- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02538406
The Utility of Time Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate.
26. Oktober 2020 aktualisiert von: 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.
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
232
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Texas
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Houston, Texas, Vereinigte Staaten, 77030
- Baylor College of Medicine
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
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.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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non segmental withdrawal
A standard of care colonoscopy will be done on the patient without extra time on the right side of the colon.
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|
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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)
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Interventional group will have at least 3 minutes dedicated to the right side of the colon during segmental withdrawal.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Increase in detection rate of adenomas in the right side of the colon
Zeitfenster: 30 minutes
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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.
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30 minutes
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Sessile Serrated lesion detection rate
Zeitfenster: 30 minutes
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Compare sessile serrated lesion detection rate between patients undergoing a screening colonoscopy with segmental withdrawal protocol and non-segmental withdrawal protocol.
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30 minutes
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Mohamed O. Othman, MD, Baylor College of Medicine
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. August 2015
Primärer Abschluss (Voraussichtlich)
1. Juni 2020
Studienabschluss (Tatsächlich)
2. April 2020
Studienanmeldedaten
Zuerst eingereicht
31. August 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. September 2015
Zuerst gepostet (Schätzen)
2. September 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
28. Oktober 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. Oktober 2020
Zuletzt verifiziert
1. Oktober 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- H-37320
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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