- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02305251
Patient Preferences of a Resect and Discard Paradigm
Studieoversigt
Detaljeret beskrivelse
The American Society of Gastrointestinal Endoscopy (ASGE) published a review article on a new paradigm in colorectal cancer screening termed "resect and discard". This new paradigm challenges the current practice of sending all colorectal polyps, regardless of appearance or size, to pathology for analysis. "Resect and Discard" describes a new approach in which small polyps could be removed, but be discarded instead of sent for pathology analysis. This is based on data showing that gastroenterologists can predict the pathology of small colorectal polyps with 80-90% accuracy, and that discarding small polyps would not alter surveillance recommendations.
Neither the ASGE document nor published research, however, assessed patient attitudes toward this approach. This study surveyed patients prior to first time screening colonoscopy, in order to determine their preferences about the resect and discard approach; specifically would patients be willing to pay for pathology analysis of small colorectal polyps with their own money, and what factors influence their decision. We also inquired about factors that would influence their decision to pay/not pay pathology costs themselves.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Missouri
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Saint Louis, Missouri, Forenede Stater, 63110
- Washington University in St. Louis
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
• Indication for colonoscopy is screening or routine polyp surveillance
Exclusion Criteria:
- Indication for colonoscopy other than screening or surveillance
- Colon cancer identified at time of colonoscopy
- Known polyposis syndrome, or polyposis identified at colonoscopy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of participants willing to pay out of pocket for pathology costs when a diminutive polyp is found.
Tidsramme: June, 2012 to March, 2014: up to 2 years
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This outcome is measured in percentage.
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June, 2012 to March, 2014: up to 2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The factors that influence patients' decisions to pay or not pay for pathology costs with their own money.
Tidsramme: June, 2012 to March, 2014: up to 2 years
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These factors were measured using univariate analysis with generation of odds ratios and 95% confidence intervals.
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June, 2012 to March, 2014: up to 2 years
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Dayna S Early, MD, Washington University School of Medicine
Publikationer og nyttige links
Generelle publikationer
- Rex DK. Narrow-band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology. 2009 Apr;136(4):1174-81. doi: 10.1053/j.gastro.2008.12.009. Epub 2008 Dec 10.
- Hassan C, Pickhardt PJ, Rex DK. A resect and discard strategy would improve cost-effectiveness of colorectal cancer screening. Clin Gastroenterol Hepatol. 2010 Oct;8(10):865-9, 869.e1-3. doi: 10.1016/j.cgh.2010.05.018. Epub 2010 Jun 1.
- Vu HT, Sayuk GS, Gupta N, Hollander T, Kim A, Early DS. Patient preferences of a resect and discard paradigm. Gastrointest Endosc. 2015 Aug;82(2):381-384.e1. doi: 10.1016/j.gie.2015.01.042. Epub 2015 Apr 22.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 201202031
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Kliniske forsøg med Colonpolypper
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University of ManitobaAktiv, ikke rekrutterendePolypper | Colon polyp | Polyp af tyktarm | Colo-rektal cancer | Colon polyp | Rektal polyp | Polyp rektalCanada
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Vejle HospitalIkke rekrutterer endnuKolorektal cancer | Colon polyp | Kolorektal polyp | Fælles beslutningstagning | Beslutningshjælpemidler | Rektal polyp
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King's College Hospital NHS TrustRekrutteringPolyp af tyktarm | Kolorektal polypDet Forenede Kongerige
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University College, LondonIkke rekrutterer endnuPolypper | Colon polyp | Adenom tyktarm | Kolorektal polyp | Polypper af tyktarmDet Forenede Kongerige
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Medical University of ViennaAfsluttetFlere polypper højre kolon | Stor polyp højre kolon | Mistænkt polyp højre kolonØstrig
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South Tyneside and Sunderland NHS Foundation TrustMedtronic; Newcastle University; North Wales Organisation for Randomised...AfsluttetColon polyp | Kolorektalt adenom | Kolorektal polyp | Kolorektal SSA | Kolorektal adenomatøs polyp | Sessilt takket adenom | Fastsiddende tyktarmspolypDet Forenede Kongerige
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Nanfang Hospital of Southern Medical UniversityUkendt
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Region SkåneCarponovum ABAfsluttetKræft | PolypSverige
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