Clinical trial · Observational
Anastomotic Leakage After Colorectal Surgery.
Risk Factors for Anastomotic Leakage After Colorectal Surgery.
- 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)
Anastomotic leakage (AL) is a severe complication after colorectal surgery, with incidence rates of 2-30%. This prospective, single-center observational cohort study aims to identify and quantify independent risk factors for AL, determine its incidence and impact on outcomes, and develop a predictive model. Approximately 430 patients undergoing colorectal resection with anastomosis will be enrolled from August 2025 to August 2026. Risk factors will be assessed preoperatively, intraoperatively, and postoperatively. AL will be defined and graded per the International Study Group of Rectal Cancer (ISGRC) criteria.
Conditions
Conditions (3)
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 | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Diverticulitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patients Undergoing Colorectal Resection with Anastomosis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients Undergoing Colorectal Resection with Anastomosis
- description
- All eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, or coloanal). Risk factors and outcomes will be monitored prospectively.
- interventionNames
- Procedure: Patients Undergoing Colorectal Resection with Anastomosis
Primary outcomes (1)
- measure
- Incidence of Anastomotic Leakage (AL)
- timeFrame
- Within 30 days post-surgery.
- description
- Proportion of patients developing AL within 30 days post-surgery or during hospital stay (whichever longer), diagnosed clinically, radiologically, or operatively per ISGRC definition
Secondary outcomes (6)
- measure
- Severity of Anastomotic Leakage
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Aged ≥18 years * Undergoing elective or emergency colorectal resection with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal) * Providing written informed consent Exclusion Criteria: * Colorectal resection without anastomosis (e.g., end stoma) * Inflammatory bowel disease (Crohn's, ulcerative colitis) * History of previous colorectal surgery involving anastomosis * Pregnancy * Unable to provide informed consent or comply with follow-up
References
Publications (0)
Data not yet available