Ostomy Readmission Reduction Program

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 Overview

• Status: Not yet recruiting
• Conditions: Ostomy - Ileostomy or Colostomy
• Intervention / Treatment: Other: Preoperative Telehealth; Other: Measure Ostomy Output

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Yosef Nasseri, MD; Phone Number: 310-289-1518; Email: Yosef.Nasseri@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Surgery Group LA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 Days Post Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	Total duration of hospitalization from the time of the index surgery until discharge.	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.	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.	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.	From index surgery through 30 days postoperatively

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Yosef Nasseri, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: May 1, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00003920

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No