Effect of Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix for Preventing Pancreatic Fistula after Pancreatectomy: A Randomized Clinical Trial

Background: The aim of this study was to evaluate the safety and efficacy of a flowable hemostatic matrix, and their effects for postoperative pancreatic fistula (POPF) after pancreatectomy. Methods: This was a randomized, clinical, single-center, single-blind (participant), non-inferiority, phase IV, and parallel-group trial. The primary endpoint was the incidence of POPF. The secondary endpoints were risk factors for POPF, drain removal days, incidence of complication, 90-day mortality, and length of hospital stay. Results: This study evaluated a total of 53 patients, of whom 26 patients were in the intervention group (flowable hemostatic matrix) and 27 patients were in the control group (thrombin-coated collagen patch). POPF was more common in the control group than in the intervention group (59.3% vs. 30.8%, p = 0.037). Among participants who underwent distal pancreatectomy, POPF (33.3% vs. 92.3%, p = 0.004), and clinically relevant POPF (8.3% vs. 46.2%, p = 0.027) was more common in the control group. A multivariate logistic regression model identified flowable hemostatic matrix use as an independent negative risk factor for POPF, especially in cases of distal pancreatectomy (DP) (odds ratio 17.379, 95% confidential interval 1.453–207.870, p = 0.024). Conclusion: Flowable hemostatic matrix application is a simple, feasible, and effective method of preventing POPF after pancreatectomy, especially for patients with DP. Non-inferiority was demonstrated in the efficacy of preventing POPF in the intervention group compared to the control group.

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Design of a Mobile Application and Evaluation of Its Effects on Psychological Parameters of Covid-19 Inpatients: A Protocol for a Randomized Controlled Trial

Frontiers in Psychiatry ◽

10.3389/fpsyt.2021.612384 ◽

2021 ◽

Vol 12 ◽

Author(s):

Shokoufeh Aalaei ◽

Farnaz Khoshrounejad ◽

Lahya Afshari Saleh ◽

Mahnaz Amini

Keyword(s):

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Care Providers ◽

Psychological Conditions ◽

Parallel Group ◽

High Prevalence ◽

Group A ◽

Discharge From Hospital

Background: Panic of the disease and the associated concerns can lower the quality of life and physical performance. As long as the COVID-19 pandemic is ever on the rise, the psychological pandemic of the disease is on the rise, too. The high prevalence of COVID-19 has further increased physicians' work pressure. Patients' needs are not met adequately by physicians. It seems essential to use aids to monitor patients' needs and serve them properly. Thus, in the present research, suggestions are made on how to evaluate patients' physical and psychological conditions during the treatment via a mobile application.Methods and Analysis: The present research is a randomized, two parallel-group, controlled trial. One-hundred-twelve inpatients diagnosed with the coronavirus will be assigned randomly to the control and intervention groups. In the intervention group, a mobile application will be provided to educate patients, establish two-way interactions between patients and care providers and record patients' symptoms. Those in the control group will receive the usual care. The primary outcome is the change to the depression anxiety stress scales-21 (DASS-21) score from the baseline to 2 weeks after discharge from hospital. It will be measured at the baseline, at the time of discharge, and two weeks later.Ethics and Dissemination: The Ethics committee of Mashhad University of Medical Sciences' approval date was 2020-04-19 with IR.MUMS.REC.1399.118 reference code. Thus far, participants' recruitment has not been completed and is scheduled to end in March 2021. The results will be disseminated in a peer-reviewed journal.Trial Registration: IRCT20170922036314N4 (https://www.irct.ir/trial/47383).

