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Compared with open resection, laparoscopic resection of rectal cancers is associated with improved short-term outcomes, but high-level evidence showing similar long-term outcomes is scarce. We aimed to compare survival outcomes of laparoscopic surgery with open surgery for patients with mid-rectal or low-rectal cancer. The Comparison of Open versus laparoscopic surgery for mid or low REctal cancer After Neoadjuvant chemoradiotherapy (COREAN) trial was an open-label, non-inferiority, randomised controlled trial done between April 4, 2006, and Aug 26, 2009, at three centres in Korea. Patients (aged 18–80 years) with cT3N0–2M0 mid-rectal or low-rectal cancer who had received preoperative chemoradiotherapy were randomly assigned (1:1) to receive either open or laparoscopic surgery. Randomisation was stratified by sex and preoperative chemotherapy regimen. Investigators were masked to the randomisation sequence; patients and clinicians were not masked to the treatment assignments. The primary endpoint was 3 year disease-free survival, with a non-inferiority margin of 15%. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00470951. We randomly assigned 340 patients to receive either open surgery (n=170) or laparoscopic surgery (n=170). 3 year disease-free survival was 72·5% (95% CI 65·0–78·6) for the open surgery group and 79·2% (72·3–84·6) for the laparoscopic surgery group, with a difference that was lower than the prespecified non-inferiority margin (–6·7%, 95% CI −15·8 to 2·4; p<0·0001). 25 (15%) patients died in the open group and 20 (12%) died in the laparoscopic group. No deaths were treatment related. Our results show that laparoscopic resection for locally advanced rectal cancer after preoperative chemoradiotherapy provides similar outcomes for disease-free survival as open resection, thus justifying its use. National Cancer Center, South Korea.

The safety and short-term efficacy of laparoscopic surgery for rectal cancer after preoperative chemoradiotherapy has not been demonstrated. The aim of the randomised Comparison of Open versus laparoscopic surgery for mid and low REctal cancer After Neoadjuvant chemoradiotherapy (COREAN) trial was to compare open surgery with laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy. Between April 4, 2006, and Aug 26, 2009, patients with cT3N0–2 mid or low rectal cancer without distant metastasis after preoperative chemoradiotherapy were enrolled at three tertiary-referral hospitals. Patients were randomised 1:1 to receive either open surgery (n=170) or laparoscopic surgery (n=170), stratified according to sex and preoperative chemotherapy regimen. Short-term outcomes assessed were involvement of the circumferential resection margin, macroscopic quality of the total mesorectal excision specimen, number of harvested lymph nodes, recovery of bowel function, perioperative morbidity, postoperative pain, and quality of life. Analyses were based on the intention-to-treat population. Patients continue to be followed up for the primary outcome (3-year disease-free survival). This study is registered with ClinicalTrials.gov, number NCT00470951. Two patients (1·2%) in the laparoscopic group were converted to open surgery, but were included in the laparoscopic group for analyses. Estimated blood loss was less in the laparoscopic group than in the open group (median 217·5 mL [150·0–400·0] in the open group vs 200·0 mL [100·0–300·0] in the laparoscopic group, p=0·006), although surgery time was longer in the laparoscopic group (mean 244·9 min [SD 75·4] vs 197·0 min [62·9], p<0·0001). Involvement of the circumferential resection margin, macroscopic quality of the total mesorectal excision specimen, number of harvested lymph nodes, and perioperative morbidity did not differ between the two groups. The laparoscopic surgery group showed earlier recovery of bowel function than the open surgery group (time to pass first flatus, median 38·5 h [23·0–53·0] vs 60·0 h [43·0–73·0], p<0·0001; time to resume a normal diet, 85·0 h [66·0–95·0] vs 93·0 h [86·0–121·0], p<0·0001; time to first defecation, 96·5 h [70·0–125·0] vs 123 h [94·0–156·0], p<0·0001). The total amount of morphine used was less in the laparoscopic group than in the open group (median 107·2 mg [80·0–150·0] vs 156·9 mg [117·0–185·2], p<0·0001). 3 months after proctectomy or ileostomy takedown, the laparoscopic group showed better physical functioning score than the open group (0·501 [n=122] vs −4·970 [n=128], p=0·0073), less fatigue (−5·659 [n=122] vs 0·098 [n=129], p=0·0206), and fewer micturition (−2·583 [n=122] vs 4·725 [n=129], p=0·0002), gastrointestinal (−0·400 [n=122] vs 4·331 [n=129], p=0·0102), and defecation problems (0·535 [n=103] vs 5·327 [n=99], p=0·0184) in repeated measures analysis of covariance, adjusted for baseline values. Laparoscopic surgery after preoperative chemoradiotherapy for mid or low rectal cancer is safe and has short-term benefits compared with open surgery; the quality of oncological resection was equivalent. The National Cancer Center, South Korea.

