Trial Outcomes & Findings for Warm Water for Unsedated Colonoscopy (NCT NCT00905554)

NCT ID: NCT00905554

Last Updated: 2011-10-25

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 230 participants
• Primary outcome timeframe: 6-9 months
• Results posted on: 2011-10-25

Participant Flow

medical clinic since march 2009 until sample size was reached

no patient excluded from the study flow after being allocated in the study or control arm

Participant milestones

Measure	Warm Water warm water irrigation during the insertion phase of colonoscopy	Air Insufflation air insufflation during the insertion phase of colonoscopy
Overall Study STARTED	116	114
Overall Study COMPLETED	116	114
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Warm Water for Unsedated Colonoscopy

Baseline characteristics by cohort

Measure	Warm Water n=116 Participants warm water irrigation during the insertion phase of colonoscopy	Air Insufflation n=114 Participants air insufflation during the insertion phase of colonoscopy	Total n=230 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	108 Participants n=5 Participants	109 Participants n=7 Participants	217 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Age Continuous	58.4 years STANDARD_DEVIATION 11.5 • n=5 Participants	58.8 years STANDARD_DEVIATION 13.3 • n=7 Participants	58.4 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	48 Participants n=7 Participants	96 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	66 Participants n=7 Participants	134 Participants n=5 Participants
Region of Enrollment Italy	116 participants n=5 Participants	114 participants n=7 Participants	230 participants n=5 Participants

PRIMARY outcome

Timeframe: 6-9 months

Outcome measures

Measure	Warm Water n=116 Participants warm water irrigation during the insertion phase of colonoscopy	Air Insufflation n=114 Participants air insufflation during the insertion phase of colonoscopy
Number of Patients Undergoing Complete Unsedated Colonoscopy	101 participants	89 participants

SECONDARY outcome

Timeframe: 6-9 months

Entity of pain and tolerability level on a visual analogic scale (ranging from 0 - no pain, optimal tolerability - to 100 mm - worst pain ever, unbearable)

Outcome measures

Measure	Warm Water n=116 Participants warm water irrigation during the insertion phase of colonoscopy	Air Insufflation n=114 Participants air insufflation during the insertion phase of colonoscopy
Evaluation of Pain and Tolerability Scores	28 Scores on a VAS scale Interval 12.0 to 44.0	39 Scores on a VAS scale Interval 14.0 to 54.0

Adverse Events

Warm Water

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Air Insufflation

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

Vittorio Terruzzi, MD

Valduce Hospital - Como - Italy

Phone: +39031324009

Email: vterruzzi@valduce.it

Results disclosure agreements

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