Impact of copper compression stockings on venous insufficiency and lipodermatosclerosis: A randomised controlled trial

2018 ◽  
Vol 34 (4) ◽  
pp. 224-230 ◽  
Author(s):  
Linda P Arendsen ◽  
Stella Vig ◽  
Ranee Thakar ◽  
Abdul H Sultan
Keyword(s):  
Surface Area ◽  
Controlled Trial ◽  
Chronic Venous Disease ◽  
Control Group ◽  
Venous Disease ◽  
Compression Stocking ◽  
Compression Stockings ◽  
Significant Difference ◽  
Randomised Controlled ◽  
The Impact

Objective Compression stockings are the primary treatment for lipodermatosclerosis secondary to chronic venous disease, but do not improve the skin condition. The aim of this study was to investigate the impact of copper on lipodermatosclerosis. Methods A double-blind randomised controlled pilot study was performed including patients with bilateral lipodermatosclerosis. One compression stocking of a pair was impregnated with copper. Symptom score and surface area of lipodermatosclerosis were assessed at baseline, after 2, 4 and 8 weeks. Results Sixteen patients were included. There was no significant difference in mean symptom scores; however, there was a significant reduction of the surface area in the study group 42,637 to 35,739 mm2 versus 41,487 to 43,210 mm2 in the control group (p = 0.04). Conclusion This study demonstrates the beneficial effect of copper on lipodermatosclerosis secondary to chronic venous disease with reduction in surface area but no benefit on symptoms. Trials identification number: NCT03283800

Graduated Compression Elastic Stockings Reduce Lipodermatosclerosis and Ulcer Recurrence

2000 ◽  
Vol 15 (1) ◽  
pp. 33-37 ◽  
Author(s):  
Y. K. Vandongen ◽  
M. C. Stacey
Keyword(s):  
Controlled Trial ◽  
Venous Ulcer ◽  
Control Group ◽  
Venous Disease ◽  
Ulcer Recurrence ◽  
Compression Stockings ◽  
Venous Ulceration ◽  
Tertiary Teaching ◽  
Elastic Stockings ◽  
Randomised Controlled

Objective: To assess the effect of elastic stockings on reducing the area of lipodermatosclerosis in patients with healed venous ulceration. Design: Patients in this study were part of a randomised controlled trial to assess elastic stockings in preventing venous ulcer recurrence. Setting: Leg ulcer clinic at a tertiary teaching hospital. Patients: Consecutive consenting patients with leg ulcers due to venous disease alone, that had healed 2 weeks previously. Interventions: Patients were randomised to below-knee graduated compression stockings (Venosan 2003) or no stockings. Main outcome measures: Patients had the area of lipodermatosclerosis measured on admission to the study and at 6-monthly intervals. Time to ulcer recurrence was also recorded for a 2-year follow-up period. Results: One hundred and fifty-three patients were randomised to the main study (stockings 72, no stockings 81); 52 had re-ulcerated by 6 months (15 stockings, 37 no stockings). Lipodermatosclerosis was significantly reduced after 6 and 12 months in those patients wearing stockings but not in the control group (repeat measures ANOVA p = 0.01, p = 0.04). The initial area of lipodermatosclerosis was significantly larger in those patients who re-ulcerated within 2 years of entering the study compared with those who did not re-ulcerate (re-ulceration, 293 cm2; no re-ulceration, 50 cm2). Conclusions: Elastic stockings alone can improve the skin changes of lipodermatosclerosis and lower the rate of ulcer recurrence.

scholarly journals Corticosteroid Resistance in Smokers—A Substudy Analysis of the CORTICO-COP Randomised Controlled Trial

2021 ◽  
Vol 10 (12) ◽  
pp. 2734
Author(s):  
Pradeesh Sivapalan ◽  
Andras Bikov ◽  
Charlotte Suppli Ulrik ◽  
Therese Sophie Lapperre ◽  
Alexander G. Mathioudakis ◽  
...  
Keyword(s):  
Smoking Status ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Control Group ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Corticosteroid Resistance ◽  
Significant Difference ◽  
Randomised Controlled ◽  
The Impact

