CC BY-NC-ND 4.0 · Endosc Int Open 2021; 09(07): E1070-E1076
DOI: 10.1055/a-1452-9242
Original article

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

Marco Alburquerque
1   Department of Gastroenterology, Hospital de Palamós, Girona, Spain
2   Department of Gastroenterology, Clínica Girona, Girona, Spain
,
Antonella Smarrelli
1   Department of Gastroenterology, Hospital de Palamós, Girona, Spain
,
Julio Chevarria Montesinos
3   Department of Nephrology, Beaumont Hospital, Dublin, Ireland
,
Sergi Ortega Carreño
4   Department of Nursing, Hospital de Palamós, Girona, Spain
,
Ana Zaragoza Fernandez
4   Department of Nursing, Hospital de Palamós, Girona, Spain
,
Alba Vargas García
1   Department of Gastroenterology, Hospital de Palamós, Girona, Spain
2   Department of Gastroenterology, Clínica Girona, Girona, Spain
,
Cesar Ledezma Frontado
1   Department of Gastroenterology, Hospital de Palamós, Girona, Spain
,
Lluís Vidal
1   Department of Gastroenterology, Hospital de Palamós, Girona, Spain
,
Montserrat Figa Francesch
2   Department of Gastroenterology, Clínica Girona, Girona, Spain
,
Ferrán González-Huix Lladó
2   Department of Gastroenterology, Clínica Girona, Girona, Spain
5   Department of Gastroenterology, Arnau de Vilanova University Hospital, Lleida, Spain
› Institutsangaben

Abstract

Background and study aims Efficacy 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 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 We included 315 patients per group. The median age was 59.76 ± 5.81 years; 40.5 % of patients were women. The cecal intubation rate was 97 %, 81.8 % of patients had adequate bowel preparation, withdrawal time was > 6 minutes in 98.7 %, and the median global exploration time was 24.25 ± 8.86 minutes (range, 8–70 minutes). The ADR was 62.9 % and the complication rate (CR) was 0.6 %. Analysis by intention-to-treat showed an ADR in the NAAP group of 64.13 % compared with 61.59 % in the MAC group, a difference (δADR) of 2.54 %, 95 %CI: −0.10 to 0.05. Analysis by per-protocol showed an ADR in the NAAP group of 62.98 %, compared with 61.94 % in the MAC group, δADR: 1.04 %, 95 %CI: −0.09 to 0.07. There was no difference in CR (NAAP: 0,63 vs. MAC: 0.63); P = 1.0.

Conclusions ADR 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.



Publikationsverlauf

Eingereicht: 01. November 2020

Angenommen: 19. Februar 2021

Artikel online veröffentlicht:
17. Juni 2021

© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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  • References

