NCT02887573

Free-residue Nutrients for the Bowel Preparation of Colon Capsule Endoscopy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Kaichun Wu · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Colon capsule endoscopy(CCE) is a new diagnostic method of colonic lesions.It has advantages of no requirement for sedation and air insufflation.The bowel preparation has a closely relationship with yield of diagnosing diseases.Bowel preparation of CCE is not only to clean the colon but also to promote capsule propulsion.Now there is not an optimal method for CCE.

Detailed description

Objective: In this study, a new bowel preparation regime of the colon capsule is used.This regime combines free-residue nutrients and polyethylene glycol (PEG) to achieve a better preparation quality. Methods: Participants who underwent a diagnostic colonoscopy examination that demonstrated a colorectal polyps that required endoscopic treatment will be recruited to patients in the study. The first 32 participants receive a traditional low fiber diet two days before the test.Then the patients will take 2L polyethylene glycol (PEG) at 21:00-23:00 before the test day and 2L PEG at 05:00-07:00 on the test day for bowel preparation. The subsequent 30 participants receive two-days free-residue nutrients without other diet before the test.Then the patients will take 2L PEG at 05:00-07:00 on the examination day for bowel preparation. Then they will take 5mg mosapride citrate at 8:00 and ingest the colon capsule at 8:30.0.75L and 0.50L PEG are administered as boosters.And the therapeutic endoscopy will be given on the following day.Before the therapeutic colonoscopy, the participants will take 2L PEG. The colon capsule results will be reviewed by two experienced endoscopists who are blinded to first endoscopy results.

Conditions

• Colorectal Polyps

Interventions

Type	Name	Description
DRUG	Free-residue nutrients	This trial evaluated the efficiency of free-residue nutrients for the bowel prepartion of CCE.
DRUG	Low fiber diet	Low fiber diet often used in the bowel prepartion of CCE. In this study, it is the control group.
PROCEDURE	Colon capsule endoscopy	In the study,all patients should undergo two colonoscopies.The first is for examinations and the second for therapy.
DRUG	2L PEG	2L PEG are laxatives for experiment group.
DRUG	4L PEG	4L PEG are laxatives in the control group.
DRUG	PEG	These PEG are for boosters. All patients will take 0.75L and 0.5L PEG for two boosters.
DRUG	Mosapride citrate	5mg mosapride citrate are used to promote gastric motivity.

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2016-09-02
• Last updated: 2017-02-07