Defining Ileorectal Syndrome: a Prospective Observational Study

NCT07385196 | Recruiting

• 1 other identifier: 828 - 19.12.2025
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.
• Expected Benefits and Risks of the Study:
• 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
• Type, scope, and design of the planned study:
• Type: Prospective, observational
• Scope: Single-center
• Design: Questionnaire-based clinical trial
• 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.
• Parameters to be examined:
• Where and by whom the parameters will be examined
• Which parameters to be used in the study are routine for that disease group and which are specific to the study?
• Estimated study duration, start and end dates:
• Inclusion, exclusion, and withdrawal 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
• Termination criteria:
• 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

Conditions

Total Colectomy; Diarrhea; Urgency Incontinence; Soilings, Fecal

Outcome Measures

Primary Outcomes (1)

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

  Baseline and 1 year

Interventions

survey study BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 -

You may not qualify if:

• Age \<18 years
• Permanent stoma
• Total rectal excision
• Inability to complete follow-up assessments

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

general surgery clinic(Gazi Yaşargil Tr and Res Hospital

Diyarbakır, 21070, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diarrhea; Fecal Incontinence

Interventions

Longitudinal Studies

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: operator doctor

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 3, 2026
• Study Start: December 19, 2025
• Primary Completion (Estimated): December 19, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)