Endoscopic radical antrectomy: a permanent replacement for the Caldwell–Luc operation

2007 ◽  
Vol 122 (3) ◽  
pp. 268-276 ◽  
Author(s):  
H Abd El-Fattah ◽  
Y A Nour ◽  
A El-Daly
Keyword(s):  
Controlled Trial ◽  
Clinic Visit ◽  
Treatment Groups ◽  
Middle Meatal Antrostomy ◽  
Permanent Replacement ◽  
Mucosal Changes ◽  
Randomised Controlled ◽  
Sinus Mucosa ◽  
Maxillary Sinuses ◽  
Better Than

AbstractIntroduction:Chronic inflammation of sinus mucosa is a multifactorial condition which sometimes results in irreversible pathological mucosal changes.Aims:To evaluate the efficacy of endoscopic radical antrectomy in treating chronic, hyperplastic, eosinophilic sinusitis, and to compare this procedure with classical endoscopic middle meatal antrostomy.Materials and methods:A randomised, controlled trial with parallel design was conducted between July 2000 and December 2004, including 119 patients who fulfilled the clinical, radiological and histopathological criteria for chronic, hyperplastic, eosinophilic sinusitis. Patients were randomly allocated to two treatment groups: classical endoscopic middle meatal antrostomy and endoscopic radical antrectomy. The main outcome measures were recorded in each subgroup at the time of the patient's last clinic visit. In each subgroup, these included subjective improvement and evaluation of the endoscopic appearance of the maxillary sinus.Results:Thirty-two per cent of patients in the endoscopic middle meatal antrostomy group were considered surgical failures, compared with 14.5 per cent of the endoscopic radical antrectomy group. This was statistically significant (p = 0.023). Unhealthy maxillary sinuses were significantly more prevalent in the endoscopic middle meatal antrostomy group (p = 0.029).Conclusions:In those patients fulfilling the criteria suggestive of chronic, irreversible sinonasal pathology, primary endoscopic radical antrectomy was significantly better than endoscopic middle meatal antrostomy, based on subjective and objective findings.

Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

2021 ◽  
pp. 112070002110057
Author(s):  
Niels H Bech ◽  
Inger N Sierevelt ◽  
Sheryl de Waard ◽  
Boudijn S H Joling ◽  
Gino M M J Kerkhoffs ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Controlled Trial ◽  
Poor Quality ◽  
Control Group ◽  
Treatment Groups ◽  
Significant Difference ◽  
Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p  > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

Effectiveness of two tobacco cessation methods among TB patients

2022 ◽  
Vol 26 (1) ◽  
pp. 12-17
Author(s):  
S. Malhotra ◽  
V. Mohanty ◽  
A. Y. Balappanavar ◽  
N. Sharma ◽  
A. Khanna ◽  
...  
Keyword(s):  
Tobacco Cessation ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Study Groups ◽  
Adverse Outcomes ◽  
Control Group ◽  
Treatment Groups ◽  
Integrated Intervention ◽  
Randomised Controlled ◽  
And Control

BACKGROUND: Tobacco and TB are the world´s two greatest public health problems. Exposure to tobacco has been shown to be associated with higher risk of acquiring TB and adverse outcomes such as relapse and TB mortality.OBJECTIVE: To assess and compare self-reported tobacco quit status and biochemically verified cotinine levels among TB patients at different time intervals among two study groups.METHODS: A cluster, randomised controlled trial was conducted on TB patients attending DOTS centres in Delhi, India, who reported using tobacco in any form. Participants were assigned into one of two treatment groups. Centres were randomly assigned to two intervention groups: 1) integrated intervention using behavioural counselling with nicotine replacement therapy (NRT) gum, and 2) intervention using behavioural counselling alone (50 each in intervention and control group). The subjects were followed at Week 1, Month 1, Month 3 and Month 6 for tobacco cessation.RESULTS: At the end of 6 months, patients who received the integrated intervention had significantly higher rate of success in quitting tobacco than those who received the conventional TB treatment alone (78.7% vs. 57.8%; P < 0.03).CONCLUSION: DOTS with tobacco use dependence treatment was successful in our study in helping TB patients to quit tobacco dependence and should therefore be offered to every tobacco user.

