Study Protocol for the Use of Conventional Open Haemorrhoidectomy versus Laser Haemorrhoidoplasty in the Treatment of Symptomatic Haemorrhoids: A Randomized Controlled Trial

2020 ◽  
Vol 61 (6) ◽  
pp. 201-208
Author(s):  
Frederick H. Koh ◽  
Fung Joon Foo ◽  
Leonard Ho ◽  
Sharmini S. Sivarajah ◽  
Winson J. Tan ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Patient Anxiety ◽  
Double Blind ◽  
Patient Demographics ◽  
Vas Score ◽  
Post Operative Pain ◽  
Increased Risk ◽  
Conventional Haemorrhoidectomy ◽  
Grade Ii ◽  
Anxiety Treatment

Background: Haemorrhoids result in a variety of symptoms that cause significant patient anxiety. Treatment has long been associated with post-operative complications, which cause significant symptoms and may result in readmissions. The open conventional haemorrhoidectomy (COH) is still regarded as the gold standard treatment for non-circumferential grade II–IV haemorrhoids. Laser haemorrhoidoplasty (LAH) has recently been studied and the initial results appear promising. This study aims to compare these 2 techniques in the treatment of symptomatic haemorrhoids. We hypothesize that LAH has significantly less pain and bleeding and better quality of life (QoL) scores 1, 3 and 12 months post-operatively. Methods: A prospective, randomized, double-blind, single-centre clinical trial will be conducted. All patients aged between 21 and 90 years who present with symptomatic grade II–IV haemorrhoids will be recruited. Exclusion criteria include those who have had previous operations for haemorrhoids and those with an increased risk of bleeding. Data collected will include patient demographics, pre- and intra-operative characteristics of the haemorrhoids, operative details and post-operative pain Visual Analogue Scale (VAS) score, complications, readmissions, and haemorrhoid-specific QoL surveys. Primary outcome will be median post-operative pain VAS score on post-operative days (POD) 1–10. Secondary outcomes include operative duration, bleeding on the first 10 days post-operatively, readmissions, procedure-related complications (fistulation, incontinence, stenosis), QoL scores, and recurrence of symptoms up to 12 months. Discussion: Results from this trial may demonstrate the superiority of LAH over COH in terms of post-operative pain and recovery. This would likely increase the adoption of LAH for the treatment of symptomatic haemorrhoids. Trial Registration: This trial was registered on 1/4/2020 at ClinicalTrials.gov. URL: https://www.clinicaltrials.gov/ct2/show/NCT04329364?term=NCT04329364&draw=2&rank=1.

scholarly journals Neurological Development and Iron Supplementation in Healthy Late-Preterm Neonates: A Randomized Double-Blind Controlled Trial

2021 ◽  
Author(s):  
Rita Luciano ◽  
Domenico Marco Romeo ◽  
Giuseppina Mancini ◽  
Serena Sivo ◽  
Carolina Dolci ◽  
...  
Keyword(s):  
Placebo Group ◽  
Iron Supplementation ◽  
Controlled Trial ◽  
Preterm Neonates ◽  
Neurological Development ◽  
Double Blind ◽  
Neurological Outcomes ◽  
Increased Risk ◽  
The Mean

Abstract ObjectiveLate-preterm infants (LPT) are at increased risk for long-term neurodevelopmental sequelaeand iron deficiency. Aim of the study is to assess the positive effect of iron supplementation on neurological development in healthy LPT.DesignWe designed a perspective, randomized placebo-controlled double-blind trial. The newborns were randomized in two groups: thirty-three patients received martial prophylaxis, thirty-three placebo. Every patient was assessed using the Griffith Mental Development Scales (GMDS)-II edition at 12 months of post-conceptional age.SettingThe study was performed at the Neonatology Unit of Fondazione Policlinico Gemelli IRCCS.PatientsSixty-six healthy LPT infants born between 340⁄7 and 366⁄7 weeks of Gestational Age were enrolled in the study.InterventionsOne group received martial prophylaxis from the third week of life to six months of post-conceptional age (2 mg/kg/day of iron pidolate), the other received placebo.Main outcome measuresFifty-two of the enrolled infants were assessed using the GMDS at 12-month of post-conceptional age. Statistical analysis of the mean scores of the Griffith subscales was performed.ResultsThere was a difference in the mean Developmental Quotient (DQ) (p<0.01) between the two groups: Iron Group mean DQ 121.45+10.53 vs Placebo Group mean DQ 113.25+9.70. Moreover, mean scores of the Griffith subscales A, B and D showed significant differences between the two Groups (scale A p<0.05, scale B p<0.02, scale D p<0.01 respectively).ConclusionsOur data show that newborns who received iron supplementation during the first six months of life achieved significantly better neurological outcomes at GMDS than Placebo group.

