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

10.2196/14533 ◽  
2019 ◽  
Vol 8 (12) ◽  
pp. e14533
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 (CO2) during laparoscopic procedures may contribute to this problem. Evidence exists that the HumiGard device, which humidifies and heats CO2 for insufflation, can reduce the risk of perioperative hypothermia. Objective The aim is to determine if insufflation with warmed, humidified CO2 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. International Registered Report Identifier (IRRID) PRR1-10.2196/14533

scholarly journals Matrix-Augmented Bone Marrow Stimulation With a Polyglycolic Acid Membrane With Hyaluronan vs Microfracture in Local Cartilage Defects of the Femoral Condyles: A Multicenter Randomized Controlled Trial

2020 ◽  
Vol 8 (5) ◽  
pp. 232596712092293
Author(s):  
Johannes Glasbrenner ◽  
Wolf Petersen ◽  
Michael J. Raschke ◽  
Matthias Steiger ◽  
René Verdonk ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Polyglycolic Acid ◽  
Tissue Formation ◽  
Bone Marrow Stimulation ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Patient Reported

Background: Microfracture (MF) is an established operative treatment for small, localized chondral defects of the knee joint. There is evidence from animal studies that matrix augmentation of bone marrow stimulation (m-BMS) can improve the quality of the repair tissue formation. Purpose: To evaluate the therapeutic outcome of a matrix made of polyglycolic acid and hyaluronan as compared with a conventional MF technique. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients between the ages of 18 and 68 years who had an articular femoral cartilage defect of 0.5 to 3 cm2 in the weightbearing area of the femoral condyles with indication for MF were included in this study. Patients were randomized and treated with either MF or m-BMS with Chondrotissue. Defect filling, as assessed on magnetic resonance imaging (MRI), at postoperative 12 weeks was defined as the primary outcome measure, with follow-up MRI at weeks 54 and 108. Follow-up data were also collected at 12, 54, and 108 weeks after surgery and included patient-reported clinical scores: visual analog scale for pain, Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee score, and 36-Item Short Form Health Survey. Results: MRI scans confirmed cartilage repair tissue formation in both groups 12 weeks after treatment. There was no significant difference between the m-BMS and MF groups in the percentage of defect filling at 12, 54, and 108 weeks postoperatively. No significant difference was found in terms of patient-reported clinical scores. Both groups showed significant improvement in 4 KOOS subscales—Pain, Activities of Daily Living, Sport and Recreation, and Quality of Life—at 54 and 108 weeks after treatment. Conclusion: This is the first randomized controlled trial comparing m-BMS with a polyglycolic acid matrix with hyaluronan with MF. The use of the Chondrotissue implant in m-BMS has been proven to be a safe procedure. No difference was found between m-BMS and MF in terms of patient-reported outcome scores and MRI assessment until postoperative 2 years. Long-term follow-up studies including histological assessment are desirable for further investigation. Registration: EUCTR2011-003594-28-DE (EU Clinical Trials Register).

scholarly journals The Stepped Care Intervention to Suppress Viral Load in Youth Living With HIV: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Elizabeth Mayfield Arnold ◽  
Dallas Swendeman ◽  
Danielle Harris ◽  
Jasmine Fournier ◽  
Leslie Kozina ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Viral Suppression ◽  
Controlled Trial ◽  
Stepped Care ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Youth Living With Hiv ◽  
Living With Hiv

