scholarly journals Laparoscopic Intra-abdominal Pressure Study: A Double Blinded Randomised Control Trial

HPB ◽  
2021 ◽  
Vol 23 ◽  
pp. S94
Author(s):  
E. Gin ◽  
D. Lowen ◽  
M. Tacey ◽  
R. Hodgson
Keyword(s):  
Randomised Control Trial ◽  
Abdominal Pressure ◽  
Double Blinded

scholarly journals Impact of duration of antibiotic prophylaxis on rates of surgical site infection (SSI) in patients undergoing mastectomy without immediate reconstruction, comparing a single prophylactic dose versus continued antibiotic prophylaxis postoperatively: a multicentre, double-blinded randomised control trial protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e049572
Author(s):  
Abida K Sattar ◽  
Nida Zahid ◽  
Hania Shahzad ◽  
Rufina Soomro ◽  
Omema Saleem ◽  
...  
Keyword(s):  
Surgical Site Infection ◽  
Antibiotic Prophylaxis ◽  
Randomised Control Trial ◽  
Categorical Variables ◽  
Adjusted Relative Risk ◽  
Trial Protocol ◽  
Site Infection ◽  
Immediate Reconstruction ◽  
Prophylactic Dose ◽  
Double Blinded

IntroductionIn breast surgeries, prophylactic antibiotics given before the surgical incision as per Joint Commission Surgical Care Improvement Project guidelines have been shown to decrease the rate of postoperative infections. There is, however, no clear consensus on postoperative antibiotic prophylaxis in patients undergoing mastectomy with indwelling drains. This trial protocol proposes to study the difference in rates of surgical site infection (SSI) with or without continuation of postoperative antibiotics in patients undergoing mastectomy without immediate reconstruction and with indwelling drains.Methods and analysisIn this multicentre, double-blinded clinical trial, all patients undergoing mastectomy (without immediate reconstruction) will receive a single prophylactic dose of preoperative antibiotics at induction of anaesthesia and will then get randomised to either continue antibiotic prophylaxis or a placebo postoperatively, for the duration of indwelling drains. The primary and secondary outcomes will be development of an SSI and antibiotic-associated adverse effects, respectively. Data will be collected through a standard questionnaire by wound assessors. Intention-to-treat analysis will be carried out using STATA V.12. For categorical variables, frequencies and percentages will be assessed by χ2 test/Fisher’s exact test as appropriate. The quantitative variables will be computed by their mean±SD or median (IQR) and will be assessed by independent t-test/Mann-Whitney test as appropriate. Unadjusted and adjusted relative risk with their 95% CI will be reported using Cox proportional regression. A p value of <0.05 will be considered statistically significant.Ethics and disseminationEthical approval has been obtained from each site’s Ethical Review Board. The study background and procedure will be explained to the study participants and informed consent will be obtained. Participation in the study is voluntary. All data will be deidentified and kept confidential. The study findings will be published in scientific media and authorship guidelines of International Committee of Medical Journal Editors will be followed.Trial registration numberNCT04577846. (patient recruitment)

scholarly journals Strain Engraftment Competition and Functional Augmentation in a Multi-donor Fecal Microbiota Transplantation Trial for Obesity

2020 ◽  
Author(s):  
Brooke Wilson ◽  
Tommi Vatanen ◽  
Thilini Jayasinghe ◽  
Karen Leong ◽  
José Derraik ◽  
...  
Keyword(s):  
Fecal Microbiota Transplantation ◽  
Critical Role ◽  
Fecal Microbiota ◽  
Randomised Control Trial ◽  
Metagenomic Sequencing ◽  
Metabolic Potential ◽  
Microbial Dysbiosis ◽  
Shotgun Metagenomic Sequencing ◽  
Level Shifts ◽  
Double Blinded

Abstract Background Donor selection is an important factor influencing the engraftment and efficacy of fecal microbiota transplantation (FMT) for complex conditions associated with microbial dysbiosis. However, the degree, variation, and stability of strain engraftment has not yet been assessed in the context of multiple donors. Methods We conducted a double-blinded randomised control trial of FMT in 42 adolescents with obesity. Participants were randomised to receive multi-donor FMT (capsules containing the fecal microbiota of four sex-matched lean donors) or placebo (saline capsules). Following a bowel cleanse, participants ingested a total of 28 capsules over two consecutive days. Capsules from individual donors and participant stool samples collected at baseline, 6-, 12-, and 26-weeks post-treatment were analysed by shotgun metagenomic sequencing allowing us to track bacterial strain engraftment and its functional implications on recipients’ gut microbiomes. Results Multi-donor FMT sustainably altered the structure and the function of the gut microbiome. In what was effectively a microbiome competition experiment, we discovered that two donor microbiomes (one female, one male) dominated strain engraftment and were characterised by high microbial diversity and a high Prevotella to Bacteroides (P/B) ratio. Engrafted strains led to enterotype-level shifts in community composition and provided genes that altered the metabolic potential of the community. Despite our attempts to standardise FMT dose and origin, FMT recipients varied widely in their engraftment of donor strains. Conclusion Our study provides evidence for the existence of FMT super-donors whose microbiomes are highly effective at engrafting in the recipient gut. Dominant engrafting male and female donor microbiomes harboured diverse microbial species and genes, and were characterised by a high P/B ratio. Yet, the high variability of strain engraftment among FMT recipients suggests the host environment also plays a critical role in mediating FMT receptivity. Trial registration The Gut Bugs Trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615001351505)

scholarly journals A double blinded comparative study between omega 3 fatty acid infusion versus octreotide infusion in acute pancreatitis

2020 ◽  
Vol 7 (10) ◽  
pp. 3251
Author(s):  
Narayanswamy T. ◽  
Supreeth K. ◽  
Sridhar G.
Keyword(s):  
Acute Pancreatitis ◽  
Fatty Acid ◽  
Hospital Stay ◽  
Treatment Guidelines ◽  
Medical Expenditure ◽  
Randomised Control Trial ◽  
Omega 3 ◽  
Acid Infusion ◽  
Omega 3 Fatty Acid ◽  
Double Blinded

Background: Over decades the treatment of acute pancreatitis remains debatable with no common consensus on treatment guidelines, with some workers using octreotide infusion and some workers only relying on fluid therapy and symptomatic management. This double blinded comparative trial between omega 3 fatty acid infusion versus octreotide infusion and its response in cases of acute pancreatitis. Methods: This is a study where a double blinded randomised control trial was undertaken in proven cases of acute pancreatitis and patients were given omega 3 fatty acid infusion and octreotide infusion and the observations were documented and followed upon. 50 cases were given omega 3 fatty acid infusion and other 50 were given octreotide infusion and the clinical response, symptomatic improvement was assessed and compared using BISAP and Marshal scoring systems and lipase levels.Results: Omega 3 fatty acid infusion was found to be highly significant as compared to octreotide in cases of acute pancreatitis in terms of clinical improvement, reduced hospital stay, and SIRS.Conclusions: Omega 3 fatty acid infusion is the future in cases of acute pancreatitis which is cheap and easily available with no side effects and reduces the morbidity and mortality in acute pancreatitis with reduced hospital stay in turn resulting in overall reduced medical expenditure.

Sign in / Sign up

Export Citation Format

Share Document