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Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial

BMC Infectious Diseases ◽

10.1186/s12879-021-06045-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Keivan Ranjbar ◽

Mohsen Moghadami ◽

Alireza Mirahmadizadeh ◽

Mohammad Javad Fallahi ◽

Vahid Khaloo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Clinical Status ◽

Intervention Group ◽

Length Of Hospital Stay ◽

Ordinal Scale ◽

Control Group ◽

Randomized Controlled ◽

Group Data ◽

Significant Difference

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

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Perioperative Gabapentin Does Not Reduce Postoperative Delirium in Older Surgical Patients

Anesthesiology ◽

10.1097/aln.0000000000001804 ◽

2017 ◽

Vol 127 (4) ◽

pp. 633-644 ◽

Cited By ~ 18

Author(s):

Keyword(s):

Postoperative Pain ◽

Postoperative Delirium ◽

Intervention Group ◽

Group Versus ◽

Length Of Hospital Stay ◽

Treated Group ◽

Assessment Method ◽

Hospital Length Of Stay ◽

Control Group ◽

Opioid Use

Abstract Background Postoperative pain and opioid use are associated with postoperative delirium. We designed a single-center, randomized, placebo-controlled, parallel-arm, double-blinded trial to determine whether perioperative administration of gabapentin reduced postoperative delirium after noncardiac surgery. Methods Patients were randomly assigned to receive placebo (N = 347) or gabapentin 900 mg (N = 350) administered preoperatively and for the first 3 postoperative days. The primary outcome was postoperative delirium as measured by the Confusion Assessment Method. Secondary outcomes were postoperative pain, opioid use, and length of hospital stay. Results Data for 697 patients were included, with a mean ± SD age of 72 ± 6 yr. The overall incidence of postoperative delirium in any of the first 3 days was 22.4% (24.0% in the gabapentin and 20.8% in the placebo groups; the difference was 3.20%; 95% CI, 3.22% to 9.72%; P = 0.30). The incidence of delirium did not differ between the two groups when stratified by surgery type, anesthesia type, or preoperative risk status. Gabapentin was shown to be opioid sparing, with lower doses for the intervention group versus the control group. For example, the morphine equivalents for the gabapentin-treated group, median 6.7 mg (25th, 75th quartiles: 1.3, 20.0 mg), versus control group, median 6.7 mg (25th, 75th quartiles: 2.7, 24.8 mg), differed on the first postoperative day (P = 0.04). Conclusions Although postoperative opioid use was reduced, perioperative administration of gabapentin did not result in a reduction of postoperative delirium or hospital length of stay.

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EVALUATION OF EFFECTIVENESS OF AROGYA KASHAYAM-20 IN COVID-19 CASES - A RANDOMIZED CONTROLLED STUDY

10.31219/osf.io/au3ct ◽

2021 ◽

Author(s):

Umesh Shukla ◽

Nitin Ujjaliya

Keyword(s):

Controlled Trial ◽

Care Center ◽

Large Population ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Rt Pcr ◽

Randomized Controlled ◽

Group A ◽

Negative Conversion

Introduction: The characteristic clinical features of Covid-19 disease range between asymptomatic to mild-moderate symptoms. Studies suggest that a large population (80%) presents its asymptomatic or milder form. Remaining 20 percent, owing to severity of the diseases, need hospital-based care. Many treatment protocols and strategies have been promoted and recommended by authorities including WHO, but nothing has actually been finalized till date. The present study was planned to evaluate the effectiveness of an Ayurvedic formulation viz. Arogya Kashayam-20 in the hospitalized cases of Covid-19.Aim: To evaluate the effectiveness of Arogya Kashayam-20 in the cases of COVID-19 particularly the negative conversion of RTPCR in 10 days duration.Material and Methods: This was a randomized controlled trial conducted at COVID-19 Care Center, Pt. Khushilal Sharma Government Ayurveda College & Institute, Bhopal, Madhya Pradesh with a sample size of 112 participants, aged between 16 to 60 years of either sex. Participants were divided in two groups viz. group A and B. Both the groups received Hydroxychloroquine (HCQ), vitamin C and Zinc as per the prevailing ICMR guidelines and group 'A' received additionally Arogya Kashayam-20 for 10 days. Outcome measure of the study was to see the negative conversion RT-PCR test after intervention period of 10 days. CTRI Registration: CTRI/2020/06/026221. Results: Among the 60 cases registered in study group (group A), 51 cases (85.00%) were reported with negative RTPCR on 10th day. Out of 52 cases registered in control group (group B); 39 cases (75.00%) were tested negative RTPCR on 10th day. In both the groups all the cases were discharged asymptomatically on 10th day as per the prevailing ICMR guidelines. No ADR/AE observed during the intervention period.Conclusion: The study observes that the add on intervention group has a better outcome in terms of RT-PCR negative reports after 10 days comparing to the control group.

