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

4 novembre 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

246

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Italia
    • CI
      • Iglesias, CI, Italia, 09016
        • Digestive Endoscopy Unit, Ospedale S. Barbara
  • Repubblica Ceca
      • Ostrava, Repubblica Ceca, 703 84
        • Digestive Diseases Center, Vìtkovice Hospital
  • Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti, 91343
        • Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: Carbon dioxide method
Insufflation with CO2 during insertion and withdrawal phases of colonoscopy.
Sperimentale: 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.
Altro: Water Exchange-CO2
Insertion using water exchange, withdrawal using CO2 insufflation.
Sperimentale: 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.
Altro: Water Exchange-AI
Insertion using water exchange, withdrawal using air insufflation.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in abdominal bloating sensation after colonoscopy.
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in pain score after colonoscopy.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Cecal intubation rate.
Lasso di tempo: 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.
Lasso di tempo: 1 hour.
Defined as the time for passage of the colonoscope from the rectum to the cecum.
1 hour.
Total procedure time.
Lasso di tempo: 1 hour.
Total procedure time (including time required for water infusion, polyp resection or biopsy).
1 hour.
Adenoma detection rate.
Lasso di tempo: 9 months.
Proportion of subjects with at least one adenoma of any size.
9 months.
On-demand sedation.
Lasso di tempo: 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.
Lasso di tempo: 1 hour.
Significant oxygen desaturation (<85% for >15 seconds) will be recorded.
1 hour.
Vagal reaction.
Lasso di tempo: 1 hour.
Vagal reaction (heart rate <60 beats per minute accompanied by excessive sweating, nausea and/or vomiting) will be recorded.
1 hour.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Presidio Ospedaliero Santa Barbara

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2015

Completamento primario (Effettivo)

1 novembre 2015

Completamento dello studio (Effettivo)

1 novembre 2015

Date di iscrizione allo studio

Primo inviato

23 marzo 2015

Primo inviato che soddisfa i criteri di controllo qualità

1 aprile 2015

Primo Inserito (Stima)

7 aprile 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

5 novembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 novembre 2015

Ultimo verificato

1 ottobre 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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