The CORTICO-COP trial showed that eosinophil-guided corticosteroid-sparing treatment for acute exacerbation of chronic obstructive pulmonary disease was non-inferior to standard of care and decreased the accumulated dose of systemic corticosteroids that patients were exposed to by approximately 60%. Smoking status has been shown to affect corticosteroid responsiveness. This post hoc analysis investigated whether eosinophil-guided treatment is non-inferior to conventional treatment in current smokers. The main analysis of current smokers showed no significant difference in the primary endpoint, days alive, and out of hospital within 14 days between the control group (mean, 9.8 days; 95% confidence interval (CI), 8.7–10.8) and the eosinophil-guided group (mean, 8.7 days; 95% CI, 7.5–9.9; p = 0.34). Secondary analyses of the number of exacerbations or deaths, the number of intensive care unit admissions or deaths, lung function improvement, and change in health-related quality of life also showed no significant differences between the two groups. The results of a sensitivity analysis of ex-smokers are consistent with the main analysis. Our results suggest that eosinophil-guided treatment is non-inferior to standard of care in current smokers and ex-smokers. Because data on the impact of smoking status on eosinophil-guided treatments are sparse, more randomised trials are needed to confirm our results.

Reducing the Social Stigma Associated with Obsessive Compulsive Disorder: A Controlled Trial of an Intervention Program in a Turkish Community Sample

2020 ◽  
Vol 20 (2) ◽  
pp. 101-120
Author(s):  
Ayça Aktaç Gürbüz ◽  
Orçun YORULMAZ ◽  
Gülşah DURNA
Keyword(s):  
Obsessive Compulsive Disorder ◽  
Intervention Program ◽  
Controlled Trial ◽  
Community Sample ◽  
Case Vignette ◽  
Control Group ◽  
Obsessive Compulsive ◽  
Compulsive Disorder ◽  
Significant Difference ◽  
The Impact

Scientific research into the reduction of stigmatization, particularly related to specific problems such as Obsessive-Compulsive Disorder (OCD), is scarce. In the present study, we examine the impact of a video-based antistigma intervention program for OCD in a pretest-posttest control group research. After being randomly assigned to either an intervention (n= 101) or control group (n= 96), the participants reported their attitudes on a hypothetical case vignette before and after OCD vs. Multiple Sclerosis (MS) videos, and again six months later as a follow up assessment. The mixed design analyses for the group comparisons indicated that although there was no significant difference in the measures of the control group, the participants watching the anti-stigma OCD video, in which the focus was psychoeducation and interaction strategies, reported significantly lower scores on social distances and negative beliefs for the case vignettes they read, and this difference was maintained six months later. Then, the present results indicate the effectiveness of our anti-stigma intervention program for OCD. Interventions to reduce stigmatization can also be viewed as effective tools for changing the attitudes of people toward OCD, although further research and applications are needed related to specific disorders if a longlasting impact is to be achieved.

Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

2021 ◽  
pp. 112070002110057
Author(s):  
Niels H Bech ◽  
Inger N Sierevelt ◽  
Sheryl de Waard ◽  
Boudijn S H Joling ◽  
Gino M M J Kerkhoffs ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Controlled Trial ◽  
Poor Quality ◽  
Control Group ◽  
Treatment Groups ◽  
Significant Difference ◽  
Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p  > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

scholarly journals Effect of Engaging Trainees by Assessing Peer Performance: A Randomised Controlled Trial Using Simulated Patient Scenarios

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Charlotte Loumann Krogh ◽  
Charlotte Ringsted ◽  
Charles B. Kromann ◽  
Maria Birkvad Rasmussen ◽  
Tobias Todsen ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Global Rating ◽  
Training Performance ◽  
Significant Difference ◽  
Training Format ◽  
Peer Performance ◽  
And Performance ◽  
Randomised Controlled

