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

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

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

10.21203/rs.3.rs-31109/v3 ◽

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

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

10.21203/rs.3.rs-31109/v2 ◽

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

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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 ◽

10.1136/bmjopen-2016-014851 ◽

2017 ◽

Vol 7 (8) ◽

pp. e014851 ◽

Cited By ~ 14

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).

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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

BMJ Global Health ◽

10.1136/bmjgh-2020-003897 ◽

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).

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

BMJ Open ◽

10.1136/bmjopen-2017-015983 ◽

2017 ◽

Vol 7 (11) ◽

pp. e015983 ◽

Cited By ~ 2

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.

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Comparison of two dose escalation strategies of methotrexate in active rheumatoid arthritis: a multicentre, parallel group, randomised controlled trial

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-220512 ◽

2021 ◽

pp. annrheumdis-2021-220512

Author(s):

Siddharth Jain ◽

Varun Dhir ◽

Amita Aggarwal ◽

Ranjan Gupta ◽

Bidyalaxmi Leishangthem ◽

...

Keyword(s):

Dose Escalation ◽

Controlled Trial ◽

Group Differences ◽

Drug Discontinuation ◽

Open Label ◽

Intention To Treat ◽

Parallel Group ◽

Registration Number ◽

Randomised Controlled

ObjectivesThere are no head-to-head trials of different dose escalation strategies of methotrexate (MTX) in RA. We compared the efficacy, safety and tolerability of ‘usual’ (5 mg every 4 weeks) versus ‘fast’ (5 mg every 2 weeks) escalation of oral MTX.MethodsThis multicentre, open-label (assessor blinded) RCT included patients 18-55 years of age having active RA with disease duration <5 years, and not on DMARDs. Patients were randomized 1:1 into usual or fast escalation groups, both groups starting MTX at 15 mg/week till a maximum of 25 mg/week. Primary outcome was EULAR good response at 16 weeks, secondary outcomes were ΔDAS28 and adverse effects (AE). Analyses were intention-to-treat.Results178 patients with mean DAS28-CRP of 5.4(1.1) were randomized to usual (n=89) or fast escalation groups (n=89). At 16 weeks, there was no difference in good EULAR response in the usual (28.1%) or fast escalation (22.5%) groups (p=0.8). There was no difference in mean ΔDAS28-CRP at 8 weeks (-0.9, -0.8, p=0.72) or 16 weeks (-1.3, -1.3, p=0.98). Even at 24 weeks (extended follow-up), responses were similar. There were no inter-group differences in ΔHAQ, or MTX-polyglutamates 1-3 levels at 8 or 16 weeks. Gastrointestinal AE were higher in the fast escalation group over initial 8 weeks (27%, 40%, p=0.048), but not over 16 weeks. There was no difference in cytopenias, transaminitis, or drug discontinuation/dose reduction between the groups. No serious AE were seen.ConclusionA faster MTX escalation strategy in RA was not more efficacious over 16-24 weeks, and did not significantly increase AE, except higher gastrointestinal AE initially.Trial registration numberCTRI/2018/12/016549

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A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation

BioMed Research International ◽

10.1155/2016/4740907 ◽

2016 ◽

Vol 2016 ◽

pp. 1-10 ◽

Cited By ~ 19

Author(s):

Valerio Mezzasalma ◽

Enrico Manfrini ◽

Emanuele Ferri ◽

Anna Sandionigi ◽

Barbara La Ferla ◽

...

Keyword(s):

Clinical Study ◽

Controlled Trial ◽

Double Blind ◽

Parallel Group ◽

Registration Number ◽

The Times ◽

Irritable Bowel ◽

Species Specific ◽

Microbiological Analyses

Background and Aim. The efficacy of supplementation treatment with two multispecies probiotic formulates on subjects diagnosed with IBS-C and the assessment of their gut microbiota were investigated.Methods. A randomized, double-blind, three-arm parallel group trial was carried out on 150 IBS-C subjects divided into three groups (F_1, F_2, and F_3). Each group received a daily oral administration of probiotic mixtures (for 60 days) F_1 or F_2 or placebo F_3, respectively. Fecal microbiological analyses were performed by species-specific qPCR to assess the different amount of probiotics.Results. The percentage of responders for each symptom was higher in the probiotic groups when compared to placebo group during the treatment period (t60) and was maintained quite similar during the follow-up period (t90). Fecal analysis demonstrated that probiotics of the formulations increased during the times of treatment only in fecal DNA from subjects treated with F_1 and F_2 and not with F_3, and the same level was maintained during the follow-up period.Conclusions. Multispecies probiotic supplementations are effective in IBS-C subjects and induce a different assessment in the composition of intestinal microbiota. This clinical study is registered with the clinical study registration numberISRCTN15032219.

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Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: A structured summary of a study protocol for a randomised controlled trial.