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Effect of Beta-casomorphin-7 on Renal Function and Immunity in Aging Mice

Indian Journal of Animal Research ◽

10.18805/ijar.b-1333 ◽

2021 ◽

Author(s):

Hong Yin ◽

Fangpeng Chen ◽

Xiaqing Su ◽

Jingyi Wang ◽

Yan Xu ◽

...

Keyword(s):

Renal Function ◽

Adrenocorticotropic Hormone ◽

Inflammatory Cell ◽

Histopathological Examination ◽

Intervention Group ◽

Control Group ◽

Paraffin Sections ◽

Gain Rate ◽

Group A ◽

Medium Dose

Background: Most studies have shown that Beta-Casomorphin-7 (BCM-7) has many physiological functions, this study aims to investigate the effects of BCM-7 on renal function and immunity in naturally aging mice and to reveal the effects of BCM-7 on health and provide more theoretical reference for inflammatory aging.Methods: All mice were weighed weekly and the organ indexes were calculated, Paraffin sections were prepared for kidney histopathological examination with conventional Haematoxylin and Eosin (HE) staining, renal function indexes and cytokines were main measured by ELISA and biochemical colorimetry.Result: The weight of each group increased during gastric perfusion and the higher the intervention concentration, the lower the weight gain rate. The renal index was not affected by BCM-7, but the spleen index was significantly decreased by medium-dose BCM-7. There were inflammatory cell infiltration and other renal lesions in the aging control group and intervention group. A medium dose of BCM-7 can significantly reduce Cystatin C (Cys-C) content in aging mice, the content of Adrenocorticotropic hormone (ACTH) in aged mice decreased with the increase of BCM-7 intervention dose. BCM-7 and aging caused cytokine imbalance in mice.

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Pengaruh Pendidikan Kesehatan dengan Lembar Balik Terhadap Perilaku Pemberian Asi pada Ibu Post Partum

Jurnal Kebidanan Midwiferia ◽

10.21070/mid.v3i2.1522 ◽

2017 ◽

Vol 3 (2) ◽

pp. 40

Author(s):

Luluk Fajria Maulida

Keyword(s):

Health Education ◽

Healthy Lifestyle ◽

Post Partum ◽

Intervention Group ◽

Average Score ◽

Control Group ◽

Chi Square ◽

Group A ◽

And Control ◽

Breastfeeding Attitude

One of the obstacles in breastfeeding attitude is the lack of lactation communication and counseling. Breastfeeding health education is designed to enforce healthy lifestyle of breastfeeding by delivering proof based information. Flipchart media usage can be easily understood by health counsellors and clients. The study is to investigate the influence of health education using flipchart over breastfeeding attitude in post-partum mothers. This research was used a quasi experiment design with posttest only design with control group. A random assignment sampling design was used to 42 respondents which were divided into 2 groups; intervention group and control group. The samples were randomized using numbers and were divided into intervention and control group. The intervention group was given health education after delivery and questionnaires were given in intervention and control group a week after postpartum. The average score postpartum maternal behavior in the intervention group (18,43) is higher than the control group (15,14). The results of chi square test p = 0.00; RR = 3.16; CI = 1,58-6,31. External variables related to the behavior of breastfeeding is the education level of p = 0.02. Health education using flipchart significantly affects breastfeeding behavior in postpartum mothers.

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Effect of vitamin D supplementation on asthma control in patients with vitamin D deficiency: the ACVID randomised clinical trial

Thorax ◽

10.1136/thoraxjnl-2019-213936 ◽

2020 ◽

pp. thoraxjnl-2019-213936

Author(s):

Rubén Andújar-Espinosa ◽

Lourdes Salinero-González ◽

Fátima Illán-Gómez ◽

Manuel Castilla-Martínez ◽

Chunshao Hu-Yang ◽

...

