Clinical trial · Observational
Enhanced Recovery and Patient Blood Management in Colorectal Surgery
Enhanced Recovery and Patient Blood Management in Colorectal Surgery: the Italian ColoRectal Anastomotic Leakage Study Group (iCral 4).
NCT05227014CI-TRIAL-00071009iCral4unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To prospectively study the effect of adherence to ERAS and PBM programs on early outcomes after colorectal surgery
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Blood Transfusion Complication | — | UNRESOLVED | — |
| Colorectal Disorders | — | UNRESOLVED | — |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colorectal resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Anastomotic leakage rate
- timeFrame
- within 8 weeks from the operation
- description
- number of patient with anastomotic leakage
- measure
- Major morbidity rate
- timeFrame
- within 8 weeks from the operation
- description
- number of patient with any Clavien-Dindo grade \> II adverse event
- measure
- Transfusion rate
- timeFrame
- from 4 weeks before to 8 weeks after the operation
- description
- number of patient receiving at least one unit of packed red blood cells
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGuadagni 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. PMID 42548154