Variability of prospective general surgery trials by subspecialty: An analysis of the national clinical trials registry.

Abstract

Prospective clinical trials provide robust data to drive guideline recommendations and clinical practice. Surgical trials, as opposed to other medical specialties, have been underrepresented. Our aim was to examine how surgical practice is reflected in current prospective clinical trial activity. This is a cross-sectional study of ClinicalTrials.gov. We identified all active phase I through IV surgery clinical trials using keywords represented by 5 surgical specialties: general, hepatobiliary, metabolic and bariatric, robotic/minimally invasive, and endocrine. Trials were categorized by intervention (diagnostic, treatment/prevention, surgical technique) and primary outcomes based on surgical phase of care (preoperative, intraoperative, postoperative). Descriptive statistics were used for analysis. Of 2,708 clinical trials identified, only 429 (16%) pertained to surgery. Hepatobiliary trials constituted a majority (68%) compared with other subspecialties. Among trial interventions, most (73%) focused on treatments, such as anticancer therapies, whereas a minority evaluated diagnostic modalities (12%) or assessed surgical technique (11%). Four out of 5 trial outcomes involved postoperative care (eg, complications or mortality); only 19 (4%) were intraoperative trials. Surgery trials represent a minority of modern clinical trials. Surgical oncologic specialties make up a significant percentage of trials, likely due to their multidisciplinary nature and rigorous research approaches aimed at treating cancer. Very few trials are studying procedure-based outcomes in the intraoperative phase of care, mirroring the lack of high-quality evidence supporting practices such as surgical technique, and should be prioritized.