Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05227014 |
| Other study ID # |
iCral4 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2022 |
| Est. completion date |
February 29, 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Ospedale Sandro Pertini, Roma |
| Contact |
Marco Catarci, MD, FACS |
| Phone |
+393298610040 |
| Email |
marco.catarci[@]aslroma2.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To prospectively study the effect of adherence to ERAS and PBM programs on early outcomes
after colorectal surgery
Description:
The ultimate goal of any surgery is to return the patient to his baseline functional status,
if not an improved one, as rapidly as possible and with the least amount of intercurrent
disability. Enhanced Recovery After Surgery (ERAS) is a multimodal and multifactorial
approach to the optimization of perioperative management. In order to modify and improve the
response to surgery-induced trauma, the program relies on a series of evidence-based items
related to pre-, intra- and post-operative care. Preoperative anemia is a contraindication to
elective surgery. Nonetheless, it is very common, affecting up to 39% of patients candidate
to general surgery. Logically, it is the strongest predictor of blood transfusions
(five-fold) in the post-operative period and it is associated to several risks and
significant morbidity, such as infections (two-fold) and kidney injury (four-fold), as well
as a 22% longer hospital stay. More importantly, peri-operative anemia is now recognized as
strongly and independently related to post-operative mortality (adjusted odd ratio 2.36),
also besides blood transfusions. Post-operative anemia regards up to 90% of patients after
major surgery. The immediate and most widely used treatment for post-operative anemia is
blood transfusion. Blood transfusions carry several complications, culminating in a high
incidence of morbidity and mortality. In particular, they are related to increased length of
hospital stay and rate of discharge to an inpatient facility, worse surgical and medical
outcomes, allergic reactions, transfusion-related acute lung injury, volemic overload, venous
thromboembolism, graft versus host disease, immunosuppression, and post-operative infections.
Two previous prospective studies of the Italian ColoRectal Anastomotic Leakage (iCral) study
group identified intra- and post-operative blood transfusions as an independent factor with
negative influence on all early outcomes after colorectal surgery. In particular, they
resulted as a major independent determinant of anastomotic leakage.
In recent years, various strategies have been studied to reduce the use of blood transfusions
to prevent transfusion-related adverse events, increase patient safety, and reduce costs. As
a consequence, a new concept was born: the patient blood management (PBM). According to the
World Health Organization (WHO), PBM is defined as the timely application of evidence-based
medical and surgical concepts designed to maintain a patient's hemoglobin (Hb) concentration,
optimize hemostasis and minimize blood loss in an effort to improve the outcomes. More in
detail, PBM focuses on three pillars:
- optimizing red cell mass;
- minimizing blood loss and bleeding;
- optimizing tolerance of anemia.
The implementation of the three pillars of PBM leads to improved patient' outcomes by relying
on his/her own blood rather than on that of a donor. PBM goes beyond the concept of
appropriate use of blood products, because it precedes and strongly reduces the use of
transfusions by correcting modifiable risk factors long before a transfusion may even be
considered. Importantly, the PBM is transversal to diseases, procedures and disciplines. It
is solely aimed at managing a patient's resource (i.e., his/her blood), shifting the
attention from the blood component to the patient himself/herself.
The recent and growing interest in PBM is principally driven by its notable impact on several
outcomes. According to different studies PBM is able to reduce mortality up to 68%,
reoperation up to 43%, readmissions up to 43%, composite morbidity up to 41%, infection rate
up to 80%, average length of stay by 16 to 33%, transfusion from 10% to 95%, and costs from
10% to 84% (dependently from the healthcare system). Consistently, from patient's safety and
better outcomes, the PBM achieves the aim of costs saving and fast-track policies adoption,
satisfying some key performance indicators. In this sense, there clearly appears to be an
extraordinary similitude between ERAS and PBM programs: they are both multidisciplinary and
multifactorial, both centered on the patient, embracing the entire perioperative period, both
evidence-based, both offering measurable positive influence on early outcomes after surgery.
Actually, most recent guidelines on ERAS programs in colorectal surgery include preoperative
anemia management in their suggested items. Finally, although the available evidence strongly
suggests that the adoption of ERAS and PBM programs may lead to a significant improvement of
outcomes, there still are no studies investigating the effects of adherence to the two
programs. Therefore, the Italian ColoRectal Anastomotic Leakage (iCral) study group decided
to design this prospective study.
