Anastomotic Leak, Colon Cancer, Colorectal Cancer, Intestinal Stoma, Postoperative Complication
Conditions
Keywords
Rectal cancer, colon cancer, anastomotic leak, stoma, Postoperative mortality, Failure to rescue
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Alexandria University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Permanent Stoma | Twelve months after the index colorectal resection | 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. |
| Proportion of Participants Requiring Unplanned Rescue Surgery | Within 30 days after diagnosis of anastomotic leakage | 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. |
| Ninety-Day Mortality | Within 90 days after diagnosis of anastomotic leakage | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Failure to Rescue | Within 90 days after anastomotic leak diagnosis | Death within 90 days following anastomotic leakage among patients who developed the complication. |
| Anastomotic Salvage | Twelve months after the index operation | Proportion of participants in whom the original anastomosis remains in place and intestinal continuity has been maintained or restored without a permanent stoma. |
| Stoma Reversal | Up to 24 months after the index operation | Proportion of participants undergoing successful reversal of a diverting or leak-related ileostomy or colostomy. |
| Time to Stoma Reversal | From index colorectal resection to stoma reversal, up to 24 months | Number of days between the index colorectal cancer operation and successful restoration of intestinal continuity. |
| Intensive Care Unit Admission | From leak diagnosis to 30 days | Admission or readmission to an intensive care unit as a consequence of the anastomotic leak or its treatment. |
| Organ Support | Within 30 days after leak diagnosis | Requirement for vasopressor therapy, invasive mechanical ventilation, or renal replacement therapy. |
| Number of Reinterventions | Within 90 days after leak diagnosis | Total number of operative, radiological, endoscopic, and transanal interventions required for management of the anastomotic leak. |
| Length of Hospital Stay | From index colorectal resection to discharge in 7 days to 30 days | Total duration of hospitalization associated with the index operation and anastomotic leak. |
| Hospital Readmission | Within 90 days after the index colorectal resection | Any unplanned hospital readmission related to the anastomotic leak, stoma, infection, or postoperative recovery. |
| Delay in Adjuvant Cancer Treatment | Within six months after the index operation | 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. |
| Permanent Stoma at 24 Months | Twenty-four months after the index operation | Presence of an ileostomy or colostomy at 24 months or a documented decision that reversal will not be attempted. |
Countries
Egypt
Outcome results
None listed