scholarly journals Suicidal behaviour in psychosis: Prevalence and predictors from a randomised controlled trial of case management

2001 ◽  
Vol 178 (3) ◽  
pp. 255-260 ◽  
Author(s):  
Elizabeth Walsh ◽  
Kate Harvey ◽  
Ian White ◽  
Anna Higgitt ◽  
Janelle Fraser ◽  
...  
Keyword(s):  
Case Management ◽  
Suicidal Behaviour ◽  
Standard Care ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Intensive Case Management ◽  
Treatment Groups ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Chronic Psychosis

BackgroundIt is unclear whether intensive case management influences the prevalence of suicidal behaviour in patients with psychosis.AimsTo compare the effect of intensive case management and standard care on prevalence of suicidal behaviour in patients with chronic psychosis.MethodPatients with established psychosis (n=708) were randomised either to intensive case management or to standard care. The prevalence of suicidal behaviour was estimated at 2-year follow-up and compared between treatment groups. Suicide attempters and non-attempters were compared on multiple socio-demographic and clinical variables to identify predictors of suicidal behaviour.ResultsThere was no significant difference in prevalence of suicidal behaviour between treatment groups. Recent attempts at suicide and multiple recent hospital admissions best predicted future attempts.ConclusionsIntensive case management does not appear to influence the prevalence of suicidal behaviour in chronic psychosis. Predictors identified in this study confirm some previous findings.

Intravenous cefazolin plus oral probenecid versus oral cephalexin for the treatment of skin and soft tissue infections: a double-blind, non-inferiority, randomised controlled trial

2018 ◽  
Vol 35 (8) ◽  
pp. 492-498 ◽  
Author(s):  
Dawn Dalen ◽  
Amy Fry ◽  
Samuel G Campbell ◽  
Jeffrey Eppler ◽  
Peter J Zed
Keyword(s):  
Soft Tissue ◽  
Clinical Cure ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Risk Difference ◽  
Teaching Hospitals ◽  
Double Blind ◽  
Treatment Groups ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveThe purpose of our study was to determine if cephalexin 500 mg orally four times daily was non-inferior to cefazolin 2 g intravenously daily plus probenecid 1 g orally daily in the management of patients with uncomplicated mild–moderate skin and soft tissue infection (SSTI) presenting to the ED.MethodsThis was a prospective, multicentre, double dummy-blind, randomised controlled non-inferiority trial conducted at two tertiary care teaching hospitals in Canada. Patients were enrolled if they presented to the ED with an uncomplicated SSTI, and randomly assigned in a 1:1 fashion to oral cephalexin or intravenous cefazolin plus oral probenecid for up to 7 days. The primary outcome was failure of therapy at 72 hours. Clinical cure at 7 days, intravenous to oral medication transition admission to hospital and adverse events were also evaluated.Results206 patients were randomised with 104 patients in the cephalexin group and 102 in the cefazolin and probenecid group. The proportion of patients failing therapy at 72 hours was similar between the treatment groups (4.2% and 6.1%, risk difference 1.9%, 95% CI −3.7% to 7.6%). Clinical cure at 7 days was not significantly different (100% and 97.7%, risk difference −2.3%, 95% CI −6.7% to 0.8%).ConclusionCephalexin at appropriate doses appears to be a safe and effective alternative to outpatient parenteral cefazolin in the treatment of uncomplicated mild–moderate SSTIs who present to the ED.Trial registration numberNCT01029782; Results.

scholarly journals Tocilizumab in early progressive rheumatoid arthritis: FUNCTION, a randomised controlled trial

2015 ◽  
Vol 75 (6) ◽  
pp. 1081-1091 ◽  
Author(s):  
Gerd R Burmester ◽  
William F Rigby ◽  
Ronald F van Vollenhoven ◽  
Jonathan Kay ◽  
Andrea Rubbert-Roth ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Randomised Controlled Trial ◽  
Adverse Events ◽  
Physical Function ◽  
Controlled Trial ◽  
Health Assessment ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Treatment Groups ◽  
Randomised Controlled

