NCT03141697

Brief Summary

In this double-blind, randomised and controlled study 150 Patients referred to colonoscopy were assigned to either CO2 or air insufflation. We recorded basic characteristics of colonoscopy and the amount of drugs used for sedation. Patients and investigators filled out questionnaires to record pain, abdominal bloating and flatulence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration 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

April 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2014

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

2.4 years

First QC Date

April 26, 2017

Last Update Submit

May 4, 2017

Conditions

Colonoscopy

Keywords

Carbon DioxideColoboscopy

Outcome Measures

Primary Outcomes (1)

  • Post-procedural pain

    Pain after Colonoscopy, assessed by visual analog scale (VAS)

    0 - 24 hrs after colonoscopy

Secondary Outcomes (4)

  • Abdominal bloating

    0 - 24 hrs after colonoscopy

  • flatulence

    0 - 24 hrs after colonoscopy

  • procedure time

    duration of colonoscopy

  • Used amount of sedative drugs

    during endoscopy

Study Arms (2)

Carbon Dioxide

EXPERIMENTAL

Colonoscopy with Insufflation of Carbon Dioxide

Device: Carbon Dioxide

Room Air

PLACEBO COMPARATOR

Colonoscopy with Insufflatioin of Room Air

Device: Room air

Interventions

Carbon DioxideDEVICE

Insufflation of Carbon Dioxide

Carbon Dioxide
Room airDEVICE

Insufflation of room air

Room Air

Eligibility Criteria

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

You may qualify if:

  • older than 18 years
  • informed consent

You may not qualify if:

  • former colonic resections
  • severe heart or lung disease (NYHA III or IV)
  • Pregnancy
  • Patients with planned gastroscopy within 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leipzig

Leipzig, 04103, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Principal Investigator

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 5, 2017

Study Start

April 1, 2012

Primary Completion

August 31, 2014

Study Completion

August 31, 2014

Last Updated

May 5, 2017

Record last verified: 2017-05

Locations

DE(1)