NCT00153647

Brief Summary

The primary aim of the study is to increase the success rate of cecal intubation in first colonoscopy and in repeated colonoscopy for the first failed procedure. The secondary aims are to assess the procedure time, the terminal ileum intubation rate, the endoscopist satisfaction score, the patients' acceptance, the complication rate of these two procedures, and the intravenous sedative drugs used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2005

Geographic Reach
1 country

2 active sites

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

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

March 18, 2008

Status Verified

August 1, 2007

Enrollment Period

1.5 years

First QC Date

September 8, 2005

Last Update Submit

March 14, 2008

Conditions

ColonoscopyLower Gastrointestinal Tract

Outcome Measures

Primary Outcomes (1)

  • The success rate of cecal intubation

    24 hours

Secondary Outcomes (8)

  • The procedure time to achieve cecal intubation

    24 hours

  • Success rate in achieving terminal ileum intubation

    24 hours

  • The procedure time to achieve terminal ileum intubation

    24 hours

  • Complications related to the procedure

    24 hours

  • The procedure difficulty as assessed by the endoscopist using a 10 cm visual analog scale

    24 hours

  • +3 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Cap-assisted Colonoscopy

Procedure: Cap-assisted colonoscopy

2

PLACEBO COMPARATOR

Regular Colonoscopy

Procedure: Cap-assisted colonoscopy

Interventions

Cap-assisted colonoscopyPROCEDURE

Cap-assisted colonoscopy

1

Eligibility Criteria

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

You may qualify if:

  • Patients who undergo their first colonoscopy examination

You may not qualify if:

  • Patients had received colonoscopy examination before
  • Patients had prior colorectal surgery done (apart from appendectomy)
  • Known to have colonic stricture or obstructing tumor from the results of other investigations such as CT scan or barium enema
  • Presence of acute surgical conditions such as severe colitis, megacolon, ischemic colitis and active gastrointestinal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Endoscopy Center, Alice Ho Miu Ling Nethersole Hospital

Hong Kong, China

Location

Endoscopy Center, Prince of Wales Hospital

Hong Kong, China

Location

Study Officials

  • Y T Lee, MD

    Department of Medicine & Therapeutics, Prince of Wales Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

May 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

March 18, 2008

Record last verified: 2007-08

Locations

CN(2)