10.21203/rs.3.pex-969/v1 ◽

2020 ◽

Author(s):

Abolghasem Allahyari ◽

Hossein Rahimi ◽

Majid Khadem-Rezaiyan ◽

Zahra Mozaheb ◽

Mohsen Seddigh-Shamsi ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Total Sample ◽

Phase 2 ◽

Data Analyst ◽

Parallel Group ◽

Myeloid Leukemias ◽

Registration Number ◽

Allocation Ratio ◽

Randomised Controlled

Abstract This is a multi-center, two-arm, parallel-group, triple-blind, phase 2-3 randomised controlled trial. All patients over the age of 15 from 5 types of cancer, acute lymphoid and myeloid leukemias, non-Hodgkin's lymphoma, breast and colon cancer will enter the study. Patients are randomly assigned to two groups. During two months of treatment, the two groups are treated with either hydroxychloroquine or placebo. Patients will be monitored for COVID-19 symptoms. The primary end point of the study is to investigate the incidence of COVID-19 in patients.Randomisation will be performed using randomly permuted blocks. The allocation ratio in two groups is 1:1. Participants, caregivers, outcome assessor and the data analyst are blinded to group assignment.The calculated total sample size is 60 patients, with 30 patients in each group. The trial began on April 14, 2020 and recruitment is ongoing. Recruitment is anticipated to be completed by June 14, 2020. This trial has been registered on the Iranian Registry of Clinical Trials (IRCT) with the registration number of IRCT20200405046958N1.

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Application of intravenous lidocaine in patients undergoing operative hysteroscopy: a randomized, double-blind, controlled study

10.21203/rs.2.181/v1 ◽

2019 ◽

Author(s):

Huaxin Wang ◽

Xuan Peng ◽

Yeda Xiao ◽

Bo Zhao ◽

Liying Zhan

Keyword(s):

Controlled Study ◽

Intravenous Lidocaine ◽

Clinical Trial Registry ◽

Double Blind ◽

Operative Hysteroscopy ◽

Throat Pain ◽

Hysteroscopic Surgery ◽

Registration Number ◽

Operative Recovery ◽

Double Blinded

Abstract Background: The role of intraoperative intravenous lidocaine infusion has been previously evaluated for pain relief, inflammatory response, and post-operative recovery, including in endoscopic surgery. The present study is a randomized double-blinded trial in which we evaluated whether intravenous lidocaine infusion would reduce postoperative pain, propofol requirement and remifentanil consumption in patients undergoing hysteroscopy surgery. Methods: Eighty-five patients scheduled to undergo elective operative hysteroscopy surgery under general anesthesia were randomized into two groups. Group L included patients who received an intravenous lidocaine bolus 1.5mg/kg over 3 min followed by a continuous infusion at the rate of 2 mg/kg/h until surgery completed, and Group C received 0.9% normal saline solution at an equivalent rate. The depth of anesthesia was monitored using the Narcotrend, which was based on measurement of the patient’s cerebral electrical activity. Primary outcome of the study was postoperative hypogastric pain evaluating by visual analogue scale (VAS). Secondary outcomes include propofol requirement and remifentanil requirement. Results: VAS score of Group L was significantly lower than Group C at postoperative 0.5 h, 4 h, respectively (P < 0.05), while no obvious difference was found at postoperative 24 h. There was no difference between groups in propofol requirement, but Group L required less dosage of remifentanil than Group C (P < 0.05). Moreover, the incidence of throat pain was significantly lower in Group L. No adverse events associated with lidocaine was discovered. Conclusions: Administration of intravenous lidocaine infusion as an adjuvant alleviated short-term postoperative hypogastric pain and throat pain, and reduced remifentanil requirement in patients undergoing operative hysteroscopy surgery. Trial registration: Chinese Clinical Trial Registry (chictr.org.cn) with registration number ChiCTR1800016857. Keywords: Lidocaine, hysteroscopic surgery, remifentanil, propofol

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Haemostasis treatment using dual red imaging during endoscopic submucosal dissection: a multicentre, open-label, randomised controlled trial

BMJ Open Gastroenterology ◽

10.1136/bmjgast-2019-000275 ◽

2019 ◽

Vol 6 (1) ◽

pp. e000275 ◽

Cited By ~ 1

Author(s):

Ai Fujimoto ◽

Yutaka Saito ◽

Seiirhicro Abe ◽

Shu Hoteya ◽

Kosuke Nomura ◽

...

Keyword(s):

Endoscopic Submucosal Dissection ◽

Controlled Trial ◽

Operation Time ◽

Open Label ◽

Submucosal Dissection ◽

Parallel Group ◽

Registration Number ◽

Mucosal Incision ◽

Colorectal Endoscopic Submucosal Dissection ◽

Randomised Controlled

IntroductionPatients scheduled to undergo oesophageal, gastric and colorectal endoscopic submucosal dissection (ESD) are to be investigated to verify the efficacy of dual red imaging (DRI) for establishing haemostasis during ESD.Methods and analysisThe trial is designed as a multicentre, open-label randomised, parallel-group, controlled intervention study. Registered patients will be randomly assigned to DRI and white light imaging (WLI) groups. In the DRI group, the mucosal incision and submucosal dissection will be performed by WLI, and haemostasis will be managed by DRI when bleeding occurs. In the WLI group, the mucosal incision and submucosal dissection are to be performed by WLI and the haemostasis management is to be performed by WLI. The primary endpoint is the time from the recognition of bleeding up to the achievement of complete haemostasis (haemostasis time). The secondary endpoints are the operation time, the proportion of cases in which perforation occurs, and the psychological stress experienced by the endoscopist during haemostasis treatment.Ethics and disseminationThis trial was approved by the Keio University Review Board for Clinical Trials (5 December 2016).DiscussionThis will be the first multicentre collaborative research using DRI for haemostasis treatment during ESD. When the safety and simplicity of DRI as a treatment for haemostasis during ESD can be proven, the ESD procedure can be simplified and disseminated more widely in clinical practice.Trial registration numberUMIN000025134

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