Increased risk of acquisition and transmission of ESBL-producing Enterobacteriaceae in malnourished children exposed to amoxicillin

2019 ◽  
Vol 75 (3) ◽  
pp. 709-717 ◽  
Author(s):  
Naouale Maataoui ◽  
Céline Langendorf ◽  
Fatou Berthe ◽  
Jumamurat R Bayjanov ◽  
Willem van Schaik ◽  
...  
Keyword(s):  
Placebo Group ◽  
Severe Acute Malnutrition ◽  
Controlled Trial ◽  
Acute Malnutrition ◽  
Double Blind ◽  
Adjusted Risk ◽  
Malnourished Children ◽  
Nutritional Recovery ◽  
Adjusted Risk Ratio ◽  
Increased Risk

Abstract Objectives Routine amoxicillin for children with uncomplicated severe acute malnutrition raises concerns of increasing antibiotic resistance. We performed an ancillary study nested within a double-blind, placebo-controlled trial in Niger testing the role of routine 7 day amoxicillin therapy in nutritional recovery of children 6 to 59 months of age with uncomplicated severe acute malnutrition. Methods We screened 472 children for rectal carriage of ESBL-producing Enterobacteriaceae (ESBL-E) as well as their household siblings under 5 years old, at baseline and Week 1 (W1) and Week 4 (W4) after start of therapy, and characterized strains by WGS. ClinicalTrials.gov: NCT01613547. Results Carriage in index children at baseline was similar in the amoxicillin and the placebo groups (33.8% versus 27.9%, P = 0.17). However, acquisition of ESBL-E in index children at W1 was higher in the amoxicillin group than in the placebo group (53.7% versus 32.2%, adjusted risk ratio = 2.29, P = 0.001). Among 209 index and sibling households possibly exposed to ESBL-E transmission, 16 (7.7%) had paired strains differing by ≤10 SNPs, suggesting a high probability of transmission. This was more frequent in households from the amoxicillin group than from the placebo group [11.5% (12/104) versus 3.8% (4/105), P = 0.04]. Conclusions Among children exposed to amoxicillin, ESBL-E colonization was more frequent and the risk of transmission to siblings higher. Routine amoxicillin should be carefully balanced with the risks associated with ESBL-E colonization.

scholarly journals Neurologic Safety of Etomidate-Based Sedation during Upper Endoscopy in Patients with Liver Cirrhosis Compared with Propofol: A Double-Blind, Randomized Controlled Trial

2020 ◽  
Vol 9 (8) ◽  
pp. 2424
Author(s):  
Jang Han Jung ◽  
Bomi Hyun ◽  
Jin Lee ◽  
Dong Hee Koh ◽  
Jung Hee Kim ◽  
...  
Keyword(s):  
Liver Cirrhosis ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Early Discharge ◽  
Double Blind ◽  
Increased Risk ◽  
Overt Hepatic Encephalopathy ◽  
Secondary Endpoints ◽  
Number Connection Test ◽  
Severe Degree