BACKGROUND Among youth living with HIV (YLH) aged 12-24 years who have health care in the United States, only 30% to 40% are virally suppressed. YLH must achieve viral suppression in order to reduce the probability of infecting others as well as increasing the length and quality of their own life. OBJECTIVE This randomized controlled trial aimed to evaluate the efficacy of an Enhanced Standard Care condition (n=110) compared to an Enhanced Stepped Care intervention condition (n=110) to increase viral suppression among YLH aged 12-24 years with established infection (not acutely infected). METHODS YLH (N=220) who are not virally suppressed will be identified at homeless shelters, health clinics, and gay-identified community-based organizations in Los Angeles, CA, and New Orleans, LA. Informed consent will be obtained from all participants. YLH will be randomly assigned to one of two study conditions: Enhanced Standard Care, which includes standard clinical care plus an automated messaging and monitoring intervention (AMMI), or an Enhanced Stepped Care, which includes three levels of intervention (AMMI, Peer Support via social media plus AMMI, or Coaching plus Peer Support and AMMI). The primary outcome is viral suppression of HIV, and YLH will be assessed at 4-month intervals for 24 months. For the Enhanced Stepped Care intervention group, those who do not achieve viral suppression (via blood draw, viral load<200 copies/mL) at any 4-month assessment will “step up” to the next level of intervention. Secondary outcomes will be retention in care, antiretroviral therapy adherence, alcohol use, substance use, sexual behavior, and mental health symptoms. RESULTS Recruitment for this study began in June 2017 and is ongoing. We estimate data collection to be completed by the end of 2020. CONCLUSIONS This is the first known application of an Enhanced Stepped Care intervention model for YLH. By providing the lowest level of intervention needed to achieve viral suppression, this model has the potential to be a cost-effective method of helping YLH achieve viral suppression and improve their quality of life. CLINICALTRIAL ClinicalTrials.gov NCT03109431; https://clinicaltrials.gov/ct2/show/NCT03109431 INTERNATIONAL REGISTERED REPOR DERR1-10.2196/10791

scholarly journals A Brief Mindfulness-Based Intervention for Primary Care Physicians: A Pilot Randomized Controlled Trial

2016 ◽  
Vol 12 (1) ◽  
pp. 83-91 ◽  
Author(s):  
David A. Schroeder ◽  
Elizabeth Stephens ◽  
Dharmakaya Colgan ◽  
Matthew Hunsinger ◽  
Dan Rubin ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Primary Care Physicians ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
Patient Reported ◽  
The Impact

Primary care physicians experience high rates of burnout, which results in diminished quality of life, poorer quality of care, and workforce attrition. In this randomized controlled trial, our primary aim was to examine the impact of a brief mindfulness-based intervention (MBI) on burnout, stress, mindfulness, compassion, and resilience among physicians. A total of 33 physicians completed the baseline assessment and were randomized to the Mindful Medicine Curriculum (MMC; n = 17) or waitlist control group (n = 16). Participants completed self-report measures at baseline, post-MBI, and 3-month follow-up. We also analyzed satisfaction with doctor communication (DCC) and overall doctor rating (ODR) data from patients of the physicians in our sample. Participants in the MMC group reported significant improvements in stress (P < .001), mindfulness (P = .05), emotional exhaustion (P = .004), and depersonalization (P = .01) whereas in the control group, there were no improvements on these outcomes. Although the MMC had no impact on patient-reported DCC or ODR, among the entire sample at baseline, DCC and ODR were significantly correlated with several physician outcomes, including resilience and personal achievement. Overall, these findings suggest that a brief MBI can have a positive impact on physician well-being and potentially enhance patient care.

scholarly journals EXPRESS: Bufei Huoxue Capsules in the management of convalescent COVID-19 infection: study protocol for a multicentre, double-blind, and randomized controlled trial

2021 ◽  
pp. 204589402110321
Author(s):  
Yuqin Chen ◽  
Wenjun He ◽  
Wenju Lu ◽  
Yue Xing ◽  
Jianling Bai ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Blood Stasis ◽  
Blood Stasis Syndrome ◽  
Small Scale ◽  
Control Group ◽  
Cumulative Number ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Number Of Patients

