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

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ClinicalTrials.gov Identifier: NCT02409979
Recruitment Status : Completed
First Posted : April 7, 2015
Last Update Posted : November 5, 2015
Sponsor:
Information provided by (Responsible Party):
Sergio Cadoni, M.D., Presidio Ospedaliero Santa Barbara

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Abdominal Pain Other: Carbon dioxide method Other: Water Exchange-CO2 Other: Water Exchange-AI Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes: A Randomized Controlled Trial
Study Start Date : April 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Other: 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.
Other: 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.
Other: Water Exchange-AI
Insertion using water exchange, withdrawal using air insufflation.




Primary Outcome Measures :
  1. Change in abdominal bloating sensation after colonoscopy. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in pain score after colonoscopy. [ Time Frame: 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.

  2. Real-time insertion pain. [ Time Frame: 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.

  3. Number of episodes of incontinence or of soiled underwear experienced in the 6 hours after colonoscopy. [ Time Frame: 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.

  4. Number of flatus episodes post-procedure. [ Time Frame: 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.

  5. Number of incontinence episodes post-procedure. [ Time Frame: 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. Toilet use for bowel movement post-procedure. [ Time Frame: 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.

  7. Patients' satisfaction with the procedure. [ Time Frame: 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.

  8. Willingness to repeat colonoscopy. [ Time Frame: 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.

  9. Interference of colonoscopy on work/normal activities the same day of the procedure. [ Time Frame: 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.

  10. Day of work missed the day after the procedure. [ Time Frame: 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.


Other Outcome Measures:
  1. Cecal intubation rate. [ Time Frame: 1 hour. ]
    Cecal intubation will be defined as reaching beyond the ileocecal valve with adequate visualization of the appendix orifice.

  2. Cecal intubation time. [ Time Frame: 1 hour. ]
    Defined as the time for passage of the colonoscope from the rectum to the cecum.

  3. Total procedure time. [ Time Frame: 1 hour. ]
    Total procedure time (including time required for water infusion, polyp resection or biopsy).

  4. Adenoma detection rate. [ Time Frame: 9 months. ]
    Proportion of subjects with at least one adenoma of any size.

  5. On-demand sedation. [ Time Frame: 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.

  6. Oxygen desaturation. [ Time Frame: 1 hour. ]
    Significant oxygen desaturation (<85% for >15 seconds) will be recorded.

  7. Vagal reaction. [ Time Frame: 1 hour. ]
    Vagal reaction (heart rate <60 beats per minute accompanied by excessive sweating, nausea and/or vomiting) will be recorded.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409979


Locations
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United States, California
Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 91343
Czech Republic
Digestive Diseases Center, Vìtkovice Hospital
Ostrava, Czech Republic, 703 84
Italy
Digestive Endoscopy Unit, Ospedale S. Barbara
Iglesias, CI, Italy, 09016
Sponsors and Collaborators
Presidio Ospedaliero Santa Barbara
Investigators
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Principal Investigator: Sergio Cadoni, MD S. Barbara Hospital, Iglesias (CI) Italy

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sergio Cadoni, M.D., Responsabile Servizio Endoscopia Digestiva, Presidio Ospedaliero Santa Barbara
ClinicalTrials.gov Identifier: NCT02409979     History of Changes
Other Study ID Numbers: PG.2015/3645
Delibera 387/C 17 Marzo 2015 ( Other Identifier: Azienda USL 07 Carbonia, Regione Sardegna )
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: November 5, 2015
Last Verified: October 2015
Keywords provided by Sergio Cadoni, M.D., Presidio Ospedaliero Santa Barbara:
colonoscopy
carbon dioxide
water exchange
discomfort
colonoscopy pain
Additional relevant MeSH terms:
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Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive