Intraperitoneal drain placement and outcomes after elective colorectal surgery: international matched, prospective, cohort study

Despite current guidelines, intraperitoneal drain placement after elective colorectal surgery remains widespread. Drains were not associated with earlier detection of intraperitoneal collections, but were associated with prolonged hospital stay and increased risk of surgical-site infections.Background Many surgeons routinely place intraperitoneal drains after elective colorectal surgery. However, enhanced recovery after surgery guidelines recommend against their routine use owing to a lack of clear clinical benefit. This study aimed to describe international variation in intraperitoneal drain placement and the safety of this practice. Methods COMPASS (COMPlicAted intra-abdominal collectionS after colorectal Surgery) was a prospective, international, cohort study which enrolled consecutive adults undergoing elective colorectal surgery (February to March 2020). The primary outcome was the rate of intraperitoneal drain placement. Secondary outcomes included: rate and time to diagnosis of postoperative intraperitoneal collections; rate of surgical site infections (SSIs); time to discharge; and 30-day major postoperative complications (Clavien-Dindo grade at least III). After propensity score matching, multivariable logistic regression and Cox proportional hazards regression were used to estimate the independent association of the secondary outcomes with drain placement. Results Overall, 1805 patients from 22 countries were included (798 women, 44.2 per cent; median age 67.0 years). The drain insertion rate was 51.9 per cent (937 patients). After matching, drains were not associated with reduced rates (odds ratio (OR) 1.33, 95 per cent c.i. 0.79 to 2.23; P = 0.287) or earlier detection (hazard ratio (HR) 0.87, 0.33 to 2.31; P = 0.780) of collections. Although not associated with worse major postoperative complications (OR 1.09, 0.68 to 1.75; P = 0.709), drains were associated with delayed hospital discharge (HR 0.58, 0.52 to 0.66; P < 0.001) and an increased risk of SSIs (OR 2.47, 1.50 to 4.05; P < 0.001). Conclusion Intraperitoneal drain placement after elective colorectal surgery is not associated with earlier detection of postoperative collections, but prolongs hospital stay and increases SSI risk

Intracranial antitumor activity with encorafenib plus binimetinib in patients with melanoma brain metastases: A case series

All clinical trials to date with encorafenib and binimetinib (US Food and Drug Administration–approved in June 2018 for BRAF ‐mutated metastatic melanoma) have excluded untreated melanoma brain metastases. This case series provides the first clinical evidence of intracranial activity of the combination of encorafenib plus binimetinib in patients with BRAF ‐mutant melanoma with active brain metastases. Intracranial clinical activity is observed for the first time in patients previously treated with BRAF/MEK inhibitors, a population that has not been previously investigated

Cupping Therapy (Al-Hijamah): An Exploratory Study of Healthcare Professionals Controversial Beliefs and Conceptions, Kingdom of Saudi Arabia

Background: Cupping therapy (Al-Hijamah) is a traditional therapy, supported and practised by people around the world since ancient times. Cupping therapy related to complementary and alternative medicine is associated with controversial, false beliefs and misconceptions. Objective: This study aimed at exploring controversial beliefs and conceptions about cupping therapy among healthcare professionals, Riyadh, Kingdom of Saudi Arabia (KSA). Methods: A cross-sectional study involving 241 healthcare professionals was carried out from January to June 2016. All participants requesting license for practicing cupping therapy underwent one week Al-Hijamah training course at National Center for Complementary and Alternative (NCCAM). Prior to training course, all subjects completed a 23-item predesigned questionnaire related to controversial beliefs and misconceptions concerning cupping therapy. All participants gave written informed consent. Results: Healthcare professionals who participated in the study (n=241) were 93 physicians, 56 physiotherapists, 61 nurses and 31 other specialists. Saudi participants represented 46.1%. 60.6% were adult males with mean clinical experience of 13.0±9.37 years. "Al-Hijamah gets rid of bad blood" was the commonest controversial belief reported by 68.1% of participants. A proportion of participants (31.5%) reported "Al-Hijamah is absolutely safe" and "Al-Hijamah is effective in the treatment of all diseases". The least controversial beliefs reported by 12%, 8.7% and 2.9% of participants were "Cupping can be used for all patients and all diseases”, "Cupping like a blood donation is not different" and "The scarification of cupping (in wet cupping) must be deep", respectively. Conclusion: The explored controversial beliefs and misconceptions related to cupping therapy may impact knowledge, attitude and practice of cupping practitioners. Therefore, all healthcare professionals need to be regularly exposed to a training course targeting these beliefs and misconceptions concerning cupping therapy prior to giving them license for practicing this traditional modality. Continuing research in cupping mechanisms of action is another prioritized area which can provide scientific explanations underlying its efficacy and outcome together with alleviating its false beliefs and misconceptions

Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial

Abstract Background It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. Methods The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. Discussion This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018. Trial registration ClinicalTrials.gov, ID: NCT02845843. Registered on 27 July 2016

Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial

Abstract The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-β1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-β1b provided with standard supportive care, compared to placebo provided with standard supportive care, in hospitalized patients with laboratory-confirmed MERS. The MIRACLE trial is designed as a recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The aim of this article is to describe the statistical analysis plan for the MIRACLE trial. The primary outcome is 90-day mortality. The primary analysis will follow the intention-to-treat principle. The MIRACLE trial is the first randomized controlled trial for MERS treatment. Trial registration ClinicalTrials.gov, NCT02845843. Registered on 27 July 2016