NCT00841282

Brief Summary

Our aim is to perform a randomized-controlled trial comparing air insufflation sedated colonoscopy (conventional method) vs. water infusion sedated colonoscopy (study method) by supervised trainees. Randomized trials demonstrating reduced need for sedation medications without compromising patients' comfort, cecal intubation rates or polyps detection may cause a paradigm shift and positively alter the way traditional colonoscopy is performed and future endoscopists are trained.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Oct 2008

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

Study Start

First participant enrolled

October 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
Last Updated

February 11, 2009

Status Verified

February 1, 2009

Enrollment Period

4 months

First QC Date

February 9, 2009

Last Update Submit

February 10, 2009

Conditions

Colorectal Cancer

Keywords

Colorectal cancer screeningOptical colonoscopyWater methodSedation

Outcome Measures

Primary Outcomes (1)

  • Increments of medications used for sedation

    duration of procedure

Secondary Outcomes (3)

  • pain score during colonoscopy

    duration of procedure

  • success of cecal intubation

    duration of study

  • willingness to repeat colonoscopy

    duration of study

Study Arms (2)

1

ACTIVE COMPARATOR

Water Infusion in lieu of Air Insufflation Colonoscopy

Procedure: Colonoscopy for colorectal cancer screeningProcedure: Water Infusion Colonoscopy

2

PLACEBO COMPARATOR

Air Insufflation Colonoscopy

Procedure: Colonoscopy for colorectal cancer screeningProcedure: Air insufflation colonoscopy

Interventions

Colonoscopy for colorectal cancer screeningPROCEDURE
12
Water Infusion ColonoscopyPROCEDURE

water infusion in lieu of air insufflation for screening colonoscopy

1
Air insufflation colonoscopyPROCEDURE

Conventional colonoscopy with air insufflation

2

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (\> 50 years old) male and female patients who are scheduled and consented for screening or surveillance colonoscopy,
  • Accept randomization to the study or the conventional method, and agree to complete study questionnaires
  • The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2

You may not qualify if:

  • Patients who have contraindications for sedation, decline to participate, unable to give informed consent or complete the questionnaires due to language or other difficulties will be excluded
  • Excluded patients will be managed by usual procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sacramento VA Medical Center,

Mather, California, 95655, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 11, 2009

Study Start

October 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 11, 2009

Record last verified: 2009-02

Locations

US(1)