scholarly journals Uterine Evacuation before Operative Hysteroscopy in Patients with Active Uterine Bleeding: A randomized controlled trial

2020 ◽  
Author(s):  
Manizheh Sayyah-Melli ◽  
Maryam Kazemi-Shishavan ◽  
Nooshin Behravan ◽  
Parvin Mostafa Gharabaghi ◽  
Vahideh Rahmani
Keyword(s):  
Postoperative Complications ◽  
Controlled Trial ◽  
Uterine Wall ◽  
Uterine Bleeding ◽  
Trial Registration ◽  
Clinical Trial Registry ◽  
Operative Hysteroscopy ◽  
Registration Number ◽  
Anesthetic Complications ◽  
Clot Evacuation

Abstract Background: Concurrent bleeding or existing clots usually obscure the vision field and decrease the success rate of hysteroscopy. Therefore, any efforts made in order to have a clear view during the hysteroscopy will improve the diagnostic or treatment outcomes. We examined the effect of preoperative clot evacuation on hysteroscopy and patient outcomes. Methods: In this parallel-group trial, 114 patients with uterine bleeding were randomly assigned to receive either clot evacuation before standard operative hysteroscopy or standard hysteroscopy alone. The investigated endpoints were the clarity of vision, amount of bleeding, the volume of distension media, duration of the procedure, and postoperative complications. Results: All 114 participants completed the study. There were statistically significant differences in the frequency of the clear vision (p<.001), the severity of bleeding (p=.0006), mean procedure time (p<.001), mean serum volume used (p<.001), and the postoperative hematocrit levels (p<.001) between groups, in favor of women with preprocedural intrauterine evacuation. There was no difference related to in-hospital stay (p=0.081) and anesthetic complications among the patients (p=0.182). The procedure was successfully performed on all patients of both groups with zero postoperative complications. Conclusion: Removal of clots and other uterine contents before the insertion of the hysteroscope rendered better and faster access to the uterine wall to observe existing abnormalities. This additional surgical step could take a significant impact on surgical and clinical outcomes. Trial registration: Clinical trial registry name: Iranian Registry of Clinical Trials Url: https://en.irct.ir/trial/33369 The registration number: IRCT20101130005283N13 Date of trial registration: 2018-11-16

scholarly journals Uterine Evacuation before Operative Hysteroscopy in Patients with Active Uterine Bleeding: A randomized controlled trial

2020 ◽  
Author(s):  
Manizheh Sayyah-Melli ◽  
Maryam Kazemi-Shishavan ◽  
Nooshin Behravan ◽  
Parvin Mostafa Gharabaghi ◽  
Vahideh Rahmani
Keyword(s):  
Clinical Trial ◽  
Postoperative Complications ◽  
Controlled Trial ◽  
Uterine Wall ◽  
Uterine Bleeding ◽  
Clinical Trial Registry ◽  
Operative Hysteroscopy ◽  
Registration Number ◽  
Anesthetic Complications ◽  
Clot Evacuation

Abstract Background: Concurrent bleeding or existing clots usually obscure the vision field and decrease the hysteroscopy success rate. Therefore, any efforts made to have a clear view during the hysteroscopy will improve the diagnostic or treatment outcomes. In this study, we examined the effect of preoperative clot evacuation on hysteroscopy and patient outcomes.Methods: In this parallel-group clinical trial conducted from December 2018 to September 2019 at the Oncology Center of Alzahra Teaching Hospital in Tabriz, Iran, 114 patients with uterine bleeding were randomly assigned to receive either clot evacuation before standard operative hysteroscopy or standard hysteroscopy alone. The investigated endpoints were the clarity of vision, the volume of used distension media, duration of the procedure, amount of bleeding, and postoperative complications.Results: All 114 participants completed the study. There were statistically significant differences in the frequency of the clear vision (p<.001), the severity of bleeding (p=.0006), mean serum volume used (p<.001), mean procedure time (p<.001), and the postoperative hematocrit levels (p<.001) between groups, in favor of women with preprocedural intrauterine evacuation. There was no difference in in-hospital stay (p=0.081) and anesthetic complications among the patients (p=0.182). The procedure was successfully performed on all patients of both groups with zero postoperative complications.Conclusion: Removal of clots and other uterine contents before inserting hysteroscope rendered better and faster access to the uterine wall to observe existing abnormalities and reduce the hysteroscopy time. This additional surgical step could take a significant impact on surgical and clinical outcomes.Trial registration: Clinical trial registry name: Iranian Registry of Clinical Trials URL: https://en.irct.ir/trial/33369 The registration number: IRCT20101130005283N13 Date of trial registration: 2018-11-16

