Colonic Stenting With Elective Surgery Versus Emergency Surgery in the Management of Acute Malignant Colonic Obstruction: a Multicentre, Prospective, Open Label, Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- Rates of primary colorectal anastomosis
研究概览
简要总结
The use of colonic stenting with elective surgery has been suggested as an alternative management for acute malignant colonic obstruction, as emergency surgery has a high risk of morbidity and mortality.
However, the available body of literature addressing their benefit in this setting is contradictory.
The purpose of this study is to determine the efficacy and safety of colonic stenting with elective surgery versus emergency surgery in the management of acute malignant colonic obstruction.
详细描述
Colorectal cancer is one commonly diagnosed malignancy worldwide, with an estimated 10 million new cases and 6 million deaths . Around 8%-29% of patients with colorectal cancer present with acute colonic obstruction, and 70% of all malignant obstruction occurs in the left-sided colon. It has been reported that about 15%-20 % of patients with colorectal cancer present with acute obstructive symptoms at the time of diagnosis.
Conventionally, these patients are treated with emergency surgery to restore luminal continuity, which includes a variety of strategies such as the so-called two-stage surgery involving primary resection with colostomy (i.e., Hartmann's procedure) or proximal colostomy followed by resection, and one-stage surgery involving primary resection with anastomosis. Whatever the strategy chosen, the emergency surgery has an associated high risk of morbidity and mortality, and about two-thirds of such patients end up with a permanent stoma, which caused lower health-related quality of life and costs associated with stoma care.
Since 1991, the colonic stenting has been applied as palliative treatment for patients with unresectable colorectal cancer. In 1993, Tejero et al. reported using colonic stenting as a bridge to definitive surgery. Recently, Zhang et al. conducted a meta-analysis of 8 studies (6 retrospective and 2 randomized trials) and indicated that stent placement before elective surgery, also known as a bridge to surgery, lead to a reduction in need of intensive care (risk ratio [RR], 0.42; 95% confidence interval, 0.19-0.93), stoma creation (RR, 0.70; 0.50-0.99), and overall complications (RR, 0.42; 0.24-0.71) compared with the emergency surgery cohort, meanwhile, colonic stenting with elective surgery achieved higher primary anastomosis rate (RR, 1.62; 1.21-2.16), and did not adversely affect the mortality and long-term survival. The most common complications of colonic stenting were re-obstruction (12%), migration (11%), and perforation (4.5%).
However, the available body of literature addressing the benefit of colonic stenting with elective surgery is contradictory, and limited by the lack of the prospective randomised controlled trials. Therefore, we plan to conduct this multicenter, prospective, open label,cohort study, to determine the efficacy and safety of colonic stenting with elective surgery versus emergency surgery in the management of acute malignant colonic obstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Above 18 years of age.
- •Symptoms of colonic obstruction, existing less than one week.
- •Malignant obstruction in the colon.
- •Signed informed consent.
排除标准
- •Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk.
- •Patients with signs of peritonitis, perforation, sepsis, or other serious complications demanding emergency surgery.
- •Patients with distal rectal cancer less than 8 cm from the anal verge.
- •Patients with suspected or proven metastatic adenocarcinoma.
- •Patients with unresectable colorectal cancer, or planning for palliative treatment.
- •Previous colonic surgery.
- •Pregnancy or lactation women, or ready to pregnant women.
- •Not capable of filling out questionnaires.
结局指标
主要结局
Rates of primary colorectal anastomosis
时间窗: From date of randomization until the first follow-up ended, assessed up to 30 days
The primary colorectal anastomosis was defined as: the patients received one-stage surgery and colorectal anastomosis by whatever elective or emergency surgery.
次要结局
- Quality of life(From date of randomization until the follow-up ended, assessed up to 2 years)
- Stoma rates(From date of randomization until the follow-up ended, assessed up to 2 years)
- Procedure related complication(From date of randomization until the first follow-up ended, assessed up to 30 days)
- R0 resection(From date of randomization until the first follow-up ended, assessed up to 30 days)
- Hospital stay and cost(From date of the admission to discharge, assessed up to 30 days)
- Mortality(From date of randomization until the date of death from any cause, assessed up to 2 years)
- Re-operation rates(From date of randomization until the follow-up ended, assessed up to 2 years)
- Recurrence of colorectal cancer(From date of randomization until the follow-up ended, assessed up to 2 years)