Skip to content

Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments

Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02665741
Enrollment
126
Registered
2016-01-28
Start date
2016-01-31
Completion date
2017-02-28
Last updated
2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Adenomas, Colon Cancer Screening, Colon Polyps, Water Exchange Colonoscopy

Keywords

distal colonoscope attachments, colon cancer screening, screening colonoscopy, adenoma detection

Brief summary

The goal of this study is to compare two FDA approved distal colonoscope attachment devices, in order to identify which device can increase adenoma detection rate the most without increasing procedure time or risk.

Detailed description

Although mortality from colon cancer is decreasing, it remains the second leading cause of cancer related death in the United States. There are multiple factors contributing to this decrease, such as increased awareness, improving screening techniques, etc. Of the available modalities approved for colon cancer screening in the United States, colonoscopy is considered the gold standard. Colonoscopy has the advantage of being both diagnostic and therapeutic, allowing the removal of pre-cancerous polyps, before the polyps can transform into cancer. Colonic polyps can occur at any location from the rectum to the cecum. Colonoscopy has been shown to be more effective in decreasing incidence of cancer in the left colon but remains limited in the detection of right sided polyps /lesions 2. This difference based on location is thought to be due to several reasons. Typically the right side of the colon is less clean than the left side during colonoscopy, thereby impairing visualization of polyps. This problem has been overcome by incorporating a split bowel preparation, which has not become standard of care. However, the problem of not being able to visualize polyps behind folds seen in the colon persists despite improvements in the quality of cleansing of the colon. Various endoscopic technologies have been introduced with the goal of assisting with the manipulation of such colonic folds, and thereby reducing chances of missing polyps behind fold. Two such colonoscope assisted devices including the distal transparent cap and the Endocuff endoscopic overtube. The Endocuff overtube is a small device with flexible arms arranged in 2 rows. Each row has 8 short, soft arms projecting away from the device. These arms are used to peel back the colonic folds without causing physical damage to enable visualization behind colonic folds. The use of Endocuff overtube has shown promising results in terms of cecal intubation rate and time as well as adenoma detection rates 3. The transparent cap attachment is a clear plastic device that fits at the end of the colonoscope and extends a short distance past the tip of the colonoscope. It aids in the manipulation of folds and in maintaining a suitable distance from the mucosa, with the goal of improving visualization. Although some studies comparing cap fitted colonoscopy to standard (non- attachment) colonoscopies have shown improved adenoma detection 4, others have shown no significant benefit 5. Although, these devices have been compared with conventional colonoscopies (i.e without any distal attachment), to the investigator's knowledge, there are currently no studies that have compared these two distal colonoscope attachment devices head-to-head, and none has specifically evaluated effects on detection of right sided adenomas. Also, here at UCDavis, these devices are being used specifically in diagnostic colonoscopies for removal of large polyps and the choice of which specific device is used depends on level of comfort of the advanced endoscopist. The endoscopists participating in the investigators' study do not currently use these devices as part of their routine colonoscopies, thus it is important to provide head to head comparison of these devices to help guide management practice. Therefore, the investigators' goal is to compare the Endocuff overtube assisted, transparent cap fitted, and non-cap fitted (standard) colonoscopy in patients presenting to UC Davis Medical Center for screening colonoscopies. In addition, 2 of the 3 investigators will employ the water exchange method during for all arms of the trial, while the other investigator will employ the conventional air method of colonoscopy.

Interventions

DEVICEOlympus transparent cap

distal colonoscope attachment

DEVICEMedivators Endocuff

distal colonoscope attachment

DEVICEControl

No distal colonoscope attachments

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* At least 50 years old * Presenting for a screening or surveillance colonoscopy at UC Davis Endoscopy Suites

Exclusion criteria

* Age less than 50 years * Prior history of colon cancer * Patients with inflammatory bowel disease * Patients suspected to have colon cancer based on non invasive tests such as stool tests for hemoglobin or DNA, or imaging finding suggestive of colon cancer (CT or barium enema). * Patients undergoing colonoscopy for evaluation of symptoms such as abdominal pain, rectal bleeding, diarrhea, constipation, etc, or patient with iron deficiency anemia suspected to be due to ongoing bleeding inside the colon * Patients with family history of colon cancer in 1st degree relative below the age of 60 * Patients with family history of hereditary polyposis syndromes such as Lynch syndrome, familial adenomatous polyposis etc, which are associated with an increased risk of colon cancer * Patients unable to consent * Pregnant patients * Incarcerated patients * Non-English speakers

