scholarly journals Continuous Warfarin Administration Versus Heparin Bridging Therapy in Post Colorectal Polypectomy Hemorrhage: A Study Protocol for a Multicenter Randomized Controlled Trial (WHICH Study)

2020 ◽  
Author(s):  
Yasuaki Nagami ◽  
Taishi Sakai ◽  
Masafumi Yamamura ◽  
Masami Nakatani ◽  
Takayuki Katsuno ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Anticoagulant Therapy ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Postoperative Bleeding ◽  
Endoscopic Polypectomy ◽  
Bleeding Rate ◽  
Randomized Controlled ◽  
Bridge Therapy

Abstract Background: Endoscopic removal of colorectal adenoma is considered an effective treatment for reducing the mortality rates associated with colorectal cancer. Warfarin, a type of anticoagulant, is widely used for the treatment and prevention of thromboembolism; however, bleeding may increase with its administration after polypectomy. In recent times, a high incidence of bleeding after endoscopic polypectomy has been reported in patients receiving heparin bridge therapy. However, previous studies have not compared the bleeding rate after endoscopic colorectal polypectomy between patients who continued with anticoagulant therapy and those who received heparin bridge therapy. We hypothesized that endoscopic colorectal polypectomy under the novel treatment with continuous warfarin is not inferior to endoscopic colorectal polypectomy under standard treatment with heparin bridge therapy with respect to the rate of postoperative bleeding. This study aims to compare the efficacy of endoscopic colorectal polypectomy with continuous warfarin administration and endoscopic colorectal polypectomy with heparin bridge therapy with respect to the rate of postoperative bleeding.Methods: We will conduct a prospective multicentre randomized controlled non-inferiority trial of two parallel groups. We will compare patients scheduled to undergo colorectal polypectomy under anticoagulant therapy with warfarin. There will be 2 groups, namely, a standard treatment group (heparin bridge therapy) and the experimental treatment group (continued anticoagulant therapy). The primary outcome measure is the rate of postoperative bleeding. On the contrary, the secondary outcomes include the rate of cumulative bleeding, rate of overt haemorrhage (that does not qualify for the definition of haemorrhage after endoscopic polypectomy), incidence of haemorrhage requiring haemostasis during endoscopic polypectomy, intraoperative bleeding during endoscopic colorectal polypectomy requiring angiography, abdominal surgery and/or blood transfusion, total rate of bleeding, risk factors for postoperative bleeding, length of hospital stay, incidence of thromboembolism, prothrombin time-international ratio (PT-INR) 28 days after the surgery, and incidence of serious adverse events.Discussion: The results of this randomized controlled trial will provide valuable information for the standardization of management of anticoagulants in patients scheduled to undergo colorectal polypectomy.Trial registration: UMIN-CTR identifier, UMIN000023720. Registered on 22 August 2016; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027270

scholarly journals Continuous warfarin administration versus heparin bridging therapy in post colorectal polypectomy haemorrhage: a study protocol for a multicentre randomised controlled trial (WHICH study)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yasuaki Nagami ◽  
Taishi Sakai ◽  
Masafumi Yamamura ◽  
Masami Nakatani ◽  
Takayuki Katsuno ◽  
...  
Keyword(s):  
Treatment Group ◽  
Randomised Controlled Trial ◽  
Anticoagulant Therapy ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Postoperative Bleeding ◽  
Endoscopic Polypectomy ◽  
Bleeding Rate ◽  
Randomised Controlled ◽  
Bridge Therapy