scholarly journals Uterine Evacuation before Operative Hysteroscopy in Patients with Active Uterine Bleeding: A randomized controlled trial

2020 ◽  
Author(s):  
Manizheh Sayyah-Melli ◽  
Maryam Kazemi-Shishavan ◽  
Nooshin Behravan ◽  
Parvin Mostafa Gharabaghi ◽  
Vahideh Rahmani
Keyword(s):  
Controlled Trial ◽  
Uterine Wall ◽  
Uterine Bleeding ◽  
Clinical Trial Registry ◽  
Operative Hysteroscopy ◽  
Clear Vision ◽  
Parallel Group ◽  
Registration Number ◽  
Anesthetic Complications ◽  
Clot Evacuation

Abstract BackgroundConcurrent bleeding or existing clots usually obscure the vision field and decrease the success rate in hysteroscopy. Therefore, any effort to have a clear view during the hysteroscopy will meliorate the diagnostic or treatment outcomes. We examined the effect of preoperative clot evacuation on hysteroscopy and patient outcomes.MethodsIn this parallel-group trial, 114 patients with uterine bleeding were randomly assigned to receive either clot evacuation before standard operative hysteroscopy or standard hysteroscopy alone. The primary endpoints were the clarity of vision, amount of bleeding, the volume of consumed media, duration of the procedure, and postoperative complications.ResultsAll 114 participants completed the study. There were statistically significant differences in the frequency of the clear vision (p < 0.001), the severity of bleeding (p = 0.0006), mean procedure time (p < 0.001), mean serum volume used (p < 0.001), and the postoperative hematocrit levels [95% CI (-3.00, -1.88)] (p < 0.001) between groups. There was no difference related to in-hospital stay (p = 0.081) and anesthetic complications among the patients (p = 0.182). The procedure was successfully performed on all patients of both groups with zero postoperative complications.ConclusionRemoval of clots and other uterine contents before the insertion of the hysteroscope rendered better and faster access to the uterine wall to observe existing abnormalities. This method of starting the hysteroscopy procedure has a significant impact on surgical outcomes.Trial registration: Clinical trial registry name: Iranian Registry of Clinical TrialsUrl: https://en.irct.ir/trial/33369The registration number: IRCT20101130005283N13Date of registration: 2018-11-16

scholarly journals Efficacy of pediatric integrative manual therapy in positional plagiocephaly: a randomized controlled trial

2021 ◽  
Vol 47 (1) ◽  
Author(s):  
Iñaki Pastor-Pons ◽  
María Orosia Lucha-López ◽  
Marta Barrau-Lalmolda ◽  
Iñaki Rodes-Pastor ◽  
Ángel Luis Rodríguez-Fernández ◽  
...  
Keyword(s):  
Manual Therapy ◽  
Education Program ◽  
Controlled Trial ◽  
Asymmetry Index ◽  
Trial Registration ◽  
Control Group ◽  
Parental Perception ◽  
Positional Plagiocephaly ◽  
Caregiver Education ◽  
Registration Number