Introduction. The aim of this study was to explore the learning effect of engaging trainees by assessing peer performance during simulation-based training.Methods. Eighty-four final year medical students participated in the study. The intervention involved trainees assessing peer performance during training. Outcome measures were in-training performance and performance, both of which were measured two weeks after the course. Trainees’ performances were videotaped and assessed by two expert raters using a checklist that included a global rating. Trainees’ satisfaction with the training was also evaluated.Results. The intervention group obtained a significantly higher overall in-training performance score than the control group: mean checklist score 20.87 (SD 2.51) versus 19.14 (SD 2.65)P=0.003and mean global rating 3.25 SD (0.99) versus 2.95 (SD 1.09)P=0.014. Postcourse performance did not show any significant difference between the two groups. Trainees who assessed peer performance were more satisfied with the training than those who did not: mean 6.36 (SD 1.00) versus 5.74 (SD 1.33)P=0.025.Conclusion. Engaging trainees in the assessment of peer performance had an immediate effect on in-training performance, but not on the learning outcome measured two weeks later. Trainees had a positive attitude towards the training format.

scholarly journals The Effect of Glycomacropeptide versus Amino Acids on Phenylalanine and Tyrosine Variability over 24 Hours in Children with PKU: A Randomized Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (3) ◽  
pp. 520 ◽  
Author(s):  
Anne Daly ◽  
Sharon Evans ◽  
Satnam Chahal ◽  
Saikat Santra ◽  
Alex Pinto ◽  
...  
Keyword(s):  
Amino Acids ◽  
Controlled Trial ◽  
Target Range ◽  
Blood Spots ◽  
Meal Plan ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Limiting Amino Acids ◽  
The Impact ◽  
Rate Limiting

Introduction: In phenylketonuria (PKU), evidence suggests that casein glycomacropeptide supplemented with rate-limiting amino acids (CGMP-AA) is associated with better protein utilisation and less blood phenylalanine (Phe) variability. Aim: To study the impact of CGMP-AA on blood Phe variability using 3 different dietary regimens in children with PKU. Methods: This was a 6-week randomised controlled cross-over study comparing CGMP-AA vs. Phe-free l-amino acids (l-AA) assessing blood Phe and tyrosine (Tyr) variability over 24 h in 19 children (7 boys) with PKU, with a median age of 10 years (6–16). Subjects were randomised to 3 dietary regimens: (1) R1, CGMP-AA and usual dietary Phe (CGMP + Phe); (2) R2, CGMP-AA − Phe content of CGMP-AA from usual diet (CGMP − Phe); and (3) R3, l-AA and usual dietary Phe. Each regimen was administered for 14 days. Over the last 48 h on days 13 and 14, blood spots were collected every 4 h at 08 h, 12 h, 16 h, 20 h, 24 h, and 04 h. Isocaloric intake and the same meal plan and protein substitute dosage at standardised times were maintained when blood spots were collected. Results: Eighteen children completed the study. Median Phe concentrations over 24 h for each group were (range) R1, 290 (30–580), R2, 220 (10–670), R3, 165 (10–640) μmol/L. R1 vs. R2 and R1 vs. R3 p < 0.0001; R2 vs. R3 p = 0.0009. There was a significant difference in median Phe at each time point between R1 vs. R2, p = 0.0027 and R1 vs. R3, p < 0.0001, but not between any time points for R2 vs. R3. Tyr was significantly higher in both R1 and R2 [70 (20–240 μmol/L] compared to R3 [60 (10–200) μmol/L]. In children < 12 years, blood Phe remained in the target range (120–360 μmol/L), over 24 h, for 75% of the time in R1, 72% in R2 and 64% in R3; for children aged ≥ 12 years, blood Phe was in target range (120–600 μmol/L) in R1 and R2 for 100% of the time, but 64% in R3. Conclusions: The residual Phe in CGMP-AA increased blood Phe concentration in children. CGMP-AA appears to give less blood Phe variability compared to l-AA, but this effect may be masked by the increased blood Phe concentrations associated with its Phe contribution. Reducing dietary Phe intake to compensate for CGMP-AA Phe content may help.

scholarly journals A143 IMPACT OF A SIMULATION-BASED AUGMENTED REALITY CURRICULUM ON POLYPECTOMY SKILLS AMONG NOVICE ENDOSCOPISTS: A RANDOMIZED CONTROLLED TRIAL

