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Results for “Randomized controlled trial”

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PubMed2026

Comparing the efficacy of chlorhexidine and povidone-iodine for surgical site disinfection: a systematic review and meta-analysis from randomized controlled trials.

BACKGROUND: Randomized controlled trials report conflicting evidence on the efficacy of different skin disinfectants for preventing surgical site infection (SSI). METHODS: We systematically searched PubMed, Web of Science, Cochrane Library, and Embase for RCTs published up to February 2025 comparing preoperative skin disinfection with povidone-iodine (PVI) versus chlorhexidine (CH). Primary outcomes were overall, superficial, deep, and organ/space SSI rates. Secondary outcomes included hospital stay, readmission, and reoperation. RESULTS: CH was superior to PVI in preventing overall SSI (26 studies, n = 29,356; RR: 0.89; 95% confidence interval [CI]: 0.80 to 0.99). The overall SSI incidence rate in the CH group was 7.1% (1,045/14,677), compared with 7.8% (1,152/14,679) in the PVI group, equating to an 11% reduction in relative risk and a 0.7% reduction in absolute risk. The number needed to treat to prevent one SSI was 143. CH demonstrated superiority over PVI in preventing superficial SSI (13 studies, n = 16,867; RR: 0.77; 95% CI: 0.64 to 0.92), but not for deep SSI (11 studies, n = 15,842; RR: 1.00; 95% CI: 0.77 to 1.29) or organ SSI (9 studies, n = 9,471; RR: 1.17; 95% CI: 0.89 to 1.53). No significant differences were found in hospital stay, readmission, or reoperation rates between the two groups. CONCLUSION: CH demonstrates statistical superiority over PVI in preventing overall and superficial SSI, though the absolute clinical benefit is modest. No significant differences were observed for deep or organ/space SSI, nor for secondary outcomes including hospital length of stay, readmission, or reoperation rates.

Humans↗

PubMed1988

Fine catheter peritoneal cytology for the acute abdomen: a randomized, controlled trial.

A randomized, controlled clinical trial, of sequential design, was undertaken to determine whether fine catheter aspiration cytology of the peritoneal cavity, using the percentage of neutrophils in the sample as the main test marker, reduces errors about urgent laparotomy in patients admitted to a surgical unit with acute abdominal pain. One hundred and forty-four patients with acute abdominal pain were studied. Of these, 26 were excluded because the test was unlikely to be useful and 20 did not consent. Conventional clinical assessment was undertaken and then the subjects were randomly allocated to have a peritoneal cytology test or not. After the test result was made available, the surgeon(s) decided whether to operate or continue conservative treatment. The correct decision was later ascertained by a blinded clinical referee. With the entry of the 98th patient the difference between the groups achieved the 5% significance level. The groups were well-matched in regard to demographic and other variables. The decision about urgent laparotomy was incorrect in only 8.2% of the test patients, compared with 28.6% of the others. It is concluded that fine catheter aspiration cytology of the peritoneal cavity is likely to reduce the numbers of unnecessary or delayed laparotomies when used in most patients admitted with acute abdominal pain.

Abdomen, Acute↗

PubMed1987

Is pyloroplasty necessary in esophageal replacement by stomach? A prospective, randomized controlled trial.

A randomized, prospective, controlled trial compared the use of pyloroplasty (study group) with nonuse of the procedure (control group) in the treatment of 72 patients with carcinoma of the thoracic esophagus. In these patients, transthoracic esophagectomy was performed, and the whole stomach was used for reconstruction in the right side of the chest. No complications due to the pyloroplasty developed in any of the patients who underwent this procedure. Gastric emptying tests that were performed at the sixth postoperative month in 37 patients demonstrated a prolongation of emptying time in the control group (p less than 0.01). The patients' symptoms, however, did not correlate well with gastric emptying time. Follow-up assessment showed that a higher proportion of patients who did not undergo pyloroplasty suffered from symptoms of incomplete emptying while eating, but the difference was not statistically significant. Moreover, the proportion of patients who were free of postoperative symptoms gradually increased in both groups and reached 100% in the study group and 89% in the control group at 2 years. In the control group, two of the three patients with prolonged gastric emptying time complained of persistent regurgitation and distending discomfort after meals (18 and 24 months after surgery). They were the only two patients who might have benefited from a drainage procedure at the initial operation. Since there apparently were no reliable operative criteria by which to identify patients who might require drainage, and since the risk associated with pyloroplasty was negligible, it would seem reasonable to perform a pyloroplasty on every patient in whom the whole stomach was used for reconstruction after esophagectomy. This procedure would benefit the few patients who might manifest symptomatic gastric stasis.

