Failure of a trial evaluating the effect of venous surgery on healing and recurrence rates in venous ulcers? The USABLE trial: rationale, design and methodology, and reasons for failure

2004 ◽  
Vol 19 (3) ◽  
pp. 137-142 ◽  
Author(s):  
A H Davies ◽  
A J Hawdon ◽  
R M Greenhalgh ◽  
S Thompson
Keyword(s):  
Controlled Trial ◽  
Venous Ulcer ◽  
Recurrence Rates ◽  
Compression Bandaging ◽  
Venous Ulcers ◽  
Number Of Patients ◽  
Venous Surgery ◽  
Ulcer Surgery ◽  
Set Up

Objective: This Medical Research Council funded trial was set up to investigate whether venous surgery provided any additional benefit in the healing and recurrence rates of venous ulcers over compression bandaging alone. Methods: Ulcer surgery as adjuvant to compression bandaging for leg ulcers (USABLE) was a multicentre, randomized controlled trial, which planned to recruit 1000 venous ulcer patients to receive either compression bandaging alone or compression bandaging plus venous surgery. Follow up recorded ulcer healing, recurrence and patient quality of life. Results: Recruitment was slow, and involved screening a large number of patients (759) with only 75 randomized over an 18-month recruitment period. Conclusions: The results would infer that surgery is unlikely to be a management option for the majority of patients presenting to a hospital with a gaiter area leg ulcer.

scholarly journals Evaluation of the Use of Compressive Stockings Impregnated With Hesperetin-Based Nanocapsules in the Healing of Venous Ulcers: A Case Report

2019 ◽  
Vol 12 ◽  
pp. 117954761985897
Author(s):  
Paula dos Passos Menezes ◽  
Cristiane Vilaça Campos Gomes ◽  
Yasmim Maria Barbosa Gomes de Carvalho ◽  
Nayara Gomes Lima Santos ◽  
Valléria Matos Andrade ◽  
...  
Keyword(s):  
Case Report ◽  
Pain Perception ◽  
Healing Process ◽  
Treatment Method ◽  
Venous Ulcer ◽  
Venous Ulcers ◽  
Number Of Patients ◽  
Lateral Portion ◽  
The Right

Venous ulcers are a more severe complication of chronic venous insufficiency, significantly compromising patient quality of life (QoL). Compressive stockings are still the gold standard treatment method with alternative therapies currently being evaluated. In this perspective, we investigate the influence of compressive stockings impregnated with hesperetin-based nanocapsules in the healing process of venous ulcers. Compressive stockings impregnated with hesperetin-based nanocapsules were applied to a consenting patient for 6 months following all relevant ethical principles for patient studies. The patient was evaluated at baseline (T0), 3 months (T3), and 6 months (T6), using photographic register (healing) probes to measure skin melanin, erythema and hydration parameters, and venous diameters, followed by questionnaires regarding QoL and pain perception. Healing was observed at the 3-month time point and with 91.6% and 93.1% of retraction area in larger ulcers of the right leg and lateral portion of the left leg, respectively. The deepest ulcer in a medial portion of the left leg healed 47.3%. A reduction of all measured skin parameters was observed, indicating a possible hesperetin effect. The scores of QoL and pain were, respectively, in the ranges of 91.6 to 31.2 and 7 to 0. Reduction in venous diameters also indicates healing function. These preliminary findings suggest that compressive stockings impregnated with hesperetin nanocapsules enhance venous ulcer healing. Further clinical trial controlled by placebo, involving a greater number of patients, is required to confirm the findings of this case report.

scholarly journals External Application of Traditional Chinese Medicine for Venous Ulcers: A Systematic Review and Meta-Analysis

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Xin Li ◽  
Qing-qing Xiao ◽  
Kan Ze ◽  
Su Li ◽  
Yi-fei Wang ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Conventional Therapy ◽  
Meta Analysis ◽  
Recurrence Rates ◽  
External Application ◽  
Venous Ulcers ◽  
Dichotomous Data ◽  
Mean Differences

