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Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes

4. November 2015 aktualisiert von: Sergio Cadoni, M.D., Presidio Ospedaliero Santa Barbara

Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes: A Randomized Controlled Trial

Room air insufflated during colonoscopy cannot be completely suctioned, is not easily absorbed and remains in the bowel for quite some time, resulting in prolonged bowel distension with the discomfort of bloating. Sufferers often experience a sensation of fullness and abdominal pressure, relieved only after expulsion of the residual gas, often accompanied by colic pain. This can be a lengthy process, and some patients continue to report pain as long as 24 hours after the procedure. Abdominal discomfort after colonoscopy is an adverse event commonly reported by patients, and definitely associated with the procedure. Published reports show that the use of carbon dioxide (CO2) insufflation significantly decreases bloating and pain up to 24 hours post-procedure. Preliminary results of the investigators' previous study about on-demand sedation colonoscopy in diagnostic patients showed that, compared with CO2 insufflation, the water exchange group (WE, infusion of water to distend the lumen during insertion; suction of infused water, residual air pockets an feces predominantly during insertion) achieved significantly lower real-time insertion pain scores. Moreover (insertion-withdrawal method) WE-CO2 had the lowest bloating scores just after the procedure and at discharge, comparable with those achieved by CO2-CO2. Compared with WE-CO2, the use of WE-air insufflation (AI) showed significantly higher bloating scores just after the procedure and at discharge; compared with CO2-CO2 differences were significant only at discharge. The investigators decided to conduct a prospective randomized controlled trial comparing WE-CO2, WE-AI and CO2-CO2. The investigators will test the hypothesis that patients examined by the combination of WE-CO2 will have significantly lower bloating scores at specific time points after colonoscopy than those examined using WE-AI or CO2-CO2. The investigators will also assess the impact of these three methods on patients comfort and activities in the post-procedure period.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

246

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Italien
    • CI
      • Iglesias, CI, Italien, 09016
        • Digestive Endoscopy Unit, Ospedale S. Barbara
  • Tschechische Republik
      • Ostrava, Tschechische Republik, 703 84
        • Digestive Diseases Center, Vìtkovice Hospital
  • Vereinigte Staaten
    • California
      • Los Angeles, California, Vereinigte Staaten, 91343
        • Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Sonstiges: Carbon dioxide method
Insufflation with CO2 during insertion and withdrawal phases of colonoscopy.
Experimental: 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.
Sonstiges: Water Exchange-CO2
Insertion using water exchange, withdrawal using CO2 insufflation.
Experimental: 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.
Sonstiges: Water Exchange-AI
Insertion using water exchange, withdrawal using air insufflation.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in abdominal bloating sensation after colonoscopy.
Zeitfenster: Within the first 24 hours after the procedure.
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.
Within the first 24 hours after the procedure.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in pain score after colonoscopy.
Zeitfenster: Within the first 24 hours after the procedure.
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.
Within the first 24 hours after the procedure.
Real-time insertion pain.
Zeitfenster: 1 hour.
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.
1 hour.
Number of episodes of incontinence or of soiled underwear experienced in the 6 hours after colonoscopy.
Zeitfenster: 6 hours.
Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients. Results will be recorded by telephone recall.
6 hours.
Number of flatus episodes post-procedure.
Zeitfenster: 24 hours.
Recorded at discharge and assessed post-procedure up to 24 hours using a questionnaire given to patients. Results will be recorded by telephone recall.
24 hours.
Number of incontinence episodes post-procedure.
Zeitfenster: 6 hours.
Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients. Results will be recorded by telephone recall.
6 hours.
Toilet use for bowel movement post-procedure.
Zeitfenster: 6 hours.
Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients. Results will be recorded by telephone recall.
6 hours.
Patients' satisfaction with the procedure.
Zeitfenster: 24 hours.
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.
24 hours.
Willingness to repeat colonoscopy.
Zeitfenster: 24 hours.
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.
24 hours.
Interference of colonoscopy on work/normal activities the same day of the procedure.
Zeitfenster: Up to 12 hours.
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.
Up to 12 hours.
Day of work missed the day after the procedure.
Zeitfenster: 24 hours.
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.
24 hours.

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cecal intubation rate.
Zeitfenster: 1 hour.
Cecal intubation will be defined as reaching beyond the ileocecal valve with adequate visualization of the appendix orifice.
1 hour.
Cecal intubation time.
Zeitfenster: 1 hour.
Defined as the time for passage of the colonoscope from the rectum to the cecum.
1 hour.
Total procedure time.
Zeitfenster: 1 hour.
Total procedure time (including time required for water infusion, polyp resection or biopsy).
1 hour.
Adenoma detection rate.
Zeitfenster: 9 months.
Proportion of subjects with at least one adenoma of any size.
9 months.
On-demand sedation.
Zeitfenster: 1 hour.
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.
1 hour.
Oxygen desaturation.
Zeitfenster: 1 hour.
Significant oxygen desaturation (<85% for >15 seconds) will be recorded.
1 hour.
Vagal reaction.
Zeitfenster: 1 hour.
Vagal reaction (heart rate <60 beats per minute accompanied by excessive sweating, nausea and/or vomiting) will be recorded.
1 hour.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Presidio Ospedaliero Santa Barbara

Ermittler

  • Hauptermittler: Sergio Cadoni, MD, S. Barbara Hospital, Iglesias (CI) Italy

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

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. April 2015

Primärer Abschluss (Tatsächlich)

1. November 2015

Studienabschluss (Tatsächlich)

1. November 2015

Studienanmeldedaten

Zuerst eingereicht

23. März 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. April 2015

Zuerst gepostet (Schätzen)

7. April 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

5. November 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. November 2015

Zuletzt verifiziert

1. Oktober 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PG.2015/3645
  • Delibera 387/C 17 Marzo 2015 (Andere Kennung: Azienda USL 07 Carbonia, Regione Sardegna)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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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