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Anastomotic LeakiCral4NCT05227014

Enhanced Recovery and Patient Blood Management in Colorectal Surgery

An observational study of Anastomotic Leak and Colorectal Neoplasms, run by Ospedale Sandro Pertini, Roma at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Colorectal resection
Type of treatment
Surgery or procedure
How many people
5,000 participants
Where
1 siteItaly
Study dates
1 Jul 2022to 29 Feb 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Patients submitted to laparoscopic/robotic/open/converted ileo-colo-rectal resection with anastomosis, including planned Hartmann's reversals.
  • American Society of Anesthesiologists' (ASA) class I, II, III or IV
  • Elective or delayed urgency (> 24 hours from admission) surgery
  • Patients' written acceptance to be included in the study.

Who cannot join

  • American Society of Anesthesiologists' (ASA) class V
  • Emergent surgery (≤ 24 hours from admission)
  • Pregnancy
  • Hyperthermic intraperitoneal chemotherapy for carcinomatosis.

Trial locations and contacts

1 site in 1 country.

Marco Catarci, MD, FACS contact

+393298610040

marco.catarci@aslroma2.it

Italy1 site, 1 recruiting
  • Ospedale Sandro Pertini

    Roma, RM, 00157

    Marco Catarci, MD, +393298610040, marco.catarci@aslroma2.it

    Recruiting

Other trials in Italy

About this study

Official title: Enhanced Recovery and Patient Blood Management in Colorectal Surgery: the Italian ColoRectal Anastomotic Leakage Study Group (iCral 4).

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

Read the 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.

Being tested
Colorectal resection
Keywords
PBM, ERAS
Medical subject headings
Anastomotic Leak, Colorectal Neoplasms, Transfusion Reaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Colorectal resectionProcedure or surgery

    Also called Colectomy, proctectomy

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anastomotic leakage rate

    number of patient with anastomotic leakage

    Measured: within 8 weeks from the operation

  2. Major morbidity rate

    number of patient with any Clavien-Dindo grade > II adverse event

    Measured: within 8 weeks from the operation

  3. Transfusion rate

    number of patient receiving at least one unit of packed red blood cells

    Measured: from 4 weeks before to 8 weeks after the operation

Secondary outcomes (4)
  1. Overall morbidity rate

    number of patient with any adverse event

    Measured: within 8 weeks from the operation

  2. Length of Postoperative Hospital Stay (LOS)

    Total number of days spent in the hospital (including any readmission)

    Measured: within 8 weeks from the operation

  3. Number of transfused blood units

    Total number of transfused blood units

    Measured: from 4 weeks before to 8 weeks after the operation

  4. Postoperative hemoglobin values

    Values of Hemoglobin (g/L)

    Measured: 4 days after the operation, at discharge, 6 weeks after the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2022
  2. Study start1 Jul 2022
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion29 Feb 2024 (estimated)

Resources

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
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05227014
Sponsor's protocol ID
iCral4
Acronym
iCral4
Status last verified
Oct 2023
First submitted
27 Jan 2022
Last updated
2 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Anonymized participant-level datasets will be available after study completion upon reasonable request by contacting the principal investigator.

Publications

  • Guadagni S, Catarci M, Masedu F; Italian ColoRectal Anastomotic Leakage (iCral) study group. Circular stapler platform and the risk of anastomotic leakage after elective left colectomy and high anterior resection. Colorectal Dis. 2026 Aug;28(8):e70564. doi: 10.1111/codi.70564.

    PubMed 42548154

Questions about this trial

What is this clinical trial studying?

An observational study of Anastomotic Leak and Colorectal Neoplasms, run by Ospedale Sandro Pertini, Roma at 1 site in Italy.

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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. 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 Italy. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marco Catarci, MD, FACS (+393298610040, marco.catarci@aslroma2.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anastomotic leakage rate (time frame: within 8 weeks from the operation). The study lists 3 primary outcomes in all. 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 NCT05227014, 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 2 Nov 2023.

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