Objective. To evaluate the effectiveness of external application of traditional Chinese medicine (EA-TCM) on venous ulcers.Methods. Seven databases were searched until April 2015 for randomized controlled trials (RCTs) of EA-TCM for venous ulcers. Risk of bias was assessed using Cochrane Handbook guidelines. Study outcomes were presented as risk ratios (RRs) for dichotomous data or mean differences (MDs) for continuous data.Results. Sixteen of 193 potentially relevant trials met the inclusion criteria; however, their methodological qualities were low. Comparison of the same intervention strategies revealed significant differences in total effectiveness rates between EA-TCM and conventional therapy groups (RR = 1.22, 95% confidence interval [CI] = 1.16–1.29, andP<0.00001). Compared to conventional therapy, EA-TCM combined with conventional therapy had a superior total effectiveness rate (RR = 1.11, 95% CI = 1.04–1.19, andP=0.003). There were no significant differences in recurrence rates during followup and final pain measurements between the experimental and those in the control groups (RR = 0.86, 95% CI = 0.31–2.39, andP=0.85; MD −0.75, 95% CI = −2.15–0.65, andP=0.29).Conclusion. The evidence that EA-TCM is an effective treatment for venous ulcers is encouraging, but not conclusive due to the low methodological quality of the RCTs. Therefore, more high-quality RCTs with larger sample sizes are required.

scholarly journals Adjunctive inspiratory muscle training for patients with COVID-19 (COVIDIMT): protocol for randomised controlled double-blind trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e049545
Author(s):  
Vinicius Maldaner ◽  
Jean Coutinho ◽  
Alfredo Nicodemos da Cruz Santana ◽  
Graziella F B Cipriano ◽  
Miriã Cândida Oliveira ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Exercise Capacity ◽  
Controlled Trial ◽  
Inspiratory Muscle ◽  
Inspiratory Muscle Training ◽  
Muscle Training ◽  
Number Of Patients ◽  
Psychosocial Counselling ◽  
Randomised Controlled

IntroductionA significant number of patients with COVID-19 may experience dyspnoea, anxiety, depression, pain, fatigue and physical impairment symptoms, raising the need for a multidisciplinary rehabilitation approach, especially for those with advanced age, obesity, comorbidities and organ failure. Traditional pulmonary rehabilitation (PR), including exercise training, psychosocial counselling and education, has been employed to improve pulmonary function, exercise capacity and quality of life in patients with COVID-19. However, the effects of inspiratory muscle training (IMT) in PR programmes remain unclear. This study aimed to determine whether the addition of a supervised IMT in a PR is more effective than PR itself in improving dyspnoea, health-related quality of life and exercise capacity in symptomatic patients with post-COVID-19.Methods and analysisThis parallel-group, assessor-blinded randomised controlled trial, powered for superiority, aimed to assess exercise capacity as the primary outcome. A total of 138 are being recruited at two PR centres in Brazil. Following baseline testing, participants will be randomised using concealed allocation, to receive either (1) standard PR with sham IMT or (2) standard PR added to IMT. Treatment effects or differences between the outcomes (at baseline, after 8 and 16 weeks, and after 6 months) of the study groups will be analysed using an ordinary two-way analysis of variance.Ethics and disseminationThis trial was approved by the Brazilian National Ethics Committee and obtained approval on 7 October 2020 (document number 4324069). The findings will be disseminated through publications in peer-reviewed journals and conference presentations.Trial registration numberNCT04595097.

scholarly journals Normothermic Insufflation to Prevent Perioperative Hypothermia and Improve Quality of Recovery in Elective Colectomy Patients: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Edyta Ryczek ◽  
Judith White ◽  
Ruth Louise Poole ◽  
Nicola Laura Reeves ◽  
Jared Torkington ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Small Scale ◽  
Perioperative Hypothermia ◽  
Quality Of Recovery ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Patient Reported

BACKGROUND Perioperative hypothermia during laparoscopy for bowel resection is a risk factor for postoperative medical complications and surgical wound infections. Despite various warming methods used during surgery, a significant number of patients experience perioperative hypothermia. Use of dry, unwarmed insufflation carbon dioxide (CO<sub>2</sub>) during laparoscopic procedures may contribute to this problem. Evidence exists that the HumiGard device, which humidifies and heats CO<sub>2</sub> for insufflation, can reduce the risk of perioperative hypothermia. OBJECTIVE The aim is to determine if insufflation with warmed, humidified CO<sub>2</sub> using the HumiGard device, alongside standard perioperative warming techniques, can improve patient recovery, including pain, surgical site infections, complications, and the use of analgesia compared with standard care alone. METHODS The study is a multicenter, randomized, blinded (patient, surgeon, and assessor), sham device-controlled, parallel group-controlled trial of 232 patients. The study aims to recruit patients undergoing elective laparoscopic, segmental, or total colectomy. Patients will be randomized to receive HumiGard plus standard care or standard care alone (1:1 ratio). The primary outcome is patient-reported quality of recovery, measured by the validated QoR-40 (quality of recovery) questionnaire, from baseline to postoperative day 1. Secondary outcomes include postoperative pain, the incidence of hypothermia, and the rate of postoperative complications. RESULTS The information gathered during a small-scale service evaluation at a single hospital was used to inform this study protocol. Before applying for a grant for this full randomized controlled trial, the authors will conduct a feasibility study of 40 patients to ensure that the protocol is feasible and to inform our sample size calculation. CONCLUSIONS The randomized controlled trial is designed to provide high-quality evidence on the effectiveness of the HumiGard device in potentially reducing the risk of perioperative hypothermia in patients scheduled for laparoscopic colectomy. The results will be used to improve the maintenance of adequate patient body temperature during surgery.

