Prepackaged Nutritional Formulations Versus Restricted Diet for Bowel Preparation

Ningbo No. 1 Hospital196 enrolled

Overview

In order to analyze the effectiveness and patient tolerance of the two bowel preparation regimens, the investigators will compare prepackaged semisolid nutritional formulations and restricted diet. The aim was to demonstrate that prepackaged semisolid nutritional formulations is not inferior in overall quality of intestinal preparation to restricted diet in subjects undergoing colonoscopy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Enrollment

196

Conditions

Bowel Preparation

Interventions

prepackaged semisolid nutritional formulationsOTHER

The day before the colonoscopy: 3 bags of pre-packaged food were used for diet preparation. On the day of the colonoscopy: a bag of pre-packaged food were used for breakfast.

restricted dietOTHER

The day before the colonoscopy: restricted diet prepared by patients were used for diet preparation. On the day of the colonoscopy: restricted diet prepared by patients were used for breakfast.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients age between 18-75 years old requiring colonoscopy and willing to participate in this study. Exclusion Criteria: 1. Patients with constipation; 2. Patients with congestive heart failure; 3. Patients with a history of kidney disease; 4. Patients with a history of poor intestinal preparation; 5. Pregnant / lactating women; 6. Patients without informed consent; 7. Allergic or intolerant to any research drug; 8. Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis and toxic megacolon; 9. Patients with a history of inflammatory bowel disease; 10. History of colorectal resection； 11. Patients with diabetes.

Locations (1)

Ningbo First Hospital

Ningbo, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Quality of Bowel Preparation

The OBPS，a scoring system with scores between 0 and 14, where 0 is the best score，divides the colon into 3 segments (right, transverse and rectosigmoid colon); each is scored from 0-4 (0=excellent, If it is necessary to suction liquid stool to adequately see the colonic wall, a score of 2 (fair) is given; if it is necessary to wash and to suction, a score of 3 (poor) is given. The remaining scores fall into place around these anchors. ). A score 0-2 is added to indicate the total amount of luminal fluid.(0=The total amount of fluid in the colon is very small,1=a moderate volume of fluid overall in the colon,2=a large volume of fluid overall in the colon)

Time frame: 1 Day of colonoscopy

Data from ClinicalTrials.gov

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