Disposable Intestinal Isolation and Protection Device for Patients With Rectal and Lower Sigmoid Colon Tumors Undergoing Laparoscopic AR/LAR Surgery

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.

Sex

All

Minimum age

22 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.