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Not yet recruiting NCT06956274

Ostomy Readmission Reduction Program

Observational Ostomy - Ileostomy or Colostomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preoperative Telehealth, Measure Ostomy Output.
Who it may be relevant to
Registry conditions: Ostomy - Ileostomy or Colostomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Readmission to hospital within 30 Days of Surgery [Time frame: 30 Days Post Surgery]
Secondary outcome measures (4)
  • Hospital Length of Stay [Time frame: From index surgery to discharge (up to 30 days postoperatively)]
  • Incidence of Acute Kidney Injury (AKI) [Time frame: From index surgery through 30 days postoperatively]
  • Incidence of Peristomal Skin Complications [Time frame: From index surgery through 30 days postoperatively]
  • Incidence of Stoma-Related Leakage [Time frame: From index surgery through 30 days postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Surgery Group LA — Los Angeles

Identifiers

NCT: NCT06956274 · STUDY00003920

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