Up to the 30th May, 2021, the cumulative number of patients diagnosed with Corona Virus Disease-19 (COVID-19) globally has exceeded 170 million, with more than 152 million patients recovered from COVID-19. However, the long-term effect of the virus infection on the human body’s function is unknown for convalescent patients. It was reported that about 63% of COVID-19 patients had observable lung damage on CT scans after being released from the hospital. Bufei Huoxue Capsules (BFHX), including three active ingredients of traditional Chinese herbal medicine, has been used clinically to prevent and treat pulmonary heart diseases with Qi deficiency and blood stasis syndrome. Some small-scale clinical trials have found that BFHX can improve lung ventilation function, reduce blood viscosity, and improve cardiopulmonary function. However, the efficacy and safety of BFHX in the treatment of the recovery phase of COVID-19 are unknown. This study is a multicentre, double-blinded, randomized, controlled trial. Subjects with convalescent COVID-19 were randomized (1:1) into either a BFHX or control group and observed for 3months concomitant with receiving routine treatment. The primary efficacy indicators are the evaluation results and changes of the St. George’s Respiratory Questionnaire (SGRQ) score, Fatigue Assessment Inventory (FAI), and 6-minute walk distance (6MWD). Based on the intention-to-treat (ITT) principle, all randomly assigned participants will be included in the statistical analysis. The last visit’s outcomes will be used as the final outcomes for participants who prematurely withdraw from the trial. Per protocol set will pick up from the full analysis set for analysis. Efficacy analysis will be performed on the ITT datasets and per-protocol datasets. Prior to participation, all subjects provided written informed consent. Results will be disseminated at medical conferences and in journal publications. We aimed to determine the efficacy and safety of BFHX for the treatment of the convalescent COVID-19 patients.

scholarly journals Enhanced Patient Activation in Cancer Care Transitions: Protocol for a Randomized Controlled Trial of a Tailored Electronic Health Intervention for Men With Prostate Cancer (Preprint)

2018 ◽  
Author(s):  
Mirjam Ekstedt ◽  
Kristina Schildmeijer ◽  
Camilla Wennerberg ◽  
Lina Nilsson ◽  
Carolina Wannheden ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Randomized Controlled Trial ◽  
Urinary Incontinence ◽  
Radical Prostatectomy ◽  
Standard Care ◽  
Controlled Trial ◽  
Patient Activation ◽  
Randomized Controlled

BACKGROUND Prostate cancer has increased in incidence worldwide and is the leading cause of cancer death in 24 countries. The most common treatment is radical prostatectomy. However, surgery is associated with postoperative complications such as urinary incontinence and sexual dysfunction, causing decreased quality of life. If survivors are encouraged to be more active in self-care management, the symptom burden may decrease and quality of life may improve. An electronic health (eHealth) intervention based on motivational behavioral theory has been developed for this purpose. OBJECTIVE This study aimed to compare the effectiveness of standard care in combination with a tailored eHealth and mobile health self-management support system, electronic Patient Activation in Treatment at Home (ePATH), with standard care of adverse effects of prostate cancer treatment (urinary incontinence and sexual functioning) in men undergoing radical prostatectomy. The secondary aim was to test the effect on patient activaftion, motivation, overall well-being, and health literacy over time in and between groups. METHODS A pragmatic multicenter, block-randomized controlled trial with 2 study arms, standard care (control) and eHealth-assisted standard care (intervention), for patients undergoing radical prostatectomy. For 80% power, a sample of 242 men will need to be recruited. RESULTS Recruitment started in January 2018 and is expected to be completed by August 2019. Data collection will be completed in August 2020. The first cross-sectional results from this trial are anticipated to be published in January 2020. CONCLUSIONS With the increasing number of prostate cancer survivors, attention should be paid to rehabilitation, psychosocial care, and support for endurance of self-care to reduce suffering from adverse treatment effects, poor quality of life, and depression because of postoperative complications. This project may increase knowledge of how patients can be supported to feel involved in their care and returning to as normal a life as possible. The anticipated effects of ePATH could improve health outcomes for individuals and facilitate follow-up for health care professionals. CLINICALTRIAL International Standard Randomised Controlled Trial Number: 18055968; http://www.isrctn.com/ISRCTN18055968 (Archived by WebCite at http://www.isrctn.com/ISRCTN18055968). INTERNATIONAL REGISTERED REPOR DERR1-10.2196/11625

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