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At least 145 records · Page 8Linked to original sources
PubMed1998

Early results of a prospective multicenter study on 500 consecutive cases of laparoscopic colorectal surgery. Laparoscopic Colorectal Surgery Study Group (LCSSG).

BACKGROUND: Prospective randomized multicenter studies comparing laparoscopic with open colorectal surgery are not yet available. Reliable data from prospective multicenter studies involving consecutive patients are also lacking. On the basis of the personal caseloads of specialized surgeons or of retrospective analyses, it is difficult to judge the true effectiveness of this new technique. This study aims to investigate the results of laparoscopic colorectal surgery in consecutive patients operated on by unselected surgeons. METHODS: This observational study was begun August 1, 1995, in the German-speaking part of Europe (Germany and Austria) and 43 centers initially agreed to participate. All consecutive cases were documented. All data were rendered anonymous. Analysis was performed on an intention-to-treat basis. The study committee was blinded to the participating center. RESULTS: By the end of the 1st year, 500 patients (M:F ratio 0.83, mean age 62.9 years) had been treated by 18 centers; 269 operations were performed for benign indications and 231 for cancer (palliative and curative). Most operations were done on the distal colon or rectum. An anastomosis was performed in 84%, with an overall leakage rate of 5.3% (colon 3.6% and rectum 11.8%), which required surgical reintervention in 1.7%. The mean operating time was 176 min and showed a decreasing tendency over the period under study. The conversion rate was 7.0% and the overall complication rate 21.4%. The reoperation rate was 6.6%; the most common cause was bleeding. There was one ureteral lesion (0.2%), but urinary tract infections were fairly common (4.8%). A postoperative pneumonia was diagnosed in 1.6% of the cases. No thromboembolic complications were reported. The 30-day mortality rate was 1.4% and overall hospital mortality 1.8%. CONCLUSIONS: Laparoscopic colorectal operations are still rare (about 1% of all colorectal operations in Germany). Laparoscopic procedures are more common on the left colon and rectum than on the right colon. The surgical complication rate is acceptable, comparable with rates reported by others for open surgery. Cardiopulmonary and thromboembolic complications were rarely seen. Mortality and surgical morbidity rates do not differ significantly among participating centers. A learning curve, reflected by a shortening of the operating time and a somewhat lower conversion rate, was observed over the observation period.

Aged↗
PubMed1993

Improving intensive care: observations based on organizational case studies in nine intensive care units: a prospective, multicenter study.

OBJECTIVE: To examine organizational practices associated with higher and lower intensive care unit (ICU) outcome performance. DESIGN: Prospective multicenter study. Onsite organizational analysis; prospective inception cohort. SETTING: Nine ICUs (one medical, two surgical, six medical-surgical) at five teaching and four nonteaching hospitals. PARTICIPANTS: A sample of 3,672 ICU admissions; 316 nurses and 202 physicians. MATERIALS AND METHODS: Interviews and direct observations by a team of clinical and organizational researchers. Demographic, physiologic, and outcome data for an average of 408 admissions per ICU; and questionnaires on ICU structure and organization. The ratio of actual/predicted hospital death rate was used to measure ICU effectiveness; the ratio of actual/predicted length of ICU stay was used to assess efficiency. MEASUREMENTS AND MAIN RESULTS: ICUs with superior risk-adjusted survival could not be distinguished by structural and organizational questionnaires or by global judgment following on-site analysis. Superior organizational practices among these ICUs were related to a patient-centered culture, strong medical and nursing leadership, effective communication and coordination, and open, collaborative approaches to solving problems and managing conflict. CONCLUSIONS: The best and worst organizational practices found in this study can be used by ICU leaders as a checklist for improving ICU management.

Critical Care↗
PubMed1996

Prospective, multicenter study of spinal cord stimulation for relief of chronic back and extremity pain.

