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Original Investigation |

Population-Based Colonoscopy Screening for Colorectal Cancer A Randomized Clinical Trial

Michael Bretthauer, MD1,2,3; Michal F. Kaminski, MD1,4; Magnus Løberg, MD1,2; Ann G. Zauber, PhD5; Jaroslaw Regula, MD4; Ernst J. Kuipers, MD6; Miguel A. Hernán, MD3,7,8; Eleanor McFadden, MA9; Annike Sunde, MSc9; Mette Kalager, MD1,2,3; Evelien Dekker, MD10; Iris Lansdorp-Vogelaar, PhD6; Kjetil Garborg, MD2; Maciej Rupinski, MD4; Manon C. W. Spaander, MD6; Marek Bugajski, MD4; Ole Høie, MD11; Tryggvi Stefansson, MD12; Geir Hoff, MD1,13; Hans-Olov Adami, MD1,2,3,14 ; for the Nordic-European Initiative on Colorectal Cancer (NordICC) Study Group
[+] Author Affiliations
1Department of Health Management and Health Economy, University of Oslo, Oslo, Norway
2Department of Transplantation Medicine and KG Jebsen Center for Colorectal Cancer Research, Oslo University Hospital, Oslo, Norway
3Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA
4Department of Gastroenterological Oncology, The Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology and Medical Center for Postgraduate Education, Warsaw, Poland
5Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY
6Department of Gastroenterology and Hepatology, Erasmus Medical Centre, Rotterdam, the Netherlands
7Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA
8Division of Health Sciences and Technology, Harvard–Massachusetts Institute of Technology, Boston
9Frontier Science Scotland, Kincraig, UK
10Department of Gastroenterology and Hepatology, Academic Medical Centre, Amsterdam, the Netherlands
11Department of Medicine, Sørlandet Hospital, Arendal, Norway
12Department of Surgery, The National University Hospital of Iceland, Reykjavik, Iceland
13Department of Research and Development, Telemark Hospital, Skien, Norway
14Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
JAMA Intern Med. 2016;176(7):894-902. doi:10.1001/jamainternmed.2016.0960.
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Importance  Although some countries have implemented widespread colonoscopy screening, most European countries have not introduced it because of uncertainty regarding participation rates, procedure-related pain and discomfort, endoscopist performance, and effectiveness. To our knowledge, no randomized trials on colonoscopy screening currently exist.

Objective  To investigate participation rate, adenoma yield, performance, and adverse events of population-based colonoscopy screening in several European countries.

Design, Setting, and Population  A population-based randomized clinical trial was conducted among 94 959 men and women aged 55 to 64 years of average risk for colon cancer in Poland, Norway, the Netherlands, and Sweden from June 8, 2009, to June 23, 2014.

Interventions  Colonoscopy screening or no screening.

Main Outcomes and Measures  Participation in colonoscopy screening, cancer and adenoma yield, and participant experience. Study outcomes were compared by country and endoscopist.

Results  Of 31 420 eligible participants randomized to the colonoscopy group, 12 574 (40.0%) underwent screening. Participation rates were 60.7% in Norway (5354 of 8816), 39.8% in Sweden (486 of 1222), 33.0% in Poland (6004 of 18 188), and 22.9% in the Netherlands (730 of 3194) (P < .001). The cecum intubation rate was 97.2% (12 217 of 12 574), with 9726 participants (77.4%) not receiving sedation. Of the 12 574 participants undergoing colonoscopy screening, we observed 1 perforation (0.01%), 2 postpolypectomy serosal burns (0.02%), and 18 cases of bleeding owing to polypectomy (0.14%). Sixty-two individuals (0.5%) were diagnosed with colorectal cancer and 3861 (30.7%) had adenomas, of which 1304 (10.4%) were high-risk adenomas. Detection rates were similar in the proximal and distal colon. Performance differed significantly between endoscopists; recommended benchmarks for cecal intubation (95%) and adenoma detection (25%) were not met by 6 (17.1%) and 10 of 35 endoscopists (28.6%), respectively. Moderate or severe abdominal pain after colonoscopy was reported by 601 of 3611 participants (16.7%) examined with standard air insufflation vs 214 of 5144 participants (4.2%) examined with carbon dioxide (CO2) insufflation (P < .001).

Conclusions and Relevance  Colonoscopy screening entails high detection rates in the proximal and distal colon. Participation rates and endoscopist performance vary significantly. Postprocedure abdominal pain is common with standard air insufflation and can be significantly reduced by using CO2.

Trial Registration  clinicaltrials.gov Identifier: NCT00883792

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Figure 1.
CONSORT Diagram of Participant Inclusion
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Figure 2.
Participants’ Self-Reported Abdominal Pain During and After Colonoscopy Screening

A, Participants’ self-reported moderate or severe abdominal pain during colonoscopy screening (P < .001 for difference between countries; P = .40 for difference between insufflation gases after adjustment for country).

B, Participants’ self-reported moderate or severe abdominal pain after screening colonoscopy (P < .001 for difference between insufflation gas after adjustment for country). CO2 indicates carbon dioxide.

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Figure 3.
Individual Endoscopist Performance in Colonoscopy Screening

Performance indicators for endoscopists who performed at least 30 examinations in the Nordic-European Initiative on Colorectal Cancer trial. The horizontal lines represent the mean value (solid) with 95% CIs (dashed). These are estimated with a random effects model to account for clustering at the endoscopist level. A, Cecum intubation rate. B, Adenoma yield. C, Percentage of participants with moderate or severe pain during colonoscopy. D, Percentage of participants with moderate or severe pain 24 hours after colonoscopy.

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Submit a Comment
Screening colonoscopy
Posted on May 24, 2016
M. Plunkett MD
None
Conflict of Interest: None Declared
This \"study\" says almost nothing. Did any one live a minute longer? What was the NNT to save a life? That's what colonoscopists have yet to prove. How many are done in the US each of the past 30 years and all we have to show is we can find polyps bigger than 10 mm! Shame on us for not gathering the evidence to practice evidence based medicine.

I would refer the editorialist to last weeks NEJM of Dr. Welch. That's a concept worth pondering.
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