Trial Outcomes & Findings for The Alberta Primary Care Endoscopy (APC-Endo) Study (NCT NCT01320826)

Results Overview

The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100

Recruitment status

COMPLETED

Target enrollment

577 participants

Primary outcome timeframe

At time of colonoscopy (DAY 1 of study)

Results posted on

2012-08-15

Participant Flow

Patients were enrolled if they were undergoing a colonoscopy for any reason with one of the participating study primary care colonoscopists. Due to staggered local study start dates, data collection occurred between March 15, 2010 and June 14, 2010 and patient satisfaction phone surveys were completed by August 2010.

Participant milestones

Participant milestones
Measure	Patients Undergoing Colonoscopy All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
Overall Study STARTED	577
Overall Study COMPLETED	577
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Alberta Primary Care Endoscopy (APC-Endo) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants. n=577 Participants All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	415 Participants n=5 Participants
Age, Categorical >=65 years	162 Participants n=5 Participants
Age Continuous	57.6 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	295 Participants n=5 Participants
Sex: Female, Male Male	282 Participants n=5 Participants
Region of Enrollment Canada	577 participants n=5 Participants

PRIMARY outcome

Timeframe: At time of colonoscopy (DAY 1 of study)

Population: Prospective, observational study, all study participants were analyzed

The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100

Outcome measures

Outcome measures
Measure	Percentage of Successful Cecal Intubations (Crude) n=577 Participants The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
Percentage of Successful Cecal Intubations (Crude)	95.3 percentage of colonoscopies performed Interval 93.3 to 96.9

PRIMARY outcome

Timeframe: At time of colonoscopy (DAY 1 of study)

The percentage of successful cecal intubations (adjusted) = total number of colonoscopies performed where cecal intubation was achieved / (total number of colonoscopies attempted -incomplete colonoscopies due to poor bowel preparation, colonic stricture, equipment failure or severe endoscopic colitis)

Outcome measures

Outcome measures
Measure	Percentage of Successful Cecal Intubations (Crude) n=577 Participants The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
Percentage of Successful Cecal Intubations (Adjusted)	96.5 percentage of colonoscopies attempted Interval 94.6 to 97.8

PRIMARY outcome

Timeframe: When pathology from colonoscopy available (on average 2-3 weeks after procedure)

Population: Number of patients who underwent colonoscopy

The adenoma detection ratio is the number of pathologically verified adenomas per number of colonoscopies performed. Adenoma detection ratio = total number of pathologically confirmed adenomas / number of colonoscopies attempted.

Outcome measures

Outcome measures
Measure	Percentage of Successful Cecal Intubations (Crude) n=577 Participants The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
Adenoma Detection Ratio	0.62 adenomas / colonoscopy Interval 0.51 to 0.74

PRIMARY outcome

Timeframe: When pathology from colonoscopy available (on average 2-3 weeks after procedure)

Population: We only examined this outcome for males 50 years and older having their first colonoscopy

Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100. For this specific outcome: we explored this outcome for males 50 years and older undergoing first time colonoscopy.

Outcome measures

Outcome measures
Measure	Percentage of Successful Cecal Intubations (Crude) n=282 Participants The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
Percentage of Males 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma	46.4 percentage of males Interval 38.5 to 54.3

PRIMARY outcome

Timeframe: [When pathology from colonoscopy available (on average 2-3 weeks after procedure)]

Population: For this outcome, we only examined females ≥ 50 years old having their first colonoscopy

Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100. For this specific outcome: we explored this outcome for females 50 years and older undergoing first time colonoscopy.

Outcome measures

Outcome measures
Measure	Percentage of Successful Cecal Intubations (Crude) n=295 Participants The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
Percentage of Females 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma	30.2 percentage of females Interval 22.3 to 38.2

SECONDARY outcome

Timeframe: Within four (4) weeks of colonoscopy

Potential serious complications of colonoscopy include bleeding, perforation, cardiopulmonary complications secondary to conscious sedation and death. Potential serious complications will be determined from the case report form (physician reported) and at patient satisfaction phone survey (on average four weeks after colonoscopy). All potential serious complications of colonoscopy will be externally adjudicated.

