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The Utility of Time Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate.

26. oktober 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

232

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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:

  1. Patients with a prior history of colonic surgeries
  2. Patient with Crohns colitis or ulcerative colitis
  3. Patient with prior history of colon cancer
  4. Patient with poor bowel preparation
  5. Pregnant women

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Mohamed O. Othman, MD, Baylor College of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2015

Primær færdiggørelse (Forventet)

1. juni 2020

Studieafslutning (Faktiske)

2. april 2020

Datoer for studieregistrering

Først indsendt

31. august 2015

Først indsendt, der opfyldte QC-kriterier

1. september 2015

Først opslået (Skøn)

2. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Adenomatøs polyp i tyktarmen

Kliniske forsøg med Segmental withdrawal

3
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