Trial Outcomes & Findings for Cap Assisted Colonoscopy Enhances Quality Based Competency in Colonoscopy Among Trainees (NCT NCT02472730)

NCT ID: NCT02472730

Last Updated: 2020-02-12

Results Overview

Proportion of all colonoscopies in which the trainee successfully reached the cecum within 30 minutes of insertion without the help of the attending physician.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 219 participants
• Primary outcome timeframe: Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program
• Results posted on: 2020-02-12

Participant Flow

Participant milestones

Measure	Cap Assisted Colonoscopy The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm. Distal Attachment Cap: Colonoscopies are performed under the supervision of board certified attending gastroenterologists experienced in colonoscopy. Attending physicians will provide assistance at their discretion or at the request of the trainee. All close examinations for polyps will be carried out on withdrawal of the colonoscope.	Standard Colonoscopy Standard colonoscopy without the distal attachment cap is performed in this arm.
Overall Study STARTED	110	109
Overall Study COMPLETED	101	102
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Drop out due to clinical reasons

Baseline characteristics by cohort

Measure	Cap Assisted Colonoscopy n=110 Participants The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm. Distal Attachment Cap: Colonoscopies are performed under the supervision of board certified attending gastroenterologists experienced in colonoscopy. Attending physicians will provide assistance at their discretion or at the request of the trainee. All close examinations for polyps will be carried out on withdrawal of the colonoscope.	Standard Colonoscopy n=109 Participants Standard colonoscopy without the distal attachment cap is performed in this arm.	Total n=219 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	90 Participants n=5 Participants	92 Participants n=7 Participants	182 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	017 Participants n=7 Participants	37 Participants n=5 Participants
Age, Continuous	55.6 years STANDARD_DEVIATION 8.84 • n=5 Participants	55.8 years STANDARD_DEVIATION 9.39 • n=7 Participants	55.7 years STANDARD_DEVIATION 9.09 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants • Drop out due to clinical reasons	69 Participants n=7 Participants • Drop out due to clinical reasons	147 Participants n=5 Participants • Drop out due to clinical reasons
Sex: Female, Male Male	32 Participants n=5 Participants • Drop out due to clinical reasons	40 Participants n=7 Participants • Drop out due to clinical reasons	72 Participants n=5 Participants • Drop out due to clinical reasons
Region of Enrollment United States	110 Participants n=5 Participants	109 Participants n=7 Participants	219 Participants n=5 Participants

PRIMARY outcome

Timeframe: Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program

Proportion of all colonoscopies in which the trainee successfully reached the cecum within 30 minutes of insertion without the help of the attending physician.

Outcome measures

Measure	Cap Assisted Colonoscopy n=101 Participants The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm. Distal Attachment Cap: Colonoscopies are performed under the supervision of board certified attending gastroenterologists experienced in colonoscopy. Attending physicians will provide assistance at their discretion or at the request of the trainee. All close examinations for polyps will be carried out on withdrawal of the colonoscope.	Standard Colonoscopy n=102 Participants Standard colonoscopy without the distal attachment cap is performed in this arm.
Number of Participants That Successfully Reached the Cecum Within 30 Minutes of Insertion	80 Participants	67 Participants

SECONDARY outcome

Timeframe: Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program

Time from the moment of colonoscope insertion until the appendiceal orifice or ileocecal valve is identified

Outcome measures

Measure	Cap Assisted Colonoscopy n=101 Participants The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm. Distal Attachment Cap: Colonoscopies are performed under the supervision of board certified attending gastroenterologists experienced in colonoscopy. Attending physicians will provide assistance at their discretion or at the request of the trainee. All close examinations for polyps will be carried out on withdrawal of the colonoscope.	Standard Colonoscopy n=102 Participants Standard colonoscopy without the distal attachment cap is performed in this arm.
Mean Time From the Moment of Colonoscope Insertion Until the Appendiceal Orifice or Ileocecal Valve is Identified	13.7 minutes Interval 12.3 to 15.2	16.5 minutes Interval 14.7 to 18.2

SECONDARY outcome

Timeframe: Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program

Proportion of colonoscopies that identify at least one adenoma

Outcome measures

Measure	Cap Assisted Colonoscopy n=101 Participants The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm. Distal Attachment Cap: Colonoscopies are performed under the supervision of board certified attending gastroenterologists experienced in colonoscopy. Attending physicians will provide assistance at their discretion or at the request of the trainee. All close examinations for polyps will be carried out on withdrawal of the colonoscope.	Standard Colonoscopy n=102 Participants Standard colonoscopy without the distal attachment cap is performed in this arm.
Number of Colonoscopies During Which at Least One Adenoma Was Identified	38 Participants	44 Participants

SECONDARY outcome

Timeframe: Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program

Proportion of colonoscopies that identify at least one polyp

Outcome measures

Measure	Cap Assisted Colonoscopy n=101 Participants The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm. Distal Attachment Cap: Colonoscopies are performed under the supervision of board certified attending gastroenterologists experienced in colonoscopy. Attending physicians will provide assistance at their discretion or at the request of the trainee. All close examinations for polyps will be carried out on withdrawal of the colonoscope.	Standard Colonoscopy n=102 Participants Standard colonoscopy without the distal attachment cap is performed in this arm.
Number of Colonoscopies During Which at Least One Polyp Was Identified	54 Participants	55 Participants

Adverse Events

Cap Assisted Colonoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Colonoscopy

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

Dr. Kalpesh K. Patel

Baylor College of Medicine

Phone: 7137980947

Email: kalpeshp@bcm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place