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RecruitingNCT07385196DEFINE-IRSUpdated Feb 3, 2026

Defining Ileorectal Syndrome: a Prospective Observational Study

An observational study in Total Colectomy, Diarrhea and Urgency Incontinence, sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

  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
02

Conditions studied

  • Total Colectomy
  • Diarrhea
  • Urgency Incontinence
  • Soilings, Fecal
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Eligibility 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

-

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
10 Days
Patient registry
Yes

Interventions

  • Behavioralsurvey study

    The syndrome will be defined based on both patient observations and survey results.

05

What researchers measure

Primary outcomes

  1. Prevalence and severity of ileorectal syndrome-related bowel dysfunction symptoms assessed prospectively

    Time frame: Baseline and 1 year

06

Study locations

1 of 1 sites recruiting
  • general surgery clinic(Gazi Yaşargil Tr and Res Hospital
    Diyarbakır, 21070, Turkey (Türkiye)
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07385196
Lead sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Responsible party
Ozcem Ofkeli (operator doctor, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital) — Principal investigator
First posted
Feb 3, 2026
Start date
Dec 19, 2025
Primary completion
Dec 19, 2026 (estimated)
Completion
Feb 15, 2027 (estimated)
Last update
Feb 3, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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