Clinical trial NCT03620851: Enhanced Recovery Program After Colorectal Surgery in Elderly (ERPOLD)
Official title: Effect of Age on the Efficiency of Enhanced Recovery Program After Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Surgery
Keywords: enhanced recovery program
colorectal surgery
elderly
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 302
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients scheduled for colorectal surgery have been included in an enhanced recovery program (ERP) since the 1st November 2015. Preoperative characteristics, surgical and anesthetic data, as well postoperative parameters and complications have been entered prospectively in the GRACE (Groupe francophone de Réhabilitataion Améliorée après ChirurgiE)

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

• All patients scheduled for colorectal surgery since November 2015

Exclusion Criteria:

• Emergency surgery

Primary outcomes:
measure: length of hospital stay after colorectal surgery (day)
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: postoperative complications after colorectal surgery
timeFrame: through study completion, an average of 1 month
measure: adherence to the enhanced recovery program
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU Liége
Study officials:
affiliation: CHU Liege, Belgium
name: Jean L Joris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joris J, Hans G, Coimbra C, Decker E, Kaba A. Elderly patients over 70 years benefit from enhanced recovery programme after colorectal surgery as much as younger patients. J Visc Surg. 2020 Feb;157(1):23-31. doi: 10.1016/j.jviscsurg.2019.07.011. Epub 2019 Jul 31.