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Colonoscopy is the gold-standard for the evaluation of the colorectal mucosa. Colonoscopy quality indicators are the adenoma detection rate, the rate of cecal intubation and the bowel preparation.
The role of diet in preparing for colonoscopy is not fully established. Currently there is not enough evidence available to choice between 3 days of low residue diet versus 1 day.
The research hypothesis is that the low residue diet offers a non-inferior bowel preparation and an improved tolerance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 day low residue diet | Experimental | Patients are instructed to complete a low residue diet exclusively one day prior the colonoscopy. |
|
| 3 days low residue diet | Active Comparator | Patients are instructed to complete a low residue diet three days prior the colonoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 day low residue diet | Other | Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel preparation | Measured with the Boston Bowel Preparation Scale from 0 until 9. 9 represents an excellent preparation. | During the colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Diet tolerance | Using Likert scale. From 1 to 5, lower is better tolerance. | It is reported before entering the endoscopy room. Regarding the 3 or 1 days on low fiber diet depending on which study group is the participant. |
| Preparation tolerance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva MartÃnez, PhD | Corporació Sanitaria Parc Taulà | Study Director |
| Salvador Machlab, MD | Corporació Sanitaria Parc Taulà | Principal Investigator |
| Rafel Campo, PhD | Corporació Sanitaria Parc Taulà | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Parc Taulà | Sabadell | Barcelona | 08208 | Spain |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
| 3 day low residue diet | Other | Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy. |
|
|
Using Likert scale. From 1 to 5, lower is better tolerance.
| It is reported before entering the endoscopy room. Regarding the 3 or 1 day on bowel preparation depending on which study group is the participant. |
| Adenoma detection rate | Proportion of colonoscopies with detection of colorectal cancer or adenoma excluding distal hyperplastic | up to 2 weeks after colonoscopy depending on pathology department workload. |
| Endoscopic diagnosis | Final endoscopic diagnosis. For example; normal, diverticulosis, polyps, colorectal cancer, etc. | It is assessed during the colonoscopy and will be reported the same day. |
| Cecum intubation rate | Cecum intubation will be assessed during each colonoscopy if the endoscope reaches the cecum. | It will be calculated through study completion, approximately 1 year, for all the study period using all participants having the colonoscopy done |
| Intubation time | time lapse from the start of the exploration until cecum is reached. | it is assessed from the start of the colonoscopy until cecum is reached (1 day) |
| Withdrawal time | Time lapse between cecum withdrawal the end of the exploration. | it is assessed from at the beginning of the withdrawal of the colonoscope until the colonoscopy is finished. (procedure) |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005759 | Gastroenteritis |