CClinicalTrials.gg
Not yet recruitingNCT06956274Updated May 4, 2025

Ostomy Readmission Reduction Program

An observational study in Ostomy - Ileostomy or Colostomy, sponsored by Cedars-Sinai Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-04.

Sponsored by Cedars-Sinai Medical Center · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ostomy - Ileostomy or Colostomy
03

In context

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will be identified from our outpatient clinic during surgical consultations.

Inclusion criteria

  • Elective operations involving an ileostomy or a colostomy
  • Individuals 18 years old or older are included

Exclusion criteria

Exclusion Criteria:

  • Individuals under age 18
  • Pregnant patients
  • Emergency operations
  • Patients with existing pre operative ostomies
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • OtherPreoperative Telehealth

    Conduct a preoperative telehealth consultation with a Certified Wound, Ostomy, and Continence Nurse (WOCN) to provide patient education on post-surgical care expectations.

  • OtherMeasure Ostomy Output

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 Days Post Surgery

Secondary outcomes

  1. Hospital Length of Stay

    Total duration of hospitalization from the time of the index surgery until discharge.

    Time frame: From index surgery to discharge (up to 30 days postoperatively)

  2. 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.

    Time frame: From index surgery through 30 days postoperatively

  3. 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.

    Time frame: From index surgery through 30 days postoperatively

  4. Incidence of Stoma-Related Leakage

    Number of participants who experience unintended escape of stoma output (leakage) during index admission or within 30 days postoperatively.

    Time frame: From index surgery through 30 days postoperatively

07

Study locations

1 site
  • Surgery Group LA
    Los Angeles, California 90048, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06956274
Lead sponsor
Cedars-Sinai Medical Center
Responsible party
Yosef Nasseri, MD (Colon and Rectal Surgeon, Cedars-Sinai Medical Center) — Principal investigator
First posted
May 4, 2025
Start date
May 1, 2025 (estimated)
Primary completion
May 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
May 4, 2025

Study contacts

Yosef Nasseri, MD
Contact
Yosef.Nasseri@cshs.org
310-289-1518
Yosef Nasseri, MD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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