Cap, Colonoscopy Pain, Unsedated Colonoscopy, Water Exchange Colonoscopy
Conditions
Keywords
unsedated colonoscopy, water exchange colonoscopy, cap, colonoscopy pain
Brief summary
This is a study to compare two different, but normally, used methods of colonoscopy in patients undergoing colonoscopy without sedation. There will be two arms in this study: WE (water exchange) control, and WE (water exchange) plus cap (placed at tip of the colonoscope). The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The control method will use water instead of air during insertion of the colonoscope. The study method will use a cap that will fit onto the end of the colonoscope plus water during insertion of the colonoscope. This study will assess if the study method is less painful than the control method.
Detailed description
This will be a multi-VA site, unblinded investigators, prospective randomized control trial (RCT). Randomization (WE, WE + cap) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order set up by statistics consultant) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two arms (WE, WE + cap) to see which one is less painful. Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified type of colonoscopy (screening, surveillance, diagnostic). All subjects will have scheduled unsedated colonoscopy as a result of lack of escort or personal preference for no sedation. Randomization will be set up by statistics consultant. Control Method: One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion. Study method: The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a cap, fitted to the colonoscope per manufacturer instruction.
Interventions
OTHERControl
Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.
DEVICEStudy method
Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.
Sponsors
VA Northern California Health Care System
VA Palo Alto Health Care System
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
This will be a multi-VA site, prospective RCT to compare different methods with 2 arms to determine which is less painful: water alone or water plus cap. Randomization will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site. Control Method: Involves unsedated colonoscopy with water exchange. Residual air will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion. Study method: Involves unsedated colonoscopy with water exchange and the addition of a commercially available accessory fitted onto the colonoscope.
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Informed/educated (about pros and cons of the unsedated option) Veterans undergoing: * diagnostic * surveillance (follow up of polyps) * screening (first-time) colonoscopy at participating sites * choosing scheduled unsedated colonoscopy for any reason (lack of escort, personal preference)
Exclusion criteria
* decline to be randomized * unable to give consent or respond to questionnaires * history of colon surgery * active inflammatory bowel disease * lower gastrointestinal bleeding (except for occult blood or FIT positive in the context of colon cancer screening) * therapeutic colonoscopy (e.g., hemostasis, removal of large polyp) * proctosigmoidoscopy * bidirectional endoscopy * inadequate consumption of bowel preparation * known history of severe diverticulosis or diverticulitis * history of abdominal surgery previously requiring sedation for colonoscopy * current narcotic/anxiolytic medication use * prior unsuccessful experience with unsedated colonoscopy * emergent colonoscopy * evidence of colonic obstruction based on pre-colonoscopy clinical evaluation * current participation in other studies * medical condition that could increase the risk associated with colonoscopy * active cardiac * or pulmonary disease * or other serious disease * medical condition that would preclude a benefit from colonoscopic screening * cancer * or any terminal illness * prosthetic heart valve * anticoagulant therapy * nonmedical problems * psychiatric disorders * excessive use of alcohol * need for special precautions in performing colonoscopy * antibiotic prophylaxis * request of on demand sedation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real Time Maximum Insertion Pain | Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour | Pain during insertion reported to the unblinded assisting nurse, visual analogue scale, VAS: 0=none, 10=most severe. The highest pain score will be tabulated for analysis. Timing of data collection will be at the discretion of the nurse to minimize bias by colonoscopist behavior. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With No Insertion Pain | Pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour | Proportion of patients who report no pain during insertion of the colonoscope. |
| Insertion Time | Insertion time in minutes was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour | Time to cecum (clock display on monitor), faster insertion is a quality marker |
| Right Colon Adenoma Detection Rate (ADR) | Adenoma Detection Rate (ADR) was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour | Right colon Adenoma Detection Rate (ADR) is the proportion of patients with at least one adenoma in the part of the colon between the cecum and the hepatic flexure. |
Countries
United States
Participant flow
Recruitment details
Subjects will be selected from patients scheduled for colonoscopy as part of their routine care. Eligible subjects will be asked to sign the ICF. Control and study methods will be explained, and study subjects will undergo a questionnaire, physical examination, and unsedated colonoscopy with the standard (control) or study methods. Ineligible patients will be offered unsedated colonoscopy by standard method, outside the research study.
Participants by arm
| Arm | Count |
|---|---|
| Control Method One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Control: Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion. | 137 |
| Study Method The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Study method: Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope. | 143 |
| Total | 280 |
Baseline characteristics
| Characteristic | Control Method | Study Method | 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 | 137 Participants | 143 Participants | 280 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 18 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 120 Participants | 124 Participants | 244 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 7 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 27 Participants | 61 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 88 Participants | 100 Participants | 188 Participants |
| Region of Enrollment United States | 137 Participants | 143 Participants | 280 Participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 132 Participants | 136 Participants | 268 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 137 | 0 / 143 |
| other Total, other adverse events | 0 / 137 | 0 / 143 |
| serious Total, serious adverse events | 0 / 137 | 0 / 143 |
Outcome results
Primary
Real Time Maximum Insertion Pain
Pain during insertion reported to the unblinded assisting nurse, visual analogue scale, VAS: 0=none, 10=most severe. The highest pain score will be tabulated for analysis. Timing of data collection will be at the discretion of the nurse to minimize bias by colonoscopist behavior.
Time frame: Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Method | Real Time Maximum Insertion Pain | 2.6 score on a scale | Standard Deviation 2.4 |
| Study Method | Real Time Maximum Insertion Pain | 2.9 score on a scale | Standard Deviation 2.5 |
Comparison: Chi Squarep-value: 0.62Chi-squared
Secondary
Insertion Time
Time to cecum (clock display on monitor), faster insertion is a quality marker
Time frame: Insertion time in minutes was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Method | Insertion Time | 18.8 Minutes | Standard Deviation 15.9 |
| Study Method | Insertion Time | 18.6 Minutes | Standard Deviation 15.6 |
Secondary
Proportion of Patients With No Insertion Pain
Proportion of patients who report no pain during insertion of the colonoscope.
Time frame: Pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Method | Proportion of Patients With No Insertion Pain | 38 Participants |
| Study Method | Proportion of Patients With No Insertion Pain | 41 Participants |
Secondary
Right Colon Adenoma Detection Rate (ADR)
Right colon Adenoma Detection Rate (ADR) is the proportion of patients with at least one adenoma in the part of the colon between the cecum and the hepatic flexure.
Time frame: Adenoma Detection Rate (ADR) was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Method | Right Colon Adenoma Detection Rate (ADR) | 40 Participants |
| Study Method | Right Colon Adenoma Detection Rate (ADR) | 27 Participants |