- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06518369
Preoperative Prehabilitation Program For Geriatric Patients in a Rural Healthcare Setting
June 4, 2025 updated by: The Guthrie Clinic
Analysis of a Preoperative Prehabilitation Program Among Rural Geriatric Patients Compared to Standard of Care
The study will include patients who require elective major abdominal surgery for cancerous or non-cancerous conditions.
The goal of the research is to assess the benefit of a prehabilitation program before surgery that includes nutrition, exercise, smoking cessation, and optimization of chronic disease.
A group of 10 patients will take part in a prehabilitation program.
These patients will be compared to 20 patients who received standard of care.
Study Overview
Detailed Description
The study will include patients who require elective major abdominal surgery. The study will compare patients who received standard of care to patients who received a prehabilitation program before surgery.
The prehabilitation program will take place for 4-6 weeks before your surgery and will include:
- Review of frailty risk analysis calculator score obtained in the frailty study (#2212-74)
- Review of lab results including complete blood count, creatinine, albumin, and prealbumin
- Review of chronic conditions
- An office visit or telehealth visit to review instructions on nutrition, exercise, smoking cessation, and optimization of chronic disease.
- Drinking Surgery Immunonutrition shake twice daily for 5 days before surgery.
- Educational information and video instruction
- Weekly phone calls to motivate, ensure adherence, and assess progress.
- Measurements of hand grip strength and body weight
Study Type
Observational
Enrollment (Actual)
27
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Sayre, Pennsylvania, United States, 18840
- Robert Packer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Subjects over age 60 who require elective major abdominal surgery
Description
Inclusion Criteria:
- Subjects over age 60 who require elective major abdominal surgery
Exclusion Criteria:
- pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non-intervention or standard of care group
20 Patients who received standard of care
|
|
|
Prehabilitation Group
10 patients who take part in a prehabilitation program for 4-6 weeks before surgery
|
Prehabilitation program for 4-6 weeks before surgery will include:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative hospital length of stay
Time Frame: From date of hospitalization until date of hospital discharge, up to 30 days
|
Number of days in hospital from date of surgery to date of discharge
|
From date of hospitalization until date of hospital discharge, up to 30 days
|
|
Discharge disposition
Time Frame: From date of hospitalization until date of hospital discharge, up to 30 days
|
Binary measure of either home or rehabilitation facility
|
From date of hospitalization until date of hospital discharge, up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse outcomes after surgery
Time Frame: 30 days after surgery
|
Assess adverse outcomes postoperatively
|
30 days after surgery
|
|
Hospital readmission rates
Time Frame: 30 days after surgery
|
Number of times patients are readmitted to the hospital within 30 day of surgery
|
30 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nancy Georgetson, AGNP-C, Robert Packer Hospital Sayre PA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 18, 2024
Primary Completion (Actual)
October 16, 2024
Study Completion (Actual)
June 4, 2025
Study Registration Dates
First Submitted
July 10, 2024
First Submitted That Met QC Criteria
July 23, 2024
First Posted (Actual)
July 24, 2024
Study Record Updates
Last Update Posted (Actual)
June 8, 2025
Last Update Submitted That Met QC Criteria
June 4, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2401-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.