Radiofrequency ablation for markedly incompetent perforators versus compression therapy in the management of post-phelebtic venous ulcers: A randomized controlled trial

Vascular ◽  
2021 ◽  
pp. 170853812110100
Author(s):  
Mohamed Shukri Abdelgawad ◽  
Amr M El-Shafei ◽  
Hesham A Sharaf El-Din ◽  
Ehab M Saad ◽  
Tamer A Khafagy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Radiofrequency Ablation ◽  
Controlled Trial ◽  
Compression Therapy ◽  
Randomized Controlled ◽  
Venous Ulcers ◽  
Group A ◽  
Group B ◽  
To Receive

Background Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. Patients and methods In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. Results Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained ( p  = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B ( p = 0.004). Conclusion In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.

scholarly journals A Randomized Controlled Trial of Attentional Control Training for Treating Alcohol Use Disorder

2021 ◽  
Vol 12 ◽  
Author(s):  
Angelina Isabella Mellentin ◽  
W. Miles Cox ◽  
Javad S. Fadardi ◽  
Laila Martinussen ◽  
Nicolaj Mistarz ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Attentional Control ◽  
Alcohol Use Disorder ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Alcohol Cues ◽  
Group A ◽  
Group B

Background: There is consistent evidence that community and clinical samples of individuals with an alcohol use disorder (AUD) have attentional biases toward alcohol cues. The alcohol attentional control training program (AACTP) has shown promise for retraining these biases and decreasing alcohol consumption in community samples of excessive drinkers. However, there is a lack of evidence regarding the effectiveness of ACTP in clinical AUD samples. The main aim of the present study is to investigate whether primary pharmacological and psychological, evidence-based alcohol treatment can be enhanced by the addition of a gamified AACTP smartphone application for patients with an AUD.Design and Methods: The study will be implemented as a randomized controlled trial. A total of 317 consecutively enrolled patients with AUD will be recruited from alcohol outpatient clinics in Denmark. Patients will be randomized to one of three groups upon initiation of primary alcohol treatment: Group A: a gamified AACTP smartphone application + treatment as usual (TAU); Group B: a gamified AACTP sham-control application + TAU; or Group C: only TAU. Treatment outcomes will be assessed at baseline, post-treatment, and at 3- and 6-month follow-ups. Repeated measures MANOVA will be used to compare the trajectories of the groups over time on alcohol attentional bias, alcohol craving, and drinking reductions. It is hypothesized that Group A will achieve better treatment outcomes than either Group B or Group C.Perspectives: Because attentional bias for alcohol cues is proportional to the amount of alcohol consumed, and these biases are not addressed within current evidence-based treatment programs, this study is expected to provide new evidence regarding the effectiveness of the gamified AACTP in a clinical population. Furthermore, due to promising results found using AACTP in community samples of excessive drinkers, there is a high probability that the AACTP treatment in this study will also be effective, thereby allowing AACTP to be readily implemented in clinical settings. Finally, we expect that this study will increase the effectiveness of evidence-based AUD treatment and introduce a new, low-cost gamified treatment targeting patients with an AUD. Overall, this study is likely to have an impact at the scientific, clinical, and societal levels.Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT05102942?term=NCT05102942&draw=2&rank=1, identifier: NCT05102942.

Manganese and Lipoflavonoid Plus® to Treat Tinnitus: A Randomized Controlled Trial

2016 ◽  
Vol 27 (08) ◽  
pp. 661-668 ◽  
Author(s):  
Eveling Rojas-Roncancio ◽  
Richard Tyler ◽  
Hyung-Jin Jun ◽  
Tang-Chuan Wang ◽  
Haihong Ji ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Data Collection And Analysis ◽  
Loudness Match ◽  
Minimal Masking Level ◽  
Lost To Follow Up ◽  
To Receive

