Anterior versus posterior entry site for ventriculoperitoneal shunt insertion: a randomized controlled trial by the Hydrocephalus Clinical Research Network

2021 ◽  
pp. 1-11
Author(s):  
William E. Whitehead ◽  
Jay Riva-Cambrin ◽  
John C. Wellons ◽  
Abhaya V. Kulkarni ◽  
David D. Limbrick ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Research Network ◽  
Ventricular Catheter ◽  
Shunt Failure ◽  
Entry Site ◽  
Shunt Insertion ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Adjudication Committee

OBJECTIVE The primary objective of this trial was to determine if shunt entry site affects the risk of shunt failure. METHODS The authors performed a parallel-design randomized controlled trial with an equal allocation of patients who received shunt placement via the anterior entry site and patients who received shunt placement via the posterior entry site. All patients were children with symptoms or signs of hydrocephalus and ventriculomegaly. Patients were ineligible if they had a prior history of shunt insertion. Patients received a ventriculoperitoneal shunt after randomization; randomization was stratified by surgeon. The primary outcome was shunt failure. The planned minimum follow-up was 18 months. The trial was designed to achieve high power to detect a 10% or greater absolute difference in the shunt failure rate at 1 year. An independent, blinded adjudication committee determined eligibility and the primary outcome. The study was conducted by the Hydrocephalus Clinical Research Network. RESULTS The study randomized 467 pediatric patients at 14 tertiary care pediatric hospitals in North America from April 2015 to January 2019. The adjudication committee, blinded to intervention, excluded 7 patients in each group for not meeting the study inclusion criteria. For the primary analysis, there were 229 patients in the posterior group and 224 patients in the anterior group. The median patient age was 1.3 months, and the most common etiologies of hydrocephalus were postintraventricular hemorrhage secondary to prematurity (32.7%), myelomeningocele (16.8%), and aqueductal stenosis (10.8%). There was no significant difference in the time to shunt failure between the entry sites (log-rank test, stratified by age < 6 months and ≥ 6 months; p = 0.061). The hazard ratio (HR) of a posterior shunt relative to an anterior shunt was calculated using a univariable Cox regression model and was nonsignificant (HR 1.35, 95% CI, 0.98–1.85; p = 0.062). No significant difference was found between entry sites for the surgery duration, number of ventricular catheter passes, ventricular catheter location, and hospital length of stay. There were no significant differences between entry sites for intraoperative complications, postoperative CSF leaks, pseudomeningoceles, shunt infections, skull fractures, postoperative seizures, new-onset epilepsy, or intracranial hemorrhages. CONCLUSIONS This randomized controlled trial comparing the anterior and posterior shunt entry sites has demonstrated no significant difference in the time to shunt failure. Anterior and posterior entry site surgeries were found to have similar outcomes and similar complication rates.

scholarly journals The The Effectiveness of Early Mobilization Time on Balance and Functional Ability after Ischemic Stroke

2019 ◽  
Vol 7 (7) ◽  
pp. 1088-1092
Author(s):  
Umi Budi Rahayu ◽  
Samekto Wibowo ◽  
Ismail Setyopranoto
Keyword(s):  
Randomized Controlled Trial ◽  
Ischemic Stroke ◽  
Functional Ability ◽  
Controlled Trial ◽  
Early Mobilization ◽  
Berg Balance Scale ◽  
Early Mobilisation ◽  
Inclusion Criteria ◽  
Randomized Controlled ◽  
Significant Difference

BACKGROUND: Early mobilisation (EM) after-ischemic stroke is a motor learning intervention aimed to restore nerve cells and to improve balance and functional ability. Unfortunately, the study of when this intervention began has not been widely studied. AIM: On this study was compared the effect of EM started at 24 hours and 48 hours after an ischemic stroke on balance and functional ability. MATERIAL AND METHODS: Randomized controlled trial involving 40 patients on 2 groups meeting predefined inclusion criteria. The levels of balance were measured using the Berg Balance Scale, and the functional ability was measured using the Barthel Index, at 5th and 7th day. RESULTS: A significant difference was observed in both balance (p = 0.038) and functional ability (p = 0.021) obtained on the 7th day of assessment between both groups. A significant difference on the 5th day was observed only in the functional ability (p = 0.002) and not in the balance (p = 0.147), between the groups. CONCLUSION: EM started at 24 hours after the ischemic stroke has been found to have a better impact on balance and functional ability compared to that at 48 hours.

