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Prospective Controlled Study (prospective + controlled_study)
Selected AbstractsA Prospective Controlled Study in the Prevalence of Posttraumatic Headache Following Mild Traumatic Brain InjuryPAIN MEDICINE, Issue 8 2008S. Faux FAFRM (RACP) FFPMANZCA ABSTRACT Objective., To establish the prevalence of post traumatic headache, persisting at 3 months following minor traumatic brain injury. Design., A prospective controlled study of patients admitted with a diagnosis of mild traumatic brain injury and matched orthopedic controls over 12 months during 2004. Setting., A level two inner city Emergency Department in Sydney, Australia. Patients., One hundred eligible sequential admissions with mild traumatic brain injury as defined by American Congress of Rehabilitation Medicine, 1993, and 100 matched minor injury controls with nondeceleration injuries. Interventions., Subjects were part of a study on prediction of postconcussive syndrome and had neuropsychological tests, balance test and pain recordings taken at the time of injury, at 1 month and at 3 months post injury. Outcome Measures., Main measures were the reporting of headache "worse than prior to the injury" and concordant with the definition of Posttraumatic Headache according to International Headache Society Classification of Headache Disorders 2003. Results., 15.34% of those with minor head injury continued to complain of perisistant posttraumatic headache at 3 months compared to 2.2% of the minor injury controls. Conclusions., To the authors' knowledge this is the first controlled prospective study in the prevalence of posttraumatic headache following mild traumatic brain injury. [source] An Evaluation of Fibrin Tissue Adhesive Concentration and Application Thickness on Skin Graft SurvivalTHE LARYNGOSCOPE, Issue 11 2000Kevin M. O'Grady BS Abstract Objectives To e-amine the effects of fibrinogen concentration and application thickness of fibrin tissue adhesive on skin graft survival. Study Design Prospective controlled study. Methods Ten domestic pigs were included in the study. A 20 , 5-cm area of skin was harvested bilaterally along the flanks of the animals using a Padgett dermatome. The harvested grafts were trimmed into four 4 , 4-cm squares. Donor sites were treated according to group assignment and the non-meshed grafts were placed on the side opposite their initial orientation and secured with staples. Both single- and multiple-donor human fibrin tissue adhesive preparations, with low and high average fibrinogen concentrations of 30 mg/mL and 60 mg/mL, were used. Adhesive preparations were applied in either a thin layer (0.015 mL/cm2) or a thick layer (0.06 mL/cm2) using a spray applicator. A constant thrombin concentration of 10 U/mL was used in the study. No adhesive was used in the control group and grafts were stabilized with staples. No topical dressings were applied to any of the treatment sites. Animals were sacrificed 4 weeks after graft application. Results Based on statistical analysis, thickness of adhesive application had a significant effect on skin graft survival. Percent mean graft survival in the control and thin application groups was found to be 92% and 97.8% respectively; the mean survival rate in the thick application group was 63.1%. Fibrinogen concentration, when evaluated independently within the thin and thick application groups, was found to have no significant effect on graft survival. Conclusion Independent of fibrinogen concentration, a thin layer of fibrin tissue adhesive, when applied between two opposing surfaces, does not interfere with and may support the healing process, whereas a thick layer of adhesive inhibits skin graft healing. [source] Gastric electrical activity in patients with cholelithiasis undergoing laparoscopic cholecystectomy: A prospective controlled studyJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 6 2004SPIROS N SGOUROS Abstract Background:, The aim of the present study was to evaluate the effect of gallstone disease (GD) and laparoscopic cholecystectomy on gastric electrical activity of slow waves, which was recorded via transcutaneous electrogastrography (EGG). Methods:, Twenty-one consecutive patients (M/F: 12/9, 52.7 ± 15 years old) with GD and no previous history of abdominal operations or known disease affecting gastrointestinal motility were studied. The EGG was performed for 30 min prior to and 90 min after a standard meal, during a 4,6 month period prior to and after laparoscopic cholecystectomy. The percentile proportion of the three spectra of gastric slow waves frequency was studied, defined as follows: bradygastria, 1,2.1 cycles per min (c.p.m.); normogastria, 2.2,3.9 c.p.m.; and tachygastria, 4,9 c.p.m. The findings were compared to those of nine healthy subjects (M/F: 5/4, 49.5 ± 14.8 years old). Results:, No statistically significant difference was found in percentile distribution of bradygastria, normogastria and tachygastria, pre- or post-prandially, neither before or after laparoscopic cholecystectomy, nor between patients and controls. Conclusions:, Patients with GD do not exhibit differences in gastric electrical activity of slow waves in comparison to normal subjects and laparoscopic cholecystectomy does not alter gastric electrical activity. These findings suggest that cholelithiasis does not seem to cause dyspeptic symptoms due to gastric dysrythmias. [source] A