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

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Status: Enrolling

Conditions: Urgency Incontinence; Total Colectomy; Diarrhea; Soilings, Fecal

Treatments: Behavioral: survey study

Study type: Observational

Funder types: Other

Identifiers

NCT07385196

828 - 19.12.2025

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

-