Abstract Background Endoscopic removal of colorectal adenoma is considered an effective treatment for reducing the mortality rates associated with colorectal cancer. Warfarin, a type of anticoagulant, is widely used for the treatment and prevention of thromboembolism; however, bleeding may increase with its administration after polypectomy. In recent times, a high incidence of bleeding after endoscopic polypectomy has been reported in patients receiving heparin bridge therapy. However, previous studies have not compared the bleeding rate after endoscopic colorectal polypectomy between patients who continued with anticoagulant therapy and those who received heparin bridge therapy. We hypothesised that endoscopic colorectal polypectomy under the novel treatment with continuous warfarin is not inferior to endoscopic colorectal polypectomy under standard treatment with heparin bridge therapy with respect to the rate of postoperative bleeding. This study aims to compare the efficacy of endoscopic colorectal polypectomy with continuous warfarin administration and endoscopic colorectal polypectomy with heparin bridge therapy with respect to the rate of postoperative bleeding. Methods We will conduct a prospective multicentre randomised controlled non-inferiority trial of two parallel groups. We will compare patients scheduled to undergo colorectal polypectomy under anticoagulant therapy with warfarin. There will be 2 groups, namely, a standard treatment group (heparin bridge therapy) and the experimental treatment group (continued anticoagulant therapy). The primary outcome measure is the rate of postoperative bleeding. On the contrary, the secondary outcomes include the rate of cumulative bleeding, rate of overt haemorrhage (that does not qualify for the definition of haemorrhage after endoscopic polypectomy), incidence of haemorrhage requiring haemostasis during endoscopic polypectomy, intraoperative bleeding during endoscopic colorectal polypectomy requiring angiography, abdominal surgery and/or blood transfusion, total rate of bleeding, risk factors for postoperative bleeding, length of hospital stay, incidence of thromboembolism, prothrombin time-international ratio (PT-INR) 28 days after the surgery, and incidence of serious adverse events. Discussion The results of this randomised controlled trial will provide valuable information for the standardisation of management of anticoagulants in patients scheduled to undergo colorectal polypectomy. Trial registration UMIN-CTR UMIN000023720. Registered on 22 August 2016

scholarly journals Comparison of effects of cervical headgear treatment on skeletal facial changes when the treatment time is altered: a randomized controlled trial

2019 ◽  
Vol 41 (6) ◽  
pp. 631-640
Author(s):  
Johanna Julku ◽  
Kirsi Pirilä-Parkkinen ◽  
Mimmi Tolvanen ◽  
Pertti Pirttiniemi
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Class Ii ◽  
Class Ii Malocclusion ◽  
Gonial Angle ◽  
Randomized Controlled ◽  
Face Height ◽  
Upper Face ◽  
Facial Changes

Summary Background There is a lack of evidence based on longitudinal information in the field of Class II malocclusion management with cervical headgear (CH), especially in a randomized setting. Objectives The main objective of this study was to evaluate skeletal facial changes, particularly in vertical dimensions, after Kloehn-type CH treatment in children when the timing of treatment is altered. Trial design Prospective, parallel-group, randomized controlled trial. Methods Screened children with Class II malocclusion were randomized in 1:1 ratio to two groups of equal size by sealed-envelope randomization: the early group (EG), where active CH treatment was started at the age of 7.8 years, and the late group (LG), where CH treatment was started at the age of 9.5 years. The active treatment was continued until normal Class I occlusion on first molars was achieved. Cephalograms were taken at three different time points. Changes in cephalometric measurements were compared between groups and genders. Blinding was applicable for outcome evaluation. Results Of 67 randomized children, 56 completed the study. Upper face height increased during the CH treatment phase, as the parameter N–ANS increased significantly during the active treatments of EG (P < 0.05) and LG (P < 0.05). Also, the parameter NSL–PL increased significantly during the treatment of EG (P < 0.01) and during the treatment of LG (P < 0.01). The Gonial angle decreased significantly in the early CH treatment group compared to the later treatment group (T0–T2: P < 0.01). CH improved the antero-posterior jaw relationship. No harms were encountered. Conclusions Although the upper face height increased, the mandible showed anterior rotation after CH treatment. The Gonial angle was significantly decreased in the EG compared to the LG. There were gender-specific differences in both sagittal and vertical dimensions when examining interrelations in dimensional changes. The differences found between the early and later treatment groups were not clinically important when the cephalometric results are considered. Clinical registration ClinicalTrials.gov (NCT02010346).

scholarly journals The Impact of Fresh Hass Avocado on the Fecal Metabolome Among Adults with Overweight and Obesity: A Randomized, Controlled Trial

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1593-1593
Author(s):  
Sharon Thompson ◽  
Ziyang Pan ◽  
Caitlyn Edwards ◽  
Ginger Reeser ◽  
Naiman Khan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Overweight And Obesity ◽  
Type I ◽  
Gastrointestinal Microbiota ◽  
Randomized Controlled ◽  
Food And Agriculture ◽  
Hass Avocado ◽  
The Impact

