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Results for “Randomized trial”

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PubMed1988

A randomized trial on the effect of mannitol on postoperative renal function in patients with obstructive jaundice.

A randomized trial was undertaken to reassess the effectiveness of mannitol in preventing postoperative renal impairment in patients with obstructive jaundice. The study included 31 patients with obstructive jaundice (bilirubin, 3 mg/dl or higher) randomly allocated in two groups to receive (n = 17) or not receive (n = 14) preoperative mannitol. Sixty-five percent of patients had a creatinine clearance below 70 ml/min before surgery. Serum bilirubin and bacteribilia had no relation with preoperative renal function. No relation was found between serum bilirubin value and the percentage fall in postoperative creatinine clearance. Compared with the preoperative values, the postoperative creatinine clearance was significantly impaired in the mannitol group (p = 0.03) and remained almost unaltered in the no-mannitol group. Three patients (9.7%) died of acute renal failure; two were in the mannitol group and one was in the no-mannitol group. Serum fibrin degradation products were not sensitive markers for impending renal failure. There was no significant difference in postoperative serum sodium concentration or in the urinary sodium excretion. Administration of mannitol did not improve the postoperative renal function of jaundiced patients, nor did it prove beneficial in preventing renal failure. Our results suggest that severe disturbances of body-fluid compartments may be the basic mechanism underlying kidney dysfunction in obstructive jaundice and that further water depletion induced by mannitol may indeed prove detrimental.

Acute Kidney Injury↗

PubMed2004

Isosorbide mononitrate increases bone formation and decreases bone resorption in postmenopausal women: a randomized trial.

UNLABELLED: NO regulates bone remodeling in cellular and animal models. We examined the effect of administering ISMO, a NO donor, on bone turnover in 144 postmenopausal women. After 3 months, women randomized to ISMO had a greater decrease in bone resorption and a greater increase in bone formation compared with placebo. NO donors may prevent postmenopausal bone loss. INTRODUCTION: NO both stimulates bone formation and inhibits bone resorption in vitro. NO donors (nitrates) are inexpensive and widely available, but their value for postmenopausal osteoporosis has never been evaluated in a randomized trial. MATERIALS AND METHODS: We randomly assigned 144 healthy postmenopausal women with a hip BMD T score between 0 and -2.5 to 5 or 20 mg/day of isosorbide mononitrate (ISMO) or placebo for 12 weeks. We measured urine N-telopeptide (NTx), a marker of bone resorption, and serum bone-specific alkaline phosphatase (BSALP), a marker of bone formation. Markers were measured immediately before randomization and after 12 weeks of treatment. We calculated the percent change in NTx and BSALP for each of the treatment groups (placebo, 5 mg ISMO, and 20 mg ISMO). Our primary outcome was the percent change in NTx and BSALP in the 5- and 20-mg ISMO groups compared with placebo. RESULTS AND CONCLUSIONS: Compared with women randomized to placebo, women randomized to 20 mg of ISMO had a 45.4% decrease in NTx (95% CI, 25.8-64.9) and a 23.3% increase (95% CI, 8.9-37.8) in BSALP. Women randomized to 5 mg of ISMO had a 36.3% decrease in NTx (95% CI, 14.8-57.8) and a 15.9% increase in BSALP (95% CI, 1.1-30.7). ISMO decreases bone resorption and increases bone formation. These findings suggest that nitrates may be useful for the prevention of postmenopausal osteoporosis.

Aged↗

PubMed2005

Testosterone patch for low sexual desire in surgically menopausal women: a randomized trial.

OBJECTIVE: To assess the efficacy and safety of a 300 mug/d testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women on concomitant estrogen therapy. METHODS: Five hundred thirty-three women with hypoactive sexual desire disorder who had undergone previous hysterectomy and bilateral oophorectomy were enrolled in a 24-week, multicenter, double-blind, placebo-controlled trial. Patients were randomly assigned to receive placebo or the testosterone patch twice weekly. The primary efficacy endpoint was change from baseline at week 24 in the frequency of total satisfying sexual activity, measured by the Sexual Activity Log. Secondary measures included sexual desire using the Profile of Female Sexual Function and personal distress as measured by the Personal Distress Scale. Hormone levels, adverse events, and clinical laboratory measures were reviewed. RESULTS: Total satisfying sexual activity significantly improved in the testosterone patch group compared with placebo after 24 weeks (mean change from baseline, 1.56 compared with 0.73 episodes per 4 weeks, P = .001). Treatment with the testosterone patch also significantly improved sexual desire (mean change, 10.57 compared with 4.29, P < .001) and decreased personal distress (P = .009). Serum free, total, and bioavailable testosterone concentrations increased from baseline. Overall, adverse events were similar in both groups (P > .05). The incidence of androgenic adverse events was higher in the testosterone group; most androgenic adverse events were mild. CONCLUSION: In surgically menopausal women with hypoactive sexual desire disorder, a 300 mug/d testosterone patch significantly increased satisfying sexual activity and sexual desire, while decreasing personal distress, and was well tolerated through up to 24 weeks of use.

Administration, Cutaneous↗

PubMed2006

A comparison of permutation and mixed-model regression methods for the analysis of simulated data in the context of a group-randomized trial.

Our first purpose was to determine whether, in the context of a group-randomized trial (GRT) with Gaussian errors, permutation or mixed-model regression methods fare better in the presence of measurable confounding in terms of their Monte Carlo type I error rates and power. Our results indicate that given a proper randomization, the type I error rate is similar for both methods, whether unadjusted or adjusted, even in small studies. However, our results also show that should the investigator face the unfortunate circumstance in which modest confounding exists in the only realization available, the unadjusted analysis risks a type I error; in this regard, there was little to distinguish the two methods. Finally, our results show that power is similar for the two methods and, not surprisingly, better for the adjusted tests. Our second purpose was to examine the relative performance of permutation and mixed-model regression methods in the context of a GRT when the normality assumptions underlying the mixed model are violated. Published studies have examined the impact of violation of this assumption at the member level only. Our findings indicate that both methods perform well when the assumption is violated so long as the ICC is very small and the design is balanced at the group level. However, at ICC>or=0.01, the permutation test carries the nominal type I error rate while the model-based test is conservative and so less powerful. Binomial group- and member-level errors did not otherwise change the relative performance of the two methods with regard to confounding.

Computer Simulation↗

PubMed1989

[Surgical treatment of gastroesophageal reflux: which operation to choose: Nissen, Toupet or Lortat-Jacob? A multicenter randomized trial].

Five surgical centers conducted a clinical randomized prospective trial in order to objectively evaluate the two-year results of three anti-reflux procedures regularly performed in France: complete (360 degrees) fundoplication (Nissen), posterior partial (180 degrees) fundoplication (Toupet) and cardiophrenopexy (Lortat-Jacob). Fifty-two patients, mean age 53 years, range 28 to 74 yrs, with uncomplicated gastroesophageal reflux, as defined according to clinical, radiologic, endoscopic and pHmetry criteria, were included in this study. Twenty patients underwent a Nissen procedure, 18 had a Toupet procedure, while 14 had a Lortat-Jacob procedure. The main criterion of assessment was Minaire's pHmetry score evaluated at two years postoperative. All three groups were well matched for clinical, radiologic, endoscopic, manometry and pHmetry findings. At two years, the number of asymptomatic patients did not statistically differ within the three groups. Four patients, however, required reoperation for invalidating recurrences: three following Lortat-Jacob's procedure and one after Toupet's procedure. Nissen's and Toupet's procedures significantly improved pHmetry scores compared with Lortat-Jacob's procedure; pHmetry was improved, but non significantly, by Nissen's procedure, as compared with Toupet's procedure. Lower sphincter pressure was significantly increased (p less than 0.01) by Nissen's procedure as compared with the two other techniques. The lower sphincter was significantly lengthened by Nissen's and Toupet's procedures as compared with Lortat-Jacob's technique (p less than 0.01). The total length of esophagus was significantly increased (p less than 0.01) by Nissen's and Lortat-Jacob's procedures in comparison with Toupet's technique. The distance separating the lower sphincter of the esophagus and point of pressure reversal was significantly decreased (p less than 0.05) by the Nissen procedure only.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed2004

Methodologic issues in terminating enrollment of a subgroup of patients in a multicenter randomized trial.