Abstract Background Positional plagiocephaly frequently affects healthy babies. It is hypothesized that manual therapy tailored to pediatrics is more effective in improving plagiocephalic cranial asymmetry than just repositioning and sensory and motor stimulation. Methods Thirty-four neurologically healthy subjects aged less than 28 weeks old with a difference of at least 5 mm between cranial diagonal diameters were randomly distributed into 2 groups. For 10 weeks, the pediatric integrative manual therapy (PIMT) group received manual therapy plus a caregiver education program, while the controls received the same education program exclusively. Cranial shape was evaluated using anthropometry; cranial index (CI) and cranial vault asymmetry index (CVAI) were calculated. Parental perception of change was assessed using a visual analogue scale (− 10 cm to + 10 cm). Results CVAI presented a greater decrease in PIMT group: 3.72 ± 1.40% compared with 0.34 ± 1.72% in the control group (p = 0.000). CI did not present significant differences between groups. Manual therapy led to a more positive parental perception of cranial changes (manual therapy: 6.66 ± 2.07 cm; control: 4.25 ± 2.31 cm; p = 0.004). Conclusion Manual therapy plus a caregiver education program improved CVAI and led to parental satisfaction more effectively than solely a caregiver education program. Trial registration Trial registration number: NCT03659032; registration date: September 1, 2018. Retrospectively registered.

scholarly journals Clinical metagenomics assessments improve diagnosis and outcomes in community-acquired pneumonia

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Fei Xie ◽  
Zhimei Duan ◽  
Weiqi Zeng ◽  
Shumei Xie ◽  
Mingzhou Xie ◽  
...  
Keyword(s):  
Patient Outcomes ◽  
Clinical Management ◽  
Pathogen Detection ◽  
Community Acquired Pneumonia ◽  
Diagnostic Methods ◽  
Trial Registration ◽  
Clinical Trial Registry ◽  
Registration Number ◽  
Next Generation Sequencing Ngs ◽  
Generation Sequencing

Abstract Background Identifying the causes of community-acquired pneumonia (CAP) is challenging due to the disease’s complex etiology and the limitations of traditional microbiological diagnostic methods. Recent advances in next generation sequencing (NGS)-based metagenomics allow pan-pathogen detection in a single assay, and may have significant advantages over culture-based techniques. Results We conducted a cohort study of 159 CAP patients to assess the diagnostic performance of a clinical metagenomics assay and its impact on clinical management and patient outcomes. When compared to other techniques, clinical metagenomics detected more pathogens in more CAP cases, and identified a substantial number of polymicrobial infections. Moreover, metagenomics results led to changes in or confirmation of clinical management in 35 of 59 cases; these 35 cases also had significantly improved patient outcomes. Conclusions Clinical metagenomics could be a valuable tool for the diagnosis and treatment of CAP. Trial registration Trial registration number with the Chinese Clinical Trial Registry: ChiCTR2100043628.

scholarly journals Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e014851 ◽  
Author(s):  
Dilip Jha ◽  
Priti Gupta ◽  
Vamadevan S Ajay ◽  
Devraj Jindal ◽  
Pablo Perel ◽  
...  
Keyword(s):  
Public Health ◽  
Cost Effectiveness ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
London School ◽  
Clinical Trial Registry ◽  
Link Type ◽  
Adherence To Medication ◽  
Cluster Randomised ◽  
Registration Number

IntroductionRising burden of cardiovascular disease (CVD) and diabetes is a major challenge to the health system in India. Innovative approaches such as mobile phone technology (mHealth) for electronic decision support in delivering evidence-based and integrated care for hypertension, diabetes and comorbid depression have potential to transform the primary healthcare system.Methods and analysismWellcare trial is a multicentre, cluster randomised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India. mWellcare system is an Android-based mobile application designed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records, sending alerts and reminders for follow-up and adherence to medication. We recruited a total of 3702 participants from 40 Community Health Centres (CHCs), with ≥90 at each of the CHCs in the intervention and control (enhanced care) arms. The primary outcome is the difference in mean change (from baseline to 1 year) in systolic blood pressure and glycated haemoglobin (HbA1c) between the two treatment arms. The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose, total cholesterol, predicted 10-year risk of CVD, depression, smoking behaviour, body mass index and alcohol use between the two treatment arms and cost-effectiveness.Ethics and disseminationThe study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine. Findings will be disseminated widely through peer-reviewed publications, conference presentations and other mechanisms.Trial registrationmWellcare trial is registered with Clinicaltrial.gov (Registration numberNCT02480062; Pre-results) and Clinical Trial Registry of India (Registration number CTRI/2016/02/006641). The current version of the protocol is Version 2 dated 19 October 2015 and the study sponsor is Public Health Foundation of India, Gurgaon, India (www.phfi.org).

