Colonoscopy Clinical Trial
Official title:
Measuring the Effectiveness and Utility of Colonic Irrigation for Bowel Preparation in Patients Undergoing Screening or Surveillance Colonoscopy
The purpose of this physician blinded, randomized study is to determine the utility, effectiveness, and feasibility of using colonic irrigation as a substitute for standard oral colonic purgative solutions for colonoscopy preparation. Patients will be randomized to receive either oral isosmotic solution (PEG) or colonic irrigation using the Hydro San Plus Colon therapy system, an FDA approved and isosmotic (ISO) certified device for colonic irrigation and cleansing before endoscopic procedures.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Consecutive adult patients (>18 years old) who require screening or surveillance colonoscopy - Ability to give consent Exclusion Criteria: - Inability to obtain informed consent - Pregnant patients - Patients under the age of 18 - Active ulcerative colitis or crohn's disease flare - Prisoners |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | New York University School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of Boston Bowel Prep Score (BBPS) | Quality of bowel preparations validated by numerical scale for bowel cleanse (0-9 best) | 1 Day | No |
Secondary | Difference in Adenoma Detection Rate (ADR) | 1 Day | No | |
Secondary | Difference in the number of follow ups needed after colonoscopy | 1 Day | No | |
Secondary | Difference in overall comfort and convenience between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS) | 1 Day | No | |
Secondary | preferences regarding type of bowel prep for future colonoscopy based on difference in score between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS) | 1 Day | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04101097 -
Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy
|
||
Completed |
NCT03247595 -
Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy
|
N/A | |
Completed |
NCT04214301 -
An Open-Label Preference Evaluation of BLI800
|
Phase 4 | |
Withdrawn |
NCT05754255 -
Comparison of High-flow Oxygen With or Without Nasal Positive Airway Pressure (PAP) During Propofol Sedation for Colonoscopy in an Ambulatory Surgical Center
|
N/A | |
Recruiting |
NCT02484105 -
Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction
|
Phase 4 | |
Active, not recruiting |
NCT02264249 -
Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation
|
N/A | |
Terminated |
NCT01978509 -
The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies
|
N/A | |
Completed |
NCT01964417 -
The Comparative Study Between Bowel Preparation Method
|
Phase 3 | |
Recruiting |
NCT01685970 -
Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy
|
Phase 3 | |
Completed |
NCT01518790 -
Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children
|
N/A | |
Recruiting |
NCT00748293 -
Achievement of Better Examinee Compliance on Colon Cleansing Using Commercialized Low-Residue Diet
|
N/A | |
Completed |
NCT00779649 -
MoviPrep® Versus HalfLytely®, Low-VolUme PEG Solutions for Colon Cleansing: An InvesTigator-blindEd, Randomized, Trial
|
Phase 4 | |
Completed |
NCT00671177 -
Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique
|
N/A | |
Completed |
NCT00380497 -
Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in Children
|
Phase 4 | |
Recruiting |
NCT00160823 -
Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital Patients
|
Phase 3 | |
Completed |
NCT00390598 -
PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy
|
Phase 2/Phase 3 | |
Completed |
NCT00314418 -
Patient Position and Impact on Colonoscopy Time
|
N/A | |
Completed |
NCT00209573 -
A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy
|
Phase 3 | |
Completed |
NCT00427089 -
Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening
|
Phase 3 | |
Completed |
NCT05823350 -
The Effect of Abdominal Massage on Pain and Distention After Colonoscopy
|
N/A |