STUDY DESIGN: This prospective, multicenter study was designed to investigate the efficacy and outcome of spinal cord stimulation using a variety of clinical and psychosocial outcome measures. Data were collected before implantation and at regular intervals after implantation. This report focuses on 70 patients who had undergone 1 year of follow-up treatment at the time of data analysis. OBJECTIVES: To provide a more generalizable assessment of long-term spinal cord stimulation outcome by comparing a variety of pain and functional/quality-of-life measures before and after management. This report details results after 1 year of stimulation. SUMMARY OF BACKGROUND DATA: The historically diverse methods, patient selection criteria, and outcome measures reported in the spinal cord stimulation literature have made interpretation and comparison of results difficult. Although short-term outcomes are generally consistent, long-term outcomes of spinal cord stimulation, as determined by prospective studies that assess multidimensional aspects of the pain complaint among a relatively homogeneous population, are not well established. METHODS: Two hundred nineteen patients were entered at six centers throughout the United States. All patients underwent a trial of stimulation before implant of the permanent system. Most were psychologically screened. One hundred eighty-two patients were implanted with a permanent stimulating system. At the time of this report, complete 1-year follow-up data were available on 70 patients, 88% of whom reported pain in the back or lower extremities. Patient evaluation of pain and functional levels was completed before implantation and 3, 6, 12, and 24 months after implantation. Complications, medication usage, and work status also were monitored. RESULTS: All pain and quality-of-life measures showed statistically significant improvement during the treatment year. These included the average pain visual analogue scale, the McGill Pain Questionnaire, the Oswestry Disability Questionnaire, the Sickness Impact Profile, and the Back Depression Inventory. Overall success of the therapy was defined as at least 50% pain relief and patient assessment of the procedure as fully or partially beneficial and worthwhile. Using this definition, spinal cord stimulation successfully managed pain in 55% of patients on whom 1-year follow-up is available. Complications requiring surgical intervention were reported by 17% (12 of 70) of patients. Medication usage and work status were not changed significantly. CONCLUSIONS: This prospective, multicenter study confirms that spinal cord stimulation can be an effective therapy for management of chronic low back and extremity pain. Significant improvements in many aspects of the pain condition were measured, and complications were minimal.

Adult↗
PubMed1994

A multicenter study on hip fractures in Thailand.

The present study is a multicenter study on hip fractures aimed at estimating the incidence among Thais. It also describes treatment modalities, associated medical care costs, complications, outcome of orthopedic care, length of stay in hospitals and duration of delay in seeking orthopedic care after occurrence of fractures. An extremely low hip fracture incidence of 7.05 per 100,000 population was found. Hip fracture was shown to increase steeply with age. An average of 26.44 days of delay in seeking orthopedic care following occurrence of hip fractures was reported. In contrast to the belief in Western countries that almost all hip fractures will seek orthopedic care, 7.8 per cent of these Thai cases denied orthopedic care during admission to hospitals. Median of charge to patients was 11205.00 baht, over one fourth of the national income per capita (36,563).

Age Distribution↗
PubMed1995

Transvaginal ultrasonography of the endometrium in women with postmenopausal bleeding--a Nordic multicenter study.

OBJECTIVE: The purpose of this study was to use transvaginal ultrasonographic measurements to find the thickness of the endometrium below which the risk of endometrial abnormality in women with postmenopausal bleeding is low. STUDY DESIGN: This multicenter study was carried out at eight clinics in four Nordic countries. The study included 1168 women with postmenopausal bleeding scheduled for curettage Before the curettage was performed, the thickness of the endometrium was measured with transvaginal ultrasonography. The measurement included both endometrial layers (double-layer technique). The transvaginal ultrasonographic measurement was compared with the histopathologic diagnosis of the curettage specimens. RESULTS: In women with atrophic endometrium the mean endometrial thickness (+/- SD) was 3.9 +/- 2.5 mm. The corresponding figures for women with endometrial cancer were 21.1 +/- 11.8 mm. No malignant endometrium was thinner than 5 mm. In 30 women (2.8%) it was not possible to measure the thickness of the endometrium; one of these women had endometrial cancer. The 95% confidence limit for the probability of excluding endometrial abnormality was 5.5% when the endometrial thickness was < or = 4 mm as measured by transvaginal ultrasonography. CONCLUSION: The risk of finding pathologic endometrium at curettage when the endometrium is < or = 4 mm as measured by transvaginal ultrasonography is 5.5%. Thus in women with postmenopausal bleeding and an endometrium < or = 4 mm it would seem justified to refrain from curettage.