The National Emphysema Treatment Trial (NETT) was a multicenter randomized controlled trial comparing medical treatment plus lung-volume-reduction surgery (LVRS) to medical treatment alone for the treatment of severe emphysema. The primary outcomes specified for the trial were mortality from all causes and change in functional status as indicated by the change in maximum exercise capacity measured two years after randomization. A secondary objective of the trial was to define criteria to identify subgroups of patients at risk of harm or benefit from LVRS. Stopping guidelines for safety and efficacy based on 30-day mortality and a combination of overall mortality and functional status at two years were specified at the inception of the trial. Although specific subgroups of patients likely to benefit were not identified in advance, several clinical factors were specified as likely to be important in defining subgroups with differential outcome. In May 2001, with 40% of expected deaths accrued, the Data and Safety Monitoring Board determined that a subgroup of patients was at significantly higher risk of 30-day mortality from LVRS without counterbalancing evidence of functional benefit, and recommended that the protocol be modified to exclude further randomization of such patients. The trial's sponsor, the National Heart, Lung and Blood Institute, accepted the recommendation, which was rapidly communicated to participating clinics. This paper describes the operational aspects of identification of the subgroup and implementation of the recommendation to continue the trial, but to terminate enrollment of new patients in the subgroup. These aspects include notification of the investigators, the institutional review boards, the Research Group, the patients and the medical community. We also describe the repercussions of the publication and the misinterpretations of the results based on media coverage.

Clinical Protocols↗

PubMed1986

Reporting the results of randomized trials of empiric antibiotics in febrile neutropenic patients--a critical survey.

Twenty-one randomized trials of empiric antibiotic therapy in febrile neutropenic patients were reviewed and scored by methods suggested by Chalmers. In general, the scores were low, indicating that many of these articles failed to meet currently suggested methodologic standards for publication of results of clinical trials. Particularly striking was the lack of attention paid to statistical issues, such as power, exclusions, and repeated analyses. In addition, there appears to be a need for a better-developed system for assessing response in these circumstances.

Agranulocytosis↗

PubMed2003

Randomized trials and public health interventions: time to end the scientific double standard.

Randomized controlled trials have become the acceptedstandard for testing the efficacy and safety of clinical treatments but are rarely used in evaluating public health interventions. This article reviews the types of interventions and outcomes for which randomized trials are necessary to provide a scientifically rigorous evaluation. It also presents the results from two trials analyzed both experimentally and observationally to illustrate why observational studies can yield highly biased findings. This article provides a brief historical account of controlled human experiments, which reveals a surprising earlier tradition of rigorous experimental studies in the social sciences. After contrasting that tradition with the status quo, this article concludes with a plea to reject the double scientific standard of what constitutes acceptable evidence of efficacy for clinical versus public health interventions.

Evidence-Based Medicine↗

PubMed2000

Prophylactic sclerotherapy in children with esophageal varices: long-term results of a controlled prospective randomized trial.

BACKGROUND/PURPOSE: Experience using endoscopic prophylactic sclerotherapy (PS) is restricted to adult patients and has led to conflicting results. There has not been a randomized, controlled study on the use of PS in children. The purpose of this study is to evaluate prospectively the value of PS to prevent the first hemorrhage from esophageal varices in children with portal hypertension and to assess the effect of PS on survival rate. METHODS: In a controlled, prospective, computer-based randomized trial, the effectiveness of PS was analyzed in 100 consecutive children allocated to a group receiving sclerotherapy (n = 50) or to a control group (n = 50) subjected only to regular clinical and endoscopic examinations. Clinical characteristics in both groups were similar. The minimum follow-up period was at least 18 months after the cessation of the sessions of sclerotherapy. RESULTS: After a median follow-up of 4.5 years, PS eliminated the esophageal varices in 47 of 50 (94%) patients but only 38 (76%) of them do not present upper digestive hemorrhage. Before complete obliteration of the varices, upper gastrointestinal bleeding occurred in 12 patients (24%). Six children (12%) had gastric varices, 3 of 6 of whom (50%) bled. Congestive hypertensive gastropathy was observed to occur in 8 (16%) patients, 4 of 8 of which (50%) had hemorrhagic episodes. Two patients bled from undetermined cause. In the control group, only 29 (58%) children remained free from esophageal variceal bleeding and 26 (52%) from any upper gastrointestinal bleeding (P<.05). During the follow-up period, the development of gastric varices was observed in 5 (10%) patients (P>.05) and of congestive hypertensive gastropathy in only 3 (6%) patients (P<.05), but none of them bled. PS does not improve survival rate. CONCLUSIONS: In children with cirrhotic and noncirrhotic portal hypertension, PS reduces the overall incidence of bleeding from esophageal varices that were eradicated in 94% of cases. The source of bleeding has been different in each group, being predominantly from esophageal varices in the control group and from the stomach in the prophylaxis group. When applied with appropriate technique, PS is a safe procedure with a low incidence of minor complications. PS does not change the incidence of gastric varices but increases the development of congestive hypertensive gastropathy. PS increases the risk of bleeding from the naturally formed gastric varices and from congestive hypertensive gastropathy. PS does not affect survival rate.

