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.
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
- Conditions the study is for
- Anastomotic Leak, Colorectal Neoplasms, Blood Transfusion Complication
- 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.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Sandro Pertini
Roma, RM, 00157
Marco Catarci, MD, +393298610040, marco.catarci@aslroma2.it
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.
- Conditions
- Anastomotic Leak, Colorectal Neoplasms, Blood Transfusion Complication, Colorectal Disorders
- 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.
Anastomotic leakage rate
number of patient with anastomotic leakage
Measured: within 8 weeks from the operation
Major morbidity rate
number of patient with any Clavien-Dindo grade > II adverse event
Measured: within 8 weeks from the operation
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)
Overall morbidity rate
number of patient with any adverse event
Measured: within 8 weeks from the operation
Length of Postoperative Hospital Stay (LOS)
Total number of days spent in the hospital (including any readmission)
Measured: within 8 weeks from the operation
Number of transfused blood units
Total number of transfused blood units
Measured: from 4 weeks before to 8 weeks after the operation
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.
- First posted7 Feb 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anastomotic LeakStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ospedale Sandro Pertini, Roma
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Chirurghi Ospedalieri Italiani
- Responsible party
- Principal investigator, Marco Catarci, Ospedale Sandro Pertini, Roma
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery and Patient Blood Management in Colorectal Surgery: the Italian ColoRectal Anastomotic Leakage Study Group (iCral 4).
- ClinicalTrials.gov ID
- NCT05227014
- Acronym / sponsor ID
- iCral4 / iCral4
- Conditions
- Anastomotic Leak, Colorectal Neoplasms, Blood Transfusion Complication, Colorectal Disorders
- Keywords
- PBM, ERAS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Ospedale Sandro Pertini, RomaUniversity, hospital or other
- Collaborators
- Associazione Chirurghi Ospedalieri Italiani
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing elective colorectal surgery with anastomosis will be included in a prospective database after written informed consent.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- American Society of Anesthesiologists' (ASA) class V
- Emergent surgery (≤ 24 hours from admission)
- Pregnancy
- Hyperthermic intraperitoneal chemotherapy for carcinomatosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colorectal resectionAlso: Colectomy, proctectomyAll patients undergoing elective colorectal surgery with anastomosis will be included in a prospective database after written informed consent. | Procedure or surgery | – |
Primary outcome
Anastomotic leakage rate
Time frame: within 8 weeks from the operation
number of patient with anastomotic leakage
Major morbidity rate
Time frame: within 8 weeks from the operation
number of patient with any Clavien-Dindo grade > II adverse event
Transfusion rate
Time frame: from 4 weeks before to 8 weeks after the operation
number of patient receiving at least one unit of packed red blood cells
4 secondary outcomes
Overall morbidity rate
Time frame: within 8 weeks from the operation
Length of Postoperative Hospital Stay (LOS)
Time frame: within 8 weeks from the operation
Number of transfused blood units
Time frame: from 4 weeks before to 8 weeks after the operation
Postoperative hemoglobin values
Time frame: 4 days after the operation, at discharge, 6 weeks after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Derived from this study: PubMed 42548154Guadagni 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.
- Individual participant dataSharing planned: No. Anonymized participant-level datasets will be available after study completion upon reasonable request by contacting the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.