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

scholarly journals Interest of a standardized hypnotic message for the reduction of pain and anxiety in cancer patients treated by capsaicin patch for neuropathic pain: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Rémi Etienne ◽  
Myriam Laurent ◽  
Aline Henry ◽  
Antoine Bioy ◽  
Julia Salleron ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Neuropathic Pain ◽  
Rating Scales ◽  
Controlled Trial ◽  
Standard Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Numerical Rating ◽  
Reduction Of Pain ◽  
The Impact

Abstract Background Neuropathic pain is characterized by spontaneous painful symptoms. Medical therapies include the use of a capsaicin 8% patch (Qutenza®, Grünenthal Gmbh, Germany), and patients may experience a sharp burning sensation at application and removal of the patch. This study aimed to evaluate the impact of playing a standardized hypnosis recording during application, on the pain and anxiety induced by capsaicin treatment. Methods In a randomized, controlled trial, we assessed the benefits of the intervention firstly on pain and secondly on anxiety, as measured using numerical rating scales. All patients had application of the capsaicin patch, including the possibility for the patient to apply a cold patch. Participants were randomly assigned to one of 3 groups, namely the “Standard group” (no intervention), “Hypnosis group”, in which a standardized hypnotic message was played during application, or the “Music group” in which relaxing music was played during application of the patch. Results Sixty-nine patients were included. Overall, there was no significant difference in pain scores between groups (p = 0.355). Compared to standard application, anxiety was significantly lower in the hypnosis group after application (p = 0.007), with no significant difference between the standard and music arms (p = 0.271), or between the hypnosis and music arms (p = 0.423). Conclusions Listening to a standardized hypnotic message during application of a capsaicin patch was found to significantly lower anxiety. These findings indicate that the use of a hypnotic message can reduce discomfort and warrant its evaluation in other indications of pain or anxiety during treatment procedures. Trial registration NCT02822625.

scholarly journals Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Keivan Ranjbar ◽  
Mohsen Moghadami ◽  
Alireza Mirahmadizadeh ◽  
Mohammad Javad Fallahi ◽  
Vahid Khaloo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Clinical Status ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Ordinal Scale ◽  
Control Group ◽  
Randomized Controlled ◽  
Group Data ◽  
Significant Difference

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

scholarly journals Infectious Disease Team Review Using Antibiotic Switch and Discharge Criteria Shortens the Duration of Intravenous Antibiotic: A Single-Center Cluster-Randomized Controlled Trial in Thailand

2020 ◽  
Vol 7 (12) ◽  
Author(s):  
Thanyarak Wongkamhla ◽  
Buddharat Khan-asa ◽  
Sasima Tongsai ◽  
Nasikarn Angkasekwinai
Keyword(s):  
Infectious Disease ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Defined Daily Dose ◽  
Randomized Controlled ◽  
Days Of Therapy ◽  
Significant Difference ◽  
Cluster Randomized ◽  
Discharge Criteria

Abstract Background Strategies have been recommended to optimize early antibiotic (ATB) switching from intravenous (IV) to oral ATB. This study aimed to determine whether infectious disease (ID) team review using ATB switch and discharge criteria would shorten the duration of IV ATB and length of hospital stay (LOS). Methods This cluster-randomized controlled trial was conducted in 8 general medical wards as cluster units at Siriraj Hospital during January–October 2019. The ID team review with checklist criteria was performed on the third, fifth, and seventh day of IV-ATB treatment to determine (1) the suitability of switching to oral ATB or outpatient parenteral ATB therapy and (2) early discharge for patients receiving IV-ATB versus control. The primary outcomes were LOS and the duration or days of therapy (DOT) or defined daily dose (DDD) of IV-ATB therapy. Results Four wards each were randomly assigned to the intervention and control groups (46 patients/cluster, 184 patients/arm). No significant difference was observed between intervention and controls for median duration of IV-ATB therapy (7 vs 7 days) and LOS (9 vs 10 days). A significantly shorter duration of IV ATB was observed in patients without sepsis in the intervention group when measured by DOT (7 vs 8 days, P = .027) and DDD (7 vs 9, P = .017) in post hoc analysis. Conclusions Infectious disease team review using checklist criteria did not result in a shorter duration of IV-ATB and LOS in overall patients. Further study is needed to determine whether faster culture turnaround time or advanced testing will reduce the duration of IV-ATB therapy.