Background: Several tinnitus sufferers suggest that manganese has been helpful with their tinnitus. Purpose: We tested this in a controlled experiment where participants were committed to taking manganese and Lipoflavonoid Plus® to treat their tinnitus. Research Design: Randomized controlled trial. Study Sample: 40 participants were randomized to receive both manganese and Lipoflavonoid Plus® for 6 months, or Lipoflavonoid Plus® only (as the control). Data Collection and Analysis: Pre- and postmeasures were obtained with the Tinnitus Handicap Questionnaire, Tinnitus Primary Functions Questionnaire, and tinnitus loudness and annoyance ratings. An audiologist performed the audiogram, the tinnitus loudness match, and minimal masking level. Results: Twelve participants were dropped out of the study because of the side effects or were lost to follow-up. In the manganese group, 1 participant (out of 12) showed a decrease in the questionnaires, and another showed a decrease in the loudness and annoyance ratings. No participants from the control group (total 16) showed a decrease in the questionnaires ratings. Two participants in the control group reported a loudness decrement and one reported an annoyance decrement. Conclusions: We were not able to conclude that either manganese or Lipoflavonoid Plus® is an effective treatment for tinnitus.

scholarly journals Venous thromboembolism prevention protocol for adapting prophylaxis recommendations to the potential risk post total knee replacement: a randomized controlled trial

2020 ◽  
Vol 18 (3) ◽  
pp. 2025
Author(s):  
Mariam A. Alameri ◽  
Syed A. Syed Sulaiman ◽  
Abdullah M. Ashour ◽  
Ma’ad F. Al-Saati
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Education ◽  
Risk Stratification ◽  
Controlled Trial ◽  
Education Programs ◽  
Randomized Controlled ◽  
Group A ◽  
Total Knee ◽  
The Mean ◽  
Group B

Background: Total knee replacement (TKR) is a major orthopedic surgery that is considered high risk for the development of venous thromboembolism (VTE). Objective: The aim of this study is to evaluate the clinical outcomes that resulted from the use of a new proposed VTE risk stratification protocol for selecting a suitable extended VTE prophylaxis for post TKR surgery patients administered in conjunction with patient education programs. Method: A randomized controlled trial was conducted in two medical centers in Saudi Arabia. A total of 242 patients were enrolled in the study, 121 patients in each group. The experimental group (A) was assessed by using the proposed VTE risk stratification protocol and also took part in patient education programs about TKR and its complications. The control group (B) was assessed by using the 2005 Caprini risk assessment tool and no education programs were given to this group. Both groups were followed for 35 days post operation. Results: The mean age of the participants was 65.86 (SD 8.67) and the majority of them were female 137 (56.6%). The mean body mass index of the study sample was 32.46 (SD 5.51). There were no significant differences between the two groups except for surgery type; the proportion of bilateral TKR in group A was higher than in group B (69/121 (28.5%) vs. 40/121(16.5%), p˂0.05). There were no confirmed pulmonary embolism cases in the study sample and diagnosis of deep-vein thrombosis was confirmed in 12/242 (5.0%) of patients: 1/121 (0.8%) in group A and 11/121 (9.1%) in group B (p˂0.05). The readmission rate for all patients was 2.5% (6/242), all of whom were in group B (p˂0.05). Conclusion: The proposed VTE risk stratification protocol that was applied in conjunction with patient education programs reduced VTE complications and readmission events, post TKR surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT04031859.

Leucocyte-Rich Platelet-Rich Plasma Treatment of Gluteus Medius and Minimus Tendinopathy: A Double-Blind Randomized Controlled Trial With 2-Year Follow-up

2019 ◽  
Vol 47 (5) ◽  
pp. 1130-1137 ◽  
Author(s):  
Jane Fitzpatrick ◽  
Max K. Bulsara ◽  
John O’Donnell ◽  
Ming Hao Zheng
Keyword(s):  
Randomized Controlled Trial ◽  
Ultrasound Guidance ◽  
Platelet Rich Plasma ◽  
Corticosteroid Injection ◽  
Controlled Trial ◽  
Harris Hip Score ◽  
Randomized Controlled ◽  
Gluteal Tendinopathy ◽  
To Receive

