Enhanced Recovery and Patient Blood Management in Colorectal Surgery

NCT ID: NCT05227014

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-02-29

Brief Summary

To prospectively study the effect of adherence to ERAS and PBM programs on early outcomes after colorectal surgery

Detailed 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.

Conditions

Anastomotic Leak; Colorectal Neoplasms; Blood Transfusion Complication; Colorectal Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Colorectal resection

All patients undergoing elective colorectal surgery with anastomosis will be included in a prospective database after written informed consent.

Intervention Type: PROCEDURE

Other Intervention Names

Colectomy, proctectomy

Eligibility Criteria

Inclusion Criteria

1. Patients submitted to laparoscopic/robotic/open/converted ileo-colo-rectal resection with anastomosis, including planned Hartmann's reversals.

2. American Society of Anesthesiologists' (ASA) class I, II, III or IV

3. Elective or delayed urgency (> 24 hours from admission) surgery

4. Patients' written acceptance to be included in the study.

Exclusion Criteria

1. American Society of Anesthesiologists' (ASA) class V

2. Emergent surgery (≤ 24 hours from admission)

3. Pregnancy

4. Hyperthermic intraperitoneal chemotherapy for carcinomatosis.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Associazione Chirurghi Ospedalieri Italiani

OTHER

Sponsor Role: collaborator

Ospedale Sandro Pertini, Roma

OTHER

Sponsor Role: lead

Responsible Party

Marco Catarci

Director, General Surgery Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ospedale Sandro Pertini

Roma, RM, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Marco Catarci, MD, FACS

Role: CONTACT

marco.catarci@aslroma2.it

+393298610040

Facility Contacts

Marco Catarci, MD

Role: primary

marco.catarci@aslroma2.it

+393298610040

Other Identifiers

iCral4

Identifier Type: -

Identifier Source: org_study_id