Abstract Objectives Avocados are nutrient-rich fruits that have been recently linked to beneficial alterations to the gastrointestinal microbiota. However, previous research on shifts in the fecal metabolome with avocado intake has largely been conducted in in vitro or preclinical models and little is known about their metabolomic impact in human subjects. Methods Adult participants (n = 109) 25–45 years of age with BMI ≥ 25.0 kg/m2 were enrolled in an investigator-blinded, parallel arm, randomized, controlled trial. Participants consumed isocaloric meals with or without fresh Hass avocado once daily for 12-weeks and reported ≥ 80% meal consumption over the intervention period. Untargeted fecal metabolites were quantified in a subsample of participants (n = 48) using gas chromatography mass spectroscopy and were normalized by sample weight. Kruskal-Wallis tests and false discovery rate type I error correction were conducted and orthogonal partial least squares discriminant analysis (OPLS-DA) was used to predict treatment group by fecal metabolite concentrations (RStudio, version 3.6.2). Results A total of 292 metabolites were identified at intervention follow-up. Of these, three metabolites differed significantly between treatment groups. Fecal concentrations of lanosterol (P = 0.0004, q = 0.04) and the fatty alcohols hexadecanol (P = 0.001, q = 0.04) and octadecanol (P = 0.001, q = 0.04), were greater in the group consuming avocado as compared to control. Seventeen additional metabolites, including nine fecal lipids, two fat soluble vitamin derivatives, and three monosaccharides/disaccharides differed at P &lt; 0.05 but did not meet the q &lt; 0.05 threshold. Treatment group assignment was predicted correctly in 70% of cases (R2 = 72%, Q2 = 33%) using the trained OPLS-DA model. Conclusions Fresh Hass avocado intake increased fecal lipid and sterol concentrations among healthy adults with overweight and obesity, demonstrating diet-related modifications to the fecal metabolome. Funding Sources Support for this research was provided by the Hass Avocado Board, the USDA National Institute of Food and Agriculture, Hatch project 1009249, and the USDA National Institute of Food and Agriculture AFRI Predoctoral Fellowship, project 2018–07785.

Should Mesenchymal Stem Cell Therapy be used in the treatment of COVID-19?

2020 ◽  
Vol 54 ◽  
Author(s):  
Namnama P. Villarta-De Dios ◽  
Evelyn S. Osio-Salido
Keyword(s):  
Stem Cells ◽  
Randomized Controlled Trial ◽  
Stem Cell ◽  
Mesenchymal Stem Cell ◽  
Cell Therapy ◽  
Stem Cell Therapy ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Mesenchymal Stem Cell Therapy ◽  
Randomized Controlled

KEY FINDINGSThere is some short-term benefit from the use of mesenchymal stem cell therapy for severe COVID-19 in a lowquality, small randomized controlled trial (RCT). Further studies, ideally with good quality RCTs, are needed toconfirm benefit and safety.• Mesenchymal stem cells (MSCs) are non-hematopoietic adult stem cells that are able to self-renew anddifferentiate into various cells of any cell lineage. MSCs have the ability to migrate (homing) to damaged tissuefor repair and regeneration, as well as signal other cells to help in tissue repair. It can effect cellular differentiation,consequently shifting the immune system from Th1 to Th2 responses.1,2• A recent review showed improved disease-associated parameters in experimental acute respiratory distresssyndrome (ARDS).3• We found three studies (one case report, one prospective cohort, and one small randomized controlled trial)reporting the effects of MSC on COVID-19. Based on low-quality evidence, it appeared that human umbilicalcord blood-derived MSC, given after failure to improve with standard treatment, had beneficial effects in termsof earlier onset of clinical improvement among individuals with severe or critical COVID-19. However, 28-dayclinical improvement and mortality were not significantly different compared to standard treatment. There wasno reported adverse reaction.• There are 52 registered and ongoing clinical trials to investigate the efficacy and safety of mesenchymal stemcells as treatment for COVID-19.• Mesenchymal stem cell therapy is not included in any of the existing guidelines for the treatment of COVID-19.

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