Adult↗
PubMed1993

Multicenter study of single-dose and multiple-dose fleroxacin versus ciprofloxacin in the treatment of uncomplicated urinary tract infections.

The clinical efficacy and safety of single-dose and multiple-dose fleroxacin were assessed and compared with those of ciprofloxacin in women with uncomplicated urinary tract infection (UTI) in this clinical study. This multicenter, randomized, double-blind, prospective study compared single-dose therapy with fleroxacin, 400 mg, with 7-day courses of fleroxacin, 200 mg once a day, and ciprofloxacin, 250 mg twice a day, in the treatment of uncomplicated symptomatic UTI in women at 18 centers in the United States. Of 961 patients enrolled, 316 were in the fleroxacin single-dose group, 321 in the fleroxacin 7-day group, and 324 in the ciprofloxacin group. Of these patients, 943 met the criteria for inclusion in the safety analysis and 556 met those for inclusion in the efficacy analysis. Bacteriologic cure rates at 5-9 days after therapy in patients evaluable for efficacy were 88%, 96%, and 96% in the single-dose fleroxacin group, 7-day fleroxacin group, and 7-day ciprofloxacin group, respectively (p < 0.05). Clinical cures occurred in 93.6%, 97.2%, and 98% of the groups, respectively (difference not significant). At 4-6 weeks after therapy, the rates of bacteriologic cure in the single-dose fleroxacin group, 7-day fleroxacin group, and 7-day ciprofloxacin group were 91%, 89%, and 93%, respectively (difference not significant). Adverse events were similar to those with other new quinolones and comparable among the treatment groups. Insomnia was more frequent in patients who received fleroxacin. Fleroxacin and ciprofloxacin as multidose regimens are similarly safe and effective in the treatment of uncomplicated UTI in women. Single-dose fleroxacin achieved a clinical response rate comparable to that achieved by the multiple-dose regimens, whereas its bacteriologic eradication rate was inferior.

Adolescent↗
PubMed1999

Identification of sentinel lymph nodes in vulvar carcinoma patients with the aid of a patent blue V injection: a multicenter study.

BACKGROUND: The aim of this multicenter study was to investigate the feasibility and negative predictive value of sentinel lymph node detection with blue dye in vulvar carcinoma patients. METHODS: In patients with squamous cell carcinoma of the vulva without suspicious groin lymph nodes, patent blue V was injected intradermally shortly before surgery. Routine groin lymph node dissection and radical vulvectomy were performed. During the surgery, blue lymph vessels and lymph nodes were identified, and the blue lymph nodes were sent separately for histologic examination. The negative predictive value of the blue lymph nodes for the absence of metastases was assessed by histologic examination of the groin lymph node specimens. RESULTS: Fifty-one patients in whom 93 groin lymph node dissections were performed were entered. One or more blue lymph nodes were detected in only 52 groins (56%). Nine (17%) of these were tumor positive, and 6 blue lymph nodes were the only tumor positive lymph nodes in the specimen in which they were found. There were two false-negative blue lymph nodes. The negative predictive value was 0.953. CONCLUSIONS: It was shown in this multicenter study that sentinel lymph node detection in vulvar carcinoma patients with blue dye only is not feasible because its negative predictive value is too low. Further studies involving the use of a combination of radioactive labeled technetium and blue dye are warranted.

