Enhanced Recovery Program After Colorectal Surgery in Elderly (ERPOLD)

NCT ID: NCT03620851

Last Updated: 2018-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Colorectal Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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elderly patients (≥70 yo) vs. younger patients (<70 yo)

elderly patients (≥ 70 yo) and younger patients (\< 70 yo)

effect of age

Intervention Type OTHER

effect of age on the efficiency of enhanced recovery program

Interventions

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effect of age

effect of age on the efficiency of enhanced recovery program

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

• All patients scheduled for colorectal surgery since November 2015

Exclusion Criteria

• Emergency surgery
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Jean François Brichant

Professor in Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean L Joris, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Liege, Belgium

Locations

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CHU Liége

Liège, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 31377111 (View on PubMed)

Other Identifiers

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ERPELDERLY

Identifier Type: -

Identifier Source: org_study_id

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