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Completed

NCT Number: NCT03620851

Enhanced Recovery Program After Colorectal Surgery in Elderly (ERPOLD)

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.

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Key information

Conditions

Colorectal Surgery

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Liége

Liège, Belgium

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients scheduled for colorectal surgery since November 2015

Exclusion criteria

  • Emergency surgery

Treatment and study plan

effect of age

Other

effect of age on the efficiency of enhanced recovery program

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. adherence to the enhanced recovery program

    Time frame: through study completion, an average of 1 month

    compliance to the different items of the program

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

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

Acronym: ERPOLD

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 8, 2018
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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