Adolescent↗

PubMed1997

Microscopic tonsillectomy: a double-blind randomized trial.

OBJECTIVE: To evaluate microsurgical bipolar cautery tonsillectomy (TEmic) by comparing it with traditional blunt dissection tonsillectomy (TEtrad). DESIGN: A double-blind prospective randomized trial with stratification in two age groups. PATIENTS: 200 consecutive patients undergoing tonsillectomy for tonsillar hypertrophy, or recurrent or chronic tonsillitis. OUTCOME MEASURES: Duration of surgery, intraoperative bleeding, daily postoperative pain and otalgia, postoperative bleeding episodes. METHODS: Duration of surgery and operative bleeding were evaluated by the anesthesiologist. The patients were instructed to record daily pain and otalgia. Final postoperative evaluation was done by a different physician, blinded to the surgical technique. RESULTS: Mean intraoperative bleeding was 12 ml for TEmic and 36 ml for TEtrad (P < 0.001). Mean duration of surgery was 37 minutes for TEmic and 36 minutes for TEtrad (NS). Otalgia was present in 41% of TEmic patients and 69% of TEtrad patients (p < 0.001). Daily postoperative pain was lower in the TEmic group than it was in the TEtrad group for the entire study period (10 days). Postoperative hemorrhage was present in three TEmic patients (3%) and in eight TEtrad patients (8%), a difference that did not reach significance (p > 0.1). CONCLUSION: Microsurgical bipolar cautery tonsillectomy compares favorably with traditional techniques in terms of intraoperative bleeding, postoperative pain, otalgia, and hemorrhage. This technique combines the hemostatic advantage of cautery dissection, the excellent visualization achieved by a microscope, and, with the use of a video, greatly improves the physician's ability to teach how to perform a tonsillectomy.

Biological Products↗

PubMed2005

Combined conventional/antioxidant "Astaxanthin" treatment for male infertility: a double blind, randomized trial.

AIM: To evaluate the treatment of male infertility with a strong natural antioxidant, in addition to conventional treatment. METHODS: Using a double blind, randomized trial design, 30 men with infertility of > or =2 months and female partners with no demonstrable cause of infertility received conventional treatment according to the guidelines of the World Health Organization (WHO), and either a strong antioxidant Astaxanthin 16 mg/day (AstaCarox, AstaReal AB, Gustavsberg, Sweden) or placebo for 3 months. The effects of treatment on semen parameters, reactive oxygen species (ROS), zona-free hamster oocyte test, serum hormones including testosterone, luteinizing hormone (LH), follicle stimulating hormone (FSH) and Inhibin B, and spontaneous or intrauterine insemination (IUI)-induced pregnancies were evaluated. RESULTS: ROS and Inhibin B decreased significantly and sperm linear velocity increased in the Astaxanthin group (n = 11), but not in the placebo group (n = 19). The results of the zona-free hamster oocyte test tended to improve in the Astaxanthin group in contrast with the placebo group, though not reaching statistical significance. The total and per cycle pregnancy rates among the placebo cases (10.5 % and 3.6 %) were lower compared with 54.5 % and 23.1 % respectively in the Astaxanthin group (P = 0.028; P = 0.036). CONCLUSION: Although the present study suggests a positive effect of Astaxanthin on sperm parameters and fertility, the results need to be confirmed in a larger trial before recommending Astaxanthin for the complementary treatment of infertile men.

Adult↗

PubMed1996

A randomized trial to improve follow-up care in severe uncontrolled hypertensives at an inner-city walk-in clinic.

A single-blinded, randomized trial was conducted to determine whether a mailed postcard improved follow-up in uncontrolled hypertensives. One hundred and seven patients with a systolic blood pressure (BP) of 180 or more or a diastolic blood pressure of 110 or more at an inner-city, hospital-based walk-in clinic were enrolled; mean age was 56 years, 95 percent were African American, 73 percent were female, and mean BP was 193/106. Patients were required to be aware of their diagnosis and to have been informed of their need for medication at least a month before the trial. Of those who received postcard reminders, 45 percent followed up within 10 days, compared with 47 percent of controls (p = 0.93). At 30 days, 64 percent of the intervention group followed up, compared with 55 percent of controls (p = 0.36). In an adjusted logistic regression model, there was no difference in follow-up. Correlates of appointment noncompliance at one month included alcoholism and lack of insurance in an adjusted logistic regression model. Follow-up in severe hypertensives was poor, and a mailed postcard reminder had no effect in a walk-in setting.

