A Randomized, Controlled, Open Multicenter Clinical Study on the Efficacy and Safety of a Disposable Intestinal Isolation Protective Device in Patients With Rectal and Lower Sigmoid Colon Tumors Undergoing Laparoscopic AR/LAR Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The main efficacy evaluation index: During the surgery.
研究概览
简要总结
The small intestine is the main organ in the abdominal cavity, approximately 4 to 5 meters in length, occupying most of the middle and lower abdomen. Due to the long mesentery of the small intestine, it is in a free state and has a high degree of mobility. When performing abdominal surgery, especially lower abdominal surgery, the freedom and slippability of the small intestine often affect the exposure of the surgical site and the operating field of vision. Lower abdominal surgery generally includes colorectal surgery, gynecological surgery, urological surgery, etc. At present, in clinical practice, open surgeries, including minimally invasive laparoscopic manual surgeries, mainly involve significantly adjusting the patient's position to slide the small intestine into the surgical field, or simply surrounding and covering the small intestine with gauze pads and assisting in pulling with the help of assistants. However, the results are not satisfactory, especially for obese patients.
In the current clinical practice of performing middle and lower abdominal surgeries, especially laparoscopic surgeries, a device superior to gauze isolation pads is needed. It can separate the small intestine from the surgical site to expose the surgical area, facilitating doctors to perform manual operations calmly and reducing the operation time and complications. Avoid the special position with the head low and the feet high, which may increase the risk of restricted cardiac and respiratory functions in patients and reduce the impact on surgical anesthesia.
To collect more data on the efficacy and safety of this product for abdominal surgery, it is planned to conduct this post-market clinical study. This clinical study will adhere to the Good Clinical Practice for Medical Devices and relevant laws and regulations, and strictly implement the clinical research protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥22 years old, gender not limited.
- •Patients with rectal and lower sigmoid colon tumors who underwent laparoscopic AR/LAR surgery.
- •Patients with a BMI of ≥25 agreed to participate in this trial and signed the informed consent form.
- •The distance between the tumor and the anus as measured by enteroscopy should not exceed 20cm.
排除标准
- •Female patients who have participated in or are currently participating in other clinical studies within 3 months before the operation,
- •Have acute infections,
- •Severe small intestinal adhesions or severe edema,
- •Severe abdominal adhesions,
- •Are known to be allergic to silicone,
- •Have a history of severe allergies or severe immune deficiencies,
- •Are pregnant or lactating.
- •The researcher judged that the patient had poor compliance and was unable to complete the study as required.
- •Due to cognitive impairment, I am unable to understand the researcher's introduction or explanation of this trial.
- •Those who have undergone previous intestinal or pelvic surgery.
- •Tissues removed during surgery, including those with sharp or pointed edges, such as broken bone fragments, are not suitable for use with this instrument.
研究组 & 干预措施
Conventional gauze group
Conventional surgery method
干预措施: sterile gauze (Device)
Intestinal devrce group
Operate using specialized equipment
干预措施: According to the different structures, it is divided into TPYRIB type and TPYRIS type. According to the different outer dimensions of the pocket and the outer sleeve, it is divided into two specificat (Device)
结局指标
主要结局
The main efficacy evaluation index: During the surgery.
时间窗: The subject visit windows are set as follows: Screening period: -7 days, i.e., within 7 days before the surgery Treatment period: 0 days, on the day of the surgery Observation period: 1-7 days after the surgery (including 7 days after the surgery) Follow
Evaluation method: Treatment group: The time from opening and starting to use the disposable small intestinal isolation protection device to completing the retrieval of the disposable small intestinal isolation bag. Control group: From the first time the gauze is opened and used to the time when the last piece of gauze is retrieved.
次要结局
- Evaluation of equipment usage(From the time of enrollment until the end of the 3-month treatment period.)
- Surgical Position Record(From the time of enrollment until the end of the 3-month treatment period.)
- First exhaust time(From the time of enrollment until the end of the 3-month treatment period.)
研究者
Zhongtao Zhang
professor
Beijing Friendship Hospital