A Comparison of an Ultra-thin and Standard Colonoscope in Achieving Caecal Intubation
A Study to Assess the Success Rate of Ultra-thin Colonoscopy Versus Conventional Colonoscopy for the First or Rescue Colonoscopy for Unsuccessful Procedures (UTC Study).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Colonoscopy is a common endoscopic procedure, widely used for the investigation of lower gastrointestinal tract diseases manifesting as altered bowel habit, per rectal bleeding and abdominal pain. It is used to diagnose colonic polyps, colorectal cancer and inflammatory bowel disease to name a few examples.
Colorectal cancer screening has been shown to decrease colorectal cancer. Despite this the uptake by the general population is suboptimal.
A new prototype colonoscope from Olympus with an additional distal bending section was designed. The investigators hypothesize that its performance characteristics will be similar to a standard colonoscope with patient tolerability.
This randomised control trial aims to invite patients attending their first outpatient colonoscopy and who are able to provide informed consent.(so they have had no prior experience) to assess the completion rate, patient and endoscopist satisfaction.
Patients with prior colorectal surgery or previous colonoscopy were excluded.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
Hong Kong
-
Hong Kong, Hong Kong, Kina
- Endoscopy Center, Prince of Wales Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- First outpatient colonoscopy
- Able to provide informed consent
Exclusion Criteria:
- Unable to provide consent
- Prior colon surgery (except appendectomy)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Standard Colonoscopy
Colonoscopy with standard instrument
|
Standard colonoscopy will be used during colonoscopy
|
|
Eksperimentel: Ultra-thin colonoscopy
New prototype scope
|
Ultra-thin colonoscope will be used during colonoscopy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Successful Caecal intubation
Tidsramme: 12 weeks
|
Success of Caecal intubation for the ultra-thin colonoscope vs standard colonoscope
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Caecal intubation time
Tidsramme: 12 weeks
|
Caecal intubation time Ultra-thin colonsocope vs standard colonoscope
|
12 weeks
|
|
Patient Satisfaction and Pain score
Tidsramme: 12 weeks
|
Patient tolerability Ultra-thin vs standard colonoscope
|
12 weeks
|
|
Endoscopist satisfaction
Tidsramme: 12 weeks
|
Ease of use prototype scope vs standard colonoscope
|
12 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: James Y Lau, Chinese University of Hong Kong
Publikationer og nyttige links
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 (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- UTC Study
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