NCT01259583

Brief Summary

Due to the increasing demand for colonoscopy in clinical practice, great interest has recently renewed for unsedated colonoscopy. Both Carbon dioxide Insufflation (CO2) and Warm Water Infusion (WWI) have been advocated to improve patient tolerance for colonoscopy as compared to standard Air Insufflation (AI). This study is aimed at evaluating the performance of the above techniques versus AI in unsedated patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
341

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2010

Completed
Last Updated

March 13, 2013

Status Verified

March 1, 2013

Enrollment Period

5 months

First QC Date

December 13, 2010

Last Update Submit

March 12, 2013

Conditions

Warm WaterCO2 ColonoscopyUnsedated Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • number of patients undergoing complete unsedated colonoscopy

    6 months

Secondary Outcomes (1)

  • evaluation of pain and tolerability scores

    6 months

Study Arms (2)

CO2

EXPERIMENTAL

CO2 insufflation instead air insufflation in unsedated colonoscopy

Procedure: CO2

Warm Water irrigation

EXPERIMENTAL

warm water irrigation during the insertion phase of colonoscopy

Procedure: Warm water

Interventions

CO2PROCEDURE

CO2 insufflation

CO2
Warm waterPROCEDURE

warm water irrigation

Warm Water irrigation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult outpatients willing to undergo colonoscopy without routine initial sedation

You may not qualify if:

  • refuse to initiate colonoscopy without routine sedation
  • inadequate bowel preparation
  • incapacity to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valduce Hospital - Gastroenterology Department

Como, 22100, Italy

Location

Related Publications (1)

  • Amato A, Radaelli F, Paggi S, Baccarin A, Spinzi G, Terruzzi V. Carbon dioxide insufflation or warm-water infusion versus standard air insufflation for unsedated colonoscopy: a randomized controlled trial. Dis Colon Rectum. 2013 Apr;56(4):511-8. doi: 10.1097/DCR.0b013e318279addd.

    PMID: 23478620DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 13, 2010

First Posted

December 14, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 13, 2013

Record last verified: 2013-03

Locations

IT(1)