scholarly journals Outcomes of Side to End versus End to End Colorectal Anastomosis in Non-emergent Sigmoid and Rectal Cancers. Randomized Controlled Clinical Trial.

2021 ◽  
Author(s):  
Tamer.A.A.M.Habeeb ◽  
Hatem Mohammad ◽  
TamerWasefy ◽  
Mohamed Ibrahim Mansour
Keyword(s):  
Controlled Trial ◽  
Univariate Analysis ◽  
Colorectal Anastomosis ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Antegrade Approach ◽  
Significant Difference ◽  
Rectal Cancers ◽  
End To End ◽  
Significant Change

Abstract Purpose The outcomes of open side-to-end colorectal anastomosis versus open end to end colorectal anastomosis in non-emergent sigmoid and rectal cancers open surgery in adults were compared. Methods A randomized controlled trial on individuals with sigmoid and rectal cancers was conducted between September 2016 and September 2018. Results The majority of the participants in the study were between the ages of 50 and 70 years, with a mean age of 62.58±12.3 years in the side-to-end anastomotic group (SEA group = group A = antegrade approach) and 61.03±13.98 years in the end-to-end anastomotic group (EEA group = group B = retrograde approach), respectively. Except for the operative time, intraoperative data revealed no significant differences between the studied groups, and the SEA group revealed that the mean anastomotic time was significantly shorter. Perioperative blood loss, length of stay, reoperation, inpatient death, infection, and bleeding were all revealed to be significantly associated with leakage in univariate analysis. In a multivariate analysis of anastomotic leaks, infection was the only independent predictor. There is a statistically significant change regarding the range of bowel frequency in the EEA group only (p = 0.04). There is a statistically significant difference regarding incontinence for Flatus in the SEA group only (p = 0.00). A statistically significant change in both groups regards incontinence for liquid stools (p = 0.00) and clustering of stools (p = 0.00 and p = 0.043). The quality of life (QOL) in the SEA group significantly dropped at 6 months and returned to baseline after that as regards PWB, FWB, and CCS with no difference as regards SWB & EWB, while in the EEA group, the exact change happened only as regard PWB & FWB, but SWB and CCS percentage did not return to baseline. Conclusion The SEA group offers a safe and approach alternative to the EEA group.

scholarly journals Randomized Controlled Clinical Trial Comparing Transurethral Eneucleation and Resection of Prostate and Trans-urethral Resection of Prostate in the Management of Benign Prostatic Hyperplasia

2017 ◽  
Vol 7 (3) ◽  
pp. 216-220
Author(s):  
Md Mehedi Hasan ◽  
Samira Rahat Afroze ◽  
Muhammad Abdur Rahim ◽  
Muhammad Abdus Salam
Keyword(s):  
Controlled Trial ◽  
Ethical Review ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Transurethral Resection Of Prostate ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Transurethral resection of prostate (TURP) is the predominant surgical procedure for benign prostatic hypertension (BPH) but is not devoid of complications like capsular perforation, drop in Hb%, drop in Na+, residual adenoma; hence endeavors are evolving to combat such complications. A newer technique transurethral enucleation and resection of prostate (TUERP) has been devised to solve these problems. This study was designed to compare the safety and the efficacy of newer technique, TUERP with widely practiced TURP Methods: This randomized controlled trial was done at BSMMU, after getting ethical approval from the ethical review committee of the institute, from January to October, 2009. A total of 60 BPH patients were purposively enrolled in this study, after obtaining informed written consent and they were randomized as control, Group A (30 patients, underwent TURP) and experimental group, Group B (30 patients, underwent TEURP).Results: The mean preoperative Hb% level of Group A was 15.1 gm% (SD ± 0.5) and perioperative Hb% level was 13.04 gm% (SD ± 6.06). There was significant difference (P <0.05). The mean preoperative Hb% of Group B was 15.2 gm% (SD ± 0.5) and perioperative Hb% was 15.2 gm% (SD ± 0.48). There was no difference (P >0.05). The mean preoperative Na + of Group A was 140 mmol/l (SD ± 4.1) and perioperative Na+ was 126 mmol/l (SD ± 6.8). There was significant difference (P<0.01). The mean preoperative Na+ of Group B was 136 mmol/l (SD ± 4) and perioperative Na+ was 136 mmol/l (SD ± 2.70). There was no difference (P >0.05).Conclusion: TUERP eliminates drop in Hb% and Na+which are usual consequences following TURP. Thus TUERP can be advocated in the treatment of BPH as it also allows completeresection down to surgical capsule.Birdem Med J 2017; 7(3): 216-220

scholarly journals Post-turbinectomy Nasal Packing with Merocel versus Glove Finger Merocel: A Prospective, Randomized, Controlled Trial