Background: A previously published trial showed that patients with chronic gluteal tendinopathy achieved greater clinical improvement at 12 weeks when treated with a single platelet-rich plasma (PRP) injection than those treated with a single corticosteroid injection (CSI). Purpose: This follow-up study was conducted to determine whether there would be a sustained long-term difference in the modified Harris Hip Score (mHHS) at 2 years for a leucocyte-rich PRP (LR-PRP) injection in the treatment of chronic gluteal tendinopathy. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This trial included 80 patients randomized 1:1 to receive LR-PRP or CSI intratendinously under ultrasound guidance. Patients had a mean age of 60 years, a 9:1 ratio of women to men, a mean body mass index of 27, and a mean length of symptoms >15 months. No patients had full-thickness tears of the gluteal tendons. An open-labeled extension allowed patients to receive crossover treatment after 3 months. The main outcome measure was the mHHS. Results: The mean mHHS improved significantly at 12 weeks in the PRP group (74.05; SD, 13.92) as compared with the CSI group (67.13; SD, 16.04) ( P = .048). At 24 weeks, the LR-PRP group (77.60; SD, 11.88) improved further than the CSI group (65.72; SD, 15.28; P = .0003). Twenty-seven patients were deemed to have failed the CSI treatment at 16 to 24 weeks, with an exit score of 59.22 (SD, 11.54), and then had treatment with LR-PRP. The crossover group improved with the LR-PRP: from 59.22 (SD, 11.22) at baseline to 75.55 (SD, 16.05) at 12 weeks, 77.69 (SD, 15.30) at 24 weeks, and 77.53 (SD, 14.54) at 104 weeks. The LR-PRP group retained 38 of 39 patients to 52 weeks and continued to improve. Their baseline scores of 53.77 (SD, 12.08) improved to 82.59 (SD, 9.71) at 104 weeks ( P < .0001). Conclusion: Among patients with chronic gluteal tendinopathy and a length of symptoms >15 months, a single intratendinous LR-PRP injection performed under ultrasound guidance results in greater improvement in pain and function than a single CSI. The improvement after LR-PRP injection is sustained at 2 years, whereas the improvement from a CSI is maximal at 6 weeks and not maintained beyond 24 weeks. Registration: ACTRN12613000677707 (Australian New Zealand Clinical Trials identifier).

scholarly journals Saccharomyces boulardii Combined With Quadruple Therapy for Helicobacter pylori Eradication Decreased the Duration and Severity of Diarrhea: A Multi-Center Prospective Randomized Controlled Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Yuchong Zhao ◽  
Yilei Yang ◽  
Aruna ◽  
Jun Xiao ◽  
Jun Song ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Controlled Trial ◽  
Saccharomyces Boulardii ◽  
Quadruple Therapy ◽  
Severe Diarrhea ◽  
Randomized Controlled ◽  
Group A ◽  
H Pylori ◽  
Group B

Background: Whether probiotics helped the Helicobacter pylori (H. pylori) eradication was still highly controversial. The non-bacterial Saccharomyces boulardii (S. boulardii) has demonstrated its efficacy in the treatment of antibiotic-associated and infectious diarrhea. We aimed to evaluate the effects of S. boulardii combined with quadruple therapy for H. pylori eradication and associated side effects.Methods: Three hundred and sixty H. pylori-infected patients were recruited in this multicenter, randomized controlled trial. The patients who underwent H. pylori eradication treatment were randomized in a ratio of 1:1 into two separate groups that received standard quadruple therapy (Group A) and quadruple therapy plus S. boulardii sachets (Group B) for 14 days. The everyday medication and side-effect records were collected for compliance and adverse effect analysis. All patients accepted 13C/14C-urea breath tests 4 weeks after the therapy completion.Results:Saccharomyces boulardii and quadruple therapy-combined intervention significantly reduced the incidences of overall side effects (27.8 vs. 38.5%, p = 0.034) and diarrhea (11.2 vs. 21.2%, p = 0.012) in Group B compared with quadruple therapy alone in Group A, especially reduced the diarrhea duration (5.0 days vs. 7.7 days, p = 0.032) and incidence of severe diarrhea (4.7 vs. 10.1%, p = 0.040). Intention-to-treat (ITT) analysis and per-protocol (PP) analysis both indicated no statistical differences of eradication rate between Groups A and B (ITT: 82.7 vs. 85.8%, p = 0.426; PP: 89.7 vs. 94.2%, p = 0.146). The joint use of S. boulardii and quadruple therapy markedly improved the overall pre-eradication alimentary symptoms (hazard ratio (HR): 2.507, 95% CI: 1.449–4.338) recovery.Conclusion:Saccharomyces boulardii ameliorated H. pylori eradication-induced antibiotic-associated side effects especially reduced the incidence of severe diarrhea and the duration of diarrhea. However, there was no significant effect of S. boulardii on the rate of H. pylori eradication.Trial Registration: The protocol had retrospectively registered at ClinicalTrails.gov, Unique identifier: NCT03688828, date of registration: September 27, 2018; https://clinicaltrials.gov/show/NCT03688828

scholarly journals Home-based physical activity in breast cancer patients and cardiorespiratory fitness: during and/or after chemotherapy? A three-arm randomized controlled trial (APAC)