(1) Background: Although etomidate-based sedation is an effective and safe protocol in endoscopic procedures, there is a lack of evidence regarding the safety of etomidate in patients with liver cirrhosis (LC). This study aimed to compare the neurologic safety and efficacy of etomidate and propofol for endoscopic sedation in patients with LC. (2) Methods: From December 2017 to December 2019, consecutive cirrhotic patients who underwent sedative endoscopy using either etomidate or propofol were randomly recruited. The primary endpoint was the number connection test (NCT), and the secondary endpoints included factors for the safety of sedatives during endoscopy. (3) Results: 63 patients were enrolled in each of the etomidate and propofol groups. The NCT times were significantly lower in the etomidate group than in the propofol group. Furthermore, severe or very severe degree of encephalopathy was higher in the propofol group but was not significantly different. Pharmacological properties and the overall incidence of respiratory and cardiovascular events did not differ significantly between the groups. (4) Conclusion: Etomidate-based sedation exacerbates neither subclinical nor overt hepatic encephalopathy. It guarantees efficacies similar to those of propofol regarding rapid sedation, fast recovery, and early discharge, with no increased risk of adverse respiratory or cardiovascular events in patients with LC.

scholarly journals CoMET: a protocol for a randomised controlled trial of co-commencement of METformin as an adjunctive treatment to attenuate weight gain and metabolic syndrome in patients with schizophrenia newly commenced on clozapine

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e021000 ◽  
Author(s):  
Dan Siskind ◽  
Nadia Friend ◽  
Anthony Russell ◽  
John J McGrath ◽  
Carmen Lim ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Body Weight ◽  
Weight Gain ◽  
Controlled Trial ◽  
Adjunctive Treatment ◽  
Double Blind ◽  
Human Research Ethics ◽  
Increased Risk ◽  
Point Body ◽  
Randomised Controlled

IntroductionClozapine, while effective in treatment refractory schizophrenia, is associated with significant weight gain, heart disease and increased risk of type 2 diabetes mellitus (T2DM). Although there is evidence for weight loss with metformin for people with obesity who are already taking clozapine, there have been no published trials that have investigated the effect of metformin in attenuating weight gain at the time of clozapine initiation.Methods and analysisA 24-week double-blind placebo-controlled trial of concomitant prescription of metformin at clozapine commencement. Eighty-six people being commenced on clozapine will be randomised to placebo or metformin (variable dose, up to 2 g/day). The primary outcome is comparative end point body weight, between the placebo and metformin groups. Secondary outcomes are comparative rates of conversion to T2DM, alteration of metabolic syndrome parameters, proportion gaining >5% body weight and changes in diet and appetite. We will additionally examine biomarkers associated with change in weight among trial participants.Ethics and disseminationEthics approval was granted by the Metro South Human Research Ethics Committee HREC/17/QPAH/538-SSA/17/QPAH/565. We plan to submit a manuscript of the results to a peer-reviewed journal, and present results at conferences, consumer forums and hospital grand rounds.Trial registration numberACTRN12617001547336; Pre-results.

scholarly journals Periarticular Injection with Bupivacaine for Postoperative Pain Control in Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Varah Yuenyongviwat ◽  
Chaturong Pornrattanamaneewong ◽  
Thitima Chinachoti ◽  
Keerati Chareancholvanich
Keyword(s):  
Pain Control ◽  
Controlled Trial ◽  
Ease Of Use ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Periarticular Injection ◽  
Post Operative Pain ◽  
Significant Difference

Background. Local periarticular injection with bupivacaine alone in TKA has not been studied. Thus, we aimed to examine the effectiveness of local periarticular injection with bupivacaine for post-operative pain control in TKA.Method. Sixty patients undergoing TKA by a single surgeon were randomly assigned into two groups in a double-blind, placebo-controlled study. In the injection group, patients received periarticular injections with 0.25% bupivacaine before wound closure; in the control group, patients received a 0.9% normal saline injection. Both groups received the same anesthetic procedure, post-operative pain control, and rehabilitation protocol.Results. There was a significant reduction in post-operative morphine consumption in the first six hours after the operation (mean 0.9 mg and 2.43 mg,P=0.01), but there was no significant difference in post-operative morphine consumption between six hours and ninety-six hours after the operation, visual analogue scale (VAS) score, morphine side effects during the first 96 hours, length of hospital stay, or complications from morphine consumption.Conclusion. Local periarticular injection with bupivacaine alone before wound closer was shown to be an effective method to improve pain control after TKA with a few complications and ease of use.

