Trial Outcomes & Findings for Cap-assisted Water Immersion Versus Water Immersion Colonoscopy (NCT NCT01547247)

Results Overview

The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

208 participants

Primary outcome timeframe

3 months

Results posted on

2015-10-23

Participant Flow

* recruitment period - between March and May 2012 * consecutive patients referred to our endoscopic unit for diagnostic colonoscopy

* a total of 275 subjects assessed for eligibility * a total of 208 patients eandomized after exclusion of 67 due to not fulfilled inclusion criteria * a total of 196 subjects analyzed after exclusion of 12 patients (poor bowel preparation, IBD, malignant obstruction, protocol deviation, ischemic colitis)

Participant milestones

Participant milestones
Measure	Cap-assisted Water Immersion Colonoscopy Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.	Water Immersion Colonoscopy Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Overall Study STARTED	104	104
Overall Study COMPLETED	98	98
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cap-assisted Water Immersion Versus Water Immersion Colonoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cap-assisted Water Immersion Colonoscopy n=104 Participants Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.	Water Immersion Colonoscopy n=104 Participants Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.	Total n=208 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
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants	51 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	55 Participants n=5 Participants	53 Participants n=7 Participants	108 Participants n=5 Participants
Age, Continuous	59.2 years STANDARD_DEVIATION 12.0 • n=5 Participants	58.2 years STANDARD_DEVIATION 13.9 • n=7 Participants	58.6 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	45 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	59 Participants n=7 Participants	118 Participants n=5 Participants
Region of Enrollment Czech Republic	104 participants n=5 Participants	104 participants n=7 Participants	208 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Statistical power was calculated for the primary endpoint. A sample size of 93 subjects per arm was calculated using two-tailed alfa 0.05, beta 0.2, assuming that difference 20 % in intubation times would have been clinically relevant.

The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum.

Outcome measures

Outcome measures
Measure	Cap-assisted Water Immersion Colonoscopy n=98 Participants Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.	Water Immersion Colonoscopy n=98 Participants Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Cecal Intubation Time	6.9 minutes Interval 4.0 to 9.8	7.4 minutes Interval 3.2 to 11.6

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

A successful minimal sedation colonoscopy was defined as reaching the cecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam.

Outcome measures

Outcome measures
Measure	Cap-assisted Water Immersion Colonoscopy n=98 Participants Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.	Water Immersion Colonoscopy n=98 Participants Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Success Rate of Minimal Sedation Colonoscopy	91 percentage of all subjects in arm	91 percentage of all subjects in arm

Adverse Events

Cap-assisted Water Immersion Colonoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Water Immersion Colonoscopy

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

Přemysl Falt MD

Digestive Diseases Center, Vítkovice Hospital, Ostrava, Czech Republic

Phone: +420602689561

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place