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The aim of this study is to compare a new regimen of reduced bowel preparation that does not include low fiber diet with another reduced bowel preparation including low-fiber diet.
Bowel preparation should be safe and well tolerated by patients, particularly in a screening setting. For this reason, limited bowel preparations have been extensively investigated. Usually, they combine the use of low-fibre diet and faecal/fluid tagging. The ingestion of a positive contrast agent (either barium, iodine or a combination of the two),needed to differentiate stool or fluid residues from true colonic lesions, is now considered mandatory. A low-fibre diet has the aim of improving residue homogeneity and facilitates tagging; however, there aren't significative evidences at support. The aim of this study is to compare a new regimen of reduced bowel preparation that does not include low fiber diet with another reduced bowel preparation including low-fiber diet. Primary outcome is the overall quality of bowel preparation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet included | Active Comparator | Diet is included in bowel preparation |
|
| Diet not included | Experimental | Diet is not included in bowel preparation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Procedure | A low-fibre diet for three days before the examination |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall quality of bowel preparation using a 0-3 scale for each parameter (Homogeneity of solid-fluid fecal tagging, volume of residual fluid, colon distension). | the evaluation of overall quality of bowel preparation on CT colonography images including: homogeneity of tagging, presence of unmarked solid stool residues, the evaluation of volume of residual fluids and colon distention. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| compliance of patients | A 0-10 visual analogical scale (VAS) was used with 0 corresponding to no discomfort and 10 to severe discomfort with severe impact on patient's daily activities. Intermediate values corresponded to intermediate values of tolerance. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laghi Andrea, Professor | University of Rome "Sapienza" Faculty of Medicine and Dentistry Department of Radiological Sciences, Oncology and Pathology I.C.O.T. - Via F. Faggiana 34, 04100 Latina, Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICOT Hospital, Sapienza | Latina | 04100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20566777 | Background | Liedenbaum MH, Denters MJ, de Vries AH, van Ravesteijn VF, Bipat S, Vos FM, Dekker E, Stoker J. Low-fiber diet in limited bowel preparation for CT colonography: Influence on image quality and patient acceptance. AJR Am J Roentgenol. 2010 Jul;195(1):W31-7. doi: 10.2214/AJR.09.3572. | |
| 25149295 | Background | Iafrate F, Iannitti M, Ciolina M, Baldassari P, Pichi A, Laghi A. Bowel cleansing before CT colonography: comparison between two minimal-preparation regimens. Eur Radiol. 2015 Jan;25(1):203-10. doi: 10.1007/s00330-014-3345-0. Epub 2014 Aug 23. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Faecal Tagging | Drug | Oral ingestion of iodinated contrast media (Gastrografin 60 ml) 3h before the examination |
|
|
| Bowel cleansing | Drug | Oral ingestion of water solution (macrogol 100 mg, Sanipeg) the day before the examination |
|
|
| CT colonography | Procedure | CT Examination of the colon aimed to detect polyps and cancer |
|
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |