Colon Cleansing Quality of Polyethylene Glycol Compared With Polyethylene Glycol Plus Ascorbic Acid.
- Conditions
- Colonoscopy Preparation
- Interventions
- Registration Number
- NCT02073552
- Lead Sponsor
- Fundación Canaria Rafael Clavijo para la Investigación Biomédica
- Brief Summary
The purpose of the study is to assess whether a low volume polyethylene glycol (PEG) plus ascorbic acid based bowel preparation for colonoscopy is not inferior to a large volume polyethylene glycol preparation in subjects with past history of poor bowel preparation
- Detailed Description
Two key quality indicators for colonoscopy are the cecal intubation rate and the percentage of neoplastic lesions detected. Both factors are associated with adequate bowel cleansing. Poor cleansing ranged from 5% to 30% across studies, negatively affecting the efficiency of colonoscopy.
The most important factor associated with poor colonic preparation is the past history of poor bowel preparation. However, there are no recommendations on the proper type of preparation in those patients. In two non-randomized studies inadequate cleansing in the second colonoscopy ranged from 9.8% to 23%. Randomized studies comparing high volume (3-4 liters) with low volume (2 liters) PEG preparations, which are better tolerated by patients, are therefore needed before making any recommendations in this regard.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 472
- Age> 18 years
- Outpatients with a history of past poor bowel prep, defined according to the Boston scale as a score less than 5.
- Signed informed consent
paralytic ileus, intestinal obstruction, megacolon, poorly controlled hypertension (systolic pressure> 180, dyastolic pressure> 100), congestive heart failure, acute liver failure, end stage renal disease (dialysis or pre-dialysis), New York Heart Association class III-IV, pregnancy, diagnosis of phenylketonuria, diagnosis of glucose-6-phosphate dehydrogenase deficiency, dementia. History of poor preparation in the previous colonoscopy, colon resection, less than 75% intake of the bowel preparation in the index colonoscopy, refusal to participate in the study, patients in whom a new colonoscopy is not indicated despite a poor bowel preparation(i.e. ileal Crohn disease with poor large bowel preparation), lack of compliance with the bowel preparation schedule.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low volume Macrogol 3350 plus ascorbic acid * Two 5 mg bisacodyl tablets, taken in the same way as for the high volume group. * Macrogol 3350 plus ascorbic acid: 4 envelopes, 2 containing 112 g polyethylene glycol and electrolytes and 2 with 2 g of ascorbic acid. High volume Polyethylene glycol 4000 * Two 5 mg bisacodyl tablets It is a stimulant laxative with local action. * Polyethylene glycol 4000: 16 envelopes (70 g of powder each). It includes electrolytes and sodium sulfate.
- Primary Outcome Measures
Name Time Method Colon cleansing 30 days Colon cleansing will be assessed just after colonoscopy by the endoscopist in charge of performing the examination and afterwards images were reviewed by a the staff of endoscopists for validation (30 days). For assessing colon cleansing a validated scale (Boston scale) will be used.
- Secondary Outcome Measures
Name Time Method Detection of colorectal neoplasia 14 months Detection rate of adenoma and colorectal cancer will be assessed for both groups (low volume and high volume preparation)
Tolerance of bowel preparation Tolerance will be assessed just before colonoscopy by a research assistant It will be assessed by using a visual analog scale colon
Trial Locations
- Locations (1)
Hospital Universitario de Canarias
🇪🇸Santa Cruz de Tenerife, Spain