽  
D Olatunbode ◽  
J Dean ◽  
B Hall ◽  
D Harji ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Randomised Controlled Trial ◽  
Diagnostic Accuracy ◽  
Standard Care ◽  
Controlled Trial ◽  
Iliac Fossa ◽  
Randomised Trial ◽  
Final Analysis ◽  
Right Iliac Fossa Pain ◽  
Randomised Controlled

Background In patients with right iliac fossa pain, the need for surgery is largely determined by the likelihood of appendicitis. Patients often undergo ultrasound scanning despite a low diagnostic accuracy for appendicitis. This study aimed to determine the feasibility of a larger trial of computed tomography in the evaluation of patients with atypical right iliac fossa pain. Materials and methods A single-centre, unblinded, parallel randomised controlled trial of computed tomography in the assessment of patients with atypical right iliac fossa pain. After a retrospective evaluation, standard care was defined as serial examination with or without ultrasound. Atypical right iliac fossa pain was defined as no firm diagnosis after initial senior review. Simple descriptions of the risks and benefits of computed tomography were devised for patients to consider. Primary objectives were to assess feasibility and acceptability of the study procedures. Results A total of 71 patients were invited to participate and 68 were randomised. Final analysis included 31 participants in the standard care arm and 33 in the computed tomography arm, with comparable demographics. Computed tomography was associated with superior diagnostic accuracy, with 100% positive and negative predictive value. The proportion of scans that positively influenced management was 73% for computed tomography and 0% for ultrasound. In the computed tomography arm, there was a trend towards a shorter length of stay (2.3 vs 3.1 days) and a lower negative laparoscopy rate (2 of 11 vs 4 of 9). Conclusion A large randomised trial to evaluate the use of unenhanced computed tomography in atypical right iliac fossa pain appears feasible and justified.

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