Trial Outcomes & Findings for Cap-fitted Colonoscopy: a Randomized, Tandem Colonoscopy Study of Adenoma Miss Rates (NCT NCT00577083)

Last Updated: 2018-12-10

Results Overview

Cap Fitted Colonoscopy (CFC) may significantly reduced miss rates for colorectal adenomas, specifically for small adenomas. This study is the first North American study of any design and the largest tandem study of CFC. CFC is a safe, simple, and inexpensive technology that could improve the reliability of colonoscopy in detecting colorectal neoplasia. Additional study of CFC in Western populations is warranted.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

after the second colonoscopy is completed

Results posted on

2018-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	No Cap First, Then Cap-fitted no cap on the end of the colonoscope for the first insertion Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination.	Initial Cap-fitted First, Then No Cap Initial cap-fitted colonoscopy for the first insertion Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination.
First Intervention (14 Days) STARTED	48	52
First Intervention (14 Days) COMPLETED	48	52
First Intervention (14 Days) NOT COMPLETED	0	0
Washout (14 Days) STARTED	48	52
Washout (14 Days) COMPLETED	48	52
Washout (14 Days) NOT COMPLETED	0	0
Second Intervention (14days) STARTED	48	52
Second Intervention (14days) COMPLETED	48	52
Second Intervention (14days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cap-fitted Colonoscopy: a Randomized, Tandem Colonoscopy Study of Adenoma Miss Rates

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Cap First, Then Cap Fitted n=48 Participants no cap on the end of the colonoscope for the first insertion Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination.	Initial Cap-fitted First Then No Cap n=52 Participants Initial cap-fitted colonoscopy for the first insertion Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants	52 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	24 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants	52 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: after the second colonoscopy is completed

Outcome measures

Outcome measures
Measure	Initial Cap-fitted n=52 Participants Initial cap-fitted colonoscopy for the first insertion Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination.	Initial Regular n=48 Participants no cap on the end of the colonoscope for the first insertion Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination.	Inspection Times (Standard) Standard	Inspection Times (Cap-Fitted) Cap-fitted	Total Procedure Time (Cap-Fitted) cap-fitted	Total Procedure Time (Standard) standard
Number of Adenomas Number of adenomas detected at first colonoscopy	83 First Colonoscopy number of adenomas	89 First Colonoscopy number of adenomas	—	—	—	—
Number of Adenomas Number of adenomas detected at second colonoscopy	28 First Colonoscopy number of adenomas	44 First Colonoscopy number of adenomas	—	—	—	—

SECONDARY outcome

Timeframe: after 2nd colonoscopy was completed in 24hrs

Population: Patients aged 50 years or older who were able to give informed consent and were scheduled for elective colonoscopy at IUH were eligible for enrollment. Exclusion criteria were American Society of Anesthesiologists class III or higher, previous surgical resection of the colon or rectum, inflammatory bowel disease, and current use of anticoagulants.

During the second colonoscopy, all polyps will also be removed when detected. Any polyp identified and removed during the second procedure will be counted as a miss for the first procedure. All polyps will be sent separately for pathologic evaluation. The time required to remove and retrieve polyps with and without the cap on will be measured using a stopwatch as a secondary end point. The primary end point will be the miss rate for colonoscopy with the cap and colonoscopy without the cap.

Outcome measures

Outcome measures
Measure	Initial Cap-fitted n=48 Participants Initial cap-fitted colonoscopy for the first insertion Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination.	Initial Regular n=52 Participants no cap on the end of the colonoscope for the first insertion Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination.	Inspection Times (Standard) n=48 Participants Standard	Inspection Times (Cap-Fitted) n=52 Participants Cap-fitted	Total Procedure Time (Cap-Fitted) n=52 Participants cap-fitted	Total Procedure Time (Standard) n=48 Participants standard
Time for Examination Will be Measured With a Stopwatch, and the Stopwatch Will be Stopped at Any Time a Polyp is Located and Restarted When the Polyp Has Been Removed and Retrieved.	3.1 Minutes Standard Error 0.2	3.2 Minutes Standard Error 0.2	7.0 Minutes Standard Error 0.1	7.0 Minutes Standard Error 0.1	18.1 Minutes Standard Error 0.8	20.5 Minutes Standard Error 1.2

Adverse Events

Initial Regular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Initial Cap-fitted

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Douglas K Rex, MD

Indiana University

Phone: 317-948-8741

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place