2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. 5-7
Author(s):  
R Khan ◽  
M A Scaffidi ◽  
N Gimpaya ◽  
D Tham ◽  
M Atalla ◽  
...  
Keyword(s):  
Augmented Reality ◽  
Ad Hoc ◽  
Controlled Trial ◽  
Skill Training ◽  
Control Group ◽  
Small Group Teaching ◽  
Significant Difference ◽  
Simulation Based ◽  
Free Environment ◽  
The Impact

Abstract Background Polypectomy is an essential endoscopic skill. Training in polypectomy has been identified as a major deficiency for endoscopists worldwide as polypectomy occurs ad hoc during a colonoscopy when a polyp is detected, and a lack of standardized curricula. Augmented reality (AR), which superimposes computer-generated images on a user’s view of the world, can address these gaps by standardizing encounters with polyps while completing simulated procedures and enabling polypectomy-specific teaching. Aims Evaluate the impact of a simulation-based augmented reality curriculum on polypectomy performance among novice endoscopists. Methods This study includes two cohorts of participants from 2019 to 2020. In 2019, participants were randomized into either: (1) a control curriculum, involving 6 hours of simulation-based training (SBT) supplemented by expert feedback, interlaced with 4 hours of small group teaching on the theory of colonoscopy; or (2) the augmented reality curriculum (ARC), in involving the same curriculum with integrated AR, wherein participants engaged with an AR-enhanced video demonstrating relevant therapeutic and pathologic details during polypectomy. The SBT for all participants involved a progressive curriculum starting on a bench-top model and then moving to the EndoVR® virtual reality simulator. The primary outcome was polypectomy-specific performance using the Direct Observation of Polypectomy Skills (DOPyS) tool during a simulated polypectomy after training, with a maximum score of 100. Results Demographic characteristics are summarized in Table. In 2019, 21 novice endoscopists were enrolled. Immediately after training, the mean DOPyS score among ARC group participants was 76.2 (SD=17.9) compared to 71.8 (SD=13.2) among control group participants (Figure). In this interim analysis, there was no significant difference between groups. Data analysis will be completed after 2020 participants complete the study. Conclusions Interim results show a trend towards improved polypectomy performance with no significant difference. The results of this study have the potential to impact polypectomy education among novices. Simulation-based AR interventions may allow learners to progress towards achieving competency in polypectomy in a risk-free environment prior to first patient contact. Funding Agencies None

scholarly journals Perioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Jan Bednarsch ◽  
Zoltan Czigany ◽  
Sven H. Loosen ◽  
Lara Heij ◽  
Lorenz Ruckgaber ◽  
...  
Keyword(s):  
Liver Function ◽  
Primary Endpoint ◽  
Major Hepatectomy ◽  
Controlled Trial ◽  
Liver Volume ◽  
Relative Increase ◽  
Control Group ◽  
Open Label ◽  
Significant Difference ◽  
The Impact

AbstractThe objective of this randomized controlled trial (RCT) was to assess the impact of rifaximin on the course of liver function, liver regeneration and volumetric recovery in patients undergoing major hepatectomy. The ARROW trial was an investigator initiated, single-center, open-label, phase 3 RCT with two parallel treatment groups, conducted at our hepatobiliary center from 03/2016 to 07/2020. Patients undergoing major hepatectomy were eligible and randomly assigned 1:1 to receive oral rifaximin (550 mg twice daily for 7–10 or 14–21 days in case of portal vein embolization preoperatively and 7 days postoperatively) versus no intervention. Primary endpoint was the relative increase in postoperative liver function measured by LiMAx from postoperative day (POD) 4 to 7. Secondary endpoint were the course of liver function and liver volume during the study period as well as postoperative morbidity and mortality. Between 2016 and 2020, 45 patients were randomized and 35 patients (16 individuals in the rifaximin and 19 individuals in the control group) were eligible for per-protocol analysis. The study was prematurely terminated following interim analysis, due to the unlikelihood of reaching a significant primary endpoint. The median relative increase in liver function from POD 4 to POD 7 was 27% in the rifaximin group and 41% in the control group (p = 0.399). Further, no significant difference was found in terms of any other endpoints of functional liver- and volume regeneration or perioperative surgical complications following the application of rifaximin versus no intervention. Perioperative application of rifaximin has no effect on functional or volumetric regeneration after major hepatectomy (NCT02555293; EudraCT 2013-004644-28).

