Ostomy - Ileostomy or ColostomyNCT06956274
Ostomy Readmission Reduction Program
An observational study of Ostomy - Ileostomy or Colostomy, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to reduce complications like peristomal skin issues, stoma-related problems, dehydration, and other preventable factors that can lead to re-hospitalization within the first 30 days after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostomy - Ileostomy or Colostomy
- What is being tested?
- Preoperative Telehealth and Measure Ostomy Output
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study population will be identified from our outpatient clinic during surgical consultations.
Who may be able to join
- Elective operations involving an ileostomy or a colostomy
- Individuals 18 years old or older are included
Who cannot join
- Individuals under age 18
- Pregnant patients
- Emergency operations
- Patients with existing pre operative ostomies
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to reduce complications like peristomal skin issues, stoma-related problems, dehydration, and other preventable factors that can lead to re-hospitalization within the first 30 days after surgery.
- Conditions
- Ostomy - Ileostomy or Colostomy
- Being tested
- Preoperative Telehealth, Measure Ostomy Output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative TelehealthOther
Conduct a preoperative telehealth consultation with a Certified Wound, Ostomy, and Continence Nurse (WOCN) to provide patient education on post-surgical care expectations.
Measure Ostomy OutputOther
Patients will be sent home with a measuring container (graduated container) and will measure their ostomy output every 12 hours and record it in a pad that will be provided to them.
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission to hospital within 30 Days of Surgery
The proportion of participants who are readmitted to the hospital within 30 days following surgery. Readmissions will be evaluated for any reason, including complications, adverse events, or recovery issues that necessitate hospitalization after the initial surgical procedure.
Measured: 30 Days Post Surgery
Secondary outcomes (4)
Hospital Length of Stay
Total duration of hospitalization from the time of the index surgery until discharge.
Measured: From index surgery to discharge (up to 30 days postoperatively)
Incidence of Acute Kidney Injury (AKI)
Number of participants who develop AKI, defined as an increase in serum creatinine of ≥0.3 mg/dL from baseline, during index admission or upon 30-day readmission.
Measured: From index surgery through 30 days postoperatively
Incidence of Peristomal Skin Complications
Number of participants who develop peristomal skin problems (e.g., irritation, excoriation, or dermatitis) during the index admission or within 30 days postoperatively.
Measured: From index surgery through 30 days postoperatively
Incidence of Stoma-Related Leakage
Number of participants who experience unintended escape of stoma output (leakage) during index admission or within 30 days postoperatively.
Measured: From index surgery through 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 posted4 May 2025
- Study start1 May 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Why it stopped: The study was not initiated due to funding constraints and logistical challenges associated with study implementation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ostomy - Ileostomy or ColostomyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yosef Nasseri, MD, Cedars-Sinai Medical Center
- Investigators
- Yosef Nasseri, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956274
- Sponsor's protocol ID
- STUDY00003920
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ostomy Readmission Reduction Program
- ClinicalTrials.gov ID
- NCT06956274
- Acronym / sponsor ID
- STUDY00003920
- Conditions
- Ostomy - Ileostomy or Colostomy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was not initiated due to funding constraints and logistical challenges associated with study implementation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 May 2025 (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.
The purpose of this study is to reduce complications like peristomal skin issues, stoma-related problems, dehydration, and other preventable factors that can lead to re-hospitalization within the first 30 days after surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be identified from our outpatient clinic during surgical consultations.
Key inclusion criteria (2 listed)
- Elective operations involving an ileostomy or a colostomy
- Individuals 18 years old or older are included
Key exclusion criteria (4 listed)
- Individuals under age 18
- Pregnant patients
- Emergency operations
- Patients with existing pre operative ostomies
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 |
|---|---|---|
| Preoperative TelehealthConduct a preoperative telehealth consultation with a Certified Wound, Ostomy, and Continence Nurse (WOCN) to provide patient education on post-surgical care expectations. | Other | – |
| Measure Ostomy OutputPatients will be sent home with a measuring container (graduated container) and will measure their ostomy output every 12 hours and record it in a pad that will be provided to them. | Other | – |
Primary outcome
Readmission to hospital within 30 Days of Surgery
Time frame: 30 Days Post Surgery
The proportion of participants who are readmitted to the hospital within 30 days following surgery. Readmissions will be evaluated for any reason, including complications, adverse events, or recovery issues that necessitate hospitalization after the initial surgical procedure.
4 secondary outcomes
Hospital Length of Stay
Time frame: From index surgery to discharge (up to 30 days postoperatively)
Incidence of Acute Kidney Injury (AKI)
Time frame: From index surgery through 30 days postoperatively
Incidence of Peristomal Skin Complications
Time frame: From index surgery through 30 days postoperatively
Incidence of Stoma-Related Leakage
Time frame: From index surgery through 30 days postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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. This study is not recruiting at the moment.
Yosef Nasseri, MD principal investigator
Cedars-Sinai Medical Center
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 Ostomy - Ileostomy or Colostomy, run by Cedars-Sinai Medical Center 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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 27 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission to hospital within 30 Days of Surgery (time frame: 30 Days Post Surgery). 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 27 Oct 2026.