Evidence map›Paper›PMID 22612596›Full record

Trial reportThe New England journal of medicine2012

Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy.

Robert E Schoen, Paul F Pinsky, Joel L Weissfeld, Lance A Yokochi, Timothy Church, Adeyinka O Laiyemo, Robert Bresalier, Gerald L Andriole, Saundra S Buys, E David Crawford and 16 more

7 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 458 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
458citing papers in PubMed, 8 pooled it
54.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00002540 naactive not recruitingnot on this map

Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran1993 to 2027Enrolled76,685ConditionsProstate CarcinomaArmsLaboratory Biomarker Analysis, Medical Examination Assessment, Screening Questionnaire Administration
NCT01767870 phase4unknown statusnot on this map

Efficacy and Cost-effectiveness of Colonoscopy vs. Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia (eCOLO-FITS): A Randomized Multicenter Trial

TypeinterventionalSponsorYonsei UniversityRan2012 to 2015Enrolled5,282ConditionsColorectal AdenomaArmsFIT-sigmoidoscopy, Colonoscopy
NCT02078804 naactive not recruitingnot on this mapstarted 2014, after this paper: background citation

SCREESCO - Screening of Swedish Colons

TypeinterventionalSponsorUppsala University HospitalRan2014 to 2030Enrolled278,000ConditionsColorectal CancerArmsColonoscopy
NCT03981679 nacompletednot on this mapstarted 2018, after this paper: background citation

Prospective, Non-randomized, Open-label and Multi-center Study With the Establishment of a Clinical-biological Database.

TypeinterventionalSponsorInstitut du Cancer de Montpellier - Val d'AurelleRan2018 to 2020Enrolled278ConditionsColorectal CancerArmsBiological collection
NCT04482452 unknown statusnot on this mapstarted 2020, after this paper: background citation

Percentage Visualized Mucosa as a Marker for the Quality of Colonoscopy

TypeobservationalSponsorInsel Gruppe AG, University Hospital BernRan2020 to 2022Enrolled500ConditionsColonoscopyArmsColonoscopy
NCT06443047 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

Suturing Through-the-scope System Used for Prophylactic Closure of Colonic Post-ESD Defects: A Randomized Trial vs Conventional Clips That it Highlights the Importance of Suturing in Promoting Healing and Closure of the Colonic ESD Defects

TypeinterventionalSponsorIstituto Clinico HumanitasRan2025 to 2026Enrolled66ConditionsPrecancerous Lesion of ColonArmsTTS suturing system
NCT07040020 nacompletednot on this mapstarted 2025, after this paper: background citation

Water-Assisted Versus Standard ESD for Large Nonpedunculated Colorectal Polyps: a Prospective Randomized Trial

TypeinterventionalSponsorIstituto Clinico HumanitasRan2025 to 2026Enrolled122ConditionsPrecancerous LesionsArmsUnderwater ESD (U-ESD), Conventional ESD (C-ESD)
3 · Its place in the literature

Who cites it

458 citing papers in PubMed, 8 syntheses or guidelines pooled it, 1,021 citations in OpenAlex.

  1. Pooled it
  2. Quality indicators for colonoscopy.Gastrointestinal endoscopy · 2024
    Guideline
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  5. Pooled it
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  9. Behavioral Interventions Improve Mailed Colorectal Cancer Screening Among Overdue Patients in a Randomized Trial.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2026
    Trial
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  11. Trial
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  13. A Randomized Trial of Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2024
    Trial
  14. Trial
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398 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 18 institutions in 4 countries.

Robert E SchoenDepartment of Medicine, University of Pittsburgh, Pittsburgh, PA, USA. rschoen@pitt.edu
Paul F Pinsky
Joel L Weissfeld
Lance A Yokochi
Timothy Church
Adeyinka O Laiyemo
Robert Bresalier
Gerald L Andriole
Saundra S Buys
E David Crawford
Mona N Fouad
Claudine Isaacs
Christine C Johnson
Douglas J Reding
Barbara O'Brien
Danielle M Carrick
Patrick Wright
Thomas L Riley
Mark P Purdue
Grant Izmirlian
Barnett S Kramer
Anthony B Miller
John K Gohagan
Philip C Prorok
Christine D Berg
PLCO Project Team
National Cancer Institute · MYInformation Management Services · USUniversity of Pittsburgh · USWestat (United States) · US3M (United States) · USCancer Institute (WIA) · INGeorgetown University · USHenry Ford Health System · USHoward University · USHuntsman Cancer Institute · USMarshfield Clinic · USNational Institutes of Health · USPacific Health Research and Education Institute · USThe University of Texas MD Anderson Cancer Center · USUniversity of Alabama at Birmingham · USUniversity of Colorado Cancer Center · USUniversity of Minnesota · USWashington University in St. Louis · US

