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

Kaichun Wu

Status and phase: Unknown; Phase 4

Conditions: Colorectal Polyps

Treatments: Procedure: Colon capsule endoscopy; Drug: PEG; Drug: Free-residue nutrients; Drug: Mosapride citrate; Drug: Low fiber diet; Drug: 4L PEG; Drug: 2L PEG

Study type: Interventional

Funder types: Other

Identifiers

NCT02887573

XijingHDD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-80 years of age.
• underwent a diagnostic OC that demonstrated colorectal polyps that required endoscopic treatment.

Exclusion criteria

1. dysphagia/swallowing disorder
2. prior major abdominal surgery of the gastrointestinal tract, known or suspected bowel obstruction
3. cardiac pacemaker/implanted electromedical device
4. pregnant or nursing women
5. any allergy or contraindication to the drugs used in the study.
6. refused to sign a informed consent.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Free-residue nutrients+PEG

Experimental group

Description:

Diet: Free-residue nutrients Free-residue nutrient will be given when the patients are hungry before the two days of the capsule day.There are no other diet in this arm. Drug: PEG 2L PEG are used at 05:00-07:00 the morning of the test. Drug: Mosapride citrate The patients will take 5mg mosapride citrate at 8:00. Drug:PEG 0.75L and 0.50L PEG are administered as boosters for patients. Procedure: Colon capsule endoscopy The colon capsule will be ingested at 08:30 the day of the test.The images will be reviewed by two experienced endoscopists. Procedure: Colonoscopy On the following day of the test.All participants will undergo therapeutic colonoscopy.

Treatment:

Drug: 2L PEG

Drug: Free-residue nutrients

Procedure: Colon capsule endoscopy

Drug: Mosapride citrate

Drug: PEG

Low fiber diet+PEG

Experimental group

Description:

Diet: Low fiber diet Before the two days of the capsule day,when the patients hungry,low fiber diet wiil be given. Drug: PEG 4L PEG are used at 21:00-23:00 the night before the test and 05:00-07:00 the morning of the test. Drug: Mosapride citrate The patients will take 5mg mosapride citrate at 8:00. Drug:PEG 0.75L and 0.50L PEG are administered as boosters for patients. Procedure: Colon capsule endoscopy The colon capsule will be ingested at 08:30 the day of the test.The images will be reviewed by two experienced endoscopists. Procedure: Colonoscopy On the following day of the test,All participants will undergo therapeutic colonoscopy.

Treatment:

Drug: 4L PEG

Procedure: Colon capsule endoscopy

Drug: Low fiber diet

Drug: Mosapride citrate

Drug: PEG