Adult↗

PubMed1990

Role of pyloroplasty in the retrosternal stomach: results of a prospective, randomized, controlled trial.

A prospective, randomized, controlled trial comparing clinical outcome and emptying of a solid meal from the retrosternal stomach, with and without pyloroplasty is described. Forty consecutive patients with oesophageal cancer undergoing retrosternal gastric reconstruction of the oesophagus were studied. In 20 patients the pylorus was left intact (group 1) and 20 patients underwent an Aust pyloroplasty (group 2). Nine patients in group 1 suffered postoperative symptoms of gastric stasis compared with only one patient in group 2 (P = 0.0106). Three patients in group 1 died from aspiration pneumonia before discharge from hospital. A gastric emptying test was performed on 24 patients between 1 and 3 months after surgery. By this time, most survivors had recovered from symptoms attributed to gastric stasis and no significant difference in gastric emptying could be demonstrated between the two groups. Selection of patients, a wide range of emptying times and improvement in gastric emptying on follow-up may explain the lack of correlation between postoperative symptomatology and the gastric half-emptying times. A pyloroplasty is advised to prevent the potentially lethal effects of gastric stasis in the early postoperative period following retrosternal reconstruction of the oesophagus.

Adult↗

PubMed1991

Insulin and glucagon infusion in acute alcoholic hepatitis: a prospective randomized controlled trial.

In a randomized, controlled trial to investigate the possible benefit of insulin and glucagon therapy in severe acute alcoholic hepatitis, 86 patients were randomized to receive 30 U insulin and 3 mg glucagon in 250 ml 5% dextrose over 12 hr each day for 3 wk or a similar regime of identical placebo. No significant differences were seen in patients' clinical characteristics and disease severity in the treated and placebo groups. Of the 43 patients receiving insulin and glucagon, 15 (35%) died within 4 wk of randomization, compared with 14 deaths (33%) in the control patients (p = not significant). When the patients surviving the first 4 wk were examined there were five more deaths in the treatment group, compared with one death in the control group at 6-mo follow-up (p = not significant). No significant differences in the frequency of short-term or long-term complications of alcoholic liver disease or relapse to alcohol were seen when the two groups were compared, although hypoglycemia was seen in six patients during infusion of insulin and glucagon. Similarly, no significant differences were seen in the improvement in clinical or biochemical features at 4 wk and at 6 mo in survivors when the insulin and glucagon-treated patients were compared with patients in the placebo group. This study does not confirm previous reports that insulin and glucagon infusion improves the outcome of severe acute alcoholic hepatitis.

Acute Disease↗

PubMed1975

Proximal gastric vagotomy: interim results of a randomized controlled trial.

In a randomized controlled trial 50 patients with duodenal ulcer treated by proximal gastric vagotomy (P.G.V.) without drainage were compared with 50 who underwent selective vagotomy and gastrojejunostomy. The clinical results were assessed in 99 patients one to four years after operation. Patients who had undergone P.G.V. had significantly less dumping, nausea, and bile vomiting and fared better in their overall clinical grading. The postoperative Visick grading of the 50 patients with P.G.V. was similar to that of 56 controls with no known gastrointestinal disease who had not undergone operation. The results obtained in the patients who had had P.G.V. without drainage were compared with those of a further group of 24 patients subjected of P.G.V. with gastrojejunostomy, and the better results obtained in the former group were thought to be due to elimination of the drainage procedure. The average follow-up period of the trial was just over two years, but there were no indications that the recurrent ulceration rate after P.G.V. would be any higher than after other types of vagotomy and drainage.

Adult↗

PubMed1986

Alcohol and high-density-lipoprotein cholesterol: a randomized controlled trial.

