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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
624
Air Insufflation method.
CO2 insufflation.
Water Immersion during insertion, CO2 insufflation during withdrawal.
Water Exchange during insertion, CO2 insufflation during withdrawal.
Water Immersion during insertion, AI insufflation during withdrawal.
Water Exchange during insertion, AI insufflation during withdrawal.
Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
Vìtkovice Hospital
Ostrava, Czechia
S. Barbara Hospital
Iglesias, CI, Italy
Maximum pain score recorded during colonoscopy.
Pain assessed using a visual analogue scale (VAS) with a score 0=absence of pain, 2=simply "discomfort", 10=the worst possible pain. Before the procedure, an endoscopic nurse will explain the VAS scoring system to the patients. Every 60 seconds during colonoscopy patients will be asked about discomfort or pain. The responses will be recorded, and the maximum pain score noted.
Time frame: 1 hour
Overall pain after the procedure.
After the procedure and at discharge from the Endoscopy Unit, an assistant nurse blinded to the procedure will ask patients about overall pain using the same VAS when neither the endoscopist nor the assistant nurse who performed the colonoscopy will be present. Patients will be asked to quantify the degree of pain experienced and to place a mark over the VAS accordingly.
Time frame: 1 hour.
Cecal intubation rate.
Cecal intubation will be defined as passage of the tip of the colonoscope beyond the ileocecal valve so that the medial wall of the cecum proximal to the ileocecal valve will be observed.
Time frame: 1 hour
Cecal intubation time.
Cecal intubation time will be defined as the time for passage of the colonoscope from the rectum to the cecum.
Time frame: 1 hour.
Total procedure time.
Total procedure time (including time required for polyp resection or biopsy).
Time frame: 1 hour.
Adenoma detection rate.
Proportion of subjects with at least one adenoma of any size.
Time frame: 15 months.
Mean adenomas per procedure.
Total number of adenomas resected per subject.
Time frame: 15 months.
Advanced adenomas.
Total number of advanced adenomas: diameter ≥10mm, or high grade dysplasia, or with ≥20% villous components.
Time frame: 15 months.
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