Comparison of Methods to Distend the Colon During Insertion: CO2, Air Insufflation, Water-aided Colonoscopy
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal, Oncology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 5/5/2014 |
| Start Date: | October 2013 |
| End Date: | January 2015 |
| Contact: | Sergio Cadoni, MD |
| Email: | endodig.iglesias@gmail.com |
| Phone: | +39 0781 392 |
Comparison of Methods for Luminal Distention for on Demand Sedation Colonoscopy: Air Insufflation, Carbon Dioxide and Water-aided Colonoscopy. A Randomized Controlled Trial.
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 37°C. 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, WI/CO2, WE/CO2, WI/AI and WE/AI.
In this study we test the hypothesis that, compared to AI, CO2 insufflation and WAC/CO2-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.
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 37°C. 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, WI/CO2, WE/CO2, WI/AI and WE/AI.
In this study we test the hypothesis that, compared to AI, CO2 insufflation and WAC/CO2-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.
Design: Prospective double blinded two-center randomized controlled trial. Methods:
Colonoscopy with air insufflation, CO2, Water Immersion/CO2, Water Exchange/CO2, Water
Immersion/AI and Water Exchange/AI to aid insertion of colonoscope; split dose bowel
preparation; on demand-sedation.
Control method: Air insufflation colonoscopy. Study methods: CO2 colonoscopy, Water
Immersion/CO2 colonoscopy, Water Exchange/CO2 colonoscopy, Water Immersion/AI colonoscopy,
Water Exchange/AI 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 and/or 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.
Colonoscopy with air insufflation, CO2, Water Immersion/CO2, Water Exchange/CO2, Water
Immersion/AI and Water Exchange/AI to aid insertion of colonoscope; split dose bowel
preparation; on demand-sedation.
Control method: Air insufflation colonoscopy. Study methods: CO2 colonoscopy, Water
Immersion/CO2 colonoscopy, Water Exchange/CO2 colonoscopy, Water Immersion/AI colonoscopy,
Water Exchange/AI 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 and/or 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.
Inclusion Criteria:
- Consecutive 18 to 85 year-old diagnostic in-patients and 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 assumption of bowel preparation
- moderate or severe chronic obstructive pulmonary disease requiring oxygen
- medical history of CO2 retention
We found this trial at
1
site
Los Angeles, California 91343
Click here to add this to my saved trials