Keyword(s):

Quality Of Life ◽

Vitamin D ◽

Vitamin D Deficiency ◽

Asthma Control ◽

Intervention Group ◽

Vitamin D Supplementation ◽

Control Group ◽

Asthmatic Patients ◽

Secondary Endpoints

BackgroundThe relationship between asthma and vitamin D deficiency has been known for some time. However, interventional studies conducted in this regard have shown conflicting results.ObjectiveTo evaluate the efficacy of vitamin D supplementation in asthmatic patients in improving the degree of control of asthma.MethodsRandomised, triple-blind, placebo-controlled, parallel-group study in adult asthmatic patients with serum 25-hydroxyvitamin-D3 <30 ng/mL. The intervention group received oral supplementation with 16 000 IU of calcifediol per week, and the control group had placebo added to their usual asthma treatment. The study period was 6 months. The primary endpoint was the degree of asthma control as determined by the asthma control test (ACT). Secondary endpoints included quality of life measured using the mini Asthma Quality of Life Questionnaire, the number of asthma attacks, oral corticosteroid cycles, the dose of inhaled corticosteroids, number of emergency visits, unscheduled consultations with the primary care physician and hospitalisations for asthma.ResultsOne hundred and twelve patients were randomised (mean age 55 years, with 87 (78%) being women). Of the 112 patients, 106 (95%) completed the trial. Half the patients (56) were assigned to the intervention group and the other half to the control group. A statistically significant clinical improvement was observed in the intervention group (+3.09) compared with the control group (−0.57) (difference 3.66 (95% CI 0.89 to 5.43); p<0.001) as measured using ACT scores. Among the secondary endpoints, a significant improvement in the quality of life was found in the intervention group (5.34), compared with the control group (4.64) (difference 0.7 (95% CI 0.15 to 1.25); p=0.01).ConclusionAmong adults with asthma and vitamin D deficiency, supplementation with weekly oral calcifediol compared with placebo improved asthma control over 6 months. Further research is needed to assess long-term efficacy and safety.Trial registration numberNCT02805907.

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Impact of a delirium prevention project among older hospitalized patients who underwent orthopedic surgery: a retrospective cohort study

BMC Geriatrics ◽

10.1186/s12877-019-1303-z ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 3

Author(s):

Jung-Yeon Choi ◽

Kwang-il Kim ◽

Min-gu Kang ◽

Young-Kyun Lee ◽

Kyung-Hoi Koo ◽

...

Keyword(s):

Cohort Study ◽

Prevention Program ◽

Retrospective Cohort ◽

Screening Tool ◽

Intervention Group ◽

Length Of Hospital Stay ◽

Incidence Rates ◽

Control Group ◽

Prevention Project ◽

Delirium Prevention

Abstract Background Postoperative delirium (POD) is a common clinical syndrome with significant negative outcomes. Thus, we aimed to evaluate the feasibility and effectiveness of a delirium screening tool and multidisciplinary delirium prevention project. Methods A retrospective cohort study was conducted at a single teaching center in Korea. A cohort of patients who underwent a delirium prevention program using a simple delirium screening tool from December 2018 to February 2019 (intervention group, N = 275) was compared with the cohort from the year before implementation of the delirium prevention program (December 2017 to February 2018) (control group, N = 274). Patients aged ≥65 years who were admitted to orthopedic wards and underwent surgery were included. The incidence rates of delirium before and after implementation of the delirium prevention program, effectiveness of the delirium screening tool, change in the knowledge score of nurses, and length of hospital stay were assessed. Results The sensitivity and specificity of the screening tool for the incidence of POD were 94.1 and 72.7%, respectively. The incidence rates of POD were 10.2% (control group) and 6.2% (intervention group). The odds ratio for the risk reduction effect of the project related to the incidence of POD was 0.316 (95% confidence interval: 0.125–0.800, p = 0.015) after adjustment for possible confounders. The delirium knowledge test score increased from 40.52 to 43.24 out of 49 total points (p < 0.001). The median length of hospital stay in the intervention and control groups was 6.0 (interquartile range, 4–9) and 7.0 (interquartile range, 4–10) days, respectively (p = 0.062). Conclusion The screening tool successfully identified patients at a high risk of POD at admission. The POD prevention project was feasible to implement, effective in preventing delirium, and improved knowledge regarding delirium among the medical staff. Trial registration None.