Adult↗
PubMed1999

Probucol for treatment of hyperlipidemia in persistent childhood nephrotic syndrome. Report of a prospective uncontrolled multicenter study.

In a prospective, uncontrolled multicenter study, we have evaluated the effects of probucol on hyperlipidemia, proteinuria, and glomerular filtration rate (GFR) in hyperlipidemic children with persistent nephrotic syndrome. Probucol was started for a total of 12 weeks in 8 children and for 24 weeks in 14 children. Lipoprotein profiles, serum malondialdehyde (MDA) levels, proteinuria, renal function, and electrocardiogram were monitored every 4 weeks. Side effects were recorded by questionnaire. Treatment was completed by 7 of 8 patients for 12 weeks and by 7 of 14 children for 24 weeks. After 12 weeks, the mean serum concentrations of triglycerides (-15%), total cholesterol (-25%), very low-density lipoprotein-cholesterol (-27%), low-density lipoprotein-cholesterol (-23%), and high-density lipoprotein-cholesterol (-24%), as well as apolipoprotein (apo) A-I (-19%), apo B (-21%), and MDA (-32%) were reduced. The positive effects of probucol on the lipoprotein profile persisted over 24 weeks; however, there was no significant effect on either proteinuria or GFR. In conclusion, probucol had beneficial effects on lipoproteins and lipid peroxidation, but improved neither proteinuria nor GFR. The drug was generally tolerated well, but had to be discontinued because of a prolonged QT interval in 4 of 22 patients.

Adolescent↗
PubMed2000

Endovascular-assisted versus conventional in situ saphenous vein bypass grafting: cumulative patency, limb salvage, and cost results in a 39-month multicenter study.

OBJECTIVE: In this retrospective multicenter study, the results of a minimally invasive method of endovascular-assisted in situ bypass grafting (EISB) versus "open" conventional in situ bypass grafting (CISB) were evaluated with a comparison of primary and secondary patency, limb salvage, and cost. METHODS: Enrolled in this study were 273 patients: 117 underwent CISB (42 femoropopliteal, 75 femorocrural) and 156 underwent EISB (41 femoropopliteal, 115 femorocrural). EISB was performed with an angioscopic Side Branch Occlusion system and an angioscopically guided valvulotome. All the patients underwent follow-up examination with serial color-flow ultrasound scanning. RESULTS: Both groups had similar comorbid risk factors for diabetes mellitus, coronary artery heart disease, hypertension, and cigarette smoking. The primary patency rates (CISB, 78.2% +/- 5% [SE]; EISB, 70.5% +/- 5%; P =.156), the secondary patency rates (CISB, 84.1% +/- 4%; EISB, 82.9% +/- 5%; P =.26), and the limb salvage rates (CISB, 85.8%; EISB, 88.4%; P =.127) were statistically similar, with a follow-up period that extended to 39 months (mean, 16.6 months; range, 1 to 40 months). In veins that were less than 2.5 to 3.0 mm in diameter, the EISB grafts fared poorly, with an increased incidence of early (12-month) graft thromboses (CISB, 10 grafts, 8.5%; EISB, 24 grafts, 15.3%). However, wound complications (CISB, 23%; EISB, 4%; P =.003), mean hospital length of stay (CISB, 6.5 days +/- 4.83; EISB, 3.2 days +/- 3.19; P =.001), and mean hospital charges (CISB, $25,349 +/- $19,476; EISB, $18,096 +/- $14,573; P =.001) were all significantly reduced in the EISB group. CONCLUSION: The CISB and EISB midterm primary and secondary patency and limb salvage rates were statistically similar. In smaller veins (< 2.5 to 3.0 mm in diameter), however, EISB is not appropriate because overly aggressive instrumentation may cause intimal trauma, with resultant early graft failure. With the avoidance of a long leg incision in the EISB group, wound complications and hospital length of stay were significantly reduced, which lowered hospital charges and justified the additional cost of the endovascular instruments. When in situ bypass grafting is contemplated, EISB in appropriate patients is a safe, minimally invasive, and cost-effective alternative to CISB.

