Anastomotic Leakage Following Laparoscopic Resection for Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- Incidence of anastomotic leakage
研究概览
简要总结
Anastomotic leak (AL) is a breakdown of a suture line in a surgical anastomosis with a subsequent leakage of the luminal content. Anastomotic leakage occurs commonly in rectal and esophageal anastomosis than the other parts of the alimentary tract due to technical difficulties in accessing these areas and their easily compromised blood supply.
Anastomotic leakage is the most feared complication following rectal resection and anastomosis. The incidence of anastomotic leakage ranges from 2.8% to more than 15%, with mortality rate more than 30%. Subclinical anastomotic failure may occur in up to 51% of patients.
Anastomotic leakage leads to increase the rate of secondary interventions, re-operations, longer postoperative hospital stay, increased cost, and major impact on the patient's quality of life. In the medium to long term, patient may be unfit for post-operative adjuvant therapy with decreased the disease survival. Furthermore anastomotic leakage itself may increase the local recurrence, a reduction in overall survival, and a large proportion of patients are left with a permanent stoma.
详细描述
Study populations: all patients will sign an informed consent prior to the surgery to be included in the study, after explanation of the nature of the disease, possible treatment, and the possibility of stoma formation.
Data recording: basic demographic data are recorded including age and sex of the patient as well as detailed information on history, risk factors, preoperative diagnostics, surgical procedure, intraoperative findings, histopathological work-up, and postoperative course.
Variables analysis: the variables are divided into patient-related, tumor-related, therapy-related, and techniques-related variables.
Preoperative workup: all patients will have detailed clinical history and physical examination including DRE. Routine laboratory investigations also are included e.g. CBC, blood glucose level, liver, and kidney function tests.
Regular workup for rectal cancer are included; full colonoscopy with biopsy, gastrografin/barium enema, TRUS evaluate degree of invasion of the rectal wall and regional lymph nodes, abdominal and pelvic CT scan, Chest x-ray or CT scan, CEA level, and EORTC Quality of life Questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who undergo laparoscopic resection for biopsy proven rectal cancer.
排除标准
- •Open surgery,
- •Emergency intervention,
- •Palliative resection,
- •Stage IV with distant metastasis,
- •Recurrent cancer,
- •Multivisceral resection
结局指标
主要结局
Incidence of anastomotic leakage
时间窗: 2 years
Incidence of anastomotic leakage in patients who underwent laparoscopic resection of rectal cancer. This including clinical and sub-clinical (radiological diagnosis) leakage.
次要结局
- Role of diversion in prevention of anastomotic leakage.(2 years)
- Management of anastomotic leakage(2 years)
- Oncological outcomes of anastomotic leakage(2 years)
- 30 days postoperative morbidity and mortality(30 days)
研究者
Mostafa shalaby, MD, MSc, PhD
Dr
Mansoura University