Colorectal SurgeryERPOLDNCT03620851
Enhanced Recovery Program After Colorectal Surgery in Elderly (ERPOLD)
An observational study of Colorectal Surgery, run by University of Liege at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- effect of age
- How many people
- 302 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2018to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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)
Who may be able to join
- All patients scheduled for colorectal surgery since November 2015
Who cannot join
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Age on the Efficiency of Enhanced Recovery Program After Colorectal Surgery
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.
Read the 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.
- Conditions
- Colorectal Surgery
- Being tested
- effect of age
- Keywords
- enhanced recovery program, colorectal surgery, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
effect of ageOther
effect of age on the efficiency of enhanced recovery program
| Study group | Role | What they receive |
|---|---|---|
| elderly patients (≥70 yo) vs. younger patients (<70 yo) | elderly patients (≥ 70 yo) and younger patients (< 70 yo) Receives: Other: effect of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 month
Secondary outcomes (2)
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.
Measured: through study completion, an average of 1 month
adherence to the enhanced recovery program
compliance to the different items of the program
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Sep 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
- Investigators
- Jean L Joris, MD, Principal investigator, CHU Liege, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620851
- Sponsor's protocol ID
- ERPELDERLY
- Acronym
- ERPOLD
- Status last verified
- Nov 2018
- First submitted
- 18 Jul 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31377111
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Age on the Efficiency of Enhanced Recovery Program After Colorectal Surgery
- ClinicalTrials.gov ID
- NCT03620851
- Acronym / sponsor ID
- ERPOLD / ERPELDERLY
- Conditions
- Colorectal Surgery
- Keywords
- enhanced recovery program, colorectal surgery, elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly patients (≥70 yo) vs. younger patients (<70 yo) | – | Other: effect of ageelderly patients (≥ 70 yo) and younger patients (< 70 yo) |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- All patients scheduled for colorectal surgery since November 2015
Key exclusion criteria (1 listed)
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| effect of ageeffect of age on the efficiency of enhanced recovery program | Other | elderly patients (≥70 yo) vs. younger patients (<70 yo) |
Primary outcome
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
2 secondary outcomes
postoperative complications after colorectal surgery
Time frame: through study completion, an average of 1 month
adherence to the enhanced recovery program
Time frame: through study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Derived from this study: PubMed 31377111Joris 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean L Joris, MD principal investigator
CHU Liege, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Surgery, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of hospital stay after colorectal surgery (day) (time frame: through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03620851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.