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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03620851
Other study ID # ERPELDERLY
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date September 30, 2018

Study information

Verified date November 2018
Source University Hospital of Liege
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Comparison of the efficiency of enhanced recovery program after colorectal surgery in elderly patients (≥ 70 yo) and younger patients (< 70 yo). Efficiency will be rated as a function of length of hospital stay, postoperative complications (medical and surgical, as well as adherence to protocol.


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.


Recruitment information / eligibility

Status Completed
Enrollment 302
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

• All patients scheduled for colorectal surgery since November 2015

Exclusion Criteria:

• Emergency surgery

Study Design


Related Conditions & MeSH terms


Intervention

Other:
effect of age
effect of age on the efficiency of enhanced recovery program

Locations

Country Name City State
Belgium CHU Liége Liège

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary length of hospital stay after colorectal surgery (day) 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 postoperative complications after colorectal surgery 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
Secondary adherence to the enhanced recovery program compliance to the different items of the program through study completion, an average of 1 month
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