2018 ◽  
Vol 97 (3) ◽  
pp. 64-68 ◽  
Author(s):  
Rani Abu Eta ◽  
Ephraim Eviatar ◽  
Jacob Pitaro ◽  
Haim Gavriel
Keyword(s):  
Tranexamic Acid ◽  
Controlled Trial ◽  
Visual Analog Scale Score ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Significant Difference ◽  
Acid Consumption ◽  
Glove Finger ◽  
Group A

Nasal packs are widely used after septoplasty and turbinectomy. We conducted a prospective, randomized, controlled clinical trial including 100 patients who underwent septoplasty with/or without turbinectomy randomized into two groups. In the first group (the Merocel group), a standard tampon was inserted at the end of surgery. In the second group (the glove finger group), the tampon was first placed inside a glove finger. The main outcomes measured were pain and bleeding during the postoperative period and during tampon removal. Consumption of pain killers and tranexamic acid were also recorded. The mean visual analog scale score 12 hours after surgery and during tampon removal in the Merocel group were 6.78 and 8.92, respectively, compared to 4.06 and 5.27, respectively, in the glove finger group (p < 0.001). A statistically significant difference in the bleeding rate and tranexamic acid consumption during tampon removal in favor of the Merocel group was shown (p < 0.001). The use of Merocel in a glove finger is significantly less painful, although a higher chance of bleeding is reported. The influence of the surgeon's experience in using this technique needs further investigation.

scholarly journals Chyawanprash for the prevention of COVID-19 infection among healthcare workers: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Arun Gupta ◽  
Amit Madan ◽  
Babita Yadav ◽  
Pallavi Mundada ◽  
Richa Singhal ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Healthcare Workers ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Rt Pcr ◽  
Randomized Controlled ◽  
Group I ◽  
Significant Difference ◽  
Group Ii ◽  
Significant Change

AbstractBackgroundCoronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are at high risk of exposure, the standard of care is personal protection from getting infected. Whether Ayurvedic rasayana drug like Chyawanprash can prevent symptomatic infection in frontline health care workers is unknown.ObjectiveTo evaluate the effect of the combination of Chyawanprash and Standard Preventive Regimen compared to the use of Standard Preventive Regimen alone on the proportion of RT-PCR confirmed COVID-19 infections among frontline healthcare workers (HCWs).MethodsAn open-label randomized controlled trial was conducted in the HCWs between 25 to 60 years age currently working in an environment with chance of direct exposure to COVID-19 cases. The interventions to be compared in this trial were Standard Preventive Regimen as per institutional guidelines and based on their roles (Group I) and Ayurvedic Intervention viz., Chyawanprash 12 g twice for 30 days from day of randomization plus Standard Preventive Regimen (Group II). The incidence of RT PCR confirmed COVID-19 cases in both groups, was the primary outcome measure. Evaluation of the safety of the study drug (by any statistically significant change in various biochemical and hematological parameters and occurrence of any adverse drug reactions); incidence of any other infective diseases (bacterial /viral/ fungal / etc.) like upper respiratory tract illness during the study period and any change in the immunoglobulins like IgG, IgM and IgE and inflammatory markers like TNF alpha, IL-6 and IL-10 were the secondary outcome measures.ResultsOut of 193 participants who completed the study, no participant in both groups was COVID-19 positive at the end of one month. In post intervention follow-up, 4 subjects in Group I and 2 subjects in Group II were COVID-19 positive. No adverse drug reaction or any serious adverse event was reported during the study. No clinically significant change in the safety parameters was observed before and after the study. Statistically significant rise in Serum IgG level was seen in Group II but other inflammatory and immune markers did not show statistically significant difference.ConclusionChyawanprash was well tolerated by all the participants in the intervention group but to prove its adaptogenic effect and efficacy as an add-on to the standard care in preventing the occurrence of COVID-19, clinical trial for longer duration with larger sample size is needed.Trial registrationClinical Trials Registry of India vide CTRI/2020/05/025275 dated 20/05/2020Date of IEC approval19.5.2020

scholarly journals A multi-center randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 1: Treatment efficiency

