Outcomes of colonoscopy with non-anesthesiologist-administered propofol (NAAP): an equivalence trial

Abstract

Background and study aims \u2002Efficacy and safety of NAAP for gastrointestinal endoscopy have been widely documented, although there is no information about the outcomes of colonoscopy when the endoscopist supervises the sedation. In this context, the aim of this trial was to determine the equivalence of adenoma detection rate (ADR) in colorectal cancer (CRC) screening colonoscopies performed with non-anesthesiologist-administered propofol (NAAP) and performed with monitored anesthesia care (MAC). Patients and methods\u2002 This was a single-blind, non-randomized controlled equivalence trial that enrolled adults from a national CRC screening program (CRCSP). Patients were blindly assigned to undergo either colonoscopy with NAAP or MAC. The main outcome measure was the ADR in CRCSP colonoscopies performed with NAAP. Results\u2002 We included 315 patients per group.\u200aThe median age was 59.76\u200a±\u200a5.81 years; 40.5\u200a% of patients were women. The cecal intubation rate was 97\u200a%, 81.8\u200a% of patients had adequate bowel preparation, withdrawal time was >\u200a6 minutes in 98.7\u200a%, and the median global exploration time was 24.25\u200a±\u200a8.86 minutes (range, 8–70 minutes). The ADR was 62.9\u200a% and the complication rate (CR) was 0.6\u200a%. Analysis by intention-to-treat showed an ADR in the NAAP group of 64.13\u200a% compared with 61.59\u200a% in the MAC group, a difference (δADR) of 2.54\u200a%, 95\u200a%CI: −0.10 to 0.05. Analysis by per-protocol showed an ADR in the NAAP group of 62.98\u200a%, compared with 61.94\u200a% in the MAC group, δADR: 1.04\u200a%, 95\u200a%CI: −0.09 to 0.07.\u200aThere was no difference in CR (NAAP: 0,63 vs. MAC: 0.63); P \u200a=\u200a1.0. Conclusions \u2002ADR in colorectal cancer screening colonoscopies performed with NAAP was equivalent to that in those performed with MAC. Similarly, there was no difference in complication rates.