ObjectivesThe efficacy of tocilizumab (TCZ), an anti-interleukin-6 receptor antibody, has not previously been evaluated in a population consisting exclusively of patients with early rheumatoid arthritis (RA).MethodsIn a double-blind randomised controlled trial (FUNCTION), 1162 methotrexate (MTX)-naive patients with early progressive RA were randomly assigned (1:1:1:1) to one of four treatment groups: 4 mg/kg TCZ+MTX, 8 mg/kg TCZ+MTX, 8 mg/kg TCZ+placebo and placebo+MTX (comparator group). The primary outcome was remission according to Disease Activity Score using 28 joints (DAS28–erythrocyte sedimentation rate (ESR) <2.6) at week 24. Radiographic and physical function outcomes were also evaluated. We report results through week 52.ResultsThe intent-to-treat population included 1157 patients. Significantly more patients receiving 8 mg/kg TCZ+MTX and 8 mg/kg TCZ+placebo than receiving placebo+MTX achieved DAS28-ESR remission at week 24 (45% and 39% vs 15%; p<0.0001). The 8 mg/kg TCZ+MTX group also achieved significantly greater improvement in radiographic disease progression and physical function at week 52 than did patients treated with placebo+MTX (mean change from baseline in van der Heijde–modified total Sharp score, 0.08 vs 1.14 (p=0.0001); mean reduction in Health Assessment Disability Index, −0.81 vs −0.64 (p=0.0024)). In addition, the 8 mg/kg TCZ+placebo and 4 mg/kg TCZ+MTX groups demonstrated clinical efficacy that was at least as effective as MTX for these key secondary endpoints. Serious adverse events were similar among treatment groups. Adverse events resulting in premature withdrawal occurred in 20% of patients in the 8 mg/kg TCZ+MTX group.ConclusionsTCZ is effective in combination with MTX and as monotherapy for the treatment of patients with early RA.Trial registration numberClinicalTrials.gov, number NCT01007435

scholarly journals Can Patient-Led Surveillance Detect Subsequent New Primary or Recurrent Melanomas and Reduce the Need for Routinely Scheduled Follow Up? A Protocol for the MEL-SELF Randomised Controlled Trial.

2021 ◽  
Author(s):  
Deonna Ackermann ◽  
Amelia K Smit ◽  
Monika Janda ◽  
Cathelijne van Kemenade ◽  
Mbathio Dieng ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Clinicopathological Characteristics ◽  
Clinic Visit ◽  
Usual Practice ◽  
Technical Performance ◽  
Keratinocyte Cancer ◽  
Randomised Controlled ◽  
Clinic Visits

Abstract Background: Most subsequent new primary or recurrent melanomas might be self-detected if patients are trained to systematically self-examine their skin and have access to timely medical review (patient-led surveillance). Routinely scheduled clinic visits (clinician-led surveillance) is resource-intensive and has not been shown to improve health outcomes; fewer visits may be possible if patient-led surveillance is shown to be safe and effective. The MEL-SELF trial is a randomised controlled trial comparing patient-led surveillance with clinician-led surveillance in people who have been previously treated for localised melanoma. Methods: Stage 0/I/II melanoma patients (n=600) from dermatology, surgical, or general practice clinics in NSW Australia, will be randomised (1:1) to the intervention (patient-led surveillance, n=300) or control (usual care, n=300). Patients in the intervention will undergo a second randomisation 1:1 to polarised (n=150) or non-polarised (n=150) dermatoscope. Patient-led surveillance comprises an educational booklet, skin self-examination (SSE) instructional videos; 3-monthly email/SMS reminders to perform SSE; patient-performed dermoscopy with teledermatologist feedback; clinical review of positive teledermoscopy through fast-tracked unscheduled clinic visits; and routinely scheduled clinic visits following each clinician’s usual practice. Clinician-led surveillance comprises an educational booklet and routinely scheduled clinic visits following each clinician’s usual practice. The primary outcome, measured at 12-months, is the proportion of participants diagnosed with a subsequent new primary or recurrent melanoma diagnosed at an unscheduled clinic visit. Secondary outcomes include time from randomisation to diagnosis (of a subsequent new primary or recurrent melanoma and of a new keratinocyte cancer), clinicopathological characteristics of subsequent new primary or recurrent melanomas (including AJCC stage), psychological outcomes, and healthcare use. A nested qualitative study will include interviews with patients and clinicians, and a costing study we will compare costs from a societal perspective. We will compare the technical performance of two different models of dermatoscope (polarised vs non-polarised).Discussion: The findings from this study may inform guidance on evidence-based follow up care, that maximises early detection of subsequent new primary or recurrent melanoma and patient wellbeing, while minimising costs to patients, health systems, and society.Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000176864. Registered 18 February 2021, https://www.anzctr.org.au/ACTRN12621000176864.aspx