1. A randomized controlled trial of cross-over design was set up to examine the effect of alcohol on blood lipids and certain haematological variates relevant to ischaemic heart disease. 2. One hundred subjects drank some alcohol for 4 weeks (mean intake 18.4 g/d) and abstained totally for 4 weeks, the order of these periods being randomized. 3. Alcohol appeared to produce a rise of 7% in serum high-density-lipoprotein (HDL) cholesterol, probably due to a rise in the HDL2 subfraction. 4. No significant change was detected in plasma fibrinogen or the other haematological indices. 5. These results are consistent with the hypothesis that a moderate intake of alcohol confers some protection against heart disease.

Adult↗

PubMed1991

Elevation of serum progesterone with oral micronized progesterone after in vitro fertilization. A randomized, controlled trial.

In a randomized, controlled trial, oral micronized progesterone (P4) supplementation effectively elevated luteal phase serum P4 levels after in vitro fertilization (IVF). Of 34 nonconception IVF cycles, 12 were supplemented with oral micronized P4, 200 mg four times daily, beginning the day of oocyte retrieval, while 22 control cycles did not receive supplementation. With oral micronized P4 supplementation the P4 levels were higher (P less than .001) and the luteal phase longer (P less than .05). Oral micronized P4 supplementation appears to be a convenient method of supporting serum P4 levels during the luteal phase after IVF.

Administration, Oral↗

PubMed1986

Early physical therapy effects on the high-risk infant: a randomized controlled trial.

A prospective, randomized, controlled trial was conducted to assess the effects of early physical therapy on infants at risk for neurologic sequelae and to evaluate the impact of such early treatment on the prevention or minimization of future handicaps. A cohort of 134 infants who had received care in two Montreal inborn neonatal intensive care units was identified prospectively. Infants were stratified according to prognosis and birth weight and were randomly assigned to either an experimental or control group. Babies assigned to the experimental group received early physical therapy, whereas those allocated to the control group received conventional follow-up care. Outcome measures were administered by independent evaluators at 12 months and included measures of neurologic status, motor and overall development, and physical growth. No statistically significant differences on any of the measured outcomes at 12 months were found between the experimental and control groups. Infants weighing less than 750 g at birth, regardless of group assignment, consistently demonstrated significant delays in their growth and development when compared with their heavier peers. The early physical therapy program investigated in this study was not efficacious in altering the pattern of motor development in those high-risk infants participating in the trial.

Analysis of Variance↗

PubMed2026

Short-term aerobic exercise as an adjunct treatment for depression in acute geriatric psychiatry: Results of a randomized controlled trial.

BACKGROUND: This randomized controlled trial examined whether short-term aerobic exercise provided additional clinical benefit over an active control in older inpatients with depression in geriatric psychiatry. METHODS: 100 patients (mean age 76 years) were randomized to 2-week supervised aerobic ergometer training (intervention group, IG) or a flexibility program (control group, CG), both delivered in addition to treatment as usual (TAU). Adherence, training exposure and adverse events were recorded to assess feasibility. The primary outcome was clinical improvement measured with the Clinical Global Impression of Change (CGI). Secondary outcomes included depressive symptom severity assessed by the Beck Depression Inventory-II (BDI-II) and clinician-rated Hamilton Rating Scale for Depression (HAMD), physical activity, 6-min walk test (6MWT) performance, and fluoxetine-equivalent antidepressant dose (FLX). RESULTS: Thirty-nine participants attended at least 80% of sessions, with lower adherence in the IG. Weekly training duration differed between groups (74.0 ± 31.9 vs. 95.0 ± 25.3 min/week, p = .003). CGI did not differ between groups (IG: MD -0.31, 95% CI -0.67 to 0.05; p = .069). Depressive symptom severity decreased over time in both groups (p < .001), without significant between-group differences for HAMD (MD -0.22, 95% CI -2.55 to 2.12) or BDI-II (MD -0.62, 95% CI -3.68 to 2.45). 6MWT and FLX increased over time (both p < .001), without group differences (6MWT: MD -1.08 m, 95% CI -20.04 to 17.89; FLX: MD 5.69 mg/day, 95% CI -2.40 to 13.77). CONCLUSION: Short-term aerobic exercise was deliverable, but showed no additional clinical benefit over low-intensity flexibility during TAU. Further research should determine dose, duration and adherence for clinically relevant effects.

