Risk Factors for Inadequate Bowel Preparation in Patients With Chronic Constipation

October 29, 2016 updated by: Yanglin Pan, Air Force Military Medical University, China
Chronic constipation is one of the risk factors of inadequate bowel preparation, which could influence the effect of colonoscopy. The risk factors associated with inadequate bowel preparation in constipated patients remains unclear. Here the investigators investigated the high risk factors which might have influence on bowel preparation quality in a prospective cohort of patients with functional constipation.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital of Digestive Diseases
        • Contact:
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Tangdu Hospital
        • Contact:
      • Xi'an, Shaanxi, China, 710054
        • Recruiting
        • Chinese PLA 451 Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients >=18 years old undergoing colonoscopy

Description

Inclusion Criteria:

  • 18-90
  • Patients undergoing colonoscopy;
  • Patients meeting the criteria of chronic constipation of Rome Ⅳ;

Exclusion Criteria:

  • history of colorectal surgery;
  • known of suspected colonic stricture or obstructing tumour;
  • ulcerative colitis;
  • Crohn's disease;
  • irritable bowel syndrome;
  • toxic colitis or megacolon;
  • known or suspected bowel obstruction or perforation;
  • pregnancy or lactation;
  • unable to give informed consent;
  • haemodynamically unstable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
chronic constipation
patients with chronic constipation based on Rome Ⅳ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adequate rate of bowel preparation ≥6 with each segment ≥2
Time Frame: 6 months
The adequacy of bowel preparation is defined as Boston Bowel Preparation Scale (BBPS), a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. They were summed to give the total BBPS score, which ranged from 0 to 9.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
polyp detection rate
Time Frame: 6 months
6 months
insertion time
Time Frame: 6 months
6 months
withdrawal time
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Investigators

  • Principal Investigator: Yanglin Pan, MD, Xijing Hospital of Digestive Disease
  • Principal Investigator: Mingxin Zhang, MD, Tang-Du Hospital
  • Principal Investigator: Shiyang Ma, MD, Second Affiliated Hospital of Xi'an JiaoTong University
  • Principal Investigator: Yujie Jing, MD, Chinese PLA 451 Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

June 25, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (Estimate)

July 22, 2016

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160616-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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