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NCT Number: NCT06956274

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.

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Key information

Conditions

Ostomy - Ileostomy or Colostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Surgery Group LA

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Hospital Length of Stay

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

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

  2. Incidence of Acute Kidney Injury (AKI)

    Time frame: 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.

  3. Incidence of Peristomal Skin Complications

    Time frame: 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.

  4. Incidence of Stoma-Related Leakage

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yosef Nasseri, MD

CONTACT

[email protected]

310-289-1518

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 4, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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