NCT05627284招募中不适用
A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- stoma site incisional hernia
研究概览
简要总结
The goal of this clinical trial is to explore the safety and effectiveness of stoma reversal combining bio-mesh placement in patients with high risk of stoma site incisional hernia (SSIH). The main questions it aims to answer are:
- Whether bio-mesh placement is safe for patients with a high risk of SSIH.
- Whether stoma reversal combining bio-mesh placement is a preventive strategy for patients with high risk of SSIH.
- Whether stoma reversal combining bio-mesh placement will trigger other complications.
Participants who are eligible and are enrolled in this study will receive stoma reversal combining bio-mesh placement surgery. After that, they will be followed up for one year to evaluate the occurrence of SSIH and other complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old;
- •Patients should have colonic prophylactic stoma and have not received reversal yet;
- •There are no obvious signs of tumor recurrence or metastasis in tumor patients before stoma resection;
- •No serious underlying diseases, can tolerate general anesthesia surgery
- •Preoperative ECOG (Eastern Cooperative Oncology Group) physical status score 0/1;
- •Preoperative ASA (American Society of Anesthesiologists) grade I-III;
- •Without vital organs function failure;
- •All patients and their families signed informed consent before surgery.
排除标准
- •Incapacitated persons;
- •With a history of other types of hernia;
- •Those who have had hernia mesh implantation before;
- •Those who are allergic to bio-mesh or their components before;
- •Combined with other surgeries;
- •Severe mental illness;
- •Severe respiratory disease;
- •Severe liver and kidney insufficiency;
- •Those who have absolute contraindications to surgery;
- •Suffering from severe bleeding disorders or obvious abnormal coagulation function;
- •History of unstable angina or myocardial infarction within 6 months;
- •History of cerebral infarction or cerebral hemorrhage within 6 months;
- •Continuous intravenous application of glucocorticoid within 1 month;
- •The patient has participated or is participating in other clinical studies (within 6 months).
结局指标
主要结局
stoma site incisional hernia
时间窗: one-year after surgery
Hernia occurs on the primary stoma site
次要结局
未报告次要终点
研究者
研究点 (1)
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