Ignite Creation Date:
2024-05-06 @ 2:03 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01954862
Status:
COMPLETED
Last Update Posted:
2014-07-31
First Post:
2013-09-27
Brief Title:
Comparison of Methods to Distend the Colon During Insertion CO2 Air Insufflation Water-aided Colonoscopy
Sponsor:
Presidio Ospedaliero Santa Barbara
Organization:
Presidio Ospedaliero Santa Barbara
Study Overview
Official Title:
Comparison of Methods for Luminal Distention for on Demand Sedation Colonoscopy Air Insufflation Carbon Dioxide and Water-aided Colonoscopy A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Insufflation of the colon usually with room air is necessary to distend the lumen for exploration Carbon dioxide CO2 insufflation instead of room air insufflation AI has been shown to decrease symptoms of abdominal pain or discomfort during the procedure and particularly during the following 24 hours CO2 is is rapidly absorbed by the intestinal mucosa and exhaled through respiration AI colonoscopy has usually been the reference standard to compare colonoscopy using CO2 insufflation In two recent articles AI was compared to either CO2 insufflation and Water-aided colonoscopy WAC which entails infusion of water to facilitate insertion to the cecum
WAC can be categorized broadly in Water Immersion WI and Water Exchange WE In WI water is infused during the insertion phase of colonoscopy with removal of infused water predominantly during withdrawal Occasional use of insufflation may be allowed WE entails complete exclusion of insufflation removal of residual colonic air pockets and feces and suction of infused water predominantly during insertion to minimize distention During the withdrawal phase insufflation is used to distend the colonic lumen
In the WAC arms of the two mentioned articles the insertion method used was WI with infusion of water at room temperature or at 37C During withdrawal air insufflation or either air or CO2 insufflation were employed
Compared to AI CO2 insufflation and WI using room air insufflation or CO2 insufflation during withdrawal were effective in both studies in decreasing sedation requirement pain and tolerance scores with patients higher willingness to repeat the procedure
Until now no direct comparison has been made within a single study about pain score during colonoscopy using AI CO2 insufflation WICO2 WECO2 WIAI and WEAI
In this study we test the hypothesis that compared to AI CO2 insufflation and WACCO2-AI methods will decrease pain score during colonoscopy with reduction of sedation requirement and that WE will achieve the best result This comparative study has also the aim to test the respective peculiarities of each method
WAC can be categorized broadly in Water Immersion WI and Water Exchange WE In WI water is infused during the insertion phase of colonoscopy with removal of infused water predominantly during withdrawal Occasional use of insufflation may be allowed WE entails complete exclusion of insufflation removal of residual colonic air pockets and feces and suction of infused water predominantly during insertion to minimize distention During the withdrawal phase insufflation is used to distend the colonic lumen
In the WAC arms of the two mentioned articles the insertion method used was WI with infusion of water at room temperature or at 37C During withdrawal air insufflation or either air or CO2 insufflation were employed
Compared to AI CO2 insufflation and WI using room air insufflation or CO2 insufflation during withdrawal were effective in both studies in decreasing sedation requirement pain and tolerance scores with patients higher willingness to repeat the procedure
Until now no direct comparison has been made within a single study about pain score during colonoscopy using AI CO2 insufflation WICO2 WECO2 WIAI and WEAI
In this study we test the hypothesis that compared to AI CO2 insufflation and WACCO2-AI methods will decrease pain score during colonoscopy with reduction of sedation requirement and that WE will achieve the best result This comparative study has also the aim to test the respective peculiarities of each method
Detailed Description:
Design Prospective double blinded two-center randomized controlled trial Methods Colonoscopy with air insufflation CO2 Water ImmersionCO2 Water ExchangeCO2 Water ImmersionAI and Water ExchangeAI to aid insertion of colonoscope split dose bowel preparation on demand-sedation
Control method Air insufflation colonoscopy Study methods CO2 colonoscopy Water ImmersionCO2 colonoscopy Water ExchangeCO2 colonoscopy Water ImmersionAI colonoscopy Water ExchangeAI colonoscopy
Population Consecutive 18 to 85 year-old diagnostic in-patients and outpatients After informed consent assignment to control or study arms based on computer generated randomization list with block allocation and stratification
Primary outcome Maximum pain score recorded during colonoscopy Secondary outcomes Cecal intubation rate and time total procedure time including biopsy andor polypectomy need for sedation and its dosage overall pain score at discharge In addition Adenoma Detection Rate Mean Adenomas per Procedure position changes amount of infused and suctioned water during insertion and withdrawal will be recorded Bloating after examination and at discharge and patient willingness to repeat the examination will be evaluated
Control method Air insufflation colonoscopy Study methods CO2 colonoscopy Water ImmersionCO2 colonoscopy Water ExchangeCO2 colonoscopy Water ImmersionAI colonoscopy Water ExchangeAI colonoscopy
Population Consecutive 18 to 85 year-old diagnostic in-patients and outpatients After informed consent assignment to control or study arms based on computer generated randomization list with block allocation and stratification
Primary outcome Maximum pain score recorded during colonoscopy Secondary outcomes Cecal intubation rate and time total procedure time including biopsy andor polypectomy need for sedation and its dosage overall pain score at discharge In addition Adenoma Detection Rate Mean Adenomas per Procedure position changes amount of infused and suctioned water during insertion and withdrawal will be recorded Bloating after examination and at discharge and patient willingness to repeat the examination will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None