Enhanced Recovery Program After Colorectal Surgery in Elderly (ERPOLD)

Colorectal Surgery Clinical Trial

— ERPOLD  

Official title:

Effect of Age on the Efficiency of Enhanced Recovery Program After Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620851
• Other study ID #: ERPELDERLY
• Status: Completed
• 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
• 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
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients scheduled for colorectal surgery since November 2015

Exclusion Criteria:

• Emergency surgery

Related Conditions & MeSH terms

• Colorectal Surgery

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