Defining Ileorectal Syndrome: a Prospective Observational Study (DEFINE-IRS)

January 27, 2026 updated by: Ozcem Ofkeli, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Trying to Define Ileorectal Syndrome: a Prospective Observational Study

  1. Study Title: Trying to Define Ilorectal Syndrome: A Prospective Observational Study

  2. Study Objective and Significance:

    Primary Objective:

    To prospectively evaluate the frequency, symptom severity, and impact on quality of life of ileorectal syndrome developing in patients who have undergone total colectomy and ileorectal anastomosis.

    Secondary Objectives:

    • To examine the relationship between postoperative bowel dysfunction and quality of life
    • To investigate clinical factors affecting symptom severity This study aims to contribute to postoperative follow-up and management strategies by revealing patient-centered outcomes of ileorectal syndrome.

  3. Expected Benefits and Risks of the Study:

    Expected Benefits

    • Prospective and systematic evaluation of ileorectal syndrome
    • Identification of factors affecting the quality of life of these patients
    • Increased awareness in clinical follow-up Potential Risks
    • The study is observational and questionnaire-based and does not involve additional medical risks
    • No invasive procedures will be performed on the patients

  4. Type, scope, and design of the planned study:

    • Type: Prospective, observational
    • Scope: Single-center
    • Design: Questionnaire-based clinical trial

  5. Number of patients and volunteers to be included in the study, their qualifications, and the rationale for selection:

    • Total number of patients: 30
    • Age range: ≥18 years
    • Gender: Female and male This number was determined based on the appropriate patient population followed in our center.

  6. Parameters to be examined:

    Demographic data (age, gender, BMI) Surgical indication Whether the surgery was performed openly or laparoscopically Level of anastomosis Maximum daily bowel movement frequency and duration Feeling of urgency Nocturnal bowel movements Fluid/gas incontinence - soiling Ileus in ADBG Whether electrolyte abnormalities developed Length of hospital stay Need for re-hospitalization Severity of symptoms based on patient reports and questionnaire questions

  7. Where and by whom the parameters will be examined

    Data will be collected by the responsible investigator at the relevant clinic.

  8. Which parameters to be used in the study are routine for that disease group and which are specific to the study?

    Routine: Demographic data, surgical information, laboratory results Study-Specific: Postoperative bowel functionality, symptom questionnaire

  9. Estimated study duration, start and end dates:

    Start date: 1/1/2026 End date: 31/12/2026 Total duration: 12 months

  10. Inclusion, exclusion, and withdrawal criteria:

    Inclusion Criteria

    • Having undergone total colectomy and ileorectal anastomosis
    • 18 years of age and older
    • Providing written informed consent Exclusion Criteria
    • Serious neurological disease affecting bowel function
    • Patients with incomplete follow-up data Withdrawal
    • At the patient's request
    • If follow-up cannot be completed

  11. Termination criteria:

    By the ethics committee Termination decision Unforeseen circumstances preventing the conduct of the study

  12. Statistical methods to be used in the evaluation of the data to be obtained as a result of the research:

    • Descriptive statistics (mean, median, percentage)
    • Parametric and non-parametric tests
    • Analysis of the relationship between symptom severity and quality of life
    • p < 0.05 statistical significance level

Study Overview

Status

Status

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

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 (Estimated)

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.
30

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

  • Turkey (Türkiye)
      • Diyarbakır, Turkey (Türkiye), 21070
        • Recruiting
        • general surgery clinic(Gazi Yaşargil Tr and Res 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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥18 years) with a history of ileorectal anastomosis and preserved rectum following colorectal surgery will be prospectively enrolled. The study population includes patients with or without bowel dysfunction symptoms suggestive of ileorectal syndrome. Participants will be followed prospectively to assess the prevalence and severity of bowel function-related symptoms over time.

Description

Inclusion Criteria: Age ≥18 years

History of ileorectal anastomosis or preserved rectum following colorectal surgery

Ability to understand the study procedures and provide written informed consent

Willingness to participate in prospective follow-up assessments -

Exclusion Criteria:

Age <18 years

Permanent stoma

Total rectal excision

Inability to complete follow-up assessments

-

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

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
Time Frame
Prevalence and severity of ileorectal syndrome-related bowel dysfunction symptoms assessed prospectively
Time Frame: Baseline and 1 year
Baseline and 1 year

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.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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 (Actual)

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.
December 19, 2025

Primary Completion (Estimated)

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 19, 2026

Study Completion (Estimated)

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.
February 15, 2027

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).
January 27, 2026

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.
January 27, 2026

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.
February 3, 2026

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.
February 3, 2026

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.
January 27, 2026

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.
January 1, 2026

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.
  • 828 - 19.12.2025

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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