Long-term effectiveness of antiseptic cream for recurrent epistaxis in childhood: five-year follow up of a randomised, controlled trial

2008 ◽  
Vol 122 (10) ◽  
pp. 1084-1087 ◽  
Author(s):  
S Robertson ◽  
H Kubba
Keyword(s):  
Controlled Trial ◽  
Clinic Visit ◽  
Term Outcome ◽  
Case Record ◽  
Long Term Outcome ◽  
Recurrent Epistaxis ◽  
Randomised Controlled ◽  
Record Review

AbstractObjectives:To determine the long-term outcome for children treated for recurrent epistaxis, and to compare the efficacy of antiseptic cream treatment and nasal cautery.Study design and participants:Retrospective analytical cohort study of 88 children treated for recurrent epistaxis in 2001.Methods:Five-year data on chlorhexidine–neomycin cream usage, nasal cautery, current epistaxis frequency and emergency room attendance was collected by telephone interview and case record review.Results:During their first clinic visit, 51 per cent of the children had been treated with cautery and cream and 35 per cent with cream alone; 14 per cent had received no treatment. Five years later, 65 per cent of these children were still having ongoing epistaxis. Those who had undergone cautery and received cream had the highest ongoing bleeding rate (77 per cent).Conclusion:The majority of children treated at our clinic for recurrent epistaxis had ongoing bleeding five years later. Despite the proven short-term efficacy of chlorhexidine–neomycin cream, few patients receive further courses of cream or are referred back to the clinic.

scholarly journals The Effects of Two Maternal Vitamin A Supplementation Regimens on Serum Retinol in Postpartum Mothers: A Randomised Controlled Trial in Brazil

2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Luciana Marques Andreto ◽  
Ilma Kruze Grande de Arruda ◽  
Ariani Impieri Souza ◽  
José Natal Figueiroa ◽  
Alcides da Silva Diniz
Keyword(s):  
Randomised Controlled Trial ◽  
Vitamin A ◽  
Vitamin A Deficiency ◽  
Controlled Trial ◽  
Serum Retinol ◽  
Double Blind ◽  
Vitamin A Supplementation ◽  
Treatment Groups ◽  
Randomised Controlled ◽  
Postpartum Mothers

Objective. To test whether the serum retinol level in mothers supplemented with 400,000 IU of vitamin A is higher than in those supplemented with 200,000 IU and to estimate duration of the protective effect of vitamin A supplementation in the serum retinol level. Methods. Double-blind, randomised controlled trial performed in two hospitals in the state of Pernambuco in northeast Brazil. Three hundred twelve mothers were recruited immediately postpartum. All women received a capsule containing 200,000 IU of vitamin A, and 10 days after delivery, they were randomly assigned to one of two treatment groups. One group received a second capsule containing vitamin A and the other group received a placebo. Each group was invited back after 2, 4, and 6 months for serum retinol analyses. Results. No difference was found between the two groups in serum maternal retinol concentration at 2 months (2.13 versus 2.03 μmol/L), 4 months (2.20 versus 2.24 μmol/L) or 6 months (2.29 versus 2.31 μmol/L). Because there was no further effect and because this population has a level of vitamin A deficiency considered mild, our results do not support a proposal to increase the dosing schedule for vitamin A in postpartum women as recommended by the IVACG.

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