Although modern risk estimators, such as the American College of Cardiology/American Heart Association Pooled Cohort Equation, play a central role in the decisions of patients to start pharmacologic therapy to prevent atherosclerotic cardiovascular disease (ASCVD), there is limited evidence to inform expectations for 10-year ASCVD risk reduction from established lifestyle interventions. Using data from the original DASH (Dietary Approaches to Stop Hypertension) trial, we determined the effects of adopting the DASH diet on 10-year ASCVD risk compared with adopting a control or a fruits and vegetables (F/V) diet. The DASH trial included 459 adults aged 22 to 75 years without CVD and not taking antihypertensive or diabetes mellitus medications, who were randomized to controlled feeding of a control diet, an F/V diet, or the DASH diet for 8 weeks. We determined 10-year ASCVD risk with the American College of Cardiology/American Heart Association Pooled Cohort Equation based on blood pressure and lipids measured before and after the 8-week intervention. Compared with the control diet, the DASH and F/V diets changed 10-year ASCVD risk by −10.3% (95% confidence interval [CI] −14.4 to −5.9) and −9.9% (95% CI −14.0 to −5.5) respectively; these effects were more pronounced in women and Black adults. There was no difference between the DASH and F/V diets (−0.4%, 95% CI −6.9 to 6.5). ASCVD reductions attributable to the difference in systolic blood pressure alone were −14.6% (−17.3 to −11.7) with the DASH diet and −7.9% (−10.9 to −4.8) with the F/V diet, a net relative advantage of 7.2% greater relative reduction from DASH compared with F/V. This was offset by the effects on high-density lipoprotein of the DASH diet, which increased 10-year ASCVD by 8.8% (5.5 to 12.3) compared with the more neutral effect of the F/V diet of −1.9% (−5.0 to 1.2). In conclusion, compared with a typical American diet, the DASH and F/V diets reduced 10-year ASCVD risk scores by about 10% over 8 weeks. These findings are informative for counseling patients on both choices of diet and expectations for 10-year ASCVD risk reduction.

Background For locally advanced rectal cancer (LARC), total neoadjuvant therapy (TNT) may enhance tumour response, reduce recurrence, and improve patient compliance compared to upfront surgery. Recent studies have shown that chemoradiotherapy (CRT) followed by consolidation chemotherapy leads to higher rate of pathologic complete response (pCR) than induction chemotherapy followed by CRT. However, an optimal TNT regimen that maximise the pCR rate and minimise toxicity has not been established. Therefore, the aim of this trial was to investigate whether preoperative short-course radiotherapy followed by chemotherapy with four cycles of CAPOX can double the pCR rate compared to a standard schedule of long-course preoperative CRT in patients with LARC. Methods This is a multi-centre, prospective, open label, randomised controlled trial. Patients with clinical primary tumour stage 3 and higher or regional node-involved rectal cancer located within 10 cm from the anal verge were randomly assigned equally to short-course radiotherapy (25 Gy in 5 fractions over 1 week) followed by four cycles of CAPOX (intravenous oxaliplatin [130 mg/m 2 , once a day] on day 1 and capecitabine [1,000 mg/m 2 , twice a day] from days 1 to 14) (TNT) or CRT (50.4 Gy in 28 fractions over 5 weeks, concurrently with concomitant oral capecitabine 825 mg/m 2 twice a day). After preoperative treatment, total mesorectal excision was performed 2–4 weeks in the TNT group and 6–10 weeks in the CRT group, followed by optional additional adjuvant chemotherapy. The primary endpoint is the pCR rate, and secondary endpoints include disease-related treatment failure, quality of life, and cost-effectiveness. Assuming a pCR rate of 28% and 15% in the TNT and CRT groups, respectively, and one-side alpha error rate of 0.025 and power of 80%, 348 patients will be enrolled considering 10% dropout rate. Discussion The TV-LARK trial will evaluate the superiority of employed TNT regimen against the standard CRT regimen for patients with LARC. We aimed to identify a TNT regimen that will improve the pCR rate and decrease systemic recurrence in these patients. Trial registration Cris.nih.go.kr ID: KCT0007169 (April 08, 2022). The posted information will be updated as needed to reflect the protocol amendments and study progress.