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Preventing clinically relevant pancreatic fistula with combination of linear stapling plus continuous suture of the stump in laparoscopic distal pancreatectomy

BMC Surgery ◽

10.1186/s12893-020-00876-8 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Takeshi Aoki ◽

Doaa A. Mansour ◽

Tomotake Koizumi ◽

Kazuhiro Matsuda ◽

Tomokazu Kusano ◽

...

Keyword(s):

Pancreatic Fistula ◽

Distal Pancreatectomy ◽

Operative Time ◽

Length Of Hospital Stay ◽

Laparoscopic Distal Pancreatectomy ◽

Triple Combination ◽

Continuous Suture ◽

Remnant Pancreas ◽

Stump Closure ◽

Suture Group

Abstract Background Pancreatic fistula is one of the serious complications for patients undergoing distal pancreatectomy, which leads to significant morbidity. The aim of our study is to compare linear stapling closure plus continuous suture with linear stapling closure alone during laparoscopic distal pancreatectomy (LDP) in terms of clinically relevant postoperative pancreatic fistula (POPF) rate. Methods Twenty-two patients underwent LDP at our institution between 2011 and 2013. Twelve patients had linear stapling closure with peri-firing compression (LSC) alone compared with ten patients who had linear stapling closure, peri-firing compression plus continuous suture (LSC/CS) for stump closure of remnant pancreas in LDP. Biochemical leak and clinically relevant POPF were compared between both groups. Results POPF occurred in 4 of 12 (33.3%) patients with linear stapling closure while no patient developed a clinically relevant POPF in the triple combination of linear stapling, peri-firing compression plus continuous suture group (p = 0.043).1 patient (8.3%) in the LSC group and 5 patients (50%) in the LSC/CS group had evidence of a biochemical leak. There were no significant differences in operative time (188.3 vs 187.0 min) and blood loss (135 vs. 240 g) between both groups but there was a significantly of shorter length of hospital stay (11.9 vs. 19.9 days) in LSC/CS group (p = 0.037). There was no mortality in either group. Conclusions The triple combination of linear stapling, peri-firing compression plus continuous suture in LDP has effectively prevented occurrence of clinically relevant ISGPF POPF. Trial registration The study was retrospectively registered September 30, 2019 at Showa University Ethics Committee as IRB protocol numbers 2943.

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Postoperative risk of pancreatic fistula after distal pancreatectomy with or without spleen preservation

Tumori Journal ◽

10.1177/0300891620936744 ◽

2020 ◽

pp. 030089162093674

Author(s):

Michele Mazzola ◽

Jacopo Crippa ◽

Camillo L. Bertoglio ◽

Sara Andreani ◽

Lorenzo Morini ◽

...

Keyword(s):

Pancreatic Fistula ◽

Distal Pancreatectomy ◽

Length Of Hospital Stay ◽

Long Term Outcomes ◽

Short Term ◽

Spleen Preservation ◽

Spleen Preserving ◽

Postoperative Risk ◽

Duration Of Surgery

Introduction: Outcomes after distal pancreatectomy with or without splenectomy are controversial. The present study aims to investigate differences in short-term and long-term outcomes between spleen-preserving distal pancreatectomy (SPDP) and distal pancreatectomy with splenectomy (DPS). Methods: In this retrospective review of consecutive patients undergoing distal pancreatectomy with or without splenectomy from January 2011 until December 2017 for benign disease, the primary endpoint was to compare postoperative pancreatic fistula (POPF). The secondary endpoint was to compare duration of surgery, intraoperative blood loss, postoperative complications, length of hospital stay, and long-term outcomes. Results: Patients undergoing SPDP had a lower rate of POPF (13.6% vs 46.1%; p = 0.02). Patients undergoing SPDP (n = 22) were discharged earlier than patients undergoing DPS (n = 26) (8 [4–29] vs 12 [6.48] days; p = 0.003). No differences in other intraoperative and postoperative outcomes were found between groups. Conclusion: Patients undergoing SPDP developed fewer POPF and were discharged earlier compared to patients undergoing DPS.

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