scholarly journals Weekly iron–folic acid supplements containing 2.8 mg folic acid are associated with a lower risk of neural tube defects than the current practice of 0.4 mg: a randomised controlled trial in Malaysia

2020 ◽  
Vol 5 (12) ◽  
pp. e003897
Author(s):  
Kaitlyn L I Samson ◽  
Su Peng Loh ◽  
Siew Siew Lee ◽  
Dian C Sulistyoningrum ◽  
Geok Lin Khor ◽  
...  
Keyword(s):  
Folic Acid ◽  
Neural Tube ◽  
Controlled Trial ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Folic Acid Supplements ◽  
Registration Number ◽  
Menstruating Women ◽  
Iron Folic Acid ◽  
Randomised Controlled

IntroductionWeekly iron–folic acid (IFA) supplements are recommended for all menstruating women in countries where anaemia prevalence is >20%. Anaemia caused by folate deficiency is low worldwide, and the need to include folic acid is in question. Including folic acid might reduce the risk of a neural tube defect (NTD) should a woman become pregnant. Most weekly supplements contain 0.4 mg folic acid; however, WHO recommends 2.8 mg because it is seven times the daily dose effective in reducing NTDs. There is a reluctance to switch to supplements containing 2.8 mg of folic acid because of a lack of evidence that this dose would prevent NTDs. Our aim was to investigate the effect of two doses of folic acid, compared with placebo, on red blood cell (RBC) folate, a biomarker of NTD risk.MethodsWe conducted a three-arm double-blind efficacy trial in Malaysia. Non-pregnant women (n=331) were randomised to receive 60 mg iron and either 0, 0.4, or 2.8 mg folic acid once weekly for 16 weeks.ResultsAt 16 weeks, women receiving 0.4 mg and 2.8 mg folic acid per week had a higher mean RBC folate than those receiving 0 mg (mean difference (95% CI) 84 (54 to 113) and 355 (316 to 394) nmol/L, respectively). Women receiving 2.8 mg folic acid had a 271 (234 to 309) nmol/L greater mean RBC folate than those receiving 0.4 mg. Moreover, women in the 2.8 mg group were seven times (RR 7.3, 95% CI 3.9 to 13.7; p<0.0001) more likely to achieve an RBC folate >748 nmol/L, a concentration associated with a low risk of NTD, compared with the 0.4 mg group.ConclusionWeekly IFA supplements containing 2.8 mg folic acid increases RBC folate more than those containing 0.4 mg. Increased availability and access to the 2.8 mg formulation is needed.Trail registration numberThis trial is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12619000818134).

scholarly journals A randomized control trial of phototherapy and 20% albumin versus phototherapy and saline in Kilifi, Kenya

2019 ◽  
Vol 12 (1) ◽  
Author(s):  
Dorcas N. Magai ◽  
Michael Mwaniki ◽  
Amina Abubakar ◽  
Shebe Mohammed ◽  
Anne L. Gordon ◽  
...  
Keyword(s):  
Exchange Transfusion ◽  
Controlled Trial ◽  
Rate Of Change ◽  
Trial Registration ◽  
Total Serum ◽  
Neurological Outcomes ◽  
End Of Treatment ◽  
Registration Number ◽  
Development Outcomes

