Ostomy Readmission Reduction Program

NCT06956274 | Not Yet Recruiting

• 1 other identifier: STUDY00003920
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ostomy - Ileostomy or Colostomy

Outcome Measures

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.

  30 Days Post Surgery

Secondary Outcomes (4)

• Hospital Length of Stay

  From index surgery to discharge (up to 30 days postoperatively)

• Incidence of Acute Kidney Injury (AKI)

  From index surgery through 30 days postoperatively

• Incidence of Peristomal Skin Complications

  From index surgery through 30 days postoperatively

• Incidence of Stoma-Related Leakage

  From index surgery through 30 days postoperatively

Interventions

Preoperative Telehealth OTHER

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 Output OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Surgery Group LA

Los Angeles, California, 90048, United States

Location

Study Officials

• Yosef Nasseri, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yosef Nasseri, MD

CONTACT

310-289-1518; Yosef.Nasseri@cshs.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colon and Rectal Surgeon

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 4, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

US (1)