Funding

PROSTATE, LUNG, COLORECTAL, &OVARIAN CANCER SCREENINGN01CN025476 · CN · WESTAT, INC. · PI O'BRIEN, BARBARA B · 1992 to 2000
$7.9M
PROSTATE, LUNG, COLORECTAL AND OVARIAN (PLCO) CANCERN01CN025512 · CN · HENRY FORD HEALTH SYSTEM · PI DEMERS, RAYMOND Y · 1992 to 2001
$2.0M
PROSTATE, LUNG, COLORECTAL AND OVARIAN (PLCO) CANCERN01CN075022 · CN · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI FOUAD, MONA N. · 1997 to 2001
$1.6M
PROSTATE, LUNG, COLORECTAL &OVARIAN (PLCO) CANCERN01CN025516 · CN · WASHINGTON UNIVERSITY · PI ANDRIOLE, GERALD LOUIS · 1992 to 2001
$1.5M
PROSTATE, LUNG, COLORECTAL AND OVARIAN (PLCO) CANCERN01CN025524 · CN · UNIVERSITY OF UTAH · PI BUYS, SAUNDRA S · 1992 to 2000
$1.5M
PROSTATE, LUNG, COLORECTAL AND OVARIAN (PLCO) CANCERN01CN025514 · CN · UNIVERSITY OF COLORADO DENVER · PI CRAWFORD, E DAVID · 1992 to 2000
$1.3M
PROSTATE, LUNG, COLORECTAL AND OVARIAN (PLCO) CANCERN01CN025515 · CN · PACIFIC HEALTH RESEARCH INSTITUTE · PI YOKOCHI, LANCE L · 1992 to 2000
$1.2M
PROSTATE, LUNG, COLORECTAL AND OVARIAN (PLCO) CANCERN01CN025511 · CN · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI WEISSFELD, JOEL L · 1992 to 2000
$1.2M
PROSTATE, LUNG, COLORECTAL &OVARIAN CANCERN01CN025522 · CN · GEORGETOWN UNIVERSITY · PI GELMANN, EDWARD P · 1992 to 2000
$817k
PROSTATE, LUNG, COLORECTAL AND OVARIAN (PLCO) CANCERN01CN025513 · CN · UNIVERSITY OF MINNESOTA TWIN CITIES · PI CHURCH, TIMOTHY ROBERT · 1992 to 2001
$409k
PROSTATE, LUNG, COLORECTAL AND OVARIAN (PLCO) CANCERN01CN025518 · CN · MARSHFIELD CLINIC RESEARCH FOUNDATION · PI REDING, DOUGLAS · 1992 to 2000
$27k
PROSTATE, LUNG, COLORECTAL AND OVARIAN CANCER SCREENING TRIA-261925512N01CA025512 · NCI · HENRY FORD HEALTH SYSTEM · 2003 to 2003
–
NCI NIH HHS N01 CN025476NCI NIH HHS N01 CN025511NCI NIH HHS N01 CN025512NCI NIH HHS N01 CN025513NCI NIH HHS N01 CN025514NCI NIH HHS N01 CN025515NCI NIH HHS N01 CN025516NCI NIH HHS N01 CN025518NCI NIH HHS N01 CN025522NCI NIH HHS N01 CN025524NCI NIH HHS N01 CN075022NCI NIH HHS N01-CN-25476NCI NIH HHS N01-CN-25511NCI NIH HHS N01-CN-25512NCI NIH HHS N01-CN-25513NCI NIH HHS N01-CN-25514NCI NIH HHS N01-CN-25515NCI NIH HHS N01-CN-25516NCI NIH HHS N01-CN-25518NCI NIH HHS N01-CN-25522NCI NIH HHS N01-CN-25524NCI NIH HHS N01-CN-75022
6 · The paper itself

Abstract

backgroundThe benefits of endoscopic testing for colorectal-cancer screening are uncertain. We evaluated the effect of screening with flexible sigmoidoscopy on colorectal-cancer incidence and mortality.

methodsFrom 1993 through 2001, we randomly assigned 154,900 men and women 55 to 74 years of age either to screening with flexible sigmoidoscopy, with a repeat screening at 3 or 5 years, or to usual care. Cases of colorectal cancer and deaths from the disease were ascertained.

resultsOf the 77,445 participants randomly assigned to screening (intervention group), 83.5% underwent baseline flexible sigmoidoscopy and 54.0% were screened at 3 or 5 years. The incidence of colorectal cancer after a median follow-up of 11.9 years was 11.9 cases per 10,000 person-years in the intervention group (1012 cases), as compared with 15.2 cases per 10,000 person-years in the usual-care group (1287 cases), which represents a 21% reduction (relative risk, 0.79; 95% confidence interval [CI], 0.72 to 0.85; P<0.001). Significant reductions were observed in the incidence of both distal colorectal cancer (479 cases in the intervention group vs. 669 cases in the usual-care group; relative risk, 0.71; 95% CI, 0.64 to 0.80; P<0.001) and proximal colorectal cancer (512 cases vs. 595 cases; relative risk, 0.86; 95% CI, 0.76 to 0.97; P=0.01). There were 2.9 deaths from colorectal cancer per 10,000 person-years in the intervention group (252 deaths), as compared with 3.9 per 10,000 person-years in the usual-care group (341 deaths), which represents a 26% reduction (relative risk, 0.74; 95% CI, 0.63 to 0.87; P<0.001). Mortality from distal colorectal cancer was reduced by 50% (87 deaths in the intervention group vs. 175 in the usual-care group; relative risk, 0.50; 95% CI, 0.38 to 0.64; P<0.001); mortality from proximal colorectal cancer was unaffected (143 and 147 deaths, respectively; relative risk, 0.97; 95% CI, 0.77 to 1.22; P=0.81).

conclusionsScreening with flexible sigmoidoscopy was associated with a significant decrease in colorectal-cancer incidence (in both the distal and proximal colon) and mortality (distal colon only). (Funded by the National Cancer Institute; PLCO ClinicalTrials.gov number, NCT00002540.).

Indexed as

Early Detection of CancerSigmoidoscopyAgedColorectal NeoplasmsEquipment ContaminationFemaleHumansIncidenceMaleMiddle AgedNeoplasm StagingSigmoidoscopes

Identifiers

PMID22612596
PMCPMC3641846
OpenAlexW2147579615

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.