- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02538406
The Utility of Time Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate.
26. oktober 2020 oppdatert av: Mohamed Othman, Baylor College of Medicine
The Utility of Time Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate. A Randomized Controlled Clinical Trial.
Colonoscopy( examining the colon with a flexible tube and a camera ) is usually done for screening purposes to find any precancerous lesions (polyps) at an early stage.
During the colonoscopy the doctor will advance the colonoscope to the end of your colon and start examining the colon for any polyps.
"Withdrawal time" is the period of time the doctor spends examining the colon.
Doctors usually spend six minutes examining the colon after they reach the end of the colon.
Studies have showed that spending more withdrawal time detects more lesions.
The proposal to dedicating half of the withdrawal time during colonoscopy in examining the right side will increase the detection of polyps in the right side of the colon.
There will be no other changes in the procedural aspect of the colonoscopy.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Screening colonoscopy is an essential diagnostic tool in the early detection of precancerous colonic lesions, preventing the progression of these lesions to cancer.
Population-based and case control studies found a 50% reduction in colo-rectal cancer (CRC) incidence and up to a one-third reduction in mortality from CRC after screening colonoscopy.
The effectiveness of colonoscopy in preventing colon cancer is dependent on the adenoma detection rate (ADR) during the procedure.
Studies have demonstrated that withdrawal times of 6 minutes or more had higher rates of detection of any neoplasia.
In 2006 joint task force of the American College of Gastroenterology and American Society for Gastrointestinal Endoscopy changed the recommendation to indicate that average withdrawal time should exceed 6 minutes in normal colonoscopies in which no polypectomies or biopsies were performed.
Based on this recommendation, the 6-minute benchmark is the current standard of care.
Longer mean withdrawal times are associated with increasing adenoma detection, mainly of small or right-sided adenomas and proximal serrated adenomas, presumably due to longer inspection of the right colon.
However, it also have been showed withdrawal time using 6 minutes as the threshold is not a strong predictor of the likelihood of finding a polyp during colonoscopy and should not be used as a quality indicator.
New CRC diagnosis within 3 years of negative screening colonoscopy can be as high as 6%.
Right-sided lesions, flat polyps, and variability in endoscopist quality measures are all potential reasons why interval cancers develop.
A recent observational study was published showing increase in ADR after implementation of a protocol of careful inspection during a minimum of 8 minutes was established.
The investigators hypothesized that if colonoscopists would spend at least half of the time of the withdrawal time in the right side of the colon (referred as segmented protocol), ADR can increase mainly due to the detection of lesions in the right side, which could have been missed otherwise.
The investigators are conducting a single center randomized trial investigating the utility of timed segmental withdrawal of at least 3 minutes each in both right and left side of the colon respectively, compared to the regular 6 minutes total withdrawal time regardless of where the time was spent in the colon.
Studietype
Observasjonsmessig
Registrering (Faktiske)
232
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- Baylor College of Medicine
-
-
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
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Study participants will be recruited from patients ages 18-80 scheduled for a screening colonoscopy at Baylor College of Medicine.
Informed consent will be obtained from the patients during their Gastroenterology clinic visit if the procedure scheduled by gastroenterologist or during their pre-procedure assessment appointment if they were referred by a primary care doctor.
Participation in the study will be voluntary.
We use the split prep protocol in preparation for colonoscopy in all patients undergoing colonoscopy in our unit.
Beskrivelse
Inclusion Criteria:
- Adult patients (18-80 years) who are undergoing colonoscopy for screening or surveillance purposes.
Exclusion Criteria:
- Patients with a prior history of colonic surgeries
- Patient with Crohns colitis or ulcerative colitis
- Patient with prior history of colon cancer
- Patient with poor bowel preparation
- Pregnant women
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
non segmental withdrawal
A standard of care colonoscopy will be done on the patient without extra time on the right side of the colon.
|
|
|
Segmental withdrawal
A standard of care colonoscopy will be done on the patient , however the time spent in the right side of the colon will be more than half of the normal colonoscopy procedure (i.e. more than 3 minutes)
|
Interventional group will have at least 3 minutes dedicated to the right side of the colon during segmental withdrawal.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Increase in detection rate of adenomas in the right side of the colon
Tidsramme: 30 minutes
|
To determine if timed segmental withdrawal protocol can increase the adenoma detection rate in the right side of the colon compared to non segmental withdrawal.
|
30 minutes
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sessile Serrated lesion detection rate
Tidsramme: 30 minutes
|
Compare sessile serrated lesion detection rate between patients undergoing a screening colonoscopy with segmental withdrawal protocol and non-segmental withdrawal protocol.
|
30 minutes
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Mohamed O. Othman, MD, Baylor College of Medicine
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 2015
Primær fullføring (Forventet)
1. juni 2020
Studiet fullført (Faktiske)
2. april 2020
Datoer for studieregistrering
Først innsendt
31. august 2015
Først innsendt som oppfylte QC-kriteriene
1. september 2015
Først lagt ut (Anslag)
2. september 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. oktober 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. oktober 2020
Sist bekreftet
1. oktober 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H-37320
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .