Improving recovery and blood management in colorectal surgery
Enhanced Recovery and Patient Blood Management in Colorectal Surgery: the Italian ColoRectal Anastomotic Leakage Study Group (iCral 4).
This study is testing if following specific recovery and blood management plans can help people recover better and faster after colorectal surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ospedale Sandro Pertini, Roma Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT05227014 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how adherence to Enhanced Recovery After Surgery (ERAS) and Patient Blood Management (PBM) programs affects early outcomes in patients undergoing colorectal surgery. It focuses on optimizing perioperative care through evidence-based practices to enhance recovery and minimize complications. The study will include patients undergoing various types of colorectal resections and will assess the impact of preoperative anemia and blood transfusion complications on recovery. By analyzing these factors, the study seeks to improve patient outcomes and reduce hospital stays.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for elective or delayed colorectal resections who are classified as ASA class I, II, III, or IV.
Not a fit: Patients who are ASA class V, undergoing emergency surgery, pregnant, or receiving hyperthermic intraperitoneal chemotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery times and fewer complications for patients undergoing colorectal surgery.
How similar studies have performed: Other studies have shown promising results with ERAS and PBM approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Roma, RM
- Ospedale Sandro Pertini — Roma, Rm, Italy (Recruiting)
Study contacts
- Study coordinator: Marco Catarci, MD, FACS
- Email: marco.catarci@aslroma2.it
- Phone: +393298610040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.