2015 ◽  
Vol 86 (1) ◽  
pp. 142-148 ◽  
Author(s):  
Lian O'Dywer ◽  
Simon J. Littlewood ◽  
Shahla Rahman ◽  
R. James Spencer ◽  
Sophy K. Barber ◽  
...  
Keyword(s):  
Treatment Time ◽  
Controlled Trial ◽  
Random Sequence ◽  
Controlled Clinical Trial ◽  
Treatment Efficiency ◽  
Duration Of Treatment ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Clinically Significant ◽  
Receive Treatment

ABSTRACT Objective:  To use a two-arm parallel trial to compare treatment efficiency between a self-ligating and a conventional preadjusted edgewise appliance system. Materials and Methods:  A prospective multi-center randomized controlled clinical trial was conducted in three hospital orthodontic departments. Subjects were randomly allocated to receive treatment with either a self-ligating (3M SmartClip) or conventional (3M Victory) preadjusted edgewise appliance bracket system using a computer-generated random sequence concealed in opaque envelopes, with stratification for operator and center. Two operators followed a standardized protocol regarding bracket bonding procedure and archwire sequence. Efficiency of each ligation system was assessed by comparing the duration of treatment (months), total number of appointments (scheduled and emergency visits), and number of bracket bond failures. Results:  One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed treatment. The mean treatment time and number of visits were 25.12 months and 19.97 visits in the SmartClip group and 25.80 months and 20.37 visits in the Victory group. The overall bond failure rate was 6.6% for the SmartClip and 7.2% for Victory, with a similar debond distribution between the two appliances. No significant differences were found between the bracket systems in any of the outcome measures. No serious harm was observed from either bracket system. Conclusions:  There was no clinically significant difference in treatment efficiency between treatment with a self-ligating bracket system and a conventional ligation system.

scholarly journals A multicenter randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 2: Pain perception

2015 ◽  
Vol 86 (1) ◽  
pp. 149-156 ◽  
Author(s):  
Shahla Rahman ◽  
R. James Spencer ◽  
Simon J. Littlewood ◽  
Lian O'Dywer ◽  
Sophy K. Barber ◽  
...  
Keyword(s):  
Pain Perception ◽  
Soft Tissues ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Pain Experience ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Multicenter Randomized Controlled Trial ◽  
Clinically Significant

ABSTRACT Objective:  To compare pain experience between self-ligating and conventional preadjusted edgewise appliance systems with a two-arm parallel trial. Materials and Methods:  A prospective multicenter randomized controlled clinical trial was conducted in three hospital orthodontic departments. Subjects were randomly allocated to receive treatment with either a self-ligating (3M SmartClip™) or conventional (3M Victory™) bracket system with stratification for operator and center. Standardized protocol was followed for bracket bonding procedure and archwire sequence. Subject pain was recorded using a Verbal Rating Scale to assess discomfort felt on the teeth and soft tissues at the time of the appointment and 1, 3, and 5 days after each archwire change up to the working archwire. Multilevel modeling was used to analyze the data by blinded assessors. Results:  One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed the study and 113 (82%) returned the required data regarding pain/discomfort. Perceived pain was statistically higher with the SmartClip™ system compared to the Victory™ system, but this difference was not deemed to be clinically significant. Discomfort was greatest after placement of the initial 0.014-inch nickel-titanium archwire, compared with subsequent wires, and was greatest on day 1, less on day 3, and much less on day 5 after each archwire change. Age and gender did not affect the level of discomfort experienced by subjects undergoing fixed appliance treatment. Conclusion:  No clinically significant difference in pain experience was found between patients treated with a self-ligating bracket system compared to those treated with a conventional ligation system.

scholarly journals The effect of counseling on fathers’ stress and anxiety during pregnancy: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Maryam Mohammadpour ◽  
Sakineh Mohammad-Alizadeh Charandabi ◽  
Jamileh Malakouti ◽  
Mehriar Nadar Mohammadi ◽  
Mojgan Mirghafourvand
Keyword(s):  
Perceived Stress ◽  
State Anxiety ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Expectant Fathers ◽  
And Control

