- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02409979
Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes
Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes: A Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Design: Prospective double blinded two-center randomized controlled trial. Methods: Colonoscopy with CO2 insufflation and water exchange-CO2, water exchange-AI; split-dose bowel preparation; on demand-sedation.
Control method: CO2 insufflation colonoscopy. Study methods: water exchange-CO2 colonoscopy, water exchange-AI colonoscopy.
Population: Consecutive 18 to 80 year-old first-time diagnostic outpatients. After informed consent, assignment to control or study arms based on computer generated randomization list with block allocation and stratification.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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CI
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Iglesias, CI, Italie, 09016
- Digestive Endoscopy Unit, Ospedale S. Barbara
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Ostrava, République tchèque, 703 84
- Digestive Diseases Center, Vìtkovice Hospital
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California
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Los Angeles, California, États-Unis, 91343
- Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System
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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:
- consecutive 18 to 80 year-old first-time diagnostic outpatients agreeing to start procedure without premedication
Exclusion Criteria:
- patient unwillingness to start the procedure without sedation/analgesia
- previous colorectal surgery
- proctosigmoidoscopy or bidirectional endoscopy
- patient refusal or inability to provide informed consent
- inadequate consumption of bowel preparation
- moderate or severe chronic obstructive pulmonary disease requiring oxygen
- medical history of CO2 retention
- history of inflammatory bowel disease
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Carbon dioxide method
Colonoscopy performed as usual, with the minimal CO2 insufflation required to aid insertion and adequate distension during withdrawal for exploration.
Washing allowed as needed.
Considered to be standard procedure.
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Insufflation with CO2 during insertion and withdrawal phases of colonoscopy.
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Expérimental: Water Exchange-CO2
Insufflation not used until the cecum is reached.
Infusion of a sufficient amount of water to render the lumen a slit to progress with the colonoscope.
Part of the infused water will be constantly suctioned back exchanging clean for opaque water.
Air pockets and residual feces will be always aspirated.
Withdrawal phase done using carbon dioxide insufflation.
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Insertion using water exchange, withdrawal using CO2 insufflation.
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Expérimental: Water Exchange-AI
Insufflation not used until the cecum is reached.
Infusion of a sufficient amount of water to render the lumen a slit to progress with the colonoscope.
Part of the infused water will be constantly suctioned back exchanging clean for opaque water.
Air pockets and residual feces will be always aspirated.
Withdrawal phase done using air insufflation.
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Insertion using water exchange, withdrawal using air insufflation.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Change in abdominal bloating sensation after colonoscopy.
Délai: Within the first 24 hours after the procedure.
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Change of patients' sensation of abdominal bloating.
Assessed by blinded observer just after examination, at discharge; and at 1, 3, 6, 12 and 24 hours after the procedure using a questionnaire given to patients.
Measured on an eleven-point Numeric Rating Scale (NRS): 0=none, 10=full bloating.
Results will be recorded by telephone recall.
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Within the first 24 hours after the procedure.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in pain score after colonoscopy.
Délai: Within the first 24 hours after the procedure.
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Assessed by blinded observer just after examination, at discharge; and at 1, 3, 6, 12 and 24 hours after the procedure using a questionnaire given to patients.
Measured using an eleven-point NRS (0=none, 10=maximum pain).
Results will be recorded by telephone recall.
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Within the first 24 hours after the procedure.
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Real-time insertion pain.
Délai: 1 hour.
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Pain assessed using a NRS (0=absence of pain, 2=simply "discomfort", 10=worst pain).
Before the procedure, an endoscopic nurse will explain the NRS scoring system to the patients.
At irregular intervals during colonoscopy (around 60 seconds) assisting nurse will ask patients about discomfort or pain.
The responses will be recorded, and the maximum pain score noted.
Colonoscopists not participating in gathering the informations.
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1 hour.
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Number of episodes of incontinence or of soiled underwear experienced in the 6 hours after colonoscopy.
Délai: 6 hours.
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Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
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6 hours.
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Number of flatus episodes post-procedure.
Délai: 24 hours.
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Recorded at discharge and assessed post-procedure up to 24 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
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24 hours.
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Number of incontinence episodes post-procedure.
Délai: 6 hours.
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Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
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6 hours.
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Toilet use for bowel movement post-procedure.
Délai: 6 hours.
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Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
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6 hours.
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Patients' satisfaction with the procedure.
Délai: 24 hours.
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Assessed post-procedure after 24 hours using a questionnaire given to patients (0=not satisfied, 10=very satisfied).
Results will be recorded by telephone recall.
