N/A
Completed N=280
Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy
Unsedated Colonoscopy · Water Exchange Colonoscopy · Cap · Colonoscopy Pain
Source: ClinicalTrials.gov NCT03160859 ↗
Enrolled (actual)
280
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Real Time Maximum Insertion Pain — 2.6; 2.9 score on a scale — p=0.62
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Real Time Maximum Insertion Pain |
2.6; 2.9 | 0.62 |
| SECONDARY Proportion of Patients With No Insertion Pain |
38; 41 | — |
| SECONDARY Insertion Time |
18.8; 18.6 | — |
| SECONDARY Right Colon Adenoma Detection Rate (ADR) |
40; 27 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03160859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.