Diverticulosis
Conditions
Keywords
Balloon Enteroscopy, Looping
Brief summary
Patients with a prior incomplete colonoscopy will be enrolled in this study. Patients will be randomized to either an initial repeat attempt with a standard colonoscope or the single balloon enteroscope. If the procedures is unsuccessful, the patient can be crossed-over to the other group. The primary endpoint of the study is a complete colonoscopy.
Detailed description
Colonoscopy is a well-established practice utilized for the evaluation of lower gastrointestinal tract diseases including, mostly commonly, the screening for colorectal polyps and cancer. Despite improvements in endoscope technology, a significant minority of procedures (up to 10%) can not be safely completed due to a variety of patient factors and technical difficulties. These factors primarily include prior abdominal surgeries resulting in adhesions, severe diverticular disease, inadequate bowel cleansing, and patient discomfort. Options for an incomplete colonoscopy include several endoscopic and non-endoscopic modalities. Non-endoscopic modalities include radiologic studies such as CT/MRI colonography as well as a retrograde barium study. Relative disadvantages of these modalities is the inability to remove colonic polyps, perform biopsies, and in the case of barium studies, a lower sensitivity for pathology. Alternative endoscopic modalities have been described that may assist in successfully completing colonoscopy Of these alternative methods, balloon-overtube assisted colonoscopy is the most promising, but this method has not been studied in a randomized, controlled fashion. In this study, we aim to compare balloon-overtube assisted colonoscopy versus standard colonoscopy for patients with prior incomplete colonoscopy.
Interventions
DEVICESingle Balloon Colonoscopy
Use of the single balloon enteroscopy system (enteroscope and balloon-overtube) to complete colonoscopy.
DEVICEStandard Colonoscopy
Use of the standard adult colonoscope to complete colonoscopy.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* prior colonoscopy that was incomplete within the previous 12 months or their two most recent colonoscopies (performed at any time interval) were incomplete
Exclusion criteria
* incomplete colonoscopy due only to poor bowel preparation or inadequate sedation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Colonoscopy to the Cecum | Day of Procedure | Number of patients with a complete colonoscopy to the cecum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time (Minutes) to Cecum | Day of Procedure | Time, in minutes, until reaching cecum in each arm. |
| Procedural Complications | 7 days post procedure | Number of patients with any procedural complications as assessed 7 days after procedure. |
Countries
United States
Participant flow
Recruitment details
Subject recruitment completed.
Pre-assignment details
Early termination at 30 patients due to clinically significant differences at midpoint of study. Patients in the Standard Colonoscopy group could cross-over to the Balloon Colonoscopy group after 20 minutes of procedure time but they were not included in further analysis after cross-over.
Participants by arm
| Arm | Count |
|---|---|
| Balloon Colonoscopy Colonoscopy using the single balloon enteroscope system. | 14 |
| Standard Colonoscopy Colonoscopy using a standard adult colonoscope | 16 |
| Total | 30 |
Baseline characteristics
| Characteristic | Standard Colonoscopy | Balloon Colonoscopy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 14 Participants | 30 Participants |
| Age, Continuous | 59.9 years STANDARD_DEVIATION 10 | 58.5 years STANDARD_DEVIATION 12.5 | 59.2 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 16 participants | 14 participants | 30 participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
Primary
Complete Colonoscopy to the Cecum
Number of patients with a complete colonoscopy to the cecum
Time frame: Day of Procedure
Population: Per Protocol, Terminated at Interim Analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Colonoscopy | Complete Colonoscopy to the Cecum | 13 patients |
| Standard Colonoscopy | Complete Colonoscopy to the Cecum | 8 patients |
Secondary
Procedural Complications
Number of patients with any procedural complications as assessed 7 days after procedure.
Time frame: 7 days post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Colonoscopy | Procedural Complications | 0 participants |
| Standard Colonoscopy | Procedural Complications | 0 participants |
Secondary
Time (Minutes) to Cecum
Time, in minutes, until reaching cecum in each arm.
Time frame: Day of Procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balloon Colonoscopy | Time (Minutes) to Cecum | 24 minutes | Standard Deviation 15 |
| Standard Colonoscopy | Time (Minutes) to Cecum | 22 minutes | Standard Deviation 18 |