Trial Outcomes & Findings for Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique (NCT NCT00671177)

NCT ID: NCT00671177

Last Updated: 2017-05-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 229 participants
• Primary outcome timeframe: At the time of the procedure
• Results posted on: 2017-05-01

Participant Flow

Participant milestones

Measure	Water Immersion Colonoscopy Water Immersion Colonoscopy water immersion colonoscopy: instillation of 300cc of water in the rectum	Standard Air Colonoscopy Standard Air Colonoscopy standard air colonoscopy: air instillation in colon for visualization
Overall Study STARTED	114	115
Overall Study COMPLETED	112	114
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique

Baseline characteristics by cohort

Measure	Water Immersion Colonoscopy n=112 Participants Water immersion colonoscopy: instillation of 300cc of water in the rectum	Standard Air Colonoscopy n=114 Participants Standard air colonoscopy: air instillation in colon for visualization	Total n=226 Participants Total of all reporting groups
Age, Continuous	62.5 years STANDARD_DEVIATION 8.9 • n=5 Participants	62.5 years STANDARD_DEVIATION 8.9 • n=7 Participants	62.5 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	112 Participants n=5 Participants	114 Participants n=7 Participants	226 Participants n=5 Participants

PRIMARY outcome

Timeframe: At the time of the procedure

Outcome measures

Measure	Water Immersion Colonoscopy n=112 Participants Water immersion colonoscopy: instillation of 300cc of water in the rectum	Standard Air Colonoscopy n=114 Participants Standard air colonoscopy: air instillation in colon for visualization
Colonoscopy Success With Minimal Sedation	57 Participants	32 Participants

SECONDARY outcome

Timeframe: At the time of the procedure

Outcome measures

Measure	Water Immersion Colonoscopy n=112 Participants Water immersion colonoscopy: instillation of 300cc of water in the rectum	Standard Air Colonoscopy n=114 Participants Standard air colonoscopy: air instillation in colon for visualization
Time to Cecum Attending	5.4 minutes Standard Deviation 5.9	7.2 minutes Standard Deviation 5.8
Time to Cecum Trainee	13 minutes Standard Deviation 7.5	20.5 minutes Standard Deviation 13.9

SECONDARY outcome

Timeframe: At the time of the procedure

Patient satisfaction was measured on a scale of 1 (best) to 7 (worst).

Outcome measures

Measure	Water Immersion Colonoscopy n=112 Participants Water immersion colonoscopy: instillation of 300cc of water in the rectum	Standard Air Colonoscopy n=114 Participants Standard air colonoscopy: air instillation in colon for visualization
Patient Satisfaction	1.09 units on a scale Interval 1.0 to 7.0	1.26 units on a scale Interval 1.0 to 7.0

Adverse Events

Water Immersion Colonoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Air 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

Dr. Tonya Kaltenbach

San Francisco VA Medical Center

Phone: 415-221-4810

Email: tonya.kaltenbach@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place