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

Primary Purpose

Colorectal Polyps

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Free-residue nutrients
Low fiber diet
Colon capsule endoscopy
2L PEG
4L PEG
PEG
Mosapride citrate
Sponsored by
Kaichun Wu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Polyps focused on measuring Bowel preparation, Colorectal polyps, Colon capsule endoscopy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Free-residue nutrients+PEG

    Low fiber diet+PEG

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Accuracy parameters:assessment the yield of detection of polyps ≥6mm and ≥10mm;
    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.
    Colon capsule excretion rate between two different bowel preparation methods;
    Adverse events between two different bowel preparation methods.

    Full Information

    First Posted
    August 20, 2016
    Last Updated
    February 4, 2017
    Sponsor
    Kaichun Wu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02887573
    Brief Title
    Free-residue Nutrients for the Bowel Preparation of Colon Capsule Endoscopy
    Official Title
    Free-residue Nutrients for the Bowel Preparation of Colon Capsule Endoscopy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    July 2017 (Anticipated)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Kaichun Wu

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Polyps
    Keywords
    Bowel preparation, Colorectal polyps, Colon capsule endoscopy

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    62 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Free-residue nutrients+PEG
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Low fiber diet+PEG
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Free-residue nutrients
    Intervention Description
    This trial evaluated the efficiency of free-residue nutrients for the bowel prepartion of CCE.
    Intervention Type
    Drug
    Intervention Name(s)
    Low fiber diet
    Intervention Description
    Low fiber diet often used in the bowel prepartion of CCE. In this study, it is the control group.
    Intervention Type
    Procedure
    Intervention Name(s)
    Colon capsule endoscopy
    Intervention Description
    In the study,all patients should undergo two colonoscopies.The first is for examinations and the second for therapy.
    Intervention Type
    Drug
    Intervention Name(s)
    2L PEG
    Other Intervention Name(s)
    polyethylene glycol
    Intervention Description
    2L PEG are laxatives for experiment group.
    Intervention Type
    Drug
    Intervention Name(s)
    4L PEG
    Other Intervention Name(s)
    polyethylene glycol
    Intervention Description
    4L PEG are laxatives in the control group.
    Intervention Type
    Drug
    Intervention Name(s)
    PEG
    Other Intervention Name(s)
    polyethylene glycol
    Intervention Description
    These PEG are for boosters. All patients will take 0.75L and 0.5L PEG for two boosters.
    Intervention Type
    Drug
    Intervention Name(s)
    Mosapride citrate
    Intervention Description
    5mg mosapride citrate are used to promote gastric motivity.
    Primary Outcome Measure Information:
    Title
    Bowel Cleansing Level of Two Different Bowel Preparation Methods
    Description
    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.
    Time Frame
    an expected average of 1 months from study procedure
    Secondary Outcome Measure Information:
    Title
    Accuracy parameters:assessment the yield of detection of polyps ≥6mm and ≥10mm;
    Time Frame
    an expected average of 1 months from study procedure
    Title
    The gastrointestinal tract transit times and the colonic transit times between two different bowel preparation methods for CCE;
    Description
    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.
    Time Frame
    an expected average of 1 months from study procedure
    Title
    Colon capsule excretion rate between two different bowel preparation methods;
    Time Frame
    an expected average of 1 months from study procedure
    Title
    Adverse events between two different bowel preparation methods.
    Time Frame
    the PillCam procedure day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-80 years of age. underwent a diagnostic OC that demonstrated colorectal polyps that required endoscopic treatment. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wu Kaichun, phD
    Organizational Affiliation
    Xijing Hospital of Digestive Diseases
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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