Trial Outcomes & Findings for Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy (NCT NCT01440543)

Results Overview

Successful minimal sedation colonoscopy using assigned technique was defined as reaching the caecum without switch to another insertion method and / or without additional sedation beyond the initial administration of 2 mg of midazolam.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

420 participants

Primary outcome timeframe

six months

Results posted on

2013-01-28

Participant Flow

* recruitment process between January and June 2011 * outpatients referred to our endoscopy unit for diagnostic colonoscopy

* a total of 548 patients were assessed for eligibility * a total of 420 patients were randomized after exclusion of 128 subjects because of not fulfilled inclusion criteria * a total of 404 patients were analyzed after exclusion of 16 subjects (poor bowel preparation, IBD, argon plasmacoagulation, endoscopic resection or malignant obstruction)

Participant milestones

Participant milestones
Measure	Water/Air Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal	CO2/CO2 CO2 insufflation during both colonoscope insertion and withdrawal	Water/CO2 water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal	Air/Air room air insufflation during both colonoscope insertion and withdrawal
Overall Study STARTED	106	105	102	107
Overall Study COMPLETED	102	101	100	101
Overall Study NOT COMPLETED	4	4	2	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Water/Air n=106 Participants Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal	CO2/CO2 n=105 Participants CO2 insufflation during both colonoscope insertion and withdrawal	Water/CO2 n=102 Participants water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal	Air/Air n=107 Participants room air insufflation during both colonoscope insertion and withdrawal	Total n=420 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=5 Participants	60 Participants n=7 Participants	54 Participants n=5 Participants	58 Participants n=4 Participants	227 Participants n=21 Participants
Age, Categorical >=65 years	51 Participants n=5 Participants	45 Participants n=7 Participants	48 Participants n=5 Participants	49 Participants n=4 Participants	193 Participants n=21 Participants
Age Continuous	60.1 years STANDARD_DEVIATION 13.9 • n=5 Participants	59.4 years STANDARD_DEVIATION 14.5 • n=7 Participants	58.2 years STANDARD_DEVIATION 13.4 • n=5 Participants	58.7 years STANDARD_DEVIATION 13.8 • n=4 Participants	59.2 years STANDARD_DEVIATION 14.1 • n=21 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	52 Participants n=7 Participants	49 Participants n=5 Participants	51 Participants n=4 Participants	202 Participants n=21 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	53 Participants n=7 Participants	53 Participants n=5 Participants	56 Participants n=4 Participants	218 Participants n=21 Participants
Region of Enrollment Czech Republic	106 participants n=5 Participants	105 participants n=7 Participants	102 participants n=5 Participants	107 participants n=4 Participants	420 participants n=21 Participants

PRIMARY outcome

Timeframe: six months

Successful minimal sedation colonoscopy using assigned technique was defined as reaching the caecum without switch to another insertion method and / or without additional sedation beyond the initial administration of 2 mg of midazolam.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: Statistical power was calculated for the primary endpoint. A sample size of 145 subjects per insertion arm was calculated using two-tailed α = 0,05, β = 0,05, assuming that 80% versus 60% success rate in the water (Water/CO2 and Water/Air) and gas (CO2/CO2 and Air/Air) insertion arms would have been clinically relevant.

A succesful colonoscopy using assigned technique was defined as reaching the caecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. Any time the further insertion of the scope was not possible, the patient reported pain level \> 3 using a 7-point Likert scale \[7\] (0 = no pain, 6 = intolerable pain) or demanded additional sedation, the endoscopist preferentially switched to the other insertion technique. Enhanced sedation was used in case the other technique had not been successful.

Outcome measures

Outcome measures
Measure	CO2/CO2 n=102 Participants CO2 insufflation during both colonoscope insertion and withdrawal	Water/Air n=100 Participants Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal	Water/CO2 n=101 Participants water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal	Air/Air n=101 Participants room air insufflation during both colonoscope insertion and withdrawal
Success Rate of Minimal Sedation Colonoscopy	82.4 percentage of all participants	97 percentage of all participants	97 percentage of all participants	84.2 percentage of all participants

SECONDARY outcome

Timeframe: six months

Comfort was assessed using a 18-point questionnaire form based on 0-6 continuous scale (0 = best, 6 = worst)- abdominal pain during, 30 minutes, 3, 12 and 24 hours after the procedure, bloating duringm 30 minutes, 3, 12 and 24 hours after the procedure, flatus during, 30 minutes, 3, 12 and 24 hours after the procedure, impact on patient´s daily activities during first 24 hours after the procedure, willingnes to repeat the colonoscopy and overall satisfaction with the procedure

Outcome measures

Outcome data not reported

Adverse Events

Water/Air

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CO2/CO2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Water/CO2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Air/Air

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Premysl Falt MD

Digestive Diseases Center, Vitkovice Hospital, Ostrava, Czech Republic

Phone: +420602689561

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place