Ostomy Readmission Reduction Program

Not yet recruiting

• Conditions: Ostomy - Ileostomy or Colostomy

• Registration Number: NCT06956274
• Lead Sponsor: Cedars-Sinai Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-16
• Study Start: 2025-05-01
• Study First Submitted QC: 2025-05-01
• Last Update Submitted: 2025-05-01
• Study First Posted: 2025-05-04
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-05-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Readmission to hospital within 30 Days of Surgery	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.

Secondary Outcome Measures

Name	Time	Method
Hospital Length of Stay	From index surgery to discharge (up to 30 days postoperatively)	Total duration of hospitalization from the time of the index surgery until discharge.
Incidence of Acute Kidney Injury (AKI)	From index surgery through 30 days postoperatively	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.
Incidence of Peristomal Skin Complications	From index surgery through 30 days postoperatively	Number of participants who develop peristomal skin problems (e.g., irritation, excoriation, or dermatitis) during the index admission or within 30 days postoperatively.
Incidence of Stoma-Related Leakage	From index surgery through 30 days postoperatively	Number of participants who experience unintended escape of stoma output (leakage) during index admission or within 30 days postoperatively.

Trial Locations

Locations (1)

Surgery Group LA; 🇺🇸 Los Angeles, California, United States