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

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.

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POSTOPERATIVE ANALGESIA IN CHILDREN

The Professional Medical Journal ◽

10.29309/tpmj/2018.25.07.136 ◽

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.

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

Vascular ◽

10.1177/17085381211010022 ◽

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.

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Clinical Efficacy Of Ceftriaxone Versus Ciprofloxacin In Paediatric Enteric Fever

Journal of Bahria University Medical and Dental College ◽

10.51985/jbumdc2018031 ◽

2018 ◽

Vol 08 (02) ◽

pp. 67-71

Author(s):

Anila Farhat ◽

Asma Shaukat ◽

Tariq Mahmood Khan

Keyword(s):

Enteric Fever ◽

Research Study ◽

Controlled Trial ◽

Clinical Effectiveness ◽

Randomized Controlled ◽

Group A ◽

The Mean ◽

Group B ◽

Objective Determination

Objective: Determination of the clinical effectiveness of ciprofloxacin versus ceftriaxone in children with enteric fever on the basis of defervescence within 72 hours of commencement of treatment. Duration and Place of Study: This randomized controlled trial was carried out from 15th May to 15th November 2017 in pediatrics units of Benazir Bhutto Shaheed Teaching Hospital Abbottabad and Jinnah International Hospital Abbottabad. Methodology: 90 children with uncomplicated enteric fever were admitted and divided randomly into two groups, Group A was administered I/V Ceftriaxone 75mg/kg OD and Group B was given I/V Ciprofloxacin 10mg/kg BD for seven days. Response to drug was taken as defervescence within 72 hours while continued fever after 72 hours was taken as no response. The data was analyzed by using SPSS Version 21.00. Results: In our research study 53(58.9%) children were male and 37(41.1%) patients were female. The mean age was 8.43±3.17 years encompassing 4 to 14 years, mean weight of the patients in kg was 29.54±10.8 kg. Efficacy of ceftriaxone group was 93.3% while in ciprofloxacin group 62.2% patients became afebrile in 72 hours. The proportion of achieving defervescence within 72 hours was higher with ceftriaxone than with ciprofloxacin Conclusion: Ceftriaxone is more efficacious in terms of achieving defervescence than ciprofloxacin in children having enteric fever.

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Preparing for a randomized controlled trial: Strategies to optimize the design of a cardiovascular surgical patient education intervention.

10.32920/ryerson.14640105.v1 ◽

2021 ◽

Author(s):

Suzanne Fredericks ◽

Terrence M. Yau

Keyword(s):

Randomized Controlled Trial ◽

Patient Education ◽

Complex Intervention ◽

Randomized Control Trial ◽

Controlled Trial ◽

Surgical Patient ◽

Education Programs ◽

Randomized Controlled ◽

Clinical Methods ◽

Randomized Control

Randomized controlled trial (RCT) designs are standardized to control for bias and allow for replication. Conducting RCTs is generally straightforward when dealing with interventions that contain a single component, such as a drug. However, interventions that do not contain single components, such as a patient education programs, are more difficult to standardize, as they contain multiple elements, which may act independently or interdependently of each other. The purpose of this discursive clinical methods paper is to describe and explain a methodology that can be used to optimize the design of a complex intervention prior to its evaluation in a randomized control trial.

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Preparing for a randomized controlled trial: Strategies to optimize the design of a cardiovascular surgical patient education intervention.

10.32920/ryerson.14640105 ◽

2021 ◽

Author(s):

Suzanne Fredericks ◽

Terrence M. Yau

Keyword(s):

Randomized Controlled Trial ◽

Patient Education ◽

Complex Intervention ◽

Randomized Control Trial ◽

Controlled Trial ◽

Surgical Patient ◽

Education Programs ◽

Randomized Controlled ◽

Clinical Methods ◽

Randomized Control

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

Frontiers in Psychiatry ◽

10.3389/fpsyt.2021.748848 ◽

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.

