Enhanced Recovery Program After Colorectal Surgery in Elderly (ERPOLD) (ERPOLD)
Effect of Age on the Efficiency of Enhanced Recovery Program After Colorectal Surgery
Study Overview
Detailed Description
In 1995 Henrik Kehlet described the concept of fast track surgery after colectomy. It consisted of a multimodal and multidisciplinary approach that aimed at controlling the surgical stress response and at mitigating its consequences. Subsequently postoperative recovery is improved and accelerated, which allows a median hospital stay of 2-days after laparoscopic colectomy. The concept of fast track surgery progressively evolved into enhanced recovery programme (ERP). The acceleration of postoperative recovery and the reduction in the duration of hospitalisation are not associated with an increased incidence of surgical complications nor a greater rate of unplanned hospital readmission, but rather result in less medical complications. The economic benefits are obvious.
The elderly present specific physical, metabolic and socio-environmental characteristics that should be considered in case of surgery. Age has been shown to be an independent prognostic factor for postoperative morbidity after colorectal surgery, but this was reported before the development of ERP. Indeed implementation of ERP significantly reduces the rate of postoperative complications, even in the elderly. Increased risk of postoperative morbidity in elderly as compared to younger patients is nevertheless commonly admitted. Moreover adherence of elderly with the items of ERP is usually considered inferior than that of younger patients. Adaptation of ERP to the specificities of elderly is sometimes advocated. All these explain the reluctance of many practitioners to propose ERP in older patients. However recent meta-analyses suggest that implementation of ERP is feasible and efficient in these patients. The retrospective analysis of our first 100 patients introduced in our audit database revealed even similar length of hospital stay for elderly and younger patients.
The investigators therefore compared the length of hospital stay in the elderly and the younger patients and tested the hypothesis of non-inferiority for elderly patients as compared to younger patients. This is a retrospective analysis of 270 consecutive patients scheduled for colorectal surgery, all managed with the same ERP protocol, and prospectively introduced in our audit database.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Liège, Belgium
- CHU Liège
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
• All patients scheduled for colorectal surgery since November 2015
Exclusion Criteria:
• Emergency surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
elderly patients (≥70 yo) vs. younger patients (<70 yo)
elderly patients (≥ 70 yo) and younger patients (< 70 yo)
|
effect of age on the efficiency of enhanced recovery program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
length of hospital stay after colorectal surgery (day)
Time Frame: through study completion, an average of 1 month
|
The duration of hospitalization is defined as the numberof days the patient stays in the hospital between the day of his surgery and the day of his discharge from the hospital
|
through study completion, an average of 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative complications after colorectal surgery
Time Frame: through study completion, an average of 1 month
|
The incidence of postoperative complications (medical and surgical) occurring during the hospital stay and up-to 30-day after surgery will be recorded from our audit database.
The following medical complications will be recorded: cardiac, pulmonary, neurological, and uro-nephrologic complications.
For surgical complications, we will record postoperative ileus, parietal complications, anastomotic leakage, intra-abdominal sepsis and hemorrhage, unplanned surgery.
|
through study completion, an average of 1 month
|
|
adherence to the enhanced recovery program
Time Frame: through study completion, an average of 1 month
|
compliance to the different items of the program
|
through study completion, an average of 1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean L Joris, MD, CHU Liege, Belgium
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ERPELDERLY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.