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

NCT ID: NCT02887573

Last Updated: 2017-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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

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Colorectal Polyps

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Free-residue nutrients+PEG

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.

Group Type EXPERIMENTAL

Free-residue nutrients

Intervention Type DRUG

This trial evaluated the efficiency of free-residue nutrients for the bowel prepartion of CCE.

Colon capsule endoscopy

Intervention Type PROCEDURE

In the study,all patients should undergo two colonoscopies.The first is for examinations and the second for therapy.

2L PEG

Intervention Type DRUG

2L PEG are laxatives for experiment group.

PEG

Intervention Type DRUG

These PEG are for boosters. All patients will take 0.75L and 0.5L PEG for two boosters.

Mosapride citrate

Intervention Type DRUG

5mg mosapride citrate are used to promote gastric motivity.

Low fiber diet+PEG

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.

Group Type EXPERIMENTAL

Low fiber diet

Intervention Type DRUG

Low fiber diet often used in the bowel prepartion of CCE. In this study, it is the control group.

Colon capsule endoscopy

Intervention Type PROCEDURE

In the study,all patients should undergo two colonoscopies.The first is for examinations and the second for therapy.

4L PEG

Intervention Type DRUG

4L PEG are laxatives in the control group.

PEG

Intervention Type DRUG

These PEG are for boosters. All patients will take 0.75L and 0.5L PEG for two boosters.

Mosapride citrate

Intervention Type DRUG

5mg mosapride citrate are used to promote gastric motivity.

Interventions

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Free-residue nutrients

This trial evaluated the efficiency of free-residue nutrients for the bowel prepartion of CCE.

Intervention Type DRUG

Low fiber diet

Low fiber diet often used in the bowel prepartion of CCE. In this study, it is the control group.

Intervention Type DRUG

Colon capsule endoscopy

In the study,all patients should undergo two colonoscopies.The first is for examinations and the second for therapy.

Intervention Type PROCEDURE

2L PEG

2L PEG are laxatives for experiment group.

Intervention Type DRUG

4L PEG

4L PEG are laxatives in the control group.

Intervention Type DRUG

PEG

These PEG are for boosters. All patients will take 0.75L and 0.5L PEG for two boosters.

Intervention Type DRUG

Mosapride citrate

5mg mosapride citrate are used to promote gastric motivity.

Intervention Type DRUG

Other Intervention Names

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polyethylene glycol polyethylene glycol polyethylene glycol

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaichun Wu

OTHER

Sponsor Role lead

Responsible Party

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Kaichun Wu

President of Xijing Hospital of Digestive Diseases

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wu Kaichun, phD

Role: STUDY_DIRECTOR

Xijing Hospital of Digestive Diseases

Other Identifiers

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XijingHDD

Identifier Type: -

Identifier Source: org_study_id

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