Abstract Background Pregnancy is a challenging period for mothers and fathers. This study aimed to investigate the effect of counseling on stress and anxiety levels of fathers. Methods This randomized controlled trial was conducted on 102 spouses of pregnant women in Ardabil, Iran. The participants were randomly assigned to intervention and control groups. The intervention group attended four 60-min counseling sessions at weekly intervals. The perceived stress and anxiety questionnaires were completed before and 4 weeks after the intervention. Results The mean scores of state anxiety in the intervention group decreased significantly 4 weeks after the intervention compared with the control group (MD: -2.4; 95%CI: − 4.7 to − 0.2; p = 0.030). Four weeks after the intervention, no significant difference was found between the two groups in terms of trait anxiety (p = 0.472) and perceived stress (p = 0.635). Conclusions The findings indicate that counseling reduced state anxiety in expectant fathers; therefore, this intervention is recommended to be used to reduce fathers’ anxiety. Trial registration IRCT2017042910324N38. Registered 25 June 2017

scholarly journals Efficacy and Safety of Ningmitai Capsules in Patients with Chronic Epididymitis: A Prospective, Parallel Randomized Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Zhang Jing ◽  
Guan Liying ◽  
Wang Zhenqing ◽  
Zhang Hui ◽  
Liu Shuai ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Efficacy Rate ◽  
Efficacy And Safety ◽  
Symptom Index ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Mean ◽  
Hepatorenal Function

Objectives. To evaluate the efficacy and safety of Ningmitai (NMT) capsules in patients with chronic epididymitis. Methods. This prospective randomized controlled trial included 112 patients diagnosed with chronic epididymitis. The patients were randomized (1 : 1 : 1) to receive levofloxacin (LVX), NMT, or NMT combined with LVX for 4 weeks. The patients were followed up at 2 and 4 weeks after initiation of treatment and were evaluated in terms of Chronic Epididymitis Symptom Index (CESI) scores, epididymal nodules, and safety parameters. The primary endpoints were the CESI scores at the end of 2 and 4 weeks of treatment. The secondary endpoints included the mean epididymal nodule diameter and the clinical efficacy rate. Safety was evaluated by hepatorenal function tests and adverse event reports during the trial. Results. After 2 weeks of treatment, the CESI score of the NMT group was significantly lower than that of the LVX group ( P < 0.05 ). In addition, the clinical efficacy rate of the NMT group was significantly higher than that of the LVX group (55% vs. 8.33%, P < 0.0001 ), indicating that NMT has a rapid effect on chronic epididymitis. After 4 weeks of treatment, there was no significant difference in CESI scores or clinical efficacy rates between the two monotherapy regimens ( P > 0.05 ); however, the mean diameter of epididymal nodules was significantly smaller in the NMT group than in the LVX group ( P < 0.0001 ). Moreover, after 4 weeks of treatment, the patients in the LVX + NMT group, which had a clinical efficacy rate of 97.22%, had lower CESI scores (both P < 0.01 ) and a smaller epididymal nodule diameter (vs. LVX, P < 0.0001 ; vs. NMT, P < 0.05 ) than those in the other two groups. No adverse events or abnormal hepatorenal function were found during the study. Conclusion. NMT significantly improved CESI scores and epididymal nodule diameter in patients with chronic epididymitis. The combination of NMT and LVX provides a much better effect than monotherapy, and this treatment regimen was well tolerated.

scholarly journals The effectiveness of the robotic game kit on anxiety among hospitalized preschool children: A non-randomized controlled trial

2021 ◽  
Author(s):  
Sima Pourteimour ◽  
Sahar Kazemi
Keyword(s):  
Separation Anxiety ◽  
Controlled Trial ◽  
Intervention Group ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Psychological Burden ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Mean

Background & Aim: Hospitalization is a challenging experience all children go through in their lives, leading to their utmost anxiety. In this sense, interactive games and activities can help ease this psychological burden. Therefore, we endeavored to determine the effectiveness of a robotic game kit (RGK) on the anxiety of hospitalized preschoolers. Methods & Materials: This non-randomized controlled clinical trial was conducted in a pediatric hospital, Iran, between March and July 2019. 59 participants were assigned to intervention (n=30) or control (n=29) groups through available sampling. Inclusion criteria were Iranian native children aged 3-7 years with communication ability. The RGK was applied in eight sessions at least seven consecutive days of hospitalization. The collected data by using the demographic information form and the preschool anxiety scale (PAS) were analyzed in descriptive, chi-square, t-test, the one-way ANCOVA (analysis of covariance), and multivariate analysis of covariance (MANCOVA). Results: Two groups were homogenous in terms of demographic variables (p>0.05). There was no statistically significant difference between the mean score of PAS before the intervention in the intervention 46.33±15.81 and control groups 37.24±19.65 (p=0.055). However, the mean score of PAS in the intervention group was significantly lower than the control group (P=0.030). Also, using the RGK was effective in two subscales related to separation anxiety and physical injury fears (P=0.034). Conclusion: The modern RGKs could have a significant place in pediatric health care in hospitals. It is thus an undeniable fact that high-quality, comprehensive care can be boosted through RGK based interventions for children encountering stressful situations.