Humans↗

PubMed1991

Benefit of a stroke unit: a randomized controlled trial.

In a randomized controlled trial we compared the clinical outcome of acute stroke patients, 110 of whom were allocated to treatment in a stroke unit and 110 to treatment in general medical wards. No significant difference existed between these groups with regard to sex, age, marital status, medical history, or functional impairment on admission. Outcome was measured at 6 and 52 weeks after the stroke by the proportion of patients at home, the proportion of patients in an institution, the mortality, and the functional state. After 6 weeks 56.4% of the patients randomized to the stroke unit and 32.7% of the patients randomized to the general medical wards were at home (p = 0.0004), and after 52 weeks 62.7% and 44.6%, respectively, were at home (p = 0.002). After 6 weeks 36.3% of the patients from the stroke unit and 50.0% from the general medical wards were in an institution (p = 0.02); after 52 weeks 12.7% and 22.7%, respectively, were institutionalized (p = 0.016). After 6 weeks mortality was 7.3% for the stroke unit group and 17.3% for the general medical wards group (p = 0.027). After 52 weeks mortality was 24.6% for the stroke unit group and 32.7% for the general medical wards group (difference not significant). Functional state was significantly better for patients treated in the stroke unit after both 6 and 52 weeks. We conclude that care of patients with acute stroke in a stroke unit improves clinical outcome compared with treatment in general medical wards.

Cerebrovascular Disorders↗

PubMed2026

Effects of free-weight resistance training based on hexagonal barbell deadlift in older women: A 24-week randomized controlled trial.

PURPOSE: This randomized controlled trial examined effects of a 24-week hexagonal barbell deadlift (HBDL)-based free-weight resistance training program on body composition, trunk muscle function, and functional performance in older women. METHODS: Thirty-two women (67.6 ± 6.3 years) were randomly assigned to an HBDL group (DG, n = 16) or control group (CG, n = 16). DG trained twice weekly for 24 weeks under supervision. Primary outcomes were body composition and isokinetic trunk peak torque and average power at 60°/s and 120°/s. Secondary outcomes were isokinetic knee function, mobility, and maximal isotonic strength. Between-group differences after the intervention were examined by analysis of covariance (α = 0.05). RESULTS: After intervention, DG showed greater trunk lean mass (+0.4 kg vs. -0.2 kg, p = 0.006) than CG, and reductions in body fat percentage (-1.4% vs. +0.3%, p = 0.003), total fat mass (-1.1 kg vs. +0.3 kg, p = 0.013), and regional fat mass (trunk, gluteal, thigh; all p < 0.05). Trunk extensor peak torque at 60°/s (+26.0% vs. -6.3%, p < 0.001) and average power at 60°/s (+38.1% vs. -7.6%, p < 0.001) and 120°/s (+33.2% vs. +0.1%, p = 0.002) improved significantly. DG also showed better eyes-closed static balance and 6-min walk performance (both p < 0.05). Whole-body lean mass and lower-limb isokinetic strength did not differ between groups. Attendance was 89.6% with no adverse events. CONCLUSION: HBDL-based free-weight resistance training is a safe, feasible, and effective strategy to improve body composition, trunk extensor function, and mobility in older women.

Humans↗

PubMed1992

Erythropoietin treatment in allogeneic BMT accelerates erythroid reconstitution: results of a prospective controlled randomized trial.

Twenty-eight allogeneic BMT patients (16 with acute leukemia, 12 with chronic myeloid leukemia) were included in a single center, prospective, randomized, controlled trial to assess the value of recombinant human erythropoietin (rh-Epo) in this setting. rh-Epo was administered through a central venous catheter as a single bolus injection (days 0-7: 100 U/kg/d; days 7-30: 150 U/kg/d). No secondary effects to rh-Epo treatment were detected. An earlier appearance of reticulocytes and a diminished need of red blood cells (RBCs) transfusions were observed in patients who were treated with rh-Epo (4 units vs 12 units; p < 0.05). The time to unsupported platelets above 25 x 10(9)/l was less in patients treated with rh-Epo than in control patients (19 days vs 31; p < 0.05), and they received significantly fewer platelet transfusions (36 units vs 138.5; p < 0.05). Our results show that rh-Epo treatment is capable of accelerating the erythroid reconstitution and decreasing the need for RBC transfusions. A beneficial effect on platelet reconstitution is also suggested, but further studies are necessary to confirm this point.

