Clinical trial · Observational
Predictors of Rescue Surgery, Mortality, and Permanent Stoma After Anastomotic Leak Following Colorectal Cancer Resection
- 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 is a serious complication following colorectal cancer resection and may result in emergency reoperation, severe sepsis, death, loss of the colorectal anastomosis, and formation of a long-term or permanent intestinal stoma. This multicentre observational cohort study will investigate patients who develop an anastomotic leak following colorectal cancer resection with primary anastomosis. The study will evaluate patient-related, tumour-related, operative, biochemical, radiological, leak-related, and treatment-related factors associated with three major outcomes: unplanned rescue surgery, 90-day mortality, and permanent stoma formation. No treatment will be assigned by the investigators. Diagnosis and management of anastomotic leakage will be determined by the treating surgical teams according to their usual clinical practice. Participants will be followed for at least 12 months after the index colorectal resection. The results may help clinicians identify high-risk patients, improve the timing of intervention and source control, support discussions with patients and families, and develop future risk-prediction models for anastomotic leak outcomes.
Conditions
Conditions (5)
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 | — |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Intestinal Stoma | — | UNRESOLVED | — |
| Postoperative Complication | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- patients With Anastomotic Leak Following Colorectal Cancer Resection
- description
- Consecutive adult patients who develop a clinically, radiologically, endoscopically, or operatively confirmed anastomotic leak following colorectal cancer resection with formation of a primary colorectal, coloanal, ileocolic, colocolic, or ileorectal anastomosis. Participants will receive routine diagnostic and therapeutic management determined by their treating surgical teams. No intervention will be assigned by the investigators.
Primary outcomes (3)
- measure
- Permanent Stoma
- timeFrame
- Twelve months after the index colorectal resection
- description
- The presence of an ileostomy or colostomy 12 months after the index colorectal cancer operation, or documentation that restoration of intestinal continuity will not be attempted because of technical, medical, oncological, functional, or patient-related factors. Patients who die before the 12-month assessment will be recorded separately and considered as competing events in time-to-stoma-reversal analyses.
- measure
- Proportion of Participants Requiring Unplanned Rescue Surgery
- timeFrame
- Within 30 days after diagnosis of anastomotic leakage
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older. Histologically confirmed or clinically suspected primary colorectal adenocarcinoma requiring surgical resection. Undergoing elective or emergency colorectal resection with formation of a primary intestinal or colorectal anastomosis. Anastomotic leakage diagnosed within 90 days after the index colorectal resection or during the index hospital admission. Leak confirmed clinically, radiologically, endoscopically, through drainage of enteric contents, or during operative exploration. Availability of sufficient medical records to determine the method of leak diagnosis, treatment, and short-term outcomes. Ability to complete follow-up for stoma status, where applicable. Exclusion Criteria: * Age younger than 18 years. Colorectal operation performed for a benign condition without colorectal cancer. Abdominoperineal excision or another procedure without formation of an intestinal anastomosis. Local transanal tumour excision without colorectal anastomosis. Leakage involving only a urinary, vascular, or non-intestinal anastomosis. Planned permanent stoma without a colorectal or intestinal anastomosis. Anastomotic leak occurring after surgery for recurrent disease without resection of a primary colorectal tumour, unless specifically included in a predefined secondary cohort. Inability to verify the diagnosis of anastomotic leakage. Inadequate data to determine all three primary outcomes. Refusal to participate where individual informed consent is required.
References
Publications (0)
Data not yet available