scholarly journals Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial

2020 ◽  
Vol 7 (1) ◽  
pp. e000376
Author(s):  
Sivakami Janahiraman ◽  
Chan Yen Tay ◽  
Jie Min Lee ◽  
Wen Ling Lim ◽  
Chun Hoe Khiew ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
Tertiary Hospital ◽  
Educational Programme ◽  
Control Group ◽  
Randomised Controlled ◽  
The Impact ◽  
Experimental Group

ObjectivePreprocedural bowel preparation is necessary for optimal colonoscopy visualisation. However, it is challenging to achieve high-quality bowel preparation among patients scheduled for colonoscopy. This study aims to evaluate the impact of an intensive patient educational programme on the quality of bowel preparation.DesignAn accessor-blinded randomised controlled trial was carried out at the outpatient surgical clinic of a tertiary hospital. Patients were randomly assigned to the control group (received standard written and verbal instructions) or the experimental group (received an intensive and structured educational programme). All subjects completed a questionnaire before colonoscopy to assess their compliance, acceptability, and tolerability towards bowel preparation regime. Quality of bowel preparation was determined using the Boston Bowel Preparation Scale (BBPS).ResultsA total of 300 subjects who fulfilled the inclusion criteria were recruited. The experimental group had a significantly higher proportion of good quality bowel preparation than the control group (98.7% vs 52.3%, p<0.001). The median total BBPS score was also significantly higher in the experimental group (8 vs 5, p<0.001). Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).ConclusionAn intensive patient educational programme can significantly improve the quality of bowel preparation for colonoscopy.

scholarly journals Out-patient triple chronotherapy for the rapid treatment and maintenance of response in depression: feasibility and pilot randomised controlled trial

BJPsych Open ◽  
2021 ◽  
Vol 7 (6) ◽  
Author(s):  
David Veale ◽  
Marc Serfaty ◽  
Clara Humpston ◽  
Andriani Papageorgiou ◽  
Sarah Markham ◽  
...  
Keyword(s):  
Rating Scale ◽  
Clinical Sample ◽  
Controlled Trial ◽  
Bright Light ◽  
Light Therapy ◽  
Control Group ◽  
Intention To Treat ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Rapid Treatment

Background Triple chronotherapy (sleep deprivation for 36 h, followed by 4 days of advancing the time of sleep and daily morning bright-light therapy for 6 months) has demonstrated benefits for the rapid treatment of depressive symptoms in four small controlled trials of in-patients. Aims To test the feasibility of recruitment and delivery of triple chronotherapy for out-patients with depression (ISRCTN17706836; NCT03405493). Method In a single-blind trial, 82 participants were randomised to triple chronotherapy or a control intervention. The primary outcome was the number of participants recruited per month and adherence to the protocol. Secondary outcomes included the 6-item Hamilton Rating Scale for Depression (HRSD-6) at 1 week. Timings of observer ratings were baseline and 1, 2, 4, 8 and 26 weeks after randomisation. Results The triple chronotherapy group stayed awake for the planned 36 h and 89.9% adhered to the plan of phase advance of their sleep over the following 4 days. We achieved our recruitment target (60 participants completed the trial within 13 months). There were no reported adverse side-effects. We found a significant difference between the groups by intention-to-treat analysis for the HRSD-6 at weeks 1, 8 and 26. There was a large effect size of Cohen's d = 0.8 on HRSD-6 score at week 1, increasing to d = 1.30 at week 26. A response (≥50% reduction in symptoms) was achieved by 33.3% in the triple chronotherapy group and 16.2% in the control group. This stayed relatively steady until week 26 (35.9 v. 13.9%). Conclusions Triple chronotherapy produced a significant and rapid benefit after 1 week in out-patients with depression that was sustained at 26 weeks. Cost-effectiveness trials with a larger clinical sample are required.

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