Clinical Trials Logo
  1. Home
  2. Colonoscopy
  3. NCT01685853

Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One

Colonoscopy Clinical Trial

Official title:
Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One. A Randomized, Observer-blind, Parallel Group, Comparative Study.

Clinical Trial Summary

The present study is intended to evaluate the effectiveness, tolerability, compliance, and feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of colonoscopy, vs the standard 4L split PEG solution.

Clinical Trial Description

Eligible patients will be informed about the aims, procedures, benefits and possible risks of the study prior to sign the informed consent form from day -30 to day-3. They will provide medical history and undergo a physical examination. Patients will be evaluated by a Physician other than the blind Endoscopist. The same responsible person will instruct the patients about administration procedures in both oral and written form. The patients will be assigned to receive one of the dosing schedule bowel preparation according to a computer generated block-randomisation list. Patients will take the study treatment at home according to the given instructions. Patients will return to the clinic for colonoscopy. The colonoscopy will be performed by an Endoscopist who will be unaware of the bowel dose-regimen preparation taken by the patient. Completed colonoscopic exam will be performed with time recorded (intubation and withdrawal from ceacum). The unblind Investigator will ask the patients about safety, tolerability, overall acceptance and compliance. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01685853
Study type Interventional
Source European Institute of Oncology
Contact
Status Completed
Phase Phase 3
Start date April 2011
Completion date March 2012
View Details
See also
  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