Adolescent↗

PubMed1975

A controlled, randomized trial of highly selective vagotomy versus selective vagotomy and pyloroplasty in the treatment of duodenal ulcer.

The results of highly selective vagotomy without drainage and selective vagotomy with pyloroplasty for duodenal ulcer were compared in a randomized, controlled trial of a series of 100 patients. The frequency of dumping, diarrhoea, and epigastric fullness was significantly lower after highly selective (6, 6, and 8 percent) than after selective vagotomy (30, 20, and 28 percent) one year after the operations. Recurrent and persisting duodenal ulcers appearing from one to four years after the operations were significantly more frequent after highly selective (22 percent) than after selective vagotomy (8 percent). No significant relationships were found between recurrent ulceration and gastric acid secretion measurements after the two operations. The Hollander response was early positive in 28 percent and late positive in 30 percent of the patients subjected to highly selective vagotomy, while the corresponding figures after selective vagotomy were 26 and 32 percent. The overall clinical results of the two operations were not different according to the classification of Visick. Excluding the patients with recurrence resulted in significantly better clinical results after highly selective vagotomy.

Adult↗

PubMed1989

Efficacy of an attachable subcutaneous cuff for the prevention of intravascular catheter-related infection. A randomized, controlled trial.

We performed a randomized controlled trial of an attachable subcutaneous cuff for the prevention of central vascular catheter-related infection among patients receiving intensive care. Catheters were placed percutaneously into new sites with or without a cuff and were dressed with polyantibiotic ointment containing polymyxin, neomycin, and bacitracin. Microbial colonization developed in 34.5% of 29 control and 7.7% of 26 cuffed catheters. Catheter-related bloodstream infection occurred with 13.8% of control vs 0% of cuffed catheters. The cuff was not associated with adverse effects. An unexpectedly large proportion (75%) of catheter infections were due to Candida albicans. This may have been due, in part, to the use of polyantibiotic ointment, as suggested by a pooled analysis of previous trials that demonstrated increased Candida colonization of catheters with the ointment, which is not fungicidal. These data suggest that the cuff can reduce the incidence of catheter-related infection among high-risk patients receiving catheter site care with an antibacterial ointment.

Adult↗

PubMed2026

Understanding randomized controlled trial generalizability through an embedded molecular diagnostics trial.

BACKGROUND: Issues with randomized controlled trial generalizability are well described, but whether these issues result from differences in patient treatment across contexts remains unknown. We studied treatment of patients with high-risk prostate cancer after radical prostatectomy inside and outside a randomized controlled trial evaluating the impact of a genomic classifier on post-radical prostatectomy treatment decision making (Genomics in Michigan Impacting Observation of Radiation [G-MINOR]; ClinicalTrials.gov identifier NCT02783950). METHODS: G-MINOR enrolled 338 patients; propensity score-matched eligible but unenrolled patient cohorts (pretrial and trial contemporary) from the Michigan Urological Surgery Improvement Collaborative (MUSIC), in which the trial was embedded, were compared for rates and time to secondary treatment (adjuvant or salvage therapy) after prostatectomy. RESULTS: Among 338 patients in the G-MINOR cohort, 69 (31 adjuvant, 38 salvage) received secondary treatment compared with 266 (183 adjuvant, 83 salvage) and 104 (60 adjuvant, 44 salvage) in the 1014 contemporary and 338 pretrial-matched MUSIC cohorts. Time to secondary treatment was much shorter in the MUSIC cohort across all comparisons. For example, matching G-MINOR to synchronous MUSIC patients demonstrated 84% vs 74% estimated 2-year treatment-free survival for trial and real-world patients, respectively (P < .001). CONCLUSIONS: Controlling for key clinicopathologic factors, patients in the G-MINOR randomized controlled trial and MUSIC cohorts were treated differently, even after stratifying by genomic risk. These findings suggest that challenges in randomized controlled trial generalizability extend beyond the representativeness of trial participants. Differences in management may also explain why divergent patient outcomes are observed in randomized controlled trials vs real-world settings.

