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

Colorectal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02887573
• Other study ID #: XijingHDD
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 20, 2016
• Last updated: February 4, 2017
• Start date: January 2014
• Est. completion date: July 2017

Study information

• Verified date: February 2017
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Polyps

Intervention

Drug:
• Free-residue nutrients
This trial evaluated the efficiency of free-residue nutrients for the bowel prepartion of CCE.
• 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.
• 4L PEG
4L PEG are laxatives in the control group.
• PEG
These PEG are for boosters. All patients will take 0.75L and 0.5L PEG for two boosters.
• Mosapride citrate
5mg mosapride citrate are used to promote gastric motivity.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaichun Wu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Accuracy parameters:assessment the yield of detection of polyps =6mm and =10mm;		an expected average of 1 months from study procedure
Secondary	The gastrointestinal tract transit times and the colonic transit times between two different bowel preparation methods for CCE;	The gastrointestinal tract transit time was defined as the time from initial ingestion to capsule excretion. The colon transit time defined as first capsule image of the cecum to capsule excretion.	an expected average of 1 months from study procedure
Secondary	Colon capsule excretion rate between two different bowel preparation methods;		an expected average of 1 months from study procedure
Secondary	Adverse events between two different bowel preparation methods.		the PillCam procedure day