NCT01582178

Brief Summary

Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. There was used warm water infusion for colonoscope insertion in most of the water immersion colonoscopy trials. The investigators have been using room temperature water (20-24°C) for water immersion and the investigators did not notice any drawback of it. In our opinion, it is simpler and cheaper option for water immersion colonoscopy and proof of its efficacy and safety could support the use of water immersion technique in routine practice. The primary endpoint is cecal intubation time and the investigators suppose that the use of warm water infusion does not shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy will be also assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable colorectal-cancer

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

First Submitted

Initial submission to the registry

April 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
10 months until next milestone

Results Posted

Study results publicly available

August 1, 2013

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

4 months

First QC Date

April 18, 2012

Results QC Date

June 2, 2013

Last Update Submit

September 19, 2013

Conditions

Colorectal Cancer

Keywords

colonoscopywarm water immersioncool water immersion

Outcome Measures

Primary Outcomes (2)

  • Cecal Intubation Time

    3 months

  • Cecal Intubation Time

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

    1-30

Secondary Outcomes (1)

  • Patient Comfort During Insertion Phase of the Colonoscopy

    3 months

Study Arms (2)

Warm Water Immersion Colonoscopy

EXPERIMENTAL

Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.

Procedure: Warm Water Immersion Colonoscopy

Cool Water Immersion Colonoscopy

ACTIVE COMPARATOR

Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.

Procedure: Cool Water Immersion Colonoscopy

Interventions

Warm Water Immersion ColonoscopyPROCEDURE

Colonoscopy using warm water (37°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.

Warm Water Immersion Colonoscopy
Cool Water Immersion ColonoscopyPROCEDURE

Colonoscopy using room temperature water (20-24°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.

Cool Water Immersion Colonoscopy

Eligibility Criteria

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

You may qualify if:

  • outpatient diagnostic colonoscopy
  • bowel prep with macrogolum
  • initial 2 mg of midazolam i.v.
  • signed informed consent form

You may not qualify if:

  • planned therapeutic intervention
  • colorectal surgery in history
  • known inflammatory bowel disease or colorectal cancer
  • refusal of sedation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Digestive Diseases Center, Vitkovice Hospital

Ostrava, 703 84, Czechia

Location

Related Publications (1)

  • Falt P, Smajstrla V, Fojtik P, Tvrdik J, Urban O. Cool water vs warm water immersion for minimal sedation colonoscopy: a double-blind randomized trial. Colorectal Dis. 2013;15(10):e612-7. doi: 10.1111/codi.12336.

    PMID: 23819909BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Results Point of Contact

Title
Premysl Falt, MD
Organization
Vitkovice Hospital
faltprem@centrum.cz
+420595633

Study Officials

  • Premysl Falt, MD

    Digestive Diseases Center, Vitkovice Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

April 18, 2012

First Posted

April 20, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

September 20, 2013

Results First Posted

August 1, 2013

Record last verified: 2013-09

Locations

CZ(1)