Abstract Objective The study evaluated the efficacy of phototherapy and 20% albumin infusion to reduce total serum bilirubin (TSB) in neonates with severe hyperbilirubinemia. The primary outcome was a reduction of TSB at the end of treatment. The secondary outcomes were the need for exchange transfusion, inpatient mortality, neurological outcomes at discharge, and development outcomes at 12-months follow-up. Results One hundred and eighteen neonates were randomly assigned to phototherapy and 20% albumin (n = 59) and phototherapy and saline (n = 69). The median age at admission was 5 (interquartile range (IQR) 3–6) days, and the median gestation was 36 (IQR 36–38) weeks. No significant differences were found in the change in TSB (Mann–Whitney U =609, p = 0.98) and rate of change in TSB per hour after treatment (Mann–Whitney U = 540, p = 0.39) between the two groups. There were no significant differences between the two groups in the proportion of participants who required exchange transfusion (χ2 (2) = 0.36, p = 0.546); repeat phototherapy (χ2 (2) = 2.37, p = 0.123); and those who died (χ2 (2) = 0.92, p = 0.337). Trial registration The trial was registered in the International Standardized Randomized Controlled Trial Number (ISRCTN); trial registration number ISRCTN89732754.

scholarly journals Prophylactic Melatonin for Delirium in Intensive Care (Pro-MEDIC): study protocol for a randomised controlled trial

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
Author(s):  
F. Eduardo Martinez ◽  
Matthew Anstey ◽  
Andrew Ford ◽  
Brigit Roberts ◽  
Miranda Hardie ◽  
...  
Keyword(s):  
Intensive Care ◽  
Critically Ill ◽  
Controlled Trial ◽  
Study Drug ◽  
Assessment Method ◽  
Trial Registration ◽  
Morbidity And Mortality ◽  
Controlled Study ◽  
Clinical Trial Registry ◽  
Icu Discharge

Abstract Background Delirium is an acute state of brain dysfunction characterised by fluctuating inattention and cognitive disturbances, usually due to illness. It occurs commonly in the intensive care unit (ICU), and it is associated with greater morbidity and mortality. It is likely that disturbances of sleep and of the day-night cycle play a significant role. Melatonin is a naturally occurring, safe and cheap hormone that can be administered to improve sleep. The main aim of this trial will be to determine whether prophylactic melatonin administered to critically ill adults, when compared with placebo, decreases the rate of delirium. Methods This trial will be a multi-centre, randomised, placebo-controlled study conducted in closed ICUs in Australia. Our aim is to enrol 850 adult patients with an expected ICU length of stay (LOS) of 72 h or more. Eligible patients for whom there is consent will be randomised to receive melatonin 4 mg enterally or placebo in a 1:1 ratio according to a computer-generated randomisation list, stratified by site. The study drug will be indistinguishable from placebo. Patients, doctors, nurses, investigators and statisticians will be blinded. Melatonin or placebo will be administered once per day at 21:00 until ICU discharge or 14 days after enrolment, whichever occurs first. Trained staff will assess patients twice daily to determine the presence or absence of delirium using the Confusion Assessment Method for the ICU score. Data will also be collected on demographics, the overall prevalence of delirium, duration and severity of delirium, sleep quality, participation in physiotherapy sessions, ICU and hospital LOS, morbidity and mortality, and healthcare costs. A subgroup of 100 patients will undergo polysomnographic testing to further evaluate the quality of sleep. Discussion Delirium is a significant issue in ICU because of its frequency and associated poorer outcomes. This trial will be the largest evaluation of melatonin as a prophylactic agent to prevent delirium in the critically ill population. This study will also provide one of the largest series of polysomnographic testing done in ICU. Trial registration Australian New Zealand Clinical Trial Registry (ANZCTR) number: ACTRN12616000436471. Registered on 20 December 2015.

scholarly journals Naoxuekang, Xinnaoshutong and Xuesaitong capsules for treating stroke: a protocol for a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e015983 ◽  
Author(s):  
Huiling Chen ◽  
Hongbo Cao ◽  
Xu Guo ◽  
Meidan Zhao ◽  
Qing Xia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Facial Paralysis ◽  
Controlled Trial ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Initial Treatment Period ◽  
Double Blind Clinical Trial ◽  
Registration Number ◽  
Index Value ◽  
Randomised Controlled

