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 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:
Expected Benefits and Risks of the Study:
Expected Benefits
Type, scope, and design of the planned study:
Number of patients and volunteers to be included in the study, their qualifications, and the rationale for selection:
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
Where and by whom the parameters will be examined
Data will be collected by the responsible investigator at the relevant clinic.
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
Estimated study duration, start and end dates:
Start date: 1/1/2026 End date: 31/12/2026 Total duration: 12 months
Inclusion, exclusion, and withdrawal criteria:
Inclusion Criteria
Termination criteria:
By the ethics committee Termination decision Unforeseen circumstances preventing the conduct of the study
Statistical methods to be used in the evaluation of the data to be obtained as a result of the research:
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.
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
-
The syndrome will be defined based on both patient observations and survey results.
Prevalence and severity of ileorectal syndrome-related bowel dysfunction symptoms assessed prospectively
Time frame: Baseline and 1 year
Plan to share: No
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Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital