- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01035775
Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Background: Colonoscopy is not a perfect test. It misses a substantial number of neoplastic lesions and has some risk of missing cancer. Nearly all work on detection during colonoscopy has focused on the withdrawal phase of the examination. Thus, colonoscopy is typically performed by rapidly passing the instrument through the loops and bends of the colon in order to reach the tip of the cecum, and then performing a slow withdrawal in which the tip of the instrument is systematically deflected, and the mucosa is careful cleaned and suctioned, to expose all of the colonic mucosa for viewing.
Many experienced colonoscopists recognize that small polyps seen incidentally but not removed during insertion are sometimes quite difficult to find during withdrawal. The reason for this observation is probably because the colon is in a very different anatomical conformation during endoscope insertion and withdrawal. During insertion, the colon is in its natural conformation in which the sigmoid and transverse colon has several sharp bends or flexures, and the overall length has not yet been shortened. In this phase, the colon is often significantly stretched because of the formation of loops and bends in the colonoscope. This greatly affects the conformation of the colonic wall visualized proximal to the instrument tip. During withdrawal, the colon is shortened and pleated over the colonoscope, with successive regions of the colon being inspected as they slip off the end of the instrument. Thus, segments of visualized colon are often much straighter during withdrawal than during insertion. The insertion and withdrawal phases, therefore, expose somewhat different sections of the mucosal surface to the colonoscope and inspection on insertion and withdrawal are, quite possibly, complementary.
Aims: This randomized, controlled trial will compare the additional effect on the rate of adenoma detection of mucosal inspection during colonoscope insertion, with inspection during instrument withdrawal, in patients undergoing colonoscopy for colorectal cancer screening or surveillance.
Study procedure: In this study, we plan to investigate whether a specified interval of inspection during insertion can increase overall adenoma detection. We will conduct a randomized controlled trial, in which patients will be randomized to have all of the inspection performed during the withdrawal phase (as is usual care) versus having several minutes of examination specifically devoted to inspection during insertion.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
- Indiana University Hospital
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Indianapolis, Indiana, États-Unis, 46280
- Beltway Surgery Center
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age ≥ 50 years
- Patients undergoing colonoscopy for screening or surveillance indications
Exclusion Criteria:
- Previous surgical resection of all or part of the colon.
- Inability to give informed consent.
- Ulcerative colitis or Crohn's disease.
- Polyposis syndrome or Lynch syndrome (HNPCC)
- Any comorbid condition which the investigator deems would put the patient at increased risk from a slightly prolonged procedure
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Insertion
Inspection on colonoscope insertion in addition to inspection during withdrawal from the cecum.
|
The colonic mucosa will be inspected for lesions during insertion of the instrument, and during withdrawal of the instrument.
|
|
Comparateur actif: Withdrawal
Inspection during withdrawal (usual care) without deliberate inspection during insertion.
|
The colonic mucosa will be inspected for lesions only during withdrawal of the instrument from the cecum.
The instrument will be inserted to the cecum without deliberate inspection.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Adenoma detection rate
Délai: During colonoscopy
|
During colonoscopy
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Sedation dose
Délai: During colonoscopy
|
During colonoscopy
|
|
Post procedural pain scores
Délai: Within 1 hour of colonoscopy
|
Within 1 hour of colonoscopy
|
|
Proportion of patients with at least one adenoma detected
Délai: During colonoscopy
|
During colonoscopy
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Douglas K Rex, M.D., Indiana University School of Medicine
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 0909-22
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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