Post-Operative Ileus (POI)NCT07574437
At-Home Bowel Stimulation
An observational study of Post-Operative Ileus (POI), run by The Cleveland Clinic at 1 site in United States.
Trial summary
Postoperative ileus (POI) is a common complication after ileostomy closure and is associated with patient discomfort, delayed return of bowel function, prolonged hospital stay, and increased healthcare costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Operative Ileus (POI)
- What is being tested?
- At-home bowel stimulation
- Type of treatment
- Injection or infusion
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2025to 7 Jul 2027
- 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 who have undergone a partial colectomy or proctectomy for benign or malignant disease with a protective loop ileostomy
Who may be able to join
- Adult patients who have undergone a partial colectomy or proctectomy for benign or malignant disease with a protective loop ileostomy
Who cannot join
- Underlying inflammatory bowel disease (IBD)
- Known peritoneal metastases at the time of ileostomy closure
- Inability to provide clear and informed consent
- History of subtotal colectomy or total proctocolectomy
- Planned laparotomy for ileostomy closure
- Inability to speak English or Spanish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Marylise Boutros, MD, 954-659-5278, BOUTROM3@ccf.org
Marylise Boutros, MD
About this study
Official title: At-Home Bowel Stimulation: A Prospective Cohort Study
Postoperative ileus (POI) is a common complication after ileostomy closure and is associated with patient discomfort, delayed return of bowel function, prolonged hospital stay, and increased healthcare costs. One proposed contributor to POI is prolonged inactivity of the bowel segment distal to the ileostomy prior to restoration of intestinal continuity.
Previous studies, including a multicenter randomized controlled trial, have shown that preoperative bowel stimulation of the defunctionalized intestine can reduce rates of POI and shorten length of hospital stay. However, these interventions were performed in outpatient or hospital settings and required specialized nursing support.
Read more
This single-center, prospective interventional study aims to evaluate the feasibility and clinical impact of a patient-performed, at-home bowel stimulation program prior to ileostomy closure. Participants will perform daily bowel stimulation sessions at home for 3 weeks before surgery, following an initial supervised session. The primary objective is to assess feasibility, defined as successful completion of at least 6 of 9 at-home stimulation sessions by more than 75% of participants. Secondary outcomes include return to normal bowel function and length of hospital stay. Exploratory outcomes include postoperative bowel function, quality of life, and patient satisfaction.
Study outcomes will be compared with a retrospective cohort of patients who previously underwent ileostomy closure without at-home bowel stimulation. The long-term goal of this research is to support incorporation of preoperative bowel stimulation into Enhanced Recovery After Surgery (ERAS®) pathways for patients undergoing ileostomy closure.
- Conditions
- Post-Operative Ileus (POI)
- Being tested
- At-home bowel stimulation
- Keywords
- Post-operative ileus, Bowel stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
At-home bowel stimulationOther
All participants will undergo a standardized preoperative bowel stimulation protocol prior to ileostomy closure. The intervention includes a total of 10 stimulation sessions performed over approximately three weeks. An initial in-person visit (≤30 minutes) with a trained research nurse will include placement of a catheter into the efferent limb of the ileostomy and performance of the first supervised stimulation as instruction. Each stimulation consists of instilling 500 mL of a thickened saline solution through the catheter using a syringe. Participants will then complete nine additional stimulations at home during the two weeks prior to surgery on weekdays only. Nursing phone support will be available during business hours, and weekday check-in calls will confirm completion. Participants will receive written instructions and a log to record session details, including symptoms and bowel movements. In-office stimulation will be available if needed.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | The prospective cohort will consist of 34 adult patients undergoing elective ileostomy closure at Cleveland Clinic Florida. Participants will complete 10 bowel stimulations within 3 weeks prior to ileostomy closure. Receives: Other: At-home bowel stimulation | |
| Retrospective cohort | This cohort will consist of patients who previously underwent ileostomy closure at Cleveland Clinic Florida without the at-home bowel stimulation intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who successfully completed at least 6 of the 9 at-home bowel stimulation sessions
75% of enrolled participants successfully completing at least 6 of the 9 at-home bowel stimulation sessions
Measured: Within 3 weeks prior to operative day (i.e., ileostomy closure date - day 0)
Secondary outcomes (2)
Return to normal bowel function
Normal bowel function will be defined as the absence of postoperative ileus. Postoperative ileus is defined as intolerance of oral intake, in the absence of clinical or radiographic evidence of obstruction, that either (a) requires nasogastric tube insertion or (b) is accompanied by at least two of the following on or after postoperative day 3: nausea or vomiting, abdominal distension, and absence of flatus.
Measured: From postoperative day 0 (ileostomy closure date) until return of normal bowel function, assessed daily during the index hospitalization, up to 30 days postoperatively.