Prospective Controlled Study in the Prevalence of Posttraumatic Headache Following Mild Traumatic Brain InjuryPAIN MEDICINE, Issue 8 2008S. Faux FAFRM (RACP) FFPMANZCA ABSTRACT Objective., To establish the prevalence of post traumatic headache, persisting at 3 months following minor traumatic brain injury. Design., A prospective controlled study of patients admitted with a diagnosis of mild traumatic brain injury and matched orthopedic controls over 12 months during 2004. Setting., A level two inner city Emergency Department in Sydney, Australia. Patients., One hundred eligible sequential admissions with mild traumatic brain injury as defined by American Congress of Rehabilitation Medicine, 1993, and 100 matched minor injury controls with nondeceleration injuries. Interventions., Subjects were part of a study on prediction of postconcussive syndrome and had neuropsychological tests, balance test and pain recordings taken at the time of injury, at 1 month and at 3 months post injury. Outcome Measures., Main measures were the reporting of headache "worse than prior to the injury" and concordant with the definition of Posttraumatic Headache according to International Headache Society Classification of Headache Disorders 2003. Results., 15.34% of those with minor head injury continued to complain of perisistant posttraumatic headache at 3 months compared to 2.2% of the minor injury controls. Conclusions., To the authors' knowledge this is the first controlled prospective study in the prevalence of posttraumatic headache following mild traumatic brain injury. [source] ORIGINAL ARTICLE: Serum IL-6 Level May Have Role in the Pathophysiology of Unexplained InfertilityAMERICAN JOURNAL OF REPRODUCTIVE IMMUNOLOGY, Issue 4 2009Bulent Demir Problem, The aim of this study was to compare the serum levels of interleukin (IL)-6 of women with unexplained infertility with fertile subjects. Method of study, Serum IL-6, and tumor necrosis factor-, (TNF-,) levels of 45 infertile and 44 fertile women on day 3 of menstrual cycle were assessed and compared for this prospective controlled study. Results, The mean serum IL-6 level was significantly higher in women with unexplained infertility, compared with fertile women (5.71 ± 1.81 and 4.31 ± 1.79, P < 0.001, Student's t -test). There was no significant difference in TNF-, level among the groups. Conclusion, Significant difference in serum IL-6 levels between unexplained infertile and fertile women suggests that this cytokine may be involved in pathophysiology of unexplained infertility. [source] Multimodal microglia imaging of fiber tracts in acute subcortical stroke,ANNALS OF NEUROLOGY, Issue 6 2009Basia A. Radlinska BSc Objective Case series with 11C-PK11195 and positron emission tomography (PET) in stroke patients suggest that activated microglia may be detected in remote brain regions with fiber tract connections to the lesion site as an indicator of poststroke neuroinflammation. However, the specificity of these imaging findings remains to be demonstrated. Methods In a prospective controlled study, we measured microglia activity using 11C-PK11195-PET along the pyramidal tract, as defined by diffusion tensor imaging, in 21 patients with first-time acute subcortical ischemia within 2 weeks of stroke. Uptake ratios (affected vs unaffected side) were determined for a set of standardized volumes of interest along the pyramidal tracts (PT). Uptake ratios from patients in whom the PT was affected were compared with those in whom the PT was not affected. Uptake ratios were related to motor deficit and lesion size according to correlation analyses. Results Increased uptake ratios were only found in patients in whom the PT was affected by stroke. In the affected hemisphere, uptake was increased at the level of pons, midbrain, and internal capsule, but not in the oval center. The extent of remote microglia activation was independent of infarct size or clinical measures of stroke severity. Interpretation A specific activation of microglia was only found in patients in whom the PT was affected by the stroke and only caudal (anterograde) to the lesion; no activation was found in the retrograde direction or in those patients in whom the PT was not affected. These findings were independent of infarct size and may represent changes secondary to early Wallerian degeneration. Ann Neurol 2009;66:825,832 [source] Arresting Dialysis-Related Amyloidosis: A Prospective Multicenter Controlled Trial of Direct Hemoperfusion with a ,2 -Microglobulin Adsorption ColumnARTIFICIAL ORGANS, Issue 4 2004Fumitake Gejyo Abstract:, We investigated the clinical efficacy of direct hemoperfusion with a ,2 -microglobulin (,2 -m) adsorption column for the treatment of patients with dialysis-related amyloidosis. A 2-year prospective controlled study was performed to compare the effects of passaging blood through a (,2 -m) adsorption column (Lixelle) before it is passaged through the dialysis polysulfone membrane on the severity of amyloidosis in these individuals. Patients (n = 22) whose blood went through the Lixelle column prior to dialysis had a higher ,2 -m removal rate compared to an equal number of controls, and they showed earlier improvement in their symptoms which included impaired daily ,activities, ,joint ,stiffness, ,and ,pain. ,The ,appearance of additional bone cysts was prevented in pre-adsorbed patients but not in the controls. Thus, the