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

NCT02887573 | Unknown Phase 4

• 1 other identifier: XijingHDD
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colorectal Polyps

Keywords

Bowel preparation; Colorectal polyps; Colon capsule endoscopy

Outcome Measures

Primary Outcomes (1)

• Bowel Cleansing Level of Two Different Bowel Preparation Methods

  The first 32 patients adopted a low fiber diet two days before the CCE procedure. Bowel preparation included the ingestion of 2L polyethyleneglycol in the evening before test day and 2L PEG in the morning on the test day. The subsequent 30 patients were received free-residue Nutrients。Then they ingested 2L PEG between 5:00 and 7.00 am of the examination day. The capsule was scheduled at 8:30 am. When the capsule reached the small bowel, 0.75L PEG was used as first booster. If the capsule had not been excreted 3 hours later, the patients was received 0.5L PEG.

  an expected average of 1 months from study procedure

Secondary Outcomes (4)

• Accuracy parameters:assessment the yield of detection of polyps ≥6mm and ≥10mm;

  an expected average of 1 months from study procedure

• The gastrointestinal tract transit times and the colonic transit times between two different bowel preparation methods for CCE;

  an expected average of 1 months from study procedure

• Colon capsule excretion rate between two different bowel preparation methods;

  an expected average of 1 months from study procedure

• Adverse events between two different bowel preparation methods.

  the PillCam procedure day

Study Arms (2)

Free-residue nutrients+PEG

EXPERIMENTAL

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.

Drug: Free-residue nutrients; Procedure: Colon capsule endoscopy; Drug: 2L PEG; Drug: PEG; Drug: Mosapride citrate

Low fiber diet+PEG

EXPERIMENTAL

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.

Drug: Low fiber diet; Procedure: Colon capsule endoscopy; Drug: 4L PEG; Drug: PEG; Drug: Mosapride citrate

Interventions

Free-residue nutrients DRUG

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

Free-residue nutrients+PEG

Low fiber diet DRUG

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

Low fiber diet+PEG

Colon capsule endoscopy PROCEDURE

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

Free-residue nutrients+PEG; Low fiber diet+PEG

2L PEG DRUG

2L PEG are laxatives for experiment group.

Also known as: polyethylene glycol

Free-residue nutrients+PEG

4L PEG DRUG

4L PEG are laxatives in the control group.

Also known as: polyethylene glycol

Low fiber diet+PEG

PEG DRUG

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

Also known as: polyethylene glycol

Free-residue nutrients+PEG; Low fiber diet+PEG

Mosapride citrate DRUG

5mg mosapride citrate are used to promote gastric motivity.

Free-residue nutrients+PEG; Low fiber diet+PEG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kaichun Wu: lead

MeSH Terms

Interventions

Endoscopy; Polyethylene Glycols; mosapride

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Wu Kaichun, phD

  Xijing Hospital of Digestive Diseases

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President of Xijing Hospital of Digestive Diseases

Study Record Dates

• First Submitted: August 20, 2016
• First Posted: September 2, 2016
• Study Start: January 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 7, 2017

Record last verified: 2017-02