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Comparison of harmonic scalpel versus Milligan Morgan technique in haemorrhoidectomy patients

Journal of the Pakistan Medical Association ◽

10.47391/jpma.03-1303 ◽

2021 ◽

Author(s):

Muhammad Ahmad ◽

Syed Tatheer Abbas ◽

Amna Javaid ◽

Naveed Arshad ◽

Falak Shair

Keyword(s):

Wound Healing ◽

Operative Time ◽

Harmonic Scalpel ◽

Controlled Trial ◽

P Value ◽

Randomized Controlled ◽

Group A ◽

The Mean ◽

Complete Wound Healing ◽

Group B

Objectives: To assess the comparison of harmonic scalpel versus Milligan Morgan technique in patients undergoing haemorrhoidectomy. Methodology: This randomized controlled trial study was conducted at General Hospital, Lahore, from March 2019 to September 2019. Informed consent was obtained from eligible 60 patients. Patients were randomly divided into two equal groups. In group-A, haemorrhoidectomy was conducted according to the harmonic scalpel method. In group-B, open haemorrhoidectomy was performed by the Milligan Morgan procedure. Data was assembled through a designed questionnaire and investigated via SPSS version 25. Data were stratified for descriptive statistics, level of haemorrhoids and period of haemorrhoids. Post-stratification, independent sample t-test was used. Results: Mean age of both groups patients were 44.6±7.6 and 43.8±8.2 years, respectively. In group-A, mean operative time was 20.8±2.8 minutes, while 26.5±2.8 minutes in group-B, which was statistically significant with p-value of 0.001. In group-A, mean convalescence period was 9.7±2.9 days, while 13.4±3.7 days in group-B, which was statistically significant with p-value of 0.001. The mean convalescence period with harmonic scalpel method was 7.4 days (range 5–14, SD 3.6) versus 18.6 days (range 7–30, SD 5.4) with Milligan Morgan technique (P?0.001). This research observed that harmonic scalpel method required almost six weeks for complete wound healing, whereas in Milligan Morgan technique, complete wound healing was achieved after three months (P<0.05). Conclusion: Harmonic scalpel haemorrhoidectomy found an advantageous method when assessing the operative time and convalescence period. Hence, Harmonic scalpel haemorrhoidectomy can be adapted as a safe and effective alternative method for treating symptomatic haemorrhoids. Continuous...

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

Frontiers in Medicine ◽

10.3389/fmed.2021.776955 ◽

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

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Randomized Controlled Clinical Trial Comparing Transurethral Eneucleation and Resection of Prostate and Trans-urethral Resection of Prostate in the Management of Benign Prostatic Hyperplasia

BIRDEM Medical Journal ◽

10.3329/birdem.v7i3.33783 ◽

2017 ◽

Vol 7 (3) ◽

pp. 216-220

Author(s):

Md Mehedi Hasan ◽

Samira Rahat Afroze ◽

Muhammad Abdur Rahim ◽

Muhammad Abdus Salam

Keyword(s):

Controlled Trial ◽

Ethical Review ◽

Control Group ◽

Controlled Clinical Trial ◽

Transurethral Resection Of Prostate ◽

Randomized Controlled ◽

Significant Difference ◽

Group A ◽

The Mean ◽

Group B

Background: Transurethral resection of prostate (TURP) is the predominant surgical procedure for benign prostatic hypertension (BPH) but is not devoid of complications like capsular perforation, drop in Hb%, drop in Na+, residual adenoma; hence endeavors are evolving to combat such complications. A newer technique transurethral enucleation and resection of prostate (TUERP) has been devised to solve these problems. This study was designed to compare the safety and the efficacy of newer technique, TUERP with widely practiced TURP Methods: This randomized controlled trial was done at BSMMU, after getting ethical approval from the ethical review committee of the institute, from January to October, 2009. A total of 60 BPH patients were purposively enrolled in this study, after obtaining informed written consent and they were randomized as control, Group A (30 patients, underwent TURP) and experimental group, Group B (30 patients, underwent TEURP).Results: The mean preoperative Hb% level of Group A was 15.1 gm% (SD ± 0.5) and perioperative Hb% level was 13.04 gm% (SD ± 6.06). There was significant difference (P <0.05). The mean preoperative Hb% of Group B was 15.2 gm% (SD ± 0.5) and perioperative Hb% was 15.2 gm% (SD ± 0.48). There was no difference (P >0.05). The mean preoperative Na + of Group A was 140 mmol/l (SD ± 4.1) and perioperative Na+ was 126 mmol/l (SD ± 6.8). There was significant difference (P<0.01). The mean preoperative Na+ of Group B was 136 mmol/l (SD ± 4) and perioperative Na+ was 136 mmol/l (SD ± 2.70). There was no difference (P >0.05).Conclusion: TUERP eliminates drop in Hb% and Na+which are usual consequences following TURP. Thus TUERP can be advocated in the treatment of BPH as it also allows completeresection down to surgical capsule.Birdem Med J 2017; 7(3): 216-220

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

10.21203/rs.3.rs-33269/v1 ◽

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

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