Trial Outcomes & Findings for Warm Water Versus Room Temperature Water Immersion Colonoscopy (NCT NCT01582178)

NCT ID: NCT01582178

Last Updated: 2013-09-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 212 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2013-09-20

Participant Flow

Patients older than 18 years referred to our unit for diagnostic outpatient colonoscopy. Subjects were excluded if they has a history of colorectal surgery, known diagnosis of IBD, chronic benzodiazepine use and if they refused sedation. The period between June and October 2012.

Subjects were not included if they did not fulfill inclusion criteria.

Participant milestones

Measure	Warm Water Immersion Colonoscopy Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.	Cool Water Immersion Colonoscopy Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Overall Study STARTED	106	106
Overall Study COMPLETED	100	101
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Measure	Warm Water Immersion Colonoscopy Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.	Cool Water Immersion Colonoscopy Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Overall Study Physician Decision	6	5

Baseline Characteristics

Warm Water Versus Room Temperature Water Immersion Colonoscopy

Baseline characteristics by cohort

Measure	Warm Water Immersion Colonoscopy n=106 Participants Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.	Cool Water Immersion Colonoscopy n=106 Participants Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.	Total n=212 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	47 Participants n=5 Participants	43 Participants n=7 Participants	90 Participants n=5 Participants
Age, Categorical >=65 years	59 Participants n=5 Participants	63 Participants n=7 Participants	122 Participants n=5 Participants
Age Continuous	61.2 years STANDARD_DEVIATION 12.7 • n=5 Participants	57.8 years STANDARD_DEVIATION 14.2 • n=7 Participants	59.5 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	49 Participants n=7 Participants	97 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	57 Participants n=7 Participants	115 Participants n=5 Participants
Region of Enrollment Czech Republic	106 participants n=5 Participants	106 participants n=7 Participants	212 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1-30

= time between introduction of the colonoscope into the anus and reaching the cecum.

Outcome measures

Measure	Warm Water Immersion Colonoscopy n=100 Participants Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.	Cool Water Immersion Colonoscopy n=101 Participants Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Cecal Intubation Time	7.0 minute Standard Deviation 3.4	6.9 minute Standard Deviation 3.5

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

Adverse Events

Warm Water Immersion Colonoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cool 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

Premysl Falt, MD

Vitkovice Hospital

Phone: +420595633

Email: faltprem@centrum.cz

Results disclosure agreements

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