Length of stay
Length of hospital stay after ileostomy closure
Measured: From postoperative day 0 (ileostomy closure date) until hospital discharge, assessed during the index hospitalization, up to 30 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start28 Oct 2025
- Primary completion7 Jul 2027 (estimated)
- Study completion7 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative Ileus (POI)Studies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574437
- Sponsor's protocol ID
- 24-1049
- Status last verified
- Oct 2026
- First submitted
- 20 Mar 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At-Home Bowel Stimulation: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07574437
- Acronym / sponsor ID
- 24-1049
- Conditions
- Post-Operative Ileus (POI)
- Keywords
- Post-operative ileus, Bowel stimulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 7 Jul 2027 (estimated)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 8 May 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.
Postoperative ileus (POI) is a common complication after ileostomy closure and is associated with patient discomfort, delayed return of bowel function, prolonged hospital stay, and increased healthcare costs. One proposed contributor to POI is prolonged inactivity of the bowel segment distal to the ileostomy prior to restoration of intestinal continuity.
Previous studies, including a multicenter randomized controlled trial, have shown that preoperative bowel stimulation of the defunctionalized intestine can reduce rates of POI and shorten length of hospital stay. However, these interventions were performed in outpatient or hospital settings and required specialized nursing support.
This single-center, prospective interventional study aims to evaluate the feasibility and clinical impact of a patient-performed, at-home bowel stimulation program prior to ileostomy closure. Participants will perform daily bowel stimulation sessions at home for 3 weeks before surgery, following an initial supervised session. The primary objective is to assess feasibility, defined as successful completion of at least 6 of 9 at-home stimulation sessions by more than 75% of participants. Secondary outcomes include return to normal bowel function and length of hospital stay. Exploratory outcomes include postoperative bowel function, quality of life, and patient satisfaction.
Study outcomes will be compared with a retrospective cohort of patients who previously underwent ileostomy closure without at-home bowel stimulation. The long-term goal of this research is to support incorporation of preoperative bowel stimulation into Enhanced Recovery After Surgery (ERAS®) pathways for patients undergoing ileostomy closure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | Other: At-home bowel stimulationThe prospective cohort will consist of 34 adult patients undergoing elective ileostomy closure at Cleveland Clinic Florida. Participants will complete 10 bowel stimulations within 3 weeks prior to ileostomy closure. |
| Retrospective cohort | – | –This cohort will consist of patients who previously underwent ileostomy closure at Cleveland Clinic Florida without the at-home bowel stimulation intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who have undergone a partial colectomy or proctectomy for benign or malignant disease with a protective loop ileostomy
Key inclusion criteria (1 listed)
- Adult patients who have undergone a partial colectomy or proctectomy for benign or malignant disease with a protective loop ileostomy
Key exclusion criteria (6 listed)
- Underlying inflammatory bowel disease (IBD)
- Known peritoneal metastases at the time of ileostomy closure
- Inability to provide clear and informed consent
- History of subtotal colectomy or total proctocolectomy
- Planned laparotomy for ileostomy closure
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 |
|---|---|---|
| At-home bowel stimulationAll participants will undergo a standardized preoperative bowel stimulation protocol prior to ileostomy closure. The intervention includes a total of 10 stimulation sessions performed over approximately three weeks. An initial in-person visit (≤30 minutes) with a trained research nurse will include placement of a catheter into the efferent limb of the ileostomy and performance of the first supervised stimulation as instruction. Each stimulation consists of instilling 500 mL of a thickened saline solution through the catheter using a syringe. Participants will then complete nine additional stimulations at home during the two weeks prior to surgery on weekdays only. Nursing phone support will be available during business hours, and weekday check-in calls will confirm completion. Participants will receive written instructions and a log to record session details, including symptoms and bowel movements. In-office stimulation will be available if needed. | Other | Prospective cohort |
Primary outcome
Percentage of participants who successfully completed at least 6 of the 9 at-home bowel stimulation sessions
Time frame: Within 3 weeks prior to operative day (i.e., ileostomy closure date - day 0)
75% of enrolled participants successfully completing at least 6 of the 9 at-home bowel stimulation sessions
2 secondary outcomes
Return to normal bowel function
Time frame: From postoperative day 0 (ileostomy closure date) until return of normal bowel function, assessed daily during the index hospitalization, up to 30 days postoperatively.
Length of stay
Time frame: From postoperative day 0 (ileostomy closure date) until hospital discharge, assessed during the index hospitalization, up to 30 days postoperatively.
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 22 Oct 2026.
- Individual participant dataSharing planned: Yes
Related trials for Post-Operative Ileus (POI)
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TU-100 for Accelerating GI Recovery After Major Abdominopelvic Surgery (RC & CAWR)
Delay in GI Recovery/Postoperative Ileus (POI)
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.
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 Post-Operative Ileus (POI), run by The Cleveland Clinic at 1 site in United States.
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 1 inclusion and 6 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 22 Oct 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 United States. 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?
Contact Marylise Boutros, MD (954-659-5278, BOUTROM3@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who successfully completed at least 6 of the 9 at-home bowel stimulation sessions (time frame: Within 3 weeks prior to operative day (i.e., ileostomy closure date - day 0)). 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 22 Oct 2026.