Design outcomes

Primary

MeasureTime frameDescription
Adenoma Detection RateCompletion of procedureThe investigators will compare adenoma detection rate at completion of study across the 3 arms

Secondary

MeasureTime frameDescription
Proximal Adenoma Detection RateCompletion of procedureThe investigators will compare proximal adenoma detection rate at completion of study across the 3 arms
Cecal Intubation RateCompletion of procedureThe investigators will compare cecal intubation rate at completion of study across the 3 arms
Withdrawal TimeCompletion of procedureThe investigators will compare colonoscopy withdrawal time rate at completion of study across the 3 arms

Countries

United States

Participant flow

Participants by arm

ArmCount
Control
No distal colonoscope attachment will be used in this arm Control: No distal colonoscope attachments
42
Olympus Transparent Cap
The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure Olympus transparent cap: distal colonoscope attachment
42
Medivators Endocuff
The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure Medivators Endocuff: distal colonoscope attachment
42
Total126

Baseline characteristics

CharacteristicTotalMedivators EndocuffOlympus Transparent CapControl
Age, Continuous60 years
STANDARD_DEVIATION 8
60.0 years
STANDARD_DEVIATION 6.8
60.0 years
STANDARD_DEVIATION 6.7
59.3 years
STANDARD_DEVIATION 7.4
Alcoholic drinks per week5.07 drinks per week
STANDARD_DEVIATION 6.97
4.4 drinks per week
STANDARD_DEVIATION 4
6.8 drinks per week
STANDARD_DEVIATION 10.7
4.0 drinks per week
STANDARD_DEVIATION 3.6
BMI28.07 kg/m^2
STANDARD_DEVIATION 5.08
27.4 kg/m^2
STANDARD_DEVIATION 5.4
28.3 kg/m^2
STANDARD_DEVIATION 5.5
28.5 kg/m^2
STANDARD_DEVIATION 4.3
Diabetes12 Participants5 Participants3 Participants4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
6 Participants2 Participants1 Participants3 Participants
Race (NIH/OMB)
Black or African American
3 Participants1 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
13 Participants6 Participants2 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants1 Participants5 Participants2 Participants
Race (NIH/OMB)
White
96 Participants32 Participants33 Participants31 Participants
Sex: Female, Male
Female
56 Participants19 Participants18 Participants19 Participants
Sex: Female, Male
Male
70 Participants23 Participants24 Participants23 Participants
Smoking status
Current Smoker
4 Participants1 Participants2 Participants1 Participants
Smoking status
Former Smoker
40 Participants13 Participants16 Participants11 Participants
Smoking status
Never Smoker
82 Participants28 Participants24 Participants30 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 420 / 420 / 42
other
Total, other adverse events
0 / 420 / 422 / 42
serious
Total, serious adverse events
0 / 420 / 420 / 42

Outcome results

Primary

Adenoma Detection Rate

The investigators will compare adenoma detection rate at completion of study across the 3 arms

Time frame: Completion of procedure

ArmMeasureValue (NUMBER)
ControlAdenoma Detection Rate52.4 percentage of adenomas detected
Olympus Transparent CapAdenoma Detection Rate40.5 percentage of adenomas detected
Medivators EndocuffAdenoma Detection Rate54.8 percentage of adenomas detected
Secondary

Cecal Intubation Rate

The investigators will compare cecal intubation rate at completion of study across the 3 arms

Time frame: Completion of procedure

ArmMeasureValue (NUMBER)
ControlCecal Intubation Rate100 percentage of cecal intubation
Olympus Transparent CapCecal Intubation Rate100 percentage of cecal intubation
Medivators EndocuffCecal Intubation Rate100 percentage of cecal intubation
Secondary

Proximal Adenoma Detection Rate

The investigators will compare proximal adenoma detection rate at completion of study across the 3 arms

Time frame: Completion of procedure

ArmMeasureValue (NUMBER)
ControlProximal Adenoma Detection Rate45.2 percentage of proximal adenomas
Olympus Transparent CapProximal Adenoma Detection Rate35.7 percentage of proximal adenomas
Medivators EndocuffProximal Adenoma Detection Rate50.0 percentage of proximal adenomas
Secondary

Withdrawal Time

The investigators will compare colonoscopy withdrawal time rate at completion of study across the 3 arms

Time frame: Completion of procedure

ArmMeasureValue (MEAN)Dispersion
ControlWithdrawal Time12.9 minutesStandard Deviation 5.2
Olympus Transparent CapWithdrawal Time12.4 minutesStandard Deviation 5.6
Medivators EndocuffWithdrawal Time13.0 minutesStandard Deviation 6.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026