Neonatal outcomes in case of euglycemic control in gestational diabetes using insulin versus metformin. Randomized controlled trial

2021 ◽  
Vol 04 (01) ◽  
pp. 01-08
Author(s):  
Ahmed Mansour
Keyword(s):  
Randomized Controlled Trial ◽  
Birth Weight ◽  
Gestational Diabetes ◽  
Controlled Trial ◽  
Insulin Injection ◽  
Neonatal Outcomes ◽  
Insulin Group ◽  
Randomized Controlled ◽  
Metformin Group ◽  
Significant Difference

Background: Gestational diabetes mellitus (GDM) is a major global public health issue, with prevalence increasing in recent years due to the epidemic of obesity and type 2 diabetes. Aim of the Work: to compare different neonatal outcomes according to the different treatment modalities used in the management of GDM. Our hypothesis was that Metformin is as effective and safe as insulin in patients with gestational diabetes. Patients and Methods: The current non inferiority-Randomized controlled trial was conducted at Ain Shams Maternity hospital between June 2020 to February 2021. The study included 140 outpatient cases or admitted patients for antenatal care: Group A: women were given Metformin (Total 70) and Group B: Women were given insulin. (Total 70). Results: there was no significant difference between Metformin and Insulin groups regarding age, enrollment BMI, parity and family history of DM. There was no significant difference between Metformin and Insulin groups regarding gestational age at enrollment and delivery as well as pregnancy duration after intervention. BMI at delivery, BMI increase as well as BMI increase rate were significantly lower in Metformin group. There were no significant differences between Metformin and Insulin groups regarding fasting, two-hour postprandial and HbA1c blood glucose at enrollment and throughout treatment as well as their reduction after intervention. Maternal complications as hypoglycemia, hyperglycemia and preeclampsia were non-significantly less frequent among Metformin group than among Insulin group. Compliance to treatment was significantly more frequent among Metformin group than among Insulin group. Cesarean delivery was non­significantly less frequent among Metformin group than among Insulin group. There was no significant difference between Metformin and Insulin regarding birth weight APGAR-1, but APGAR-5 was significantly higher in Metformin group. Neonatal complications as IUFD, IUGR, macrosomia, congenital anomalies, neonatal hypoglycemia, respiratory distress and NICU admission were non-significantly less frequent among Metformin group. Conclusions: From the results of current study we can conclude that: Oral metformin was effective as insulin injection in control and management of GDM. BMI was controlled with oral metformin better than insulin injection. Maternal and neonatal complications specially birth weight were the same with both types of treatment. Women had better compliance to metformin treatment. Type of delivery wasn’t affected by type of treatment.

Randomized controlled trial of occupational performance coaching for mothers of children with cerebral palsy

2018 ◽  
Vol 82 (4) ◽  
pp. 213-219 ◽  
Author(s):  
Mina Ahmadi Kahjoogh ◽  
Dorothy Kessler ◽  
Seyed Ali Hosseini ◽  
Mehdi Rassafiani ◽  
Nazila Akbarfahimi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cerebral Palsy ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Performance Measure ◽  
Occupational Performance ◽  
Randomized Controlled ◽  
Performance Coaching ◽  
Significant Difference ◽  
Children With Cerebral Palsy