Lixelle column is useful in preventing the progression of dialysis-related amyloidosis and in ameliorating or arresting the progression of the ,symptoms ,of ,this ,disorder. [source] Effects of maternal occupational exposure to organic solvents on offspring visual functioning: A prospective controlled studyBIRTH DEFECTS RESEARCH, Issue 3 2001Christine Till Background Previous studies in adults and animals with high level exposure to organic solvents suggested impairments in visual functioning. The objective of this pilot study was to examine the effects of maternal occupational exposure to organic solvents during pregnancy on offspring color vision and visual acuity, the development of which may be especially vulnerable to organic solvent exposure. Methods We conducted a prospective cohort study of 32 offspring of women who were exposed occupationally to organic solvents during pregnancy compared with 27 nonexposed children. Monocular and binocular color vision and visual acuity were assessed using the Minimalist Test and the Cardiff Cards, respectively. Children with known hereditary color vision loss were excluded. Results Solvent-exposed children had significantly higher error scores on red-green and blue-yellow color discrimination, as well as poorer visual acuity compared with the control group. Exposure index (an estimated measure of exposure intensity) was not significantly related to color discrimination or visual acuity score. Despite excluding all children with a known family history of color vision loss, clinical red-green color vision loss was found among 3 of the 32 exposed children compared with none of the matched controls. Conclusions These preliminary findings suggest that occupational exposure to organic solvents during pregnancy is associated with an increased risk of color vision and visual acuity impairment in offspring. The importance of routine visual function screening in risk assessment after prenatal exposure to chemicals warrants further attention. Teratology 64:134,141, 2001. © 2001 Wiley-Liss, Inc. [source] The burden of caesarean section refusal in a developing country settingBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 10 2007CO Chigbu Objective, To investigate the prevalence, aetiology and outcomes of caesarean section refusal in pregnant women. Design, A prospective controlled study. Setting, University of Nigeria Teaching Hospital and Aghaeze Hospital, Enugu, Nigeria. Population, A total of 62 Nigerian women who declined elective caesarean section. Method, Interviewer-administered questionnaires at the time of caesarean section refusal and postdelivery. The delivery outcomes of the subjects were compared with that of a matched control group of women who accepted caesarean section. Main outcome measures, Prevalence, maternal reasons for caesarean section refusal and the resultant maternal and perinatal mortality. Results, The prevalence of caesarean section refusal was 11.6% of all caesarean deliveries. Maternal reasons for refusing caesarean section include fear of death, economic reasons, desire to experience vaginal delivery and inadequate counselling. Outcomes were significantly worse among women who refused elective caesarean section than in the controls with a maternal mortality of 15% (versus 2%, P = 0.008) and a perinatal mortality of 34% (versus 5%, P < 0.001). Conclusion, There is a high prevalence of caesarean section refusal in south-eastern Nigeria. Women declining caesareans have very poor maternal and perinatal outcomes and need extra support. [source] The efficacy of laparoscopic mesh colposuspension: results of a prospective controlled studyBJU INTERNATIONAL, Issue 4 2001T.A. El-Toukhy Objective To investigate the efficacy of laparoscopic mesh colposuspension as an equivalent approach to the ,gold standard' open Burch colposuspension. Patients and methods A prospective controlled study of laparoscopic mesh colposuspension was conducted over 2 years; 87 patients with genuine stress incontinence (GSI) were recruited. The preoperative evaluation included a history, examination, midstream urine analysis, urinary voiding diary, a Urilos pad test, and twin-channel subtracted cystometry, including urethral profilometry and measurement of the postvoid residual volume. The study included patients who had undergone previous incontinence surgery, but those with detrusor instability or neurogenic bladder were excluded. The patients were assessed at 6 weeks, 6 months and 1 year after surgery and then yearly thereafter. The urodynamic assessment was repeated 3 months after surgery. Results Forty-nine patients underwent laparoscopic colposuspension using Prolene mesh and titanium tacks to elevate the bladder neck, while 38 patients had open Burch colposuspension. There was no difference between the groups in age, parity, body mass index, menopausal status, medical history, previous bladder neck surgery and prolapse. At 6 weeks the cure rate was similarly high in the two groups (91% laparoscopic and 94% open). After a mean follow-up of 32 months, both groups showed a decline in efficacy, which was more marked in the laparoscopic group. Cure rates were 62% for laparoscopy and 79% for open surgery, and the improvement rates were 77% and 89%, respectively (P < 0.05). Conclusion Laparoscopic colposuspension using a mesh and tacker technique reduces the technical difficulty and operating time of the endoscopic procedure, but the long-term cure rates are inferior to open Burch colposuspension. [source] Effect of mitomycin C on ostium in dacryocystorhinostomyCLINICAL & EXPERIMENTAL OPHTHALMOLOGY, Issue 6 2006Amarendra Deka MS Abstract Background:, To observe the effect of intraoperative mitomycin C of varying concentration on postoperative ostium size after external dacryocystorhinostomy (DCR). Methods:, In this prospective controlled study, 60 cases of DCR were taken up irrespective of age and sex. Cases were divided into three groups. Group 1 was taken as a control group and operated without mitomycin C; in experimental group 2 and group 3, mitomycin C at a concentration of 0.05 mg/mL and 0.4 mg/mL was applied, respectively, for 2 min. Each group consisted of 20 cases. Half of the cases in each group underwent single-flap DCR (SFDCR) and half underwent double-flap DCR (DFDCR) surgery. Nasal endoscopic evaluation was performed on the first postoperative day, at 2 weeks and at 6 months after surgery. A Student's t -test was used to compare the osteotomy size of each group. Results:, At the end of the final follow up, average size of the ostium in group 1 was 3.6 ± 2.36 mm2 in SFDCR and 4.5 ± 3.59 mm2 in DFDCR, in group 2 was 4.8 ± 4.82 mm2 in SFDCR and 4.9 ± 4.12 mm2 in DFDCR, and in group 3 was 16.6 ± 6.80 mm2 in SFDCR and 17.5 ± 9.07 mm2 in DFDCR. The ostium size in group 3 was found to be significantly bigger in comparison with group 1 (P = 0.0001 in SFDCR, P = 0.001 in DFDCR) and with group 2 (P = 0.0009 in SFDCR, P = 0.001 in DFDCR). No statistically significant difference of ostium size was found in SFDCR and DFDCR. Conclusion:, Mitomycin C in appropriate dose minimizes postoperative fibrosis and granulations, thereby maintaining a bigger postoperative ostium throughout the postoperative observation period. [source] The use of in-line intravenous filters in sick newborn infantsACTA PAEDIATRICA, Issue 5 2004RA van Lingen Aim: This study assesses the improvement in outcome for newborn infants by decreasing major complications associated with intravenous fluid therapy by using an in-line filter, and evaluates the economical impact this might have in relation to daily changing of i.v. lines. Methods: In a prospective controlled study, 88 infants were randomly assigned to receive either filtered (except for lipids, blood and blood products) or non-filtered infusions via a central catheter. Main outcome measures such as bacteraemia, phlebitis, extravasation, thrombosis, septicaemia and necrosis were all scored. The costs attributable to patients during a standard 8-day stay were also recorded. Results: Significant reductions were found in major complications such as thrombi and clinical sepsis (control group (21), filter group (8); p < 0.05). Bacterial cultures of the filters showed a contamination rate on the upstream surface of 15/109 filters (14%). The mean costs of disposables were less in the filter group, showing a reduction from ±31.17 to ±23.79. Conclusions. The use of this in-line filter leads to a significant decrease in major complications and substantial cost savings. [source] The ,Draw-the-Family Test' in the preoperative assessment of patients with anorectal diseases and psychological distress: a prospective controlled studyCOLORECTAL DISEASE, Issue 8 2010C. Miliacca Abstract Aim, Some benign anorectal diseases may have psychosomatic aetiology, but patients often refuse direct psychological counselling. The Draw-the-Family Test (DFT) is a simple indirect investigation. The aim of this study was to evaluate the DFT in patients with psychological problems undergoing surgery for benign anorectal disease and to correlate the results with surgical outcome. Method, DFT was administered prior to surgery to 62 patients with benign anorectal disease who admitted psychological problems at the time of the outpatient visit. Of these 18 (29%) had functional disease, mainly obstructed defecation (OD) while 44 (71%) had organic disease (haemorrhoids, fissures, pilonidal sinus or fistula). DFT was also administered to 40 healthy control subjects. Each DFT was judged as normal or pathological according to 10 parameters. Patients were followed up for a median of 12 months (range 3,64) and divided into two outcome groups, success (n = 58) and failure (n = 12) according to the results of a questionnaire. The DFT of all patients was then correlated with the outcome. Results, None of the patients refused DFT. All DFT parameters but one (animal/things instead of human beings) were more frequent in patients compared with controls (P < 0.05). When comparing separately organic or functional disease patients with controls, one parameter (absence of patient in the drawing) was only pathological in the organic disease group (P < 0.05). Another parameter (schematic figures) was more frequently altered in the organic disease group compared with the functional disease group (P = 0.01). Eight out of 10 parameters were more frequently pathological in patients who failed after treatment, but none reached statistical significance. Conclusion, Results of DFT in patients with anorectal disease admitting to psychological problems are markedly different from healthy controls. Patients with organic disease and those with functional bowel disease have different DFT profiles. In our study group, DFT had an excellent compliance but could not predict the outcome of surgery. [source] | ||||||||||