Predictors of Rescue Surgery, Mortality, and Permanent Stoma After Anastomotic Leak Following Colorectal Cancer Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,200
- 试验地点
- 1
- 主要终点
- Permanent Stoma
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Permanent Stoma
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Failure to Rescue(Within 90 days after anastomotic leak diagnosis)
- Anastomotic Salvage(Twelve months after the index operation)
- Stoma Reversal(Up to 24 months after the index operation)
- Time to Stoma Reversal(From index colorectal resection to stoma reversal, up to 24 months)
- Intensive Care Unit Admission(From leak diagnosis to 30 days)
- Organ Support(Within 30 days after leak diagnosis)
- Number of Reinterventions(Within 90 days after leak diagnosis)
- Length of Hospital Stay(From index colorectal resection to discharge in 7 days to 30 days)
- Hospital Readmission(Within 90 days after the index colorectal resection)
- Delay in Adjuvant Cancer Treatment(Within six months after the index operation)
- Permanent Stoma at 24 Months(Twenty-four months after the index operation)