2020 ◽  
Author(s):  
Francois Vincent ◽  
Elise Deluche ◽  
Joelle Bonis ◽  
Sophie Leobon ◽  
Marie-Thérèse Antonini ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Cardiorespiratory Fitness ◽  
Controlled Trial ◽  
Categorical Variables ◽  
Randomized Controlled ◽  
Home Based ◽  
Group A ◽  
Group B

Abstract ObjectivesAdapted physical activity (APA) program is recommended for breast cancer care. However, their modalities have not been defined. The aim of this study was to determine the best time to begin APA. This randomized controlled trial evaluated at 12 months the effect of home-based APA performed during and/or after treatment on cardiorespiratory fitness. The primary endpoint was peak oxygen consumption (VO2peak) compared at 12 months (group A vs C and B vs C). Secondary endpoints included the 6-min walking test (6MWT), assessment of muscular strength, fatigue, quality of life, anxiety, and depression, and a questionnaire of PA levels. All tests were evaluated at baseline, 6 months, and 12 months.MethodA total of 94 patients with breast cancer were randomized to three different groups: group A, performing 6 months of APA during adjuvant care; group B, 6 months of APA after adjuvant care; and group C, 12 months of APA during and after specific care. The program combined one resistance session and two aerobic sessions per week. Analysis of variance was used for repeated measures, Student’s t-test or the Mann–Whitney U-test for continuous variables, and χ2 test for binary or categorical variables.Results A total of 81 participants were assessed at 6 months and 73 participants at 12 months. The majority of patients completed more than 85% of the exercise sessions. The baseline for VO2peak and secondary outcomes did not differ among the groups. VO2peak increased during the exercise period and decreased during the chemotherapy period without APA, but at 12 months no significant difference was observed. The same variations were observed in the 6MWT, with a significance at 6 months between A+C vs. B (p=0.04), but no difference among the groups at 12 months. In the three groups, no decrease in other studied parameters were noted, except at 6 months in group B without APA. ConclusionsHome-based APA in breast cancer survivors can decrease some of the negative side effects of cancer treatment and has a positive effect on physical function with no differences based on the timing of this program.TRIAL REGISTRATIONClinicalTrials.gouv.fr (NCT01795612). Registered 20 February 2013,https://clinicaltrials.gov/ct2/show/NCT01795612?term=APAC&draw=2&rank=3

scholarly journals POSTOPERATIVE ANALGESIA IN CHILDREN

2018 ◽  
Vol 25 (07) ◽  
pp. 1069-1072
Author(s):  
Mohsin Riaz Askri ◽  
Shumyala Maqbool ◽  
Muhammad Afzal Mirza ◽  
Muhammad Rauf
Keyword(s):  
Randomized Controlled Trial ◽  
Postoperative Analgesia ◽  
Controlled Trial ◽  
Study Group ◽  
Randomized Controlled ◽  
Caudal Analgesia ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
Independent University

Objectives: To compare the mean duration of pain relief using caudal bupivacainewith and without neostigmine for postoperative analgesia in children undergoing infra-umbilicalsurgery. Study design: Randomized Controlled trial. Settings: Department of AnaesthsiaChildren Hospital/Institute of child health Faisalabad& Independent university hospitalFaisalabad. Duration of Study: Six months from July 2017 to December 2017. Methods: 60patients (30 in each group) were included in this study. Group-A given 1ml/kg of 0.25% caudalbupivacaine and Group-B given 1ml/kg of 0.25% caudal bupivacaine and 2μg/kg neostigmine.Results: Mean age was 4.20±1.09 and 4.13±1.07 years in group-A and B, respectively. Sexdistribution shows, 22 patients (73.3%) in group-A and 9 (30.0%) in group-B were male while 8patients (26.7%) of group-A and 11 patients (36.7%) of group-B were female. Mean duration ofrelief of pain (hours) in group-A was 6.70±2.12 hours and in group-B was 11.97±3.80 hours.Difference between group-A and group-B was considered statistically significant (P<0.001).Conclusion: Neostigmine with bupivacaine caudally in paediatric patients increases theduration of analgesia. However, neostigmine may be used for prolongation of caudal analgesia.

