Colon Polyp, Colorectal Adenoma
Conditions
Keywords
Bowel preparation, Polyp, adenoma
Brief summary
Previous researches demonstrated that a prepackaged low-residue diet (LRD) could achieve better bowel preparation quality compared with a self-prepared LRD. However, up to now, there has been no widely acceptable standard of LRD for bowel preparation. Moreover, these prepackaged LRD adopted in previous studies mainly consisted of traditional foods without further processing. Recently, a prepackaged LRD for Special Medical Purpose was specifically designed for bowel preparation. This trail was to compare the impact of the prepackaged LRD on bowel preparation for colonoscopy with self-prepared LRD by patients.
Interventions
DIETARY_SUPPLEMENTPrepackaged Low-residue diet
Subjects in the prepackaged Low-residue diet group were given 6 packs (60g/pack) pre-packaged formula LRD and asked to use the formula according to individual needs prior to colonoscopy.
DIETARY_SUPPLEMENTSelf-prepared Low-residue diet
Subjects in the self-prepared Low-residue diet group were instructed to follow and prepare an Low-residue diet in the day prior to colonoscopy.
Sponsors
Qilu Hospital of Shandong University
Jinan Military General Hospital
Wuhan TongJi Hospital
Zhejiang University
First Affiliated Hospital, Sun Yat-Sen University
The First Affiliated Hospital with Nanjing Medical University
West China Hospital
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients whose age is between 18-65. * Patients who have indications for screening, surveillance and diagnostic colonoscopy. * Patients who have signed inform consent form
Exclusion criteria
* subjects who had known or suspected heart failure, stroke or renal failure; * subjects who had a history of colon surgery or inflammatory bowel disease; * subjects who Patients with had digestion or absorption dysfunction or any dietary restriction due to various reasons; * subjects who had a history of hypersensitivity to any ingredients of laxatives or soy products; * subjects who had high risk factors for bowel preparation such as chronic constipation, Body Mass Index (BMI) greater than 30 or BMI less than 18 Kg/m2, diabetes, spinal cord injury, or use of medications affecting bowel motility within a week; * subjects who had participated in another interventional clinical trial in the previous 60 days; * pregnant or lactating women and those planning to become pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate bowel preparation rate | 30 mins | Boston Bowel Preparation Scale (BBPS) was adopted to evaluate the quality of bowel preparation. Each section of the colon (i.e. the right, the transverse, and the rectosigmoid colon) was rated (0, very poor; 1, poor; 2, good; and 3, very good). Adequate bowel of bowel preparation was defined as a total score ≥ 6 and all colon segments BBPS ≥ 2. Inadequate bowel preparation was defined as any colon segment BBPS ≤ 1. |
| BBPS scores of the entire colon | 30 mins | The sum of the scores of three bowel segment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adenoma detection rate (ADR) | 30 mins | adenoma detection rate is the number of patients with at least one adenoma, divided by the total number of patients. |
| preparation completion rate | 1 day | preparation completion rate is the number of patients ingest more than 80% laxative, divided by the total number of patients. |
Countries
China
Outcome results
None listed