scholarly journals Standardizing and monitoring the delivery of surgical interventions in randomized clinical trials

2016 ◽  
Vol 103 (10) ◽  
pp. 1377-1384 ◽  
Author(s):  
N. S. Blencowe ◽  
N. Mills ◽  
J. A. Cook ◽  
J. L. Donovan ◽  
C. A. Rogers ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Surgical Interventions

Clinical research in surgical oncology: An analysis of clinicaltrials.gov.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 591-591 ◽  
Author(s):  
Amber S Menezes ◽  
Alison Barnes ◽  
Adena S Scheer ◽  
Husein Moloo ◽  
Robin P Boushey ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Surgical Techniques ◽  
Surgical Oncology ◽  
The United States ◽  
Diagnostic Methods ◽  
Phase Iii ◽  
Medical Specialties ◽  
Surgical Interventions ◽  
Adjuvant Therapies

591 Background: The conduction of randomized clinical trials has expanded in medical specialties, but to a far lesser degree in surgery. This is due to design challenges with standardization of treatment, blinding and lack of surgeon equipoise. The objective of this study was to assess the current landscape of clinical trials in surgical oncology registered at clinicaltrials.gov. Methods: Data was extracted from clinicaltrials.gov using the following search engine criteria: ‘Cancer’ as Condition, ‘Surgery OR Operation OR Resection’ as Intervention, and Non-Industry sponsored. The search was limited to Canada and the United States and included trials registered from January 1, 2001 to January 1, 2011. The search was performed on March 23, 2011 by three investigators in parallel. The total number of oncology trials was also obtained. Results: Of 9990 oncology trials, 1049 (10.5%) included any type of surgical intervention. Of these trials, 125 (11.9%; 1.3% of all oncology trials) manipulated a surgical variable, 773 (73.7%) assessed adjuvant/neoadjuvant therapies, and 151 (14.4%) were observational studies. Trials assessing adjuvant therapies focused on systemic treatment (362 trials, 46.8%) and multimodal therapy (129 trials, 16.7%). Of the 125 trials where surgery was the manipulated variable, 59 trials (47.2%) focused on surgical techniques (including minimally invasive) or devices, 45 trials (36.0%) studied invasive diagnostic methods, and 21 trials (16.8%) evaluated surgery vs. no surgery. The majority of the 125 trials were non- randomized (72, 57.6%), and Phase III trials accounted for less than one-quarter (29, 23.2%). Conclusions: The number of registered surgical oncology trials is small in comparison to oncology trials as a whole. Clinical trials specifically designed to assess surgical interventions are vastly outnumbered by trials focusing on adjuvant therapies, and are frequently non-randomized. Randomized surgical oncology trials account for <1% of all registered cancer trials. Barriers to the design and implementation of randomized trials in surgical oncology need to be clarified to facilitate higher-level evidence in surgical decision making.

scholarly journals Systematic review of reporting benefits and harms of surgical interventions in randomized clinical trials

BJS Open ◽  
2020 ◽  
Vol 4 (2) ◽  
pp. 171-181
Author(s):  
F. E. Stubenrouch ◽  
E. S. Cohen ◽  
P. M. M. Bossuyt ◽  
M. J. W. Koelemay ◽  
P. C. R. van der Vet ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Surgical Interventions

Hyperbaric oxygen for refractory osteomyelitis

2021 ◽  
pp. 297-321
Author(s):  
Brett B. Hart ◽  
Keyword(s):  
Clinical Trials ◽  
Hyperbaric Oxygen ◽  
Randomized Clinical Trials ◽  
Treatment Success ◽  
Management Strategies ◽  
Clinical Results ◽  
Daily Basis ◽  
Surgical Debridement ◽  
Surgical Interventions ◽  
Hbo2 Therapy

Refractory osteomyelitis is defined as a chronic osteomyelitis that persists or recurs after appropriate interventions have been performed or where acute osteomyelitis has not responded to accepted management techniques [1]. To date, no randomized clinical trials examining the effects of hyperbaric oxygen (HBO2) therapy on refractory osteomyelitis exist, and the number of new osteomyelitis clinical trials conducted over the past decade has been limited. However, based on a comprehensive review of the scientific literature, the addition of HBO2 therapy to routine surgical and antibiotic treatment of previously refractory osteomyelitis appears to be both safe and ultimately improves infection resolution rates. In most cases, the best clinical results are obtained when HBO2 treatment is administered in conjunction with culture-directed antibiotics and initiated soon after clinically indicated surgical debridement. Where extensive surgical debridement or removal of fixation hardware is relatively contraindicated (e.g., cranial, spinal, sternal, or pediatric osteomyelitis), a trial of culture-directed antibiotics and HBO2 therapy prior to undertaking more than limited surgical interventions provides a reasonable prospect for osteomyelitis cure. HBO2 therapy is ordinarily delivered on a once daily basis, five-seven days per week, for 90–120 minutes using 2.0–3.0 atmospheres absolute (ATA) pressure. Where prompt clinical improvement is seen, the existing regimen of antibiotics and HBO2 therapy should be continued for approximately four to six weeks. Typically, 20–40 HBO2 sessions are required to achieve sustained therapeutic benefit. In contrast, if prompt clinical response is not noted or osteomyelitis recurs after this initial treatment period, then continuation of the current antibiotic and HBO2 treatment regimen is unlikely to be effective. Instead, clinical management strategies should be reassessed and additional surgical debridement and/or modification of antibiotic therapy considered. Subsequent reinstitution of HBO2 therapy will again help maximize the overall chances for treatment success in these persistently refractory patients.

Non-surgical interventions for the treatment of masticatory muscular spasticity in patients with cerebral palsy. Systematic review of randomized clinical trials

2021 ◽  
Author(s):  
Monise Mendes Rocha ◽  
Ana Luiza Cabrera Martimbianco ◽  
Rafael Zaratin Beltramin ◽  
Anna Carolina Ratto Tempestini Horliana ◽  
Elaine Marcílio Santos ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Cerebral Palsy ◽  
Randomized Clinical Trials ◽  
Surgical Interventions

Comparison of Registered and Published Primary Outcomes in Randomized Clinical Trials of Surgical Interventions

2013 ◽  
Vol 257 (5) ◽  
pp. 818-823 ◽  
Author(s):  
Gerjon Hannink ◽  
Hein G. Gooszen ◽  
Maroeska M. Rovers
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Surgical Interventions

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Inflammatory Mediators ◽  
Randomized Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Patients With Cancer ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Human Adults ◽  
Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

Ongoing randomized clinical trials for the treatment of thrombosis in the antiphospholipid syndrome

2001 ◽  
Vol 21 (02) ◽  
pp. 77-81 ◽  
Author(s):  
G. Finazzi
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Low Dose ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Collaborative Study ◽  
Clinical Problem ◽  
Vascular Events ◽  
Dose Oral ◽  
Adverse Pregnancy

SummaryThrombotic events are a major clinical problem for patients with antiphospholipid antibodies (APA). However, current recommendations for their prevention and treatment are still based on retrospective studies. Data from large scale, prospective clinical trials are required to ultimately identify the optimal management of these patients. To date, at least four randomized studies are underway. The WAPS and PAPRE clinical trials are aimed to establish the correct duration and intensity of oral anticoagulation in APA patients with major arterial or venous thrombosis. The WARSS-APASS is a collaborative study to evaluate the efficacy and safety of aspirin or low-dose oral anticoagulants in preventing the recurrence of ischemic stroke. The recently announced UK Trial compares low-dose aspirin with or without low-intensity anticoagulation for the primary prevention of vascular events in APA-positive patients with SLE or adverse pregnancy history, but still thrombosis-free. It is hoped that the results of these trials will be available soon since clinicians urgently need more powerful data to treat their patients with the APA syndrome.

Sign in / Sign up

Export Citation Format

Share Document