ERAS Lazio Network Clinical Registry View Homepage


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2014-2017

ABSTRACT

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. Detailed 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. More... »

URL

https://clinicaltrials.gov/show/NCT03353311

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3 schema:description 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. Detailed 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.
4 schema:endDate 2017-11-01T00:00:00Z
5 schema:keywords Data Collection
6 Department of Surgery
7 General Surgery
8 Logistic Model
9 NHS
10 October
11 Patient Readmission
12 RMS
13 Rome
14 September
15 Specialization
16 UoS
17 additional cost
18 adherence
19 adherence rate
20 admission
21 anesthesiology
22 base
23 care
24 categorical variable
25 classification
26 co-variates
27 collecting
28 colorectal cancer patient
29 complication rate
30 conduct
31 consecutive series
32 consequent reduction
33 continuous variable
34 continuum
35 coordinator
36 correlation
37 database
38 definition
39 discipline
40 duration
41 end point
42 enhanced recovery
43 fast track
44 first author
45 follow-up visit
46 functional recovery
47 guideline
48 home
49 hospital
50 hospital discharge
51 hospitalization
52 individual item
53 informed consent
54 intervention
55 intra
56 investigator aim
57 last time
58 management
59 mean
60 medical campus
61 method
62 mid-1990s
63 morbidity
64 morbidity rate
65 mortality
66 multi-disciplinary
67 multi-disciplinary approach
68 network
69 nursing
70 nutrition
71 observational study
72 operation
73 own data
74 patient
75 patient recovery
76 patient safety
77 physiological function
78 postoperative recovery
79 profit
80 protocol
81 recovery
82 registry
83 regular basis
84 rehabilitation program
85 resection
86 return home
87 robotic surgery
88 sample size calculation
89 short-term outcome
90 significant reduction
91 specialty
92 standard approach
93 standard deviation
94 statistical analysis
95 surgical outcome
96 surgical procedure
97 surgical stress
98 surgical trauma
99 traditional approach
100 urgent
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