scholarly journals Improved Analgesic Effect of Paravertebral Blocks before and after Video-Assisted Thoracic Surgery: A Prospective, Double-Blinded, Randomized Controlled Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Lihua Chu ◽  
Xiaolin Zhang ◽  
Yaping Lu ◽  
Guohao Xie ◽  
Shengwen Song ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Thoracic Surgery ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Video Assisted Thoracic Surgery ◽  
Randomized Controlled ◽  
Video Assisted ◽  
Group A ◽  
Group B ◽  
Double Blinded

Despite being less invasive, patients who underwent video-assisted thoracic surgery (VATS) suffered considerable postoperative pain. Paravertebral block (PVB) was proven to provide effective analgesia in patients with VATS; however, there is no difference in pain relief between preoperative PVB and postoperative PVB. This study was aimed to investigate the analgesic efficacy of combination of preoperative and postoperative PVB on the same patient undergoing VATS. In this prospective, double-blinded, randomized controlled trial, 44 patients undergoing VATS were enrolled, and they received patient-controlled intravenous analgesia (PCIA) with sufentanil plus preoperative PVB (Group A, n = 15) or postoperative PVB (Group B, n = 15), or combination of preoperative and postoperative PVB (Group C, n = 14). The primary outcome was sufentanil consumption and PCIA press times in the first 24 hours postoperatively. Also, data of postoperative use of PCIA and visual analogue scale (VAS) were collected. In the first 24 hours postoperatively, median sufentanil consumption in Group C was 0 (0–34.75) μg, which was much less than that in Group A (45.00 (33.00–47.00) μg, p=0.005) and Group B (36 (20.00–50.00) μg, p=0.023). Patients in Group C pressed less times of PCIA (0 (0–0) times) than patients in Group A (2 (1–6) times, p<0.001) and Group B (2 (1–3) times, p=0.009). Kaplan–Meier analysis showed patients with combination of preoperative and postoperative PVB had a higher PCIA-free rate than patients with either technique alone (p=0.003). The VAS among the three groups was comparable postoperatively. The combination of both preoperative and postoperative PVB provides better analgesic efficacy during the early postoperative period and may be an alternative option for pain control after VATS. This trial is registered with ChiCTR1800017102.

Effect of Virgin Coconut Oil Application on the Skin of Preterm Newborns: A Randomized Controlled Trial

2019 ◽  
Vol 66 (2) ◽  
pp. 129-135
Author(s):  
Mithun Chandra Konar ◽  
Kamirul Islam ◽  
Atanu Roy ◽  
Taraknath Ghosh
Keyword(s):  
Adverse Effect ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Neurodevelopmental Outcome ◽  
Coconut Oil ◽  
Preterm Neonates ◽  
Virgin Coconut Oil ◽  
Randomized Controlled ◽  
Group A ◽  
Group B

Abstract Background Preterm constitutes a major part of neonatal mortality, particularly in India. Due to dermal immaturity, preterm neonates are susceptible to various complications like infection, hypothermia, etc. Emollient application is a traditional practice in our subcontinent. Aims To find out the efficacy of coconut oil application for skin maturity, prevention of sepsis, hypothermia and apnea, its effect on long-term neurodevelopment and adverse effect of it, if any. Material and methods A randomized controlled trial was conducted in the rural field practice area of Department of Community Medicine, Burdwan Medical College from March 2014 to August 2018. Preterm born in the study period was divided into Group A (received virgin coconut oil application) and Group B (received body massage without any application). Neonatal skin condition was assessed on 7th, 14th, 21st and 28th day of life. Neurodevelopmental status was assessed on 3rd, 6th and 12th months. Results A total of 2294 preterm were included in the study. Groups A and B consisted of 1146 and 1148 preterm infants, consecutively. Mean gestational age of the study population was 31.9 ± 3.4 weeks and 50.4% were male. Mean weight loss in first few days was less in group A but mean weight gain per day was higher in group B. Lesser incidences of hypothermia and apnea, and better skin maturity and neurodevelopmental outcome were noted in group A. No significant adverse effect was noted with coconut oil application. Conclusion Use of coconut oil helps in dermal maturity and better neurodevelopmental outcome. Further studies are warranted for universal recommendation.

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