scholarly journals Conservative treatment versus elective repair of umbilical hernia in patients with liver cirrhosis and ascites: results of a randomized controlled trial (CRUCIAL trial)

2020 ◽  
Author(s):  
B. de Goede ◽  
M. M. J. van Rooijen ◽  
B. J. H. van Kempen ◽  
W. G. Polak ◽  
R. A. de Man ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Liver Cirrhosis ◽  
Conservative Treatment ◽  
Umbilical Hernia ◽  
Controlled Trial ◽  
Number Of Patients ◽  
Umbilical Hernia Repair ◽  
Elective Repair

Abstract Purpose To establish optimal management of patients with an umbilical hernia complicated by liver cirrhosis and ascites. Methods Patients with an umbilical hernia and liver cirrhosis and ascites were randomly assigned to receive either elective repair or conservative treatment. The primary endpoint was overall morbidity related to the umbilical hernia or its treatment after 24 months of follow-up. Secondary endpoints included the severity of these hernia-related complications, quality of life, and cumulative hernia recurrence rate. Results Thirty-four patients were included in the study. Sixteen patients were randomly assigned to elective repair and 18 to conservative treatment. After 24 months, 8 patients (50%) assigned to elective repair compared to 14 patients (77.8%) assigned to conservative treatment had a complication related to the umbilical hernia or its repair. A recurrent hernia was reported in 16.7% of patients who underwent repair. For the secondary endpoint, quality of life through the physical (PCS) and mental component score (MCS) showed no significant differences between groups at 12 months of follow-up (mean difference PCS 11.95, 95% CI − 0.87 to 24.77; MCS 10.04, 95% CI − 2.78 to 22.86). Conclusion This trial could not show a relevant difference in overall morbidity after 24 months of follow-up in favor of elective umbilical hernia repair, because of the limited number of patients included. However, elective repair of umbilical hernia in patients with liver cirrhosis and ascites appears feasible, nudging its implementation into daily practice further, particularly for patients experiencing complaints. Trial registration Clinicaltrials.gov, NCT01421550, on 23 August 2011.

scholarly journals Efficacy of bacterial cellulose membrane for the treatment of lower limbs chronic varicose ulcers: a randomized and controlled trial

2017 ◽  
Vol 44 (1) ◽  
pp. 72-80 ◽  
Author(s):  
LUCIANA MARINS CAVALCANTI ◽  
FLÁVIA CRISTINA MORONE PINTO ◽  
GLÍCIA MARIA DE OLIVEIRA ◽  
SALVADOR VILAR CORREIA LIMA ◽  
JOSÉ LAMARTINE DE ANDRADE AGUIAR ◽  
...  
Keyword(s):  
Bacterial Cellulose ◽  
Controlled Trial ◽  
Health Department ◽  
Venous Ulcer ◽  
Lower Limbs ◽  
Controlled Study ◽  
Control Group ◽  
Cellulose Membrane ◽  
Ulcer Disease ◽  
Venous Ulcers

ABSTRACT Objective: to evaluate the efficacy of Bacterial Cellulose (BC) membrane dressings in the treatment of lower limb venous ulcers. Methods: we carried out a prospective, randomized, controlled study of 25 patients with chronic venous ulcer disease in the lower limbs from the Angiology and Vascular Surgery Service of the Federal University of Pernambuco Hospital and from the Salgado Polyclinic of the County Health Department, Caruaru, Pernambuco. We randomly assigned patients to two groups: control group, receiving dressings with triglyceride oil (11 patients) and experimental group, treated with BC membrane (14 patients). We followed the patients for a period of 120 days. Results: There was a reduction in the wound area in both groups. There were no infections or reactions to the product in any of the groups. Patients in the BC group showed decreased pain and earlier discontinuation of analgesic use. Conclusion: BC membrane can be used as a dressing for the treatment of varicose ulcers of the lower limbs.