Female↗

PubMed2006

A multisite randomized trial of social norms marketing campaigns to reduce college student drinking.

OBJECTIVE: An 18-site randomized trial was conducted to determine the effectiveness of social norms marketing (SNM) campaigns in reducing college student drinking. The SNM campaigns are intended to correct misperceptions of subjective drinking norms and thereby drive down alcohol consumption. METHOD: Institutions of higher education were randomly assigned to treatment and control groups. At the treatment group institutions, SNM campaigns delivered school-specific, data-driven messages through a mix of campus media venues. Cross-sectional student surveys were conducted by mail at baseline (n = 2,771) and at posttest 3 years later (n = 2,939). Hierarchical linear modeling was applied to examine multiple drinking outcomes, taking intraclass correlation into account. RESULTS: Controlling for other predictors, having an SNM campaign was significantly associated with lower perceptions of student drinking levels and lower alcohol consumption, as measured by a composite drinking scale, recent maximum consumption, blood alcohol concentration for recent maximum consumption, drinks consumed when partying, and drinks consumed per week. A moderate mediating effect of normative perceptions on student drinking was demonstrated by an attenuation of the Experimental Group x Time interaction, ranging from 16.4% to 39.5% across measures. Additional models that took into account the intensity of SNM campaign activity at the treatment institutions suggested that there was a dose-response relationship. CONCLUSIONS: This study is the most rigorous evaluation of SNM campaigns conducted to date. Analysis revealed that students attending institutions that implemented an SNM campaign had a lower relative risk of alcohol consumption than students attending control group institutions.

Adult↗

PubMed1992

Randomized trial of adjuvant tamoxifen in node negative postmenopausal breast cancer. Stockholm Breast Cancer Study Group.

The paper presents long-term results of a randomized trial of adjuvant tamoxifen (40 mg daily for 2 or 5 years) versus surgery alone including 1,347 postmenopausal patients with histologically negative axillary nodes and a tumour diameter less than or equal to 30 mm. Data on the estrogen receptor status of the primary tumour were available in 1,136 patients (84%). At a median follow-up of 7 years (range 1.7-13.0 years) there was a significant prolongation of the recurrence-free survival among those allocated to tamoxifen (p less than 0.01), significantly fewer deaths due to breast cancer (p = 0.02) and a trend towards improved overall survival (p = 0.11). The treatment benefit was restricted to patients with ER-positive tumours. There was no significant reduction of breast cancer recurrences in the tamoxifen group among patients whose tumours were classified as ER-negative. The results support and extend previous studies in showing a long-term benefit of tamoxifen in postmenopausal breast cancer patients with node-negative, estrogen receptor positive disease.

Breast Neoplasms↗

PubMed1993

Analysis as-randomized and the problem of non-adherence: an example from the Veterans Affairs Randomized Trial of Coronary Artery Bypass Surgery.

In most randomized clinical trials not all patients adhere to the therapy to which they were randomly assigned. Instead, they may receive the therapy assigned to another treatment group, or a therapy different from any prescribed in the protocol. When non-adherence occurs, problems occur with the analysis comparing the treatments under study. Rigorous statistical principles require attributing outcome events to the original random treatment assignment ('intent-to-treat' analysis). Using data from the Veterans Administration Cooperative Study of Coronary Artery Bypass Surgery, we report the intent-to-treat analysis and apply four other methods of analysis for analysing non-adherers: 1. exclude non-adherers from analysis; 2. transfer them to the alternative treatment group at the time of randomization; 3. censor them at the time of treatment change, and 4. transfer them to the alternative treatment group at the time of treatment change. Inherent problems and biases of these four other methods are discussed.

Angina Pectoris↗

PubMed1997

Sample sizes for randomized trials measuring quality of life in cancer patients.

This paper describes the methods appropriate for calculating sample sizes for clinical trials assessing quality of life (QOL). An example from a randomized trial of patients with small cell lung cancer completing the Hospital Anxiety and Depression Scale (HADS) is used for illustration. Sample size estimates calculated assuming that the data are either of the Normal form or binary are compared to estimates derived using an ordered categorical approach. In our example, since the data are very skewed, the Normal and binary approaches are shown to be unsatisfactory: binary methods may lead to substantial over estimates of sample size and Normal methods take no account of the asymmetric nature of the distribution. When summarizing normative data for QOL scores the frequency distributions should always be given so that one can assess if non-parametric methods should be used for sample size calculations and analysis. Further work is needed to discover what changes in QOL scores represent clinical importance for health technology interventions.