scholarly journals Sofosbuvir and daclatasvir for the treatment of COVID-19 outpatients: a double-blind, randomized controlled trial

2020 ◽  
Author(s):  
Fatemeh Roozbeh ◽  
Majid Saeedi ◽  
Reza Alizadeh-Navaei ◽  
Akbar Hedayatizadeh-Omran ◽  
Shahin Merat ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Significant Difference ◽  
The Difference ◽  
Novel Coronavirus ◽  
Loss Of Appetite

Abstract Introduction Effective treatments are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). This trial aims to evaluate sofosbuvir and daclatasvir versus standard care for outpatients with mild COVID-19 infection. Methods This was a randomized controlled clinical trial in outpatients with mild COVID-19. Patients were randomized into a treatment arm receiving sofosbuvir/daclatasvir plus hydroxychloroquine or a control arm receiving hydroxychloroquine alone. The primary endpoint of the trial was symptom alleviation after 7 days of follow-up. The secondary endpoint of the trial was hospital admission. Fatigue, dyspnoea and loss of appetite were investigated after 1 month of follow-up. This study is registered with the IRCT.ir under registration number IRCT20200403046926N1. Results Between 8 April 2020 and 19 May 2020, 55 patients were recruited and allocated to either the sofosbuvir/daclatasvir treatment arm (n = 27) or the control arm (n = 28). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms at Day 7. One patient was admitted to hospital in the sofosbuvir/daclatasvir arm and four in the control arm, but the difference was not significant. After 1 month of follow-up, two patients reported fatigue in the sofosbuvir/daclatasvir arm and 16 in the control arm; P &lt; 0.001. Conclusions In this study, sofosbuvir/daclatasvir did not significantly alleviate symptoms after 7 days of treatment compared with control. Although fewer hospitalizations were observed in the sofosbuvir/daclatasvir arm, this was not statistically significant. Sofosbuvir/daclatasvir significantly reduced the number of patients with fatigue and dyspnoea after 1 month. Larger, well-designed trials are warranted.

scholarly journals Outcomes of Open Side to End Antegrade Colorectal Single Stapler Anastomosis Versus Open End to End Retrograde Trans-anal Colorectal Single Stapler Anastomosis in Non-emergent Sigmoid and Rectal Cancers. Randomized Controlled Clinical Trial

2021 ◽  
Author(s):  
Tamer.A A.M. Habeeb ◽  
Gamal Osman ◽  
Amr Ibrahim ◽  
Abd-Elrahman M. Metwalli ◽  
Mohamed Ibrahim Mansour ◽  
...  
Keyword(s):  
Anastomotic Leak ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Open Side ◽  
Rectal Cancers ◽  
Group A ◽  
Stapling Anastomosis ◽  
Stapler Anastomosis ◽  
End To End ◽  
End Group

Abstract Introduction: Cancer rectum and sigmoid is increasing nowadays. Resection is done by open and laparoscopic approaches. Laparoscopic approach is not available in many sites worldwide. Aim of this study: To analyze the outcomes of open side to end (antegrade) colorectal single stapling anastomosis versus open end to end (retrograde) Trans-anal colorectal stapling anastomosis in non-emergent sigmoid and rectal cancers open surgery in adults.Patients and Methods: Randomized controlled trial was performed on patients with sigmoid and rectal cancers between September 2016 and September 2018. Results: The majority of studied group were between 50-70 years with mean of 62.58±12.3 years and 61.03±13.98 years in group A and group B respectively. Intraoperative data showed no significant difference was founded between studied group except at operative time and mean anastomotic time as group A was significantly shorter. Univariate analysis showed that perioperative blood loss, length of stay, reoperation, inpatient death, infection and bleeding were significantly associated with leakage. Multivariate analysis of anastomotic leak showed that infection is the only independent predictors for anastomotic leak. There is statistically significant change as regard range of bowel frequency in end to end group only (p=0.04) and there is statistically significant difference as regard incontinence for Flatus in side to end group only (p=0.00) .There is statistically significant change in both group regard Incontinence for liquid stools(p=0.00) and Clustering of stool(p=0.00 and p=0.043).The quality of life in Antegrade group significantly drop at 6 months and return to baseline after that as regard PWB, FWB and CCS with no difference as regard SWB & EWB while in retrograde group, the same change happened only as regard PWB & FWB but SWB and CCS percentage didn’t return to baselineConclusion: The side-to-end anastomoses approach is a safe approach of anastomosis and may be used as alternative to retrograde approach.

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