The following is a summary of “Characteristics and Ethics of Sham Surgeries,” published in the August 2023 issue of Surgery by Hetzler et al.
Researchers objective was to conduct a comprehensive systematic review encompassing all sham-controlled studies currently available in the medical literature to gain a deeper understanding of the ethical considerations associated with these studies. Novel surgical interventions are frequently implemented in the clinical environment without comprehensive clinical trials mandated for pharmaceutical treatments. Sham surgeries are utilized as placebo interventions by executing all procedural aspects of surgical intervention, excluding those deemed therapeutically essential. However, placebo-controlled trials should be more used due to ethical controversy.
Ovid MEDLINE was searched up until April 2022 using various combinations of Medical Subject (MeSH) terms and keywords, such as “surgery,” “endoscopy,” “randomized controlled trial,” and “sham procedure.” The primary endpoints assessed in this study included surgical indications and characteristics, outcome measurements, and the provision of an investigational treatment to the sham cohort. One hundred seventy-two articles met the criteria for inclusion, with gastrointestinal pathologies being the predominant surgical indication. The blinding of participants, personnel, and outcome assessment was observed in 8.7% of trials (n=15). The study populations consisted of adult individuals (age ≥18) in 170 studies (98.8%), while two studies involved pediatric patients. The predominant level of dissection and anesthesia modality utilized in the study were deep (n=66, 38.4%) and general (n=49, 28.5%).
An open surgical technique was employed in 20.9% of the investigations (n=36). The primary outcomes were objectively assessed in 75 studies (43.6%) and evaluated subjectively in 97 studies (56.4%), with 62 of them utilizing validated outcome measures (36.0%). Four- trials explicitly did not provide the surgical procedure to the sham arm (2.3%), while 106 problems did not mention whether the intervention was offered (61.6%). The researcher’s systematic review of 172 randomized, sham-controlled trials emphasizes the medical ethics that must be considered in these studies, the significance of straightforward study design and unbiased outcome reporting, the challenges of obtaining informed consent, and the inherent dangers associated with surgical procedures.