ERAS Lazio Network Clinical Registry

Colon Cancer Clinical Trial

— ENeRgy  

Official title:

ERAS Lazio Network Clinical Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353311
• Other study ID #: FPAG001
• Status: Completed
• Phase: N/A
• First received: November 14, 2017
• Last updated: November 22, 2017
• Start date: September 1, 2014
• Est. completion date: November 1, 2017

Study information

• Verified date: November 2017
• Source: Policlinico Universitario Agostino Gemelli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Enhanced recovery after surgery (ERAS) protocols are programs aiming to implement patients recovery following surgical procedures developed about 25 years ago. ERAS protocols are based on a multi-disciplinary approach encompassing surgery, anesthesiology, nutrition and nursing; each specialty has to fulfill a number of items which have been demonstrated to reduce morbidity rates, hospital stay and to implement functional recovery comparing standard approach. Accordingly, ERAS society developed a Guidelines for a number of procedures, including colorectal.

The aim of this study is to evaluate the adherence over the last years to these protocols in eight Department of Surgery in Rome in a series of colorectal cancer patients.

Secondary aims are to investigate the correlation of the items adherence with surgical outcome and to establish a network of hospitals aiming to promote ERAS approach on a regional base.

Description:

Background. The acronym ERAS (Enhanced Recovery After Surgery) refers to a patient-centered, evidence-based multi-disciplinary protocol designed to implement perioperative operation, reduce surgical trauma, and facilitate recovery of physiological functions aiming to an early hospital discharge.

Usually ERAS protocols give a continuum of care starting at home (pre-hospital/pre-admission phase) to continue in followed by the pre-/ intra-/ and post-operative phases.

ERAS includes a wide range of disciplines and specialists, which focus on the needs of the patient in order to improve support by facilitating his return home.

The first author to introduce the fast-track term in rectal surgery was Prof. Henrik Kehlet in the mid-1990s, proposing a multi-modal rehabilitation program aimed to reduce post-surgical stress response, morbidity, mortality and postoperative hospitalization. Since then, a number of studies were conducted leading to the first ERAS protocol; since then, these protocols were reviewed on a regular basis, the last time in 2017 and included in the guidelines by the ERAS society (http://www.erassociety.org).

Currently, it is widely demonstrated that, comparing to a traditional approach, ERAS is associated with a significant reduction in morbidity, days of hospitalization, mortality, implementing early postoperative recovery with a consequent reduction of the costs, without compromising patient safety.

In particular, ERAS for colorectal surgery, includes 24 demonstrated multi-disciplinary.

Aims. the investigators aim to evaluate the adherence to the individual items and the short-term outcomes (postoperative hospitalization, complication rates within 30 days of intervention, re-intervention) in a consecutive series of patients undergoing colorectal resection, in eight centers in the Lazio region, treated according to the ERAS protocol.

Secondary aims are to investigate the correlation of the items adherence with surgical outcome and to establish a network of hospitals aiming to promote ERAS approach on a regional base.

Design. This is a no-profit, spontaneous, observational, non-intervention Audit collecting data in eight surgical Departments based in Lazio region, since September 2014 to October 2017. Each participating center will be depositary of its own data.

Participating Centers.

1. UOC General Surgery 1, Fondazione Policlinico Universitario "A. Gemelli ", Rome (Coordinator) -

2. Department of Surgery, S. Eugenio Hospital, Rome

3. UOD Week-Day Surgery, St. Andrea Hospital, Rome

4. UOC General Surgery, Polyclinic University Bio-Medical Campus, Rome

5. UO General and Urgent Surgery, Policlinico Casilino Hospital, Rome

6. UOC Surgery, San Paolo Hospital, Civitavechia (RM)

7. UOC General Surgery, Cristo Re Hospital, Rome

8. UOSD Robotic Surgery for General Surgery, San Giovanni-Addolorata Hospital, Rome

Data Collection. Each center will collect the data in a homogeneous Database. The data will be collected in anonymous form and will be aimed at the definition of:

1. Duration of postoperative stay

2. Short-term morbidity rate (within 30 days) according to Clavien-Dindo classification

3. Re-intervention rate (within 30 days)

4. Hospital readmission (within 30 days)

f. Adherence rate to items of the series All data will be treated sensibly; each patient will be recorded with a sequential center-specific code. For all new patients and for patients seen in follow-up visits, the specific informed consent of the study will be compiled.

Statistical analysis. Categorical variables will be presented as rate and percentages, the continuous variables as mean, median, and standard deviation.

A logistic regression will also be performed, computing items as co-variates, with the end-point of post-operative morbidity and hospital stay.

Sample Size Calculation: 1000 patients, calculated on the basis of the annual case of each participating center.

For the conduct and management of this observational study no additional cost will be charged on NHS funds.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: November 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Elective colorectal surgical resection

• Open and Laparoscopic Suregry

• Benign/malignant disease

• independently from age, sex,

Exclusion Criteria:

Emergency colorectal resections

Related Conditions & MeSH terms

• Colon Cancer
• Diverticulum
• Diverticulum, Colon

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Unversitario Agostino Gemelli	Roma

Sponsors (8)

Lead Sponsor	Collaborator
Roberto Persiani	Azienda Ospedaliera Sant'Andrea, Roma, Campus Bio-Medico University, Ospedale Cristo Re - Roma, Ospedale San Paolo Civitavecchia, Policlinico Casilino ASL RMB, S.Eugenio Hospital, San Giovanni Addolorata Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (49)

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Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170. Review. — View Citation

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* Note: There are 49 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherance to ERAS protocol	Number of items included in the ERAS protocols that were applied in each centre	36 months
Secondary	Number of items of the ERAS protol correlated wih adverse events as described by the Clavien Dindo Classification and with a longer hospital stay	Multivariate analysis to relate ERAS items to morbidity or a longer hospital stay (>mean values)	36 months