The Predictive Value of Alarm Symptoms in Patients With Function Constipation Based on Roman IV

July 1, 2020 updated by: Second Affiliated Hospital of Xi'an Jiaotong University
Functional constipation is one of the five most common gastrointestinal diseases in outpatient visits. It is known that the global prevalence of chronic constipation is estimated to be 14%, and the prevalence of adults in my country is about 4.0% to 10.0%. It is generally believed that the diagnosis of functional constipation is based on a thorough history and physical examination. However, these standards are mainly used in clinical research and are not always strictly applicable to clinical practice. Therefore, in addition to the main symptoms, the medical history should include evidence of organic diseases (alarm symptoms). Rectal bleeding, anemia, weight loss, fever, family history of colon cancer and the age of onset over 50 years are considered as alarm symptoms of severe gastrointestinal diseases, but the value of alarm symptoms in distinguishing organic diseases from functional diseases is still not Ok, further research is still needed. In 2016, the Rome IV standard was updated and released, with some updates in the definition and diagnostic criteria for functional constipation. However, there are few studies on the clinical practice based on Rome IV. The advantages and disadvantages of adjusting the diagnostic criteria of Rome IV compared to Rome III in clinical application are still unclear. In order to evaluate the predictive value of the alarm symptoms of functional constipation based on Roman IV, we designed this cross-sectional study. It is used to evaluate the predictive value of alarm symptoms for functional constipation and organic bowel disease, as well as the predictive value of alarm symptoms of benign and malignant intestinal diseases related to functional constipation symptoms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

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
        • The Second Affiliated Hospital of Xi'an Jiaotong University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with constipation that meet the Rome IV diagnostic criteria are the subjects

Description

Inclusion Criteria:

  1. Patients with constipation that meet the diagnostic criteria for functional constipation in Rome III or IV (specific conditions are as follows) (1) Must include two or more of the following:

    1. More than 25% of bowel movements feel laborious;
    2. Over 25% of the bowel movements are dry ball dung or hard dung; (Bristol Manure Character Scale Type 1-2)
    3. More than 25% of bowel movements have an inexhaustible feeling;
    4. More than 25% of bowel movements require manual assistance;
    5. More than 25% of bowel movements need to be assisted by manual techniques (such as assisting bowel movements with fingers and basin support);
    6. Less than 3 times per week (spontaneous defecation). (2) Dirty feces rarely occur when laxatives are not used. (3) Does not meet the diagnostic criteria for irritable bowel syndrome. (Symptoms appear at least 6 months before diagnosis, and meet the above (existence) diagnostic criteria within the past 3 months)
  2. Age ≥18 years old;
  3. From 2020.07 to 2020.12, visit the outpatient clinic of our hospital and perform colonoscopy;
  4. Blood routine, fecal routine and fecal occult blood examination within 6 months.

Exclusion Criteria:

  1. Inflammatory bowel disease, celiac disease and other organic intestinal diseases, history of metabolic diseases (abnormal thyroid function and diabetes, etc.);
  2. Severe neurological, mental and psychological diseases, or those with severe organ dysfunction;
  3. Abdominal surgery;
  4. Patients during pregnancy, possible pregnancy and lactation;
  5. Those who have a history of colonoscopy within the past 6 months, and those who have evaluated intestinal status;
  6. Refuse to participate in this study.

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: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the predictive value of alarm symptoms for functional constipation
Time Frame: 2020/12/31
When a patient with constipation is accompanied by one or several alarm symptoms, the result of colonoscopy is confirmed as organic bowel disease
2020/12/31
Predictive value of warning symptoms to malignant intestinal tumors
Time Frame: 2020/12/31
When a patient with constipation is accompanied by one or more alarm symptoms, the result of colonoscopy is confirmed as malignant intestinal tumor
2020/12/31

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital of Xi'an Jiaotong University

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20200626

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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