a Low-residue Diet for Bowel Preparation
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|ClinicalTrials.gov Identifier: NCT03943758|
Recruitment Status : Not yet recruiting
First Posted : May 9, 2019
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colon Polyp Colorectal Adenoma||Dietary Supplement: Prepackaged Low-residue diet Dietary Supplement: Self-prepared Low-residue diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Official Title:||Effect of a Prepackaged Low-residue Diet on Bowel Preparation for Colonoscopy|
|Estimated Study Start Date :||May 10, 2019|
|Estimated Primary Completion Date :||June 10, 2019|
|Estimated Study Completion Date :||October 10, 2019|
Experimental: prepackaged Low-residue diet group
The prepackaged Low-residue diet (Maifu Nutrition Technology Co. Ltd, Beijing, China). One package of the prepackaged Low-residue diet contained quantity of heat amounts to 268 kilocalories with 12.0 g of protein, 9.6 g of lipid, and 34.1 g of carbohydrate.
Dietary Supplement: Prepackaged Low-residue diet
Subjects in the prepackaged Low-residue diet group were given three packages of the prepackaged Low-residue diet, and instructed to ingest one package per meal without any other food being allowed in the day prior to colonoscopy.
Active Comparator: self-prepared Low-residue group
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
Dietary Supplement: Self-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.
- Boston bowel preparation scale (BBPS) scores [ Time Frame: 30 mins ]BBPS was developed to evaluate the quality of colon preparation and was used in our previous study. 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 BBPS score ≥ 6 and all colon segments BBPS ≥ 2. Inadequate bowel preparation was defined as any colon segment BBPS ≤ 1.
- adequate bowel preparation rate [ Time Frame: 30 mins ]Adequate bowel of bowel preparation was defined as a total BBPS score ≥ 6 and all colon segments BBPS ≥ 2. Inadequate bowel preparation was defined as any colon segment BBPS ≤ 1
- adenoma detection rate (ADR) [ Time Frame: 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 [ Time Frame: 1 day ]preparation completion rate is the number of patients ingest more than 90% laxative, divided by the total number of patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943758
|Contact: Zhaoshen Li, M.D.||firstname.lastname@example.org|
|Contact: Yu Bai, M.D.||+email@example.com|
|Changhai Hospital, Second Military Medical University|
|Shanghai, China, 200433|
|Principal Investigator:||Zhaoshen Li, M.D.||Changhai Hospital|