Aged↗
PubMed1989

Clinical experience with ciprofloxacin: analysis of a multicenter study.

The authors report a multicenter study of 19 patients treated with ciprofloxacin (mean daily dosage, 972 mg per day; mean duration of treatment, 8.5 days) for a variety of infections, ten microbiologically proven. Of these, bacteriologic cure equaled 70%, and improvement 30%. Overall, clinical cure equaled 73.7%, while improvement was 15.8%. No infections were classified as chronic. One adverse reaction was noted; a case of severe vomiting classified as related definitely to ciprofloxacin therapy. The patient discontinued therapy.

Adolescent↗
PubMed1987

Efficacy of nifedipine gastrointestinal therapeutic system in combination with beta blockers in the management of exertional angina. A multicenter study of 54 patients.

This multicenter study assessed the efficacy of a new formulation of nifedipine in 54 patients with stable angina pectoris receiving beta-blocker therapy. This once-daily preparation of nifedipine was administered in double-blind fashion in doses of 30, 60, and 90 mg. All patients experienced pain-limited exercise at placebo baseline treadmill testing. Eight hours post-dose exercise testing resulted in a significant increase in time to onset of angina for all three dose levels of nifedipine but not for placebo. Exercise testing 24 hours after dosing showed significant improvement in time to angina and total exercise time for patients receiving 60-mg and 90-mg doses but not for the 30-mg or placebo categories. These preliminary results suggest that this new formulation of nifedipine is beneficial when added to stable doses of a beta blocker in patients in whom angina is still exhibited during exercise testing.

Adrenergic beta-Antagonists↗
PubMed1986

The prognosis of transient global amnesia. Results of a multicenter study.

In a Danish multicenter study, 74 patients 20 to 75 years of age (mean age, 58.8 years) with transient global amnesia (TGA) without accompanying major neurological signs were studied. Over a follow-up period ranging from seven to 210 months (mean, 66.6 months) the observed rates of death and cerebrovascular morbidity were similar to those expected in the Danish population, matched for age and sex. Sixteen patients (22%) had further TGAs occurring one month to nine years after the original episode; the mean annual recurrence rate was 4.7%. We concluded that TGA without associated major neurological deficits is a benign clinical phenomenon, probably caused by a functional cerebral disturbance unrelated to cerebrovascular disease in general. Furthermore, the observed temporal pattern of recurrence suggests that, although TGA is in principle a recurrent disorder, the annual risk of recurrence is so low that most of the elderly patients are likely to experience only one attack.

Adult↗
PubMed1988

Intravenous immunoglobulin (i.v. IgG) for previously treated acute or for chronic idiopathic thrombocytopenic purpura (ITP) in childhood: a prospective multicenter study.

In a prospective multicenter study 42 thrombocytopenic (less than 30 X 10(9) platelets/l) children with chronic idiopathic thrombocytopenic purpura (ITP) or with acute ITP, dependent on or refractory to corticosteroids, were given 0.4 g i.v. IgG/kg body weight/day on 5 consecutive days and thereafter once a week if the platelet count fell to less than 20 X 10(9)/l or if the patient bled. After the initial 5 days of i.v. IgG the platelets rose within a mean of 7-8 days to greater than 30 X 10(9)/l in all and to greater than 150 X 10(9)/l in 33 of 42 patients (79%). After a mean observation time of 26.6 months 26 of 42 patients (62%) showed a satisfactory long-term effect, i.e. no need for treatment for at least 6 months without bleeding and with no platelet counts below 20 X 10(9)/l. No difference in response rate was found between children with chronic and those with previously treated acute ITP. These results indicate that i.v. IgG could be used to control emergency situations, e.g. to stop bleeding or to prepare a patient for surgery. I.v. IgG also represents a good alternative to treatment modalities, such as splenectomy and/or the administration of cytostatic immunosuppressants with potentially serious side effects. In addition to the expected transient rise in serum IgG levels, i.v. IgG induced a more prolonged elevation of serum IgM. Platelet associated IgG, elevated before therapy, was correlated with the clinical long-term outcome.

