A Phase 4 interventional study of Education and Fiber free diet in Bowel Preparation for Colonoscopy, sponsored by Corporacion Parc Tauli. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-15.
Sponsored by Corporacion Parc Tauli · Phase 4, Interventional, and Treatment
Colonoscopy is the gold standard diagnostic procedure for colonic disease. Excellent bowel cleansing is critical for this procedure. However, an inadequate bowel cleansing is a common problem that occurs up to 20% of procedures. This fact has a deep clinical and economical impact. In fact, inadequate bowel preparation is associated to misdiagnosis in 30% of lesions. Moreover several clinical conditions such as cirrhosis, antidepressant drugs, and hospitalized patients are predictive factors of inadequate colonic preparations. These circumstances have promoted multiple clinical trials, however there is no consensus about the optimal strategy for colonic cleansing. Education in colonic preparation has obtained conflicting results. Polyethylene glycol (PEG) and sodium phosphate solutions have been the commonest preparations used with a similar efficacy. However, the large volume to ingest (4 litters) makes PEG compliance difficult. Likewise, sodium phosphate also contains high levels in sodium and phosphate which contraindicate its use in elderly patients and / or with comorbidity. The use of adjuvants such as olive oil and bisacodyl allows reducing the volume of polyethylene glycol thereby improving the tolerance and right colon preparation.
The aim of this study is to compare the efficacy of a multidisciplinary approach (education, fiber free diet, polyethylene glycol (PEG) 2L, and adjuvant bisacodyl + olive oil) vs. a conventional approach (fiber free diet+ PEG 4L in split doses ) in cleaning the colon of hospitalized patients.
Corporacion Parc Tauli is the lead sponsor of 163 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The multidisciplinary approach will include: Education Fiber free diet Bisacodyl: 10 mg 2 days before the procedure, 20 mg the day before the procedure and 10 mg 3 hours before the procedure Adjuvants: Olive Oil:60 mL/Apple Juice: 200 mL PEG: 1 L the night before the procedure and 1 L 3 hours before the procedure
Behavioral: Education · Other: Fiber free diet · Dietary Supplement: Adjuvants · Drug: Polyethylene glycol (PEG) · Drug: Bisacodyl
The conventional approach will include: Education Fiber free diet Polyethylene glycol (PEG): 2 L the night before the procedure, 2 L 3 hours before the procedure
Behavioral: Education · Other: Fiber free diet · Drug: Polyethylene glycol (PEG)
percentage of patients with adequate bowel preparation
Adequate bowel preparation is defined as a preparation which allows exploring the whole colonic mucose and detecting flat lesions (Rating as good or excellent in the Boston Bowel preparation scale)
Time frame: at the time of performing the colonoscopy
Percentage of patients with adequate bowel preparation by bowel segments
The boston scale will be assessed by the investigators during the procedure.
Time frame: At the time of performing the colonoscopy
Tolerance to the colonoscopy
Tolerance to the colonoscopy will be measured by VAS during the colonoscopy, 30 minutes after colonoscopy and 24 hours after colonoscopy
Time frame: from colonoscopy up to 24 hours after colonoscopy
Percentage of complete/incomplete colonoscopies and reprogramming
Evaluation of incomplete or inadequate bowel preparation will be assessed after performing the colonoscopy
Time frame: After the colonoscopy
Complications during and after the procedure
Time frame: up to 24 hours after colonoscopy
Doses of sedation needed during the colonoscopy
Final dose will be calculated at the end of the procedure
Time frame: During the colonoscopy process
Tolerance to the preparation
Time frame: up to 48 hours
Endoscopic findings
Time frame: during the colonoscopy
This study is status unknown, as verified in May 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Corporacion Parc Tauli