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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

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

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

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

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)

December 19, 2025

Primary Completion (Estimated)

December 19, 2026

Study Completion (Estimated)

February 15, 2027

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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