The Difficult Venous Ulcer: Case Series of 177 Ulcers Referred for Vascular Surgical Opinion following Failure of Conservative Management

Angiology ◽  
2009 ◽  
Vol 60 (4) ◽  
pp. 492-495 ◽  
Author(s):  
S. K. Neequaye ◽  
A. D. Douglas ◽  
D. Hofman ◽  
M. Wolz ◽  
R. Sharma ◽  
...  
Keyword(s):  
Case Series ◽  
Venous Ulcer ◽  
Service Planning ◽  
Leg Ulcers ◽  
Surgical Service ◽  
Ulcer Case ◽  
Compression Bandaging ◽  
Dermatology Clinic ◽  
Venous Surgery

Venous leg ulcers are common, chronic, debilitating, and expensive. Evidence supports use of compression bandaging, with superficial venous surgery in selected cases, but these interventions frequently fail to achieve healing. We describe a series of 152 consecutive referrals from a nurse-led specialist dermatology clinic to a vascular surgical service; a group posing particularly challenging problems. This observational study, with median follow-up of 18 months, describes outcomes in a number of important clinically identifiable subgroups. Its findings may assist service planning and discussion of the surgical role within multidisciplinary ulcer management.

scholarly journals A IMPACT OF A PHARMACIST-LED EDUCATIONAL INTERVENTION ON QUALITY OF LIFE AMONG PATIENTS WITH ASTHMA

2019 ◽  
pp. 307-312
Author(s):  
QUYNH THI HUONG BUI ◽  
KHOI XUAN PHAM ◽  
TIEN HOANG TRAN ◽  
LAN THI TUYET LE ◽  
HO NHU NGUYEN
Keyword(s):  
Quality Of Life ◽  
Intervention Program ◽  
Adverse Drug Events ◽  
Medical Center ◽  
Controlled Trial ◽  
Intervention Group ◽  
Monthly Basis ◽  
Asthmatic Patients ◽  
Number Of Patients

Objectives: Asthma is a chronic disease resulting in reduced quality of life (QoL) of most affected individuals. Training in asthma-related knowledge, inhaler skills, medicine usage, and the prevention of adverse drug events is demonstrated to improve asthma patients’ QoL. Therefore, the research was conducted to evaluate the effectiveness of education intervention undertaken by pharmacists on QoL of patients with asthma. Methods: We conducted a clinical randomized controlled trial among asthmatic outpatients aged 18 years or older in the Department of Screening Respiratory Function, University Medical Center, Ho Chi Minh City, Vietnam. Patients were randomized into an intervention group (IG) and a non-IG (NIG). The clinical pharmacists’ intervention program included training in asthma-related knowledge, inhaler technique, recognition, prevention of adverse drug events, and lifestyle adjustment. Participant screening was conducted using the telephone on a monthly basis. QoL was measured using the Vietnamese Version of the Mini Asthma QoL Questionnaire (MiniAQLQ). The main outcome was the difference in QoL scores between IG and NIG after 3 months follow-up. Results: After 3 months, the number of patients with asthma in the IG and in the NIG was 173 and 96, respectively. QoL mean scores in the IG patients were significantly higher than those in their NIG counterparts (1.79±1.01 vs. 1.06±0.93, respectively, p<0.001). Pharmacist-based interventions overall QoL scores (multivariate-adjusted regression coefficient =0.362; p<0.001). Conclusions: Clinical pharmacist-led counseling can improve asthmatic patients’ QoL.

Is Serum PSA Measurement a Good Test for Early Diagnosis of Prostate Cancer? Results of a Pilot Study and Cost Analysis

1996 ◽  
Vol 11 (1) ◽  
pp. 18-23 ◽  
Author(s):  
F. De biasi ◽  
D. Londero ◽  
D. Vanuzzo ◽  
L. Pilotto ◽  
S. Praturlon ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Early Diagnosis ◽  
Disease Incidence ◽  
Controlled Trial ◽  
Psychological Impact ◽  
Negative Effects ◽  
Good Test ◽  
Number Of Patients ◽  
All Diseases

Over the last years - late 1970s to early 1990s - the incidence of prostate carcinoma has nearly doubled, even though many more patients die suffering from prostate cancer than because of it. This finding, together with the slow growth of this tumor and the absence of a controlled trial that would suggest a benefit from screening, makes early diagnosis of this disease quite questionable. On the other hand, it is well known that prostatic carcinoma is curable as long as it is intracapsular, and that there is an ever increasing encouragement to early detection in all diseases. The costs of screening and the difficulty in balancing the benefits of screening against its negative effects, such as psychological impact and overtreatment, must be taken into account as well. In our opinion, one of the advantages of early diagnosis should be that the patients’ quality of life improves, because the stage at diagnosis and, as a result, the number of patients suffering from bone metastasis decrease, and unknown benign pathologies can be cured. These observations are not at all negligible. Our study aims to demonstrate that by using PSA as an initial test, the screening costs are reasonable and the disease incidence is just as expected.

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