A prospective double-blind randomized controlled trial of the effect of topical bupivacaine on post-operative pain in bilateral nasal surgery with bilateral nasal packs inserted

2005 ◽  
Vol 119 (4) ◽  
pp. 284-288 ◽  
Author(s):  
Malcolm A Buchanan ◽  
Graham R Dunn ◽  
Gillian M MacDougall
Keyword(s):  
Randomized Controlled Trial ◽  
Local Anaesthetic ◽  
Controlled Trial ◽  
Nasal Surgery ◽  
Double Blind ◽  
Control Power ◽  
Randomized Controlled ◽  
Post Operative Pain ◽  
Number Of Patients ◽  
Significant Difference

To ascertain whether local anaesthetic use is of clinical benefit in nasal surgery, a prospective double-blind randomized controlled trial of topical bupivacaine on post-operative pain in patients packed after bilateral nasal surgery was carried out. Each patient received a bupivacaine-soaked and a saline-soaked Merocel pack, thereby acting as their own control. Power analysis ascertained the number of patients required to enter the trial to detect a statistically significant difference in pain. Fifty-seven patients completed the trial. Visual analogue scales determined the level of post-operative pain at different time points in each nostril. Less pain was demonstrated in nostrils containing bupivacaine-soaked packs compared with saline-soaked packs at two hours (p < 0.0001), four hours (p = 0.0183) and six hours (p = 0.0476) post-operatively. Although not statistically significant, less pain was noted on pack removal on the local anaesthetic sides. These results provide clinical-based evidence for the use of bupivacaine as a local anaesthetic in reducing pain following nasal surgery with packing.

scholarly journals Effect of Pregabalin on Postcraniotomy Pain in Patients Undergoing Supratentorial Tumor Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial

2019 ◽  
Vol 10 (04) ◽  
pp. 641-645
Author(s):  
Ritesh Lamsal ◽  
Charu Mahajan ◽  
Vikas Chauhan ◽  
Nidhi Gupta ◽  
Nitasha Mishra ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Postoperative Pain Management ◽  
Attractive Alternative ◽  
Double Blind ◽  
Vas Score ◽  
Surgery Patient ◽  
Neurosurgical Patients ◽  
Duration Of Surgery ◽  
Group A ◽  
Group B

Abstract Background and Objectives Suboptimal management of postcraniotomy pain causes sympathetic and hemodynamic perturbations, leading to deleterious effects on the neurological system and overall patient outcome. Opioids are the mainstay of postoperative pain management but have various problems when given in high doses, or for prolonged durations in neurosurgical patients. The ideal method of pain control following craniotomy generally relies on a combination of various drugs. Oral pregabalin may be an attractive alternative in these patients. Materials and Methods Sixty, American Society of Anesthesiologists class I and II patients posted for elective supratentorial craniotomy, aged 18 and 60 years, were randomly assigned into three groups of 20 each to receive oral placebo (Group A), pregabalin 75 mg (Group B), or pregabalin 150 mg (Group C) before the induction of anesthesia. At the end of the surgery, patient-controlled analgesia was started with intravenous fentanyl. Visual analog scale (VAS) score was recorded every 2 hours for 24 hours, along with total postoperative fentanyl requirement. Results There were no differences in sex, duration of surgery or anesthesia and total intraoperative fentanyl administered among the three groups. The median postoperative VAS score (Group A—18.0, Group B—20, and Group C—22.0; p = 0.63) was similar in all the groups. However, postoperative fentanyl requirement over 24 hours was least in the group that received 150 mg pregabalin (Group A—190 μg, Group B—240 μg, and Group C—100 μg; p = 0.03). Conclusions Even though pain scores were not significantly different, patients receiving 150 mg oral pregabalin required the least amount of postoperative opioids.

Sign in / Sign up

Export Citation Format

Share Document