Adult↗

PubMed2005

Predictive factors of acute rejection after early cyclosporine withdrawal in renal transplant recipients who receive mycophenolate mofetil: results from a prospective, randomized trial.

The aim of this randomized, open-labeled trial was to compare the incidence of acute rejection after an early (3 mo posttransplantation) withdrawal of cyclosporine (CsA) or mycophenolate mofetil (MMF) in renal transplantation. Among 218 eligible recipients, 108 nonsensitized, rejection-free patients who were under a triple drug regimen (CsA-MMF-prednisone) and had received a first kidney from a deceased donor were enrolled. At 3 mo after graft, they were gradually withdrawn from CsA (MMF group, n = 54) or MMF (CsA group, n = 54). A graft biopsy and a pharmacokinetic study of CsA and mycophenolic acid were systematically performed before the randomization. At 1 yr, graft and patient survival rates were 100% in each group. Renal function was improved in the MMF group compared with the CsA group (Cockcroft calculated clearance 64.7 +/- 18.7 versus 56.5 +/- 18.0 ml/min; P = 0.023). However, the probability of acute rejection was higher in the MMF group (18.5 versus 5.6%; P = 0.045). The 10 patients who developed acute rejection after CsA withdrawal had a significantly higher incidence of borderline changes on the randomization biopsy than the 44 rejection-free patients (five of 10 versus eight of 44; P = 0.034), and they displayed a lower area under the curve of mycophenolic acid (43 +/- 9 versus 58 +/- 22 mg/h per L; P = 0.045). Multivariate analysis confirmed that borderline changes and area under the curve of mycophenolic acid were significant risk factors of acute rejection after CsA discontinuation. It is concluded that a systematic graft biopsy and a pharmacokinetic study of mycophenolic acid are needed to reduce the risk for acute rejection after CsA withdrawal.

Adult↗

PubMed2026

Robotic Needle Insertion for CT-guided Percutaneous Biopsy of Thoracoabdominal Lesions: A Prospective Multicenter Randomized Trial.

Purpose To compare safety and feasibility between a novel CT-guided robotic system and the conventional freehand technique for puncture biopsy of thoracoabdominal lesions. Materials and Methods In this prospective multicenter randomized trial, individuals with suspected lesions were enrolled between July 2023 and April 2024 across three university teaching hospitals and randomized to the robot-assisted group (n = 82) or the freehand group (n = 83). Procedure outcomes included the technical success rate, targeting error, number of CT scans and needle adjustments, puncture time, and complications. Descriptive and inferential statistics were calculated. Results A total of 165 participants (mean age, 60 years ± 10 [SD]; 83 male) were included. Compared with the freehand group, the robot-assisted group demonstrated a higher technical success rate (97.56% [80 of 82] vs 62.65% [52 of 83], P < .001), lower targeting error (mean Euclidean deviation: 1.7 mm ± 1.1 vs 4.5 mm ± 3.9, P < .001), and fewer CT scans (mean, 4.3 ± 1.9 vs 5.2 ± 2.3; P = .002) and needle adjustments (mean, 0.7 ± 0.7 vs 1.6 ± 1.6; P = .003). Despite differences in geometric precision, both groups achieved 100% (82 of 82 and 83 of 83) diagnostic yield. The median puncture time was comparable between groups (5.5 minutes ± 4.3 vs 4.8 minutes ± 7.0, P = .50). During lung biopsies, the robot-assisted approach yielded fewer complications compared with the freehand approach (4.88% [four of 82] vs 16.87% [14 of 83], P = .014). Conclusion Compared with the freehand approach, robot-assisted biopsy yielded greater precision and reduced adjustments and complications while demonstrating noninferior diagnostic efficacy and comparable duration. Keywords: Robotic Needle Insertion, Biopsy, Thoracoabdominal Lesions, Robot-assisted Biopsy, CT-guided Intervention, Percutaneous Needle Biopsy, Randomized Controlled Trial, Algorithm Development, CT, Clinical Testing, Interventional-Body, Biopsy/Needle Aspiration, Percutaneous, Thorax, Abdomen/GI, Liver, Lung, Kidney ©RSNA, 2026.

Humans↗