Colonoscopy Clinical Trial
Official title:
Phase IV, Prospective, Randomized Study Comparing Preparation the Day Before and Split-dose Regimen With Sodium Picosulphate/Magnesium Citrate for Morning Colonoscopies
An excellent bowel cleansing is mandatory to increase the diagnostic accuracy of colonoscopy.
Failure to adequately cleanse the bowel for colonoscopy can lead to missed lesions, prolonged
procedure duration and repeated procedures at earlier intervals. Emerging solid evidence is
pointing out the need of switching from preparation the day before to regimens in which half
or even more of the preparation is administered the same day of the procedure, which have
extensively demonstrated to provide a significantly better cleansing, being well tolerated.
Preparation can be fully administered the same day for afternoon procedures, whereas
split-dose regimens fit better with morning colonoscopies. However, the ideal regimen for
early morning colonoscopies is still to be elucidated. The second part of the preparation for
these patients is usually recommended to be taken during sleeping time (2-3 am) on the belief
that intake of fluids should be completely halted at least four hours prior to the
colonoscopy procedure Sodium picosulphate is a unique orange-flavoured cleansing agent dosed
as two powder sachets. Mayor advantages in comparison with current alternatives are
relatively small volumes (each sachet is mixed with only 150-250 mL of water) and a more
pleasant taste. It provides similar bowel cleansing than sodium phosphate and polyethylene
glycol solutions administered the day before. Nonetheless, focus on split-dose regimens has
been set on several polyethylene glycol (either high-volume or low-volume) regimens, but no
data are available for split-dose sodium-picosulphate regarding colonoscopy in adults.
The aim of the study is to evaluate the efficacy and safety of a sodium-picosulphate
low-volume split-dose regimen, in which the second-half of the preparation and fluids intake
are allowed until 2 hours for early morning colonoscopies and until 2-6 hours for morning
colonoscopies, comparing this split-dose regimen with standard cleansing the day before with
sodium picosulphate/magnesium citrate.
Justification of the study:
Several split-dose bowel cleansing regimens have raised over the last decade aiming to
substitute standard preparation the day before. These split-dose regimens (based on sodium
phosphate and polyethylene glycol solutions) have demonstrated better cleansing scores, so it
is probably more important the time that preparation is given rather than the type of
solution. However, the time to administer the second half of the solution in split-dose
regimens for morning colonoscopies remains controversial. A major concern of split-dose
regimens is the risk of aspiration pneumonia during sedation if liquids have been
administered quite close to the procedure. As such, the second part of the preparation is
usually given early in the morning (2-3 am) in order to have a safety-period of at least four
hours prior to the colonoscopy. However, this is quite disturbing for patients and may hamper
the adherence to further colonoscopies. Furthermore, On the other hand, no study addressing
the role of split-dose Citrafleet has been published to date
Therefore it is necessary to make a controlled clinical trial to directly compare "the day
before" and " split-dose" regimens with Citrafleet for morning colonoscopies. In order to
maximize the efficacy of the split-dose regimens, the time period between fluids intake and
the colonoscopy will be shortened up up to 2 hours for morning colonoscopies scheduled from 9
to 11 am and up to 3 hours for that scheduled after 11 am. The results of this study will
conclude whether there is still room for improvement in bowel cleansing for morning
colonoscopies, using more palatable low-volume solutions without interrupting sleep time.
;
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 |
NCT00314418 -
Patient Position and Impact on Colonoscopy Time
|
N/A | |
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 |
NCT00427089 -
Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening
|
Phase 3 | |
Completed |
NCT00209573 -
A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy
|
Phase 3 | |
Completed |
NCT05823350 -
The Effect of Abdominal Massage on Pain and Distention After Colonoscopy
|
N/A |