Outcome measures

Outcome measures
Measure	Percentage of Successful Cecal Intubations (Crude) n=577 Participants The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
Colonoscopy Complications: Bleeding, Perforation, Cardiopulmonary Complications Secondary to Conscious Sedation, and Death.	4 patients undergoing colonoscopy

SECONDARY outcome

Timeframe: At time of colonoscopy (DAY 1 of study)

Population: Only examined patients in which no lesions were detected.

Withdrawal time will be defined as the time from leaving the cecum until the colonoscope exits the anus. This will be calculated for cases in which no lesions were found.

Outcome measures

Outcome measures
Measure	Percentage of Successful Cecal Intubations (Crude) n=295 Participants The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
Colonoscopy Withdraw Time in Cases Where no Lesions Found	7 minutes Interval 6.6 to 7.4

SECONDARY outcome

Timeframe: At time of colonoscopy (DAY 1 of study)

To determine the patients' comfort level during the colonoscopy, a five-item question used by the Joint Advisory Group on Gastrointestinal Endoscopy in the United Kingdom will be used. Patient discomfort on the 5 point scale: 0 is no discomfort; 1. is one or two episodes of discomfort, well tolerated; 2. is more than two episodes of discomfort adequately tolerated; 3. is significant discomfort experienced several times during the procedure; 4. is extreme discomfort experienced frequency throughout the procedure. Minimum value = 0, maximum value = 4 with 4 being worse.

Outcome measures

Outcome measures
Measure	Percentage of Successful Cecal Intubations (Crude) n=577 Participants The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
Patient Comfort During Colonoscopy	0.8 units on the scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: At patient satisfaction phone survey (on average 4 weeks after colonoscopy)

Population: 443 patients completed the post procedural satisfaction survey.

Patient satisfaction with endoscopy wait time will be recorded using a 7 point Likert scale at the time of the patient phone survey. 7 is extremely satisfied and 1 is extremely dissatisfied minimum score = 1 maximum score = 7

Outcome measures

Outcome measures
Measure	Percentage of Successful Cecal Intubations (Crude) n=443 Participants The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
Patient Satisfaction With Endoscopy Wait Time	7 units on a scale Interval 5.0 to 7.0

SECONDARY outcome

Timeframe: At patient satisfaction phone survey (on average 4 weeks after colonoscopy)

Population: 443 patients consented to and completed the post procedural satisfaction survey.

Patient satisfaction with their hospital experience during their colonoscopy will be recorded by using a 7 point Likert scale at the time of the patient satisfaction phone survey. 7 = extremely satisfied 1 = extremely dissatisfied Minimum score = 1 Maximum score = 7

Outcome measures

Outcome measures
Measure	Percentage of Successful Cecal Intubations (Crude) n=443 Participants The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
Patient Satisfaction With Hospital Experience for Colonoscopy	7 units on a scale Interval 6.0 to 7.0

SECONDARY outcome

Timeframe: At time of colonoscopy (DAY 1 of study)

Colonoscopic procedural time will be defined as the time from the first insertion of the colonoscope until it is removed from the anus.

Outcome measures

Outcome measures
Measure	Percentage of Successful Cecal Intubations (Crude) n=577 Participants The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
Colonoscopy Procedure Time	23.6 minutes Interval 22.7 to 24.5

SECONDARY outcome

Timeframe: Within four (4) weeks of colonoscopy

The percentage of patients who are anticipated to be referred to specialists, for the gastrointestinal complaint for which the colonoscopy was performed will be determined and the reason for referral will be tabulated. The referral percentage will be determined both from the time of colonoscopy (physician reported) and from the patient satisfaction phone survey (patient reported).

Outcome measures

Outcome measures
Measure	Percentage of Successful Cecal Intubations (Crude) n=577 Participants The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
Percentage of Patients Referred to a Specialist.	4.8 percentage of patients

Adverse Events

Participants.

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Participants. n=577 participants at risk All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
Gastrointestinal disorders Perforation	0.17% 1/577 • Number of events 1
Gastrointestinal disorders Bleeding	0.52% 3/577 • Number of events 3

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Kolber

University of Alberta

Phone: (780) 616-8411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place