  • 1 Vargo JJ, Cohen LB, Rex DK. et al. Position statement: Non-anesthesiologist administration of propofol for GI endoscopy. Gastrointest Endosc 2009; 70: 1053-1059
  • 2 Chutkan R, Cohen J, Abedi M. et al. Training guideline for use of propofol in gastrointestinal endoscopy. Gastrointest Endosc 2004; 60: 167-172
  • 3 Waring JP, Baron TH, Hirota WK. et al. Guidelines for conscious sedation and monitoring during gastrointestinal endoscopy. Gastrointest Endosc 2003; 58: 317-322
  • 4 Vargo JJ, Niklewski PJ, Williams JL. et al. Patient safety during sedation by anesthesia professionals during routine upper endoscopy and colonoscopy: an analysis of 1,38 million procedures. Gastrointest Endosc 2017; 85: 101-108
  • 5 Adeyemo A, Bannazadeh M, Rigs Y. et al. Does sedation type affect colonoscopy perforation rates?. Dis Colon Rectum 2014; 57: 110-114
  • 6 Cooper GS, Kou TD, Rex DK. Complications following colonoscopy with anesthesia assistance: a population-based analysis. JAMA Intern Med 2013; 173: 551-556
  • 7 Agostini M, Fanti L, Gemma M. et al. Adverse events during monitored anesthesia care for GI endoscopy: an 8-year experience. Gastrointest Endosc 2011; 74: 266-275
  • 8 Wernli KJ, Brenner AT, Rutter CM. et al. Risk associated with anesthesia services during colonoscopy. Gastroenterology 2016; 150: 888-894
  • 9 Gonzalez-Huix F, Figa M, Alburquerque M. et al. Serious adverse events of nonanesthesiologist-administered propofol in relation with gastrointestinal endoscopic procedure. Gastrointest Endosc 2014; 79: 330
  • 10 Kaminski MF, Hassan C, Bisschops R. et al. Advanced imaging for detection and differentiation of colorectal neoplasia: European society of GI endoscopy (ESGE) Guideline. Endoscopy 2014; 46: 435-449
  • 11 Subramanian V, Mannath J, Hawkey CJ. et al. High definition colonoscopy vs. standard video endoscopy for the detection of colonic polyps: a meta-analysis. Endoscopy 2011; 43: 499-505
  • 12 Coe SG, Crook JE, Diehl NN. et al. An endoscopic quality improvement program improves detection of colorectal adenomas. Am J Gastroenterol 2013; 108: 219-226
  • 13 Kaminski MF, Regula J, Kraszewska E. et al. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med 2010; 362: 1795-803
  • 14 Von Karsa L, Patnick J. et al. European Colorectal Cancer Screening Guidelines WorkingGroup. European guidelines for quality assurance in colorectal cancer screening and diagnosis: overview and introduction to the full supplement publication. Endoscopy 2013; 45: 51-59
  • 15 Chernik DA, Gillings D, Laine H. et al. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol 1990; 10: 244-251
  • 16 Lai E, Calderwood A, Doros G. et al. The Boston Bowel Preparation Scale: A valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc 2009; 69: 620-625
  • 17 Paris workshop participants. The Paris endoscopic classification of superficial neoplastic lesions: esophagus, stomach and colon. Gastrointest Endosc 2003; 58: 3-43
  • 18 Williansom SB. Colorectal adenomas. N Engl J Med 2016; 374: 1065-1075
  • 19 Rex D, Boland R, Domiitz J. et al. Colorectal cancer screening: Recommendations for physicians and patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Gastrointest Endosc 2017; 86: 18-33
  • 20 Denis B, Sauleau EA, Gendre I. et al. The mean number of adenomas per procedure should become the gold standard to measure the neoplasia yield of colonoscopy: a population-based cohort study. Dig Liver Dis 2014; 46: 176-181
  • 21 Wang HS, Pisegna J, Modi R. et al. Adenoma detection rate is necessary but insufficient for distinguishing high versus low endoscopist performance. Gastrointest Endosc 2013; 77: 71-78
  • 22 Rex D, Schoenfeld P, Cohen J. et al. Quality indicators for colonoscopy. Gastrointest Endosc 2015; 81: 31-53
  • 23 Kaminski M, Thomas-Gibson S, Bugajski M. et al. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy 2017; 49: 378-397
  • 24 Hassan C, East J, Radaelli F. et al. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline-Update 2019. Endoscopy 2019; 51: 775-794
  • 25 Consell Assessor del Programa de detecció precoç de càncer de còlon i recte de Catalunya. Pla director d'oncologia. Departament de Salut. Generalitat de Catalunya. Criteris generals d'organització i funcionament del Programa de detecció precoç de càncer de còlon i recte de Catalunya. Versió 2.1-Novembre 2016. 2nd ed. Barcelona: 2016
  • 26 Buchner A, Guarner-Argente C, Ginsberg G. Outcomes of EMR of defiant colorectal lesions directed to an endoscopy referral center. Gastrointest Endosc 2012; 76: 255-263
  • 27 Ferlischt M, Moss A, Hassan C. et al. Colorectal polypectomy and endoscopic mucosal resection (EMR). European Society of Gastrointestinal Endoscopy (ESGE). Clinical Guideline. Endoscopy 2017; 49: 270-297
  • 28 Alburquerque M, Vargas A, Sanchez I. Risk factors for incomplete endoscopic mucosal resection of large colorectal polyps Paris Is-II. Gastrointest Endosc 2018; 87: 484-485
  • 29 Corley DA, Jensen CD, Marks AR. et al. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med 2014; 370: 1298-1306
  • 30 Bretthauer M. Detection rates during colonoscopy: What matters most?. Endoscopy 2020; 52: 15-16
  • 31 Klair JS, Munish A, Johnson D. et al. Serrated polyp detection rate and advanced adenoma detection rate from a US multicenter cohort. Endoscopy 2020; 51: 61-67
  • 32 Anderson J. Detection of serrated polyps: How do endoscopists rate?. Endoscopy 2018; 50: 950-952
  • 33 Crockett S, Gourevitch R, Morris M. et al. endoscopist factor that influence serrated polyp detection: a multicenter study. Endoscopy 2018; 50: 984-992