Colon Adenoma
Conditions
Brief summary
The goal of this study is to compare the adenoma detection rate achieved while using either a 24 video monitor or a 32 video monitor.
Detailed description
Gastrointestinal endoscopists perfoming routine endoscopic procedures and their patients will be randomized to one of two endoscopy rooms at the MGH Ambulatory Endoscopy Center at Charles River Plaza. The two rooms will have identical equipment with the exception that one room will have the current standard size video monitor (NDS 26) used at this facility while the other room will have a larger video monitor (NDS 32). The ADR achieved by each physician in each room will be compared.
Interventions
DEVICEMonitor size
Subjects will be randomized to perform their colonoscopy procedures while viewing a large (32) video monitor or the standard (24) video monitor.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Masking description
15 endoscopists and 1805 patients on which procedures were performed were randomly assigned to each room.
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Physician endoscopist performing colonoscopy at Massachusetts General Hospital GI Endoscopy Unit * Patients receiving these procedures at Massachusetts General Hospital GI Endoscopy Unit
Exclusion criteria
* Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Detection Rate (All Indications) | within 2 weeks (range of 1 day-14 days) of the endoscopy | Number of patients with adenoma detected |
| Adenoma Detection Rate (Screening Exams Only) | within 2 weeks (range of 1 day-14 days) of the endoscopy | Number of patients with adenoma detected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Polyp Detection Rate (All Indications) | recorded during endoscopy (immediate) | Number of patients with polyps detected |
| Polyp Detection Rate (Screening Exams Only) | recorded during endoscopy (immediate) | Number of patients with polyps detected |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Monitor (24) Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24). | 910 |
| Large Monitor (32) Endoscopists in this arm will perform colonoscopy using the large size video monitor (32). | 895 |
| Total | 1,805 |
Baseline characteristics
| Characteristic | Standard Monitor (24) | Large Monitor (32) | Total |
|---|---|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 11.8 | 55.8 years STANDARD_DEVIATION 11.5 | 55.3 years STANDARD_DEVIATION 11.7 |
| Region of Enrollment United States | 910 participants | 895 participants | 1805 participants |
| Sex: Female, Male Female | 521 Participants | 498 Participants | 1019 Participants |
| Sex: Female, Male Male | 389 Participants | 397 Participants | 786 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 910 | 0 / 895 |
| serious Total, serious adverse events | 0 / 910 | 0 / 895 |
Outcome results
Primary
Adenoma Detection Rate (All Indications)
Number of patients with adenoma detected
Time frame: within 2 weeks (range of 1 day-14 days) of the endoscopy
Population: all indications
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Monitor (24) | Adenoma Detection Rate (All Indications) | 264 Participants |
| Large Monitor (32) | Adenoma Detection Rate (All Indications) | 271 Participants |
Primary
Adenoma Detection Rate (Screening Exams Only)
Number of patients with adenoma detected
Time frame: within 2 weeks (range of 1 day-14 days) of the endoscopy
Population: screening exams only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Monitor (24) | Adenoma Detection Rate (Screening Exams Only) | 137 Participants |
| Large Monitor (32) | Adenoma Detection Rate (Screening Exams Only) | 157 Participants |
Secondary
Polyp Detection Rate (All Indications)
Number of patients with polyps detected
Time frame: recorded during endoscopy (immediate)
Population: all indications
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Monitor (24) | Polyp Detection Rate (All Indications) | 367 Participants |
| Large Monitor (32) | Polyp Detection Rate (All Indications) | 424 Participants |
Secondary
Polyp Detection Rate (Screening Exams Only)
Number of patients with polyps detected
Time frame: recorded during endoscopy (immediate)
Population: screening exams only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Monitor (24) | Polyp Detection Rate (Screening Exams Only) | 137 Participants |
| Large Monitor (32) | Polyp Detection Rate (Screening Exams Only) | 157 Participants |