Background Telephone support services are a viable means of providing population-level support to reduce health risk behaviours. While research exists on the effectiveness of Quitlines to reduce smoking, there is limited other research investigating whether telephone services can provide effective behaviour change support for people with a mental health condition for behaviours including physical activity, healthy eating, and weight management. The aims of this trial were to evaluate the effectiveness of referral of people with a mental health condition to a population-level telephone coaching service to improve health risk behaviours and increase attempts to do so. Methods A parallel-group randomised controlled trial was conducted. Participants with a mental health condition ( N  = 681) were assigned to a control (health information pack) or intervention group (information pack and referral by the research team to a coaching program). Data were collected via telephone surveys at baseline and six months post-recruitment. Primary outcomes were: (1) weekly minutes of moderate-to-vigorous physical activity, (2) daily fruit serves, (3) daily vegetable serves, and (4) attempted behaviour change/weight loss (yes/no; composite measure). Secondary outcomes included weight, Body Mass Index (BMI), and attempts to change each health behaviour individually. Results Intention-to-treat analyses found no significant differential change between groups from baseline to six months for primary or secondary outcomes. By follow-up, 242/549 (44%) of intervention participants had enrolled in coaching and completed at least one call, with 16/242 having completed the program, 79 ongoing, and 147 withdrawn. Per-protocol analyses found attempting to improve at least one health behaviour/lose weight was significantly greater in enrolees (OR = 3.7, 95% CI 1.03—13.23) than the control group. Conclusions Referral to the program did not improve risk behaviours or weight/BMI but did support behaviour change attempts. Contributing factors may include low program completion by follow-up and impact of COVID-19. Further research is required to better understand participation in and benefits of telephone coaching services for people with a mental health condition. Trial registration Registered retrospectively with the Australian New Zealand Clinical Trials Registry (ACTRN12620000351910).

BackgroundHigher intra-abdominal pressure may impair cardiopulmonary functions during laparoscopic surgery. While 12–15 mmHg is generally recommended as a standard pressure, the benefits of lower intra-abdominal pressure are unclear. We thus studied whether the low intra-abdominal pressure compared with the standard pressure improves cardiopulmonary dynamics during laparoscopic surgery.MethodsPatients were randomized according to the intra-abdominal pressure and neuromuscular blocking levels during laparoscopic colorectal surgery: low pressure (8 mmHg) with deep-block (post-tetanic count 1–2), standard pressure (12 mmHg) with deep-block, and standard pressure with moderate-block (train-of-four count 1–2) groups. During the laparoscopic procedure, we recorded cardiopulmonary variables including cardiac index, pulmonary compliance, and surgical conditions. We also assessed postoperative pain intensity and recovery time of bowel movement. The primary outcome was the cardiac index 30 min after onset of laparoscopy.ResultsPatients were included in the low pressure with deep-block (n = 44), standard pressure with deep-block (n = 44), and standard pressure with moderate-block (n = 43) groups. The mean (SD) of cardiac index 30 min after laparoscopy was 2.7 (0.7), 2.7 (0.9), and 2.6 (1.0) L min−1 m−2 in each group (P = 0.715). The pulmonary compliance was higher but the surgical condition was poorer in the low intra-abdominal pressure than the standard pressure (both P < 0.001). Other variables were comparable between groups.ConclusionWe observed few cardiopulmonary benefits but poor surgical conditions in the low intra-abdominal pressure during laparoscopy. Considering cardiopulmonary dynamics and surgical conditions, the standard intra-abdominal pressure may be preferable to the low pressure for laparoscopic surgery.

