Total ColectomyDEFINE-IRSNCT07385196
Defining Ileorectal Syndrome: a Prospective Observational Study
An observational study of Total Colectomy and Diarrhea, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Colectomy, Diarrhea, Urgency Incontinence
- What is being tested?
- survey study
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2025to 15 Feb 2027
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 -
Who cannot join
- Age <18 years
- Permanent stoma
- Total rectal excision
- Inability to complete follow-up assessments
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
general surgery clinic(Gazi Yaşargil Tr and Res Hospital
Diyarbakır, 21070
ozcem ofkeli, +905057605822, ozcem82@yahoo.com
About this study
Official title: Trying to Define Ileorectal Syndrome: a Prospective Observational Study
- Study Title: Trying to Define Ilorectal Syndrome: A Prospective Observational Study
- 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.
Read more
- 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
- 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: 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
- 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: 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:
- 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
- Being tested
- survey study
- Medical subject headings
- Diarrhea, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey studyBehavioural
The syndrome will be defined based on both patient observations and survey results.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and severity of ileorectal syndrome-related bowel dysfunction symptoms assessed prospectively
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start19 Dec 2025
- Primary completion19 Dec 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total ColectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozcem Ofkeli, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385196
- Sponsor's protocol ID
- 828 - 19.12.2025
- Acronym
- DEFINE-IRS
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trying to Define Ileorectal Syndrome: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07385196
- Acronym / sponsor ID
- DEFINE-IRS / 828 - 19.12.2025
- Conditions
- Total Colectomy, Diarrhea, Urgency Incontinence, Soilings, Fecal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 19 Dec 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Study Title: Trying to Define Ilorectal Syndrome: A Prospective Observational Study
- 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.
- 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
- 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: 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
- 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: 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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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 -
Key exclusion criteria (5 listed)
- Age <18 years
- Permanent stoma
- Total rectal excision
- Inability to complete follow-up assessments
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| survey studyThe syndrome will be defined based on both patient observations and survey results. | Behavioural | – |
Primary outcome
Prevalence and severity of ileorectal syndrome-related bowel dysfunction symptoms assessed prospectively
Time frame: Baseline and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
general surgery clinic(Gazi Yaşargil Tr and Res Hospital
Diyarbakır, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Colectomy and Diarrhea, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and severity of ileorectal syndrome-related bowel dysfunction symptoms assessed prospectively (time frame: Baseline and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.