Introduction The purpose of this study was to assess the efficacy of occupational performance coaching in mothers of children with cerebral palsy. Method A randomized controlled trial was used. Thirty mothers of children with cerebral palsy were randomly assigned to an occupational performance coaching group or control group. The Canadian Occupational Performance Measure and Sherer General Self-efficacy Scale were measured before and after the study. Results Occupational performance coaching had significant effects on participants’ occupational performance and self-efficacy. In child-related goals, there was also a statistically significant difference between two groups ( p = 0.05). Conclusion The results indicated that occupational performance coaching could be an effective intervention to increase the self-efficacy of mothers and improve the occupational performance of children and mothers of children with cerebral palsy. This trial is registered at NCT02915926 at clinicaltrials.gov

scholarly journals Open release versus radiofrequency microtenotomy in the treatment of lateral epicondylitis: a prospective randomized controlled trial

2017 ◽  
Vol 10 (1) ◽  
pp. 45-51 ◽  
Author(s):  
Katharine Hamlin ◽  
Christopher Munro ◽  
Scott L. Barker ◽  
Sean McKenna ◽  
Kapil Kumar
Keyword(s):  
Randomized Controlled Trial ◽  
Grip Strength ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Lateral Epicondylitis ◽  
Open Release ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Significant Difference

Background Optimal surgical treatment of lateral epicondylitis remains uncertain. Recently, radiofrequency microtenotomy (RFMT) has been proposed as a suitable treatment. We compared RFMT with standard open release (OR) in this prospective randomized controlled trial. Methods In total, 41 patients with symptoms for at least 6 months were randomized into two groups: 23 patients had RFMT and 18 had OR. Two patients from RFMT withdrew. Each patient underwent Numerical Rating Scale (NRS) pain score, grip strength and Disabilities of the Arm, Shoulder and Hand (DASH) scores pre-operatively and at 6 weeks. Pain and DASH scores were repeated at 6 months and 12 months. Results NRS pain scores improved by 4.8 points for RFMT and by 3.9 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Grip strength improved by 31% in the RFMT group compared to 38% in OR. There was no significant difference between the initial and 6 weeks scores or between treatments. At 1 year, DASH was 39.8 points for RFMT and 24.4 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Conclusions Both groups showed significant improvements and similar benefit to the patient. The results of the present study do not show any benefit of RFMT over the standard OR. As a result of the extra expense of RFMT, we therefore recommend that OR is offered as the standard surgical management.

scholarly journals Effectiveness of Antipyretic with Tepid Sponging Versus Antipyretic Alone in Febrile Children: A Randomized Controlled Trial

2018 ◽  
Vol 37 (2) ◽  
pp. 129-133
Author(s):  
Chetak Kadbasal Basavaraj ◽  
Shyamala Gowri Pocha ◽  
Ravi Mandyam Dhati
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Study Group ◽  
Axillary Temperature ◽  
Medical College ◽  
Randomized Controlled ◽  
Significant Difference

Introduction: Fever is the most common presenting complain for which children are brought to the paediatrician.Physical methods are widely used in treating febrile children, tepid sponging being commonly practiced in hospitals along with antipyretics. The objectives of this study were to compare the effectiveness of tepid sponging and antipyretic drug versus antipyretic drug alone in febrile children.Material and Methods: This was a Randomized controlled trial done in JSS Medical College and Hospital. All children under the age of 6 months to 12 years, admitted with axillary temperature of >99oF were included in the study. A total of 500 children were included over two years study period. Children with recorded axillary temperature of >990F were randomized into control and study group by computer generated randomisation. Children in the control group received only paracetamol (15mg/kg) at 5 minutes and combined group received paracetamol and tepid sponging at five minutes. Axillary temperature was monitored every 15 minutes for a period of 2 hours in both the groups.Results: There is no significant difference in reduction of temperature between the two groups by the end of two hours. Children in combined group had a higher level of discomfort than those in only antipyretic group.Conclusion: Tepid sponging does not add to the efficacy of paracetamol in antipyresis and that addition of tepid sponging to antipyretic, results in additional discomfort for the child. This study, therefore, endorses the view that antipyretic alone without tepid sponging should be the modality of therapy in children with fever.  

Sign in / Sign up

Export Citation Format

Share Document