Bacterial vaginosis (BV) is the most common disease in women of childbearing age and is caused by the growth of abnormal microbiota in the vagina. Probiotic consumption can be an effective alternative treatment to preserve or improve vaginal health. In the present study, MED-01, a complex of five strains of probiotic candidates isolated from the vagina of Korean women, was used. This study was designed as a 12-week, randomized, multicenter, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of MED-01 on vaginal health. A total of 101 reproductive-aged women with a Nugent score of 4–6 took MED-01 (5.0 × 109 CFU) or a placebo once a day, and 76 participants completed the procedure. MED-01 significantly reduced the Nugent score compared with the placebo. Quantitative PCR analysis confirmed that Lactobacillus plantarum was significantly increased in the vagina, whereas harmful bacteria such as Mobiluncus spp., Gardnerella vaginalis, and Atopobium vaginae were suppressed after 12 weeks of MED-01 ingestion. No adverse events to the test food supplements were observed in the participants. These results confirmed that MED-01 can be used as a probiotic for treating BV, as it improves the vaginal microbiota.

Graphene oxide (GO) is a nanomaterial with newly developing biological applications. Autophagy is an intracellular degradation system that has been associated with the progression of neurodegenerative disorders. Although induction of autophagic flux by GO has been reported, the underlying signaling pathway in neurodegenerative disorders and how this is involved in neuroprotection remain obscure. We show that GO itself activates autophagic flux in neuronal cells and confers a neuroprotective effect against prion protein (PrP) (106-126)-mediated neurotoxicity. GO can be detected in SK-N-SH neuronal cells, where it triggers autophagic flux signaling. GO-induced autophagic flux prevented PrP (106-126)-induced neurotoxicity in SK-N-SH cells. Moreover, inactivation of autophagic flux blocked GO-induced neuroprotection against prion-mediated mitochondrial neurotoxicity. This is the first study to demonstrate that GO regulates autophagic flux in neuronal cells, and that activation of autophagic flux signals, induced by GO, plays a neuroprotective role against prion-mediated mitochondrial neurotoxicity. These results suggest that the nanomaterial GO may be used to activate autophagic flux and could be used in neuroprotective strategies for treatment of neurodegenerative disorders, including prion diseases.

In this study, we compared the performance of gadobutrol and meglumine gadoterate, two macrocyclic non-ionic and ionic contrast agents, for evaluating quantitative perfusion parameters of pituitary macroadenomas using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). Patients with pituitary macroadenomas were prospectively enrolled and randomly assigned to be administered gadobutrol or meglumine gadoterate for MRI. Perfusion parameters of the pituitary macroadenoma, including Ktrans, Kep, Ve, and Vp, were measured using DCE-MRI. In total, 60 patients (mean age: 59.7 ± 13.7 years; 40 men) were evaluated. The non-inferiority test confirmed that gadobutrol was comparable to meglumine gadoterate for measuring the Ktrans of the pituitary macroadenoma. Kep was significantly higher with gadobutrol ( P  = 0.001) irrespective of tumor functional status and aggressiveness. Ktrans, Ve, and Vp and pre- and post-contrast T1-signal intensities of the tumor did not differ significantly for contrast agents. Perfusion parameters were not significantly associated with diagnostic performance in distinguishing the tumor functional status ( P  > 0.05). In summary, gadobutrol is non-inferior to meglumine gadoterate for the Ktrans measurement of pituitary macroadenomas. However, gadobutrol may lead to higher Kep, regardless of tumor functional status and aggressiveness. Awareness of this variation is crucial to preventing misinterpretation of vascular dynamics in pituitary macroadenomas.