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.
Anastomotic leakage following colorectal cancer resection is associated with substantial postoperative morbidity and mortality. Although several management strategies are available-including antibiotics, image-guided drainage, endoscopic treatment, transanal drainage, proximal diversion, operative washout, anastomotic revision, and dismantling of the anastomosis-the clinical course varies considerably between patients. Early identification of patients who are likely to require operative rescue, die following the leak, or remain with a permanent stoma may improve clinical decision-making. However, the predictors of these outcomes have not been sufficiently defined across different colorectal resections, anastomotic levels, leak presentations, and treatment strategies. This study will include consecutive adult patients with colorectal cancer who develop a confirmed anastomotic leak after colorectal resection with primary anastomosis. Anastomotic leakage will be defined as a defect in the intestinal wall at the anastomotic site resulting in communication between the intraluminal and extraluminal compartments. The diagnosis may be established clinically, radiologically, endoscopically, or operatively. For this study, "rescue surgery" means an unplanned operative intervention performed for control or treatment of the anastomotic leak. It may include laparoscopy or laparotomy, abdominal or pelvic washout, operative drainage, anastomotic repair or revision, proximal diversion, or dismantling of the anastomosis with formation of an end stoma. The decision to perform rescue surgery or any other treatment will remain entirely at the discretion of the treating clinical team. Participation in the study will not alter routine management.
Study Type
OBSERVATIONAL
Enrollment
3,200
Unnamed facility
Alexandria, Please Select, Egypt
Permanent Stoma
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.
Time frame: Twelve months after the index colorectal resection
Proportion of Participants Requiring Unplanned Rescue Surgery
The proportion of participants undergoing an unplanned operative intervention for treatment or source control of the anastomotic leak. Rescue surgery includes operative washout, surgical drainage, anastomotic repair, anastomotic revision, proximal diversion, takedown of the anastomosis, or formation of an end stoma. Image-guided, endoscopic, or transanal procedures performed without general or regional operative exploration will be recorded separately and will not constitute rescue surgery for the primary outcome.
Time frame: Within 30 days after diagnosis of anastomotic leakage
Ninety-Day Mortality
Death from any cause occurring within 90 days after the date on which the anastomotic leak was first confirmed. In-hospital deaths occurring beyond 90 days will also be reported separately.
Time frame: Within 90 days after diagnosis of anastomotic leakage
Failure to Rescue
Death within 90 days following anastomotic leakage among patients who developed the complication.
Time frame: Within 90 days after anastomotic leak diagnosis
Anastomotic Salvage
Proportion of participants in whom the original anastomosis remains in place and intestinal continuity has been maintained or restored without a permanent stoma.
Time frame: Twelve months after the index operation
Stoma Reversal
Proportion of participants undergoing successful reversal of a diverting or leak-related ileostomy or colostomy.
Time frame: Up to 24 months after the index operation
Time to Stoma Reversal
Number of days between the index colorectal cancer operation and successful restoration of intestinal continuity.
Time frame: From index colorectal resection to stoma reversal, up to 24 months
Intensive Care Unit Admission
Admission or readmission to an intensive care unit as a consequence of the anastomotic leak or its treatment.
Time frame: From leak diagnosis to 30 days
Organ Support
Requirement for vasopressor therapy, invasive mechanical ventilation, or renal replacement therapy.
Time frame: Within 30 days after leak diagnosis
Number of Reinterventions
Total number of operative, radiological, endoscopic, and transanal interventions required for management of the anastomotic leak.
Time frame: Within 90 days after leak diagnosis
Length of Hospital Stay
Total duration of hospitalization associated with the index operation and anastomotic leak.
Time frame: From index colorectal resection to discharge in 7 days to 30 days
Hospital Readmission
Any unplanned hospital readmission related to the anastomotic leak, stoma, infection, or postoperative recovery.
Time frame: Within 90 days after the index colorectal resection
Delay in Adjuvant Cancer Treatment
Time from colorectal cancer resection to initiation of indicated adjuvant chemotherapy, and the proportion of patients unable to receive planned adjuvant treatment because of the leak or its consequences.
Time frame: Within six months after the index operation
Permanent Stoma at 24 Months
Presence of an ileostomy or colostomy at 24 months or a documented decision that reversal will not be attempted.
Time frame: Twenty-four months after the index operation
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