IntroductionAfter stroke, hemiplegia, dysphasia and facial paralysis can manifest during the convalescent period. Currently, no Chinese patent medicine (CPM) is previously reported to cure each of these symptoms primarily, and thus, there are no relevant instructions for the use of CPM. This study presents a new approach based on comparative effectiveness research to distinguish the curative effects of three CPMs that are often used in stroke convalescence to determine the ideal medicine for the treatment of each symptom.Methods and analysisIn this multicentre and double-blind clinical trial, stratified randomisation is used to group the patients according to their primary symptoms (hemiplegia, dysphasia and facial paralysis). Three strata will be enrolled, with 80 eligible participants included in each stratum. Each stratum will be randomly and equally divided into four groups, and each group will receive one of the following treatments: Naoxuekang, Xinnaoshutong (XNST), Xuesaitong (XST) or placebo. This study will include two stages: the initial treatment period (30 days) and a follow-up period (180 days). Three replicates for each data point will be completed during this trial. The first visit will occur on day 0 after enrolment, the second visit on day 30±2 and the third visit on day 210±5. The Delphi technique is adopted to achieve index weighting, which ensures that the evaluation outcome is patient oriented. The weighted index value will be computed as the final measurement index of the outcome.Ethics and disseminationThis study has been approved by the Medical Ethics Committee of Tianjin University of Traditional Chinese Medicine (registration number TJUTCM-EC20160007). The results will be offered for publication in peer-reviewed journals.Trial registration numberThis trial was registered with the Chinese Clinical Trial Registry (ChiCTR-IOR-17010397). The date of registration was 11 January 2017.

scholarly journals Pressure Dressings Versus Nonpressure Dressings After Hemorrhoidectomy: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Ping Xue ◽  
Jing Wu ◽  
Ping Zhu ◽  
Dan Wang ◽  
Mei Xu ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Urinary Retention ◽  
Controlled Trial ◽  
Postoperative Bleeding ◽  
Clinical Trial Registry ◽  
Skin Injury ◽  
Open Hemorrhoidectomy ◽  
Randomized Clinical Study ◽  
Primary Endpoints ◽  
Medical Adhesive

Abstract BackgroundPressure dressings have been used after open hemorrhoidectomy to protect surgical wounds and manage postoperative bleeding for many years. However, pressure dressings may increase the incidence of postoperative complications, such as urinary retention, medical adhesive-related skin injury, and pain. A previous controlled trial included 67 patients who underwent Milligan-Morgan hemorrhoidectomy. The data indicated that the use of a nonpressure dressing after hemorrhoidectomy reduces the incidence of urinary retention and catheterization. However, the incidence of severe postoperative bleeding and other postoperative complications was not assessed. There is no consensus on whether it is necessary and beneficial to use a nonpressure dressing after hemorrhoidectomy. The results of this randomized clinical study will help answer this question.MethodsIn this study, we plan to include 186 patients who have undergone Milligan-Morgan hemorrhoidectomy. The purpose is to determine whether the use of nonpressure dressings after open hemorrhoidectomy is inferior to the use of pressure dressings in terms of severe postoperative bleeding and postoperative complications. The primary endpoints of the trial are the incidence of urinary retention within 24 hours after surgery and the incidence of severe postoperative bleeding one hour after dressing removal, which requires revision surgery within 24 hours after the surgery. The secondary endpoints of the study are the pain score, anal distension score, postoperative use of analgesics, and incidence of medical adhesive-related skin injury, all of which will be assessed before removing the dressings. The length of hospitalization in days and hospitalization expenses will be recorded. Safety will be assessed with consideration of all adverse and severe adverse events related to the study treatment.DiscussionThe study received full ethics committee approval. The first patient was enrolled on 27 November 2020. The results of this trial will finally answer the question of whether a nonpressure dressing after open hemorrhoidectomy is necessary and beneficial.Trial registrationChinese Clinical Trial Registry (registration ID: ChiCTR2000040283). Registered on 28 November. 2020. {2} http://www.chictr.org.cn/edit.aspx?pid=58894&htm=4 {2b}

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