Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy
25. august 2016 oppdatert av: Yanglin Pan, Air Force Military Medical University, China
Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy: a Single-centered, Randomized Controlled Study
Patients with colorectal adenomas are suggested to receive polypectomy.
A substantial number of adenomas may be missed in patients with polyps found by previous colonoscopy.
And water exchange (WE) method may increase the detection of missed adenoma compared with traditional air insufflation (AI) colonoscopy.
The investigators aim to investigate whether water exchange colonoscopy method, compared with air insufflation method, can improve the detection of missed adenomas in patients undergoing selective polypectomy.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
For WE method, the air pump was turned off for the full duration of insertion to avoid inadvertent air insufflations and colon elongation. Residual air in the lumen was suctioned to minimize angulations at flexures. Water at 37°C was infused with a pump (Olympus) through the biopsy channel to confirm correct tip orientation for scope advancement. The infused water was removed predominantly by suction when the colonoscope was smoothly advanced during the insertion phase, and turbid luminal water due to residual feces was exchanged by clean water until the lumen was clearly visualized. Occasionally, if it was difficult to determine whether the colonoscope tip was in the cecum, air was allowed to be insufflated for observation. If the position of the scope tip was confirmed to be not in the cecum, insufflated air would be removed by suction and the WE method would be continuously used until successful intubation.
For the AI method, water was not used, and air was insufflated during insertion.
Air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal for both methods. Polyps will be removed by forceps biopsy (polyps size <3mm), cold snare technique (3-6mm) or endoscopic mucosal resection (size≥6mm).
Studietype
Intervensjonell
Registrering (Forventet)
450
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Shaanxi
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Xi'an, Shaanxi, Kina, 710032
- Rekruttering
- Endoscopic center, Xijing Hospital of Digestive Diseases
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Ta kontakt med:
- Gui Ren, MD
- Telefonnummer: +862984771536
- E-post: renguigz@hotmail.com
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Hovedetterforsker:
- Gui Ren, MD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Age 18-80 patients undergoing selective polypectomy
Exclusion Criteria:
- Polyps found more than 6 months
- Patients with polyposis syndrome or hereditary nonpolyposis colorectal cancer
- Patients with history of inflammatory bowel disease
- Patients with planning to undergo Endoscopic Submucosal Dissection(ESD)
- Patients not undergoing standard bowel preparation
- Patients with solid feces in the last stool after bowel preparation
- Patients considered to be high risk for bleeding during Endoscopic mucosal resection (EMR), e.g. using antiplatelet drugs (clopidogrel) within 5 days before the current colonoscopy
- Hemodynamically unstable
- Pregnant women
- Unable to provide informed consent
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Water exchange (WE) method
Water exchange (WE) method was used for insertion to the cecum.
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Water exchange (WE) method was used for insertion to the cecum.
And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.
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Aktiv komparator: Air insufflation (AI) method
Air insufflation (AI) method was used for insertion to the cecum.
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Air insufflation (AI) method was used for insertion to the cecum.
And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Adenoma miss rate
Tidsramme: 12 months
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Adenoma miss rate was calculated as the number of patients with one and more additional adenomas during polypectomy procedure divided by the total number of patients in each group.
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12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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adenoma-level miss rate
Tidsramme: 12 months
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Adenoma-level miss rate was calculated as the number of additional adenomas detected in polypectomy procedure divided by the total number of adenomas in each group.
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12 months
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Advanced adenoma miss rate/Miss advanced adenoma per colonoscopy
Tidsramme: 12 months
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Advanced adenoma: any with 3 or more adenomas of any size, 1 or more large adenomas 1 cm, or 1 or more adenomas with villous architecture or highgrade dysplasia.
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12 months
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Adenoma per positive patient (APP)
Tidsramme: 12 months
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The mean number of adenoma per positive patient
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12 months
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Quality of Bowel Preparation
Tidsramme: 12 months
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The Boston Bowel Preparation Scale (BBPS): cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.
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12 months
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Complication rate
Tidsramme: 12 months
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Bleeding, perforation and others
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12 months
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Pain Scores on the Visual Analog Scale compared with previous colonoscopy
Tidsramme: 12 months
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0 = no pain, to 10 = most severe pain
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12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Hewett DG, Rex DK. Cap-fitted colonoscopy: a randomized, tandem colonoscopy study of adenoma miss rates. Gastrointest Endosc. 2010 Oct;72(4):775-81. doi: 10.1016/j.gie.2010.04.030. Epub 2010 Jun 25.
- Veitch AM, Vanbiervliet G, Gershlick AH, Boustiere C, Baglin TP, Smith LA, Radaelli F, Knight E, Gralnek IM, Hassan C, Dumonceau JM. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Gut. 2016 Mar;65(3):374-89. doi: 10.1136/gutjnl-2015-311110.
- Ren G, Wang X, Luo H, Yao S, Liang S, Zhang L, Dong T, Chen L, Tao Q, Guo X, Han Y, Pan Y. Effect of water exchange method on adenoma miss rate of patients undergoing selective polypectomy: A randomized controlled trial. Dig Liver Dis. 2021 May;53(5):625-630. doi: 10.1016/j.dld.2020.11.012. Epub 2020 Dec 31.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2016
Primær fullføring (Forventet)
1. august 2017
Studiet fullført (Forventet)
1. august 2017
Datoer for studieregistrering
Først innsendt
19. august 2016
Først innsendt som oppfylte QC-kriteriene
25. august 2016
Først lagt ut (Anslag)
26. august 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
26. august 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. august 2016
Sist bekreftet
1. august 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KY20162059-2
Plan for individuelle deltakerdata (IPD)
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UBESLUTTE
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