Acute Disease↗
PubMed1996

Trajectories and profiles of adaptive behavior in males with fragile X syndrome: multicenter studies.

We conducted two multicenter studies on adaptive trajectories and profiles in males with fragile X syndrome. Study 1 longitudinally assessed 29 males ages 1-20 years using age-equivalent scores from the Vineland Adaptive Behavior Scales. Fragile X boys ages 1-10 years showed significant gains in adaptive skills from first to second testing; males ages 11-20 years were stable in their adaptive development. Study 2 cross-sectionally examined 132 males ages 1-20 years. Significant age-related gains were found in boys ages 1-10, particularly in preschool children. Subjects ages 11-20 showed increased variability and nonsignificant relations between age and adaptive skills. Preliminary findings from 26 young adults with fragile X syndrome ages 21-40 years showed stable age-equivalent adaptive scores during these years. Relative strengths in daily living skills and weaknesses in communication were only evident among older subjects. Significant relations were found between adaptive behavior standard scores and IQ; these two scores also showed age-related declines that likely parallel one another. Findings are related to adaptive features in other genetic syndromes, and to directions for future adaptive behavior research.

Activities of Daily Living↗
PubMed1986

Cardiovascular complications of estrogen therapy for nondisseminated prostatic carcinoma. A preliminary report from a randomized multicenter study.

In a prospective multicenter study, 244 men with highly or moderately differentiated prostatic cancer in stage I, II or III (VACURG) were consecutively randomized to three groups of treatment: Group A (77 patients) received polyestradiol phosphate (Estradurin, Leo) 80 mg i.m. every fourth week + ethinyl estradiol (Etivex, Leo) 150 micrograms daily, group B (72 patients) estramustine phosphate (Estracyt, Leo) 280 mg twice daily, and group C (76 patients) no therapy. Only men without current or previous other malignancy and without cardiovascular disease were admitted to the study. After 4 1/2 years 125 of the 244 patients had left the study, 9 because of cancer progression (stage IV, VACURG). The most serious complications were cardiovascular, including ischemic heart disease, cardiac decompensation, cerebral ischemia and venous thromboembolism, which occurred in 24 patients from group A and 9 from group B as compared to only one patient in group C. The subgroup superficial or deep venous thrombosis comprised 11 group A and 2 group B patients. Estrogens (E + e) offered as palliative treatment to patients with non-generalized prostatic carcinoma is burdened with a high incidence of serious cardiovascular complications.

Aged↗
PubMed1995

[Postoperative complications and fatalities in surgical therapy of colon carcinoma. Results of the German multicenter study by the Colorectal Carcinoma Study Group].

In a prospective multicenter study an analysis of postoperative morbidity and mortality of 1224 patients with colon carcinoma treated in 7 departments of surgery was performed. The postoperative morbidity rate was 23.2% in elective surgery and 39.1% in emergency surgery. Postoperative mortality was 3.4% in elective cases and 11.6% in emergency cases. Preoperative associated diseases, which are more frequent in higher age, advanced tumor stage, and postoperative non-surgical complications rise operative mortality. However, surgical complications increase postoperative mortality only in cases of anastomotic leaks. The rates of postoperative complications depended on different surgical departments. Departments performing a delayed tumor resection in emergency surgery had better results. In elective cases the standard of oncological resections should be observed. In emergency cases operative procedure and extension of the resection should be planed in consideration of preoperative risk factors of the individual patient.

Adult↗