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24 hours.
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Willingness to repeat colonoscopy.
Délai: 24 hours.
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Assessed post-procedure after 24 hours using a questionnaire given to patients (0=not willing to repeat, 10=very likely to repeat).
Results will be recorded by telephone recall.
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24 hours.
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Interference of colonoscopy on work/normal activities the same day of the procedure.
Délai: Up to 12 hours.
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Assessed post-procedure after 12 hours using a questionnaire given to patients (0=nothing at all, 10=a lot).
Results will be recorded by telephone recall.
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Up to 12 hours.
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Day of work missed the day after the procedure.
Délai: 24 hours.
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Work activities missed the day after colonoscopy due to some effect of the procedure (yes, no).
Assessed post-procedure after 24 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
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24 hours.
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Cecal intubation rate.
Délai: 1 hour.
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Cecal intubation will be defined as reaching beyond the ileocecal valve with adequate visualization of the appendix orifice.
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1 hour.
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Cecal intubation time.
Délai: 1 hour.
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Defined as the time for passage of the colonoscope from the rectum to the cecum.
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1 hour.
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Total procedure time.
Délai: 1 hour.
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Total procedure time (including time required for water infusion, polyp resection or biopsy).
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1 hour.
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Adenoma detection rate.
Délai: 9 months.
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Proportion of subjects with at least one adenoma of any size.
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9 months.
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On-demand sedation.
Délai: 1 hour.
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Offered at patient request for a NRS score ≥2.
Medications given as per institutional regulation.
Dose titrated based on patients' reported real-time pain score, age, weight and comorbidity.
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1 hour.
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Oxygen desaturation.
Délai: 1 hour.
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Significant oxygen desaturation (<85% for >15 seconds) will be recorded.
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1 hour.
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Vagal reaction.
Délai: 1 hour.
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Vagal reaction (heart rate <60 beats per minute accompanied by excessive sweating, nausea and/or vomiting) will be recorded.
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1 hour.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sergio Cadoni, MD, S. Barbara Hospital, Iglesias (CI) Italy
Publications et liens utiles
Publications générales
- Sumanac K, Zealley I, Fox BM, Rawlinson J, Salena B, Marshall JK, Stevenson GW, Hunt RH. Minimizing postcolonoscopy abdominal pain by using CO(2) insufflation: a prospective, randomized, double blind, controlled trial evaluating a new commercially available CO(2) delivery system. Gastrointest Endosc. 2002 Aug;56(2):190-4. doi: 10.1016/s0016-5107(02)70176-4.
- Zubarik R, Fleischer DE, Mastropietro C, Lopez J, Carroll J, Benjamin S, Eisen G. Prospective analysis of complications 30 days after outpatient colonoscopy. Gastrointest Endosc. 1999 Sep;50(3):322-8. doi: 10.1053/ge.1999.v50.97111.
- de Jonge V, Sint Nicolaas J, van Baalen O, Brouwer JT, Stolk MF, Tang TJ, van Tilburg AJ, van Leerdam ME, Kuipers EJ; SCoPE consortium. The incidence of 30-day adverse events after colonoscopy among outpatients in the Netherlands. Am J Gastroenterol. 2012 Jun;107(6):878-84. doi: 10.1038/ajg.2012.40. Epub 2012 Mar 6.
- Lee YC, Wang HP, Chiu HM, Lin CP, Huang SP, Lai YP, Wu MS, Chen MF, Lin JT. Factors determining post-colonoscopy abdominal pain: prospective study of screening colonoscopy in 1000 subjects. J Gastroenterol Hepatol. 2006 Oct;21(10):1575-80. doi: 10.1111/j.1440-1746.2006.04145.x.
- Falt P, Liberda M, Smajstrla V, Kliment M, Bartkova A, Tvrdik J, Fojtik P, Urban O. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):971-7. doi: 10.1097/MEG.0b013e3283543f16.
- Cadoni S, Falt P, Gallittu P, Liggi M, Smajstrla V, Leung FW. Impact of carbon dioxide insufflation and water exchange on postcolonoscopy outcomes in patients receiving on-demand sedation: a randomized controlled trial. Gastrointest Endosc. 2017 Jan;85(1):210-218.e1. doi: 10.1016/j.gie.2016.05.021. Epub 2016 May 17.
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PG.2015/3645
- Delibera 387/C 17 Marzo 2015 (Autre identifiant: Azienda USL 07 Carbonia, Regione Sardegna)
Informations sur les médicaments et les dispositifs, documents d'étude
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