Aged↗

PubMedDate not supplied

Endoscopic sclerosis and esophageal balloon tamponade in acute hemorrhage from esophagogastric varices: a prospective controlled randomized trial.

A prospective randomized controlled clinical trial was performed in 43 consecutive histologically proved cirrhotic patients with endoscopically proved actively bleeding esophageal varices. Twenty-two were randomly selected to have esophageal tamponade with the Sengstaken-Blakemore tube, and 21 were selected to have endoscopic sclerosis of the esophageal wall. The two groups were similar in demographic, clinical and laboratory data. Bleeding was controlled by the Sengstaken-Blakemore tube in 16 of 22 patients (73%) and by endoscopic sclerosis in 20 of 21 (95%). Among those controlled by the Sengstaken-Blakemore tube, seven (44%) rebled and three (43%) were again controlled by the Sengstaken-Blakemore tube; in the endoscopic sclerosis group, four (20%) rebled and three (75%) were controlled. Thus, hemorrhage was definitively controlled in 52% of patients and 66% of bleeding episodes in the Sengstaken-Blakemore tube group and in 90% of patients and 92% of bleeding episodes in the endoscopic sclerosis group. The definite control of hemorrhage was significantly better in the endoscopic sclerosis group (p less than 0.01). The Sengstaken-Blakemore tube patients received no definitive therapy after bleeding had been controlled. Within 30 days, six patients (27%) in the Sengstaken-Blakemore tube group had died compared to 2 (10%) in the endoscopic sclerosis group which is statistically significant (p less than 0.01) in favor of endoscopic sclerosis. The frequency of complications was similar in the two groups. Endoscopic sclerosis patients received serial endoscopic sclerosis after bleeding had been stopped during the whole period of follow-up.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Trials as Topic↗

PubMed2026

Clinical performance of monolithic and veneered zirconia three-unit posterior FDPs: A five-year multicenter randomized controlled trial.

AIM: This randomized controlled clinical study compared monolithic, partially veneered, and fully veneered zirconia FDPs over a 5-year period with respect to survival, technical and biological complications, and patient-reported outcome measures (PROMs). MATERIALS AND METHODS: Sixty-four patients requiring three-unit posterior FDPs were randomly allocated to monolithic (MONO-FDP), partially veneered (PV-FDP), or fully veneered (FV-FDP) groups. All FDPs were fabricated from 4 mol% Y₂O₃ partially stabilized zirconia (4Y-TZP). Follow-up examinations were conducted at baseline, 1, 3, and 5 years. Technical parameters were evaluated using modified USPHS criteria. Periodontal measurements (PPD, BOP, PI) and patient satisfaction were assessed at all time points. RESULTS: A total of 63 FDPs were evaluated at baseline, 57 at 3 years, and 54 at 5 years. Survival at 5 years was 94.7% for MONO-FDPs, 100% for FV-FDPs and 100% for PV-FDPs. Technical complications occurred exclusively in PV-FDP (33%) and FV-FDP (38%) groups and consisted of minor, polishable chipping; no chipping or fractures were recorded in MONO-FDPs (0%) with statistically significant difference between MONO-FDP and the other two groups (p ≤ 0.014). Biological parameters remained stable across all groups, with no significant differences in PPD, BOP, or PI. PV-FDPs and FV-FDPs tended to receive more favorable professional color ratings, whereas PROMs were similar among the groups. CONCLUSIONS: All three FDP designs-monolithic, partially veneered, and fully veneered-fabricated from 4Y-TZP zirconia demonstrated excellent 5-year clinical performance. Technical complications were limited to PV- and FV-FDPs and consisted of minor chipping. Biological outcomes and patient satisfaction were similar across groups. CLINICAL SIGNIFICANCE: The five-year outcomes suggest that veneered, partially veneered, and monolithic FDPs can be used with high clinical reliability; however, restorations incorporating veneering ceramic may present an elevated risk of ceramic chipping.

Humans↗