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Laparoscopic natural orifice specimen extraction surgery (NOSES) for low rectal cancer has a good minimally invasive effect. However, the NOSES prognosis studies are all small sample retrospective studies. This study conducted a multicenter prospective randomized controlled trial of NOSES surgery for low rectal cancer to compare the difference in surgical outcomes between conventional laparoscopic surgery and NOSES surgery for low rectal cancer. A total of 500 patients were planned to be enrolled, including 250 in the control group and 250 in the experimental group. The primary end point was 2-year disease-free survival (DFS), and the secondary end points were surgical safety, postoperative pathology, postoperative defecation, urination, and sexual function. Through a large sample size study, this study aims to clarify the advantages of NOSE surgery for low rectal cancer, promote the promotion of low rectal cancer NOSES surgery in the country, standardize the way of low rectal cancer NOSES surgery, improve the surgical treatment of patients with low rectal cancer, improve the quality of life of patients, reduce the burden of patients, and increase the satisfaction. And improve the international influence of the project team in the field of minimally invasive surgical treatment of colorectal cancer.
Research Objectives:
Primary end Point: 2-year Disease-free survival (DFS) Secondary end points :(1) incidence of SSI; (2) Incidence of serious postoperative complications (anastomotic leakage, postoperative bleeding, etc.); (3) R0 removal rate; (4) Postoperative recovery (pain, exhaust and defecation time, eating time, postoperative hospital stay, etc.); (5) Postoperative pathological conditions (distance between upper and lower margins, number of lymph nodes, circumferential margins, etc.); (6) 2-year RFS and OS.
Exploratory end points :(1) prophylactic colostomy rate; (2) Positive rate of tumor cells in pelvic flushing fluid.
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Exclusion criteria:
Exit Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natural Orifice Specimen Extraction Surgery Group | Experimental | The patient underwent laparoscopic lower rectal cancer surgery with transanal specimen collection |
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| Traditional laparoscopic surgery | No Intervention | The patient underwent conventional laparoscopic lower rectal cancer surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic radical resection of low rectal cancer with transanal specimens | Procedure | According to the standard laparoscopic anterior rectum resection, the rectum was separated 2-3cm below the tumor, the rectum was severed 1-2cm from the lower edge of the tumor, the rectal stump was connected with the tumor through the anus, and the sigmoid colon was severed 10cm from the upper edge of the tumor. The stapler head was placed in the sigmoid colon stump, and then the sigmoid colon stump was closed with a linear cutting closure device. Then, the sigmoid colon stump is returned to the abdominal cavity through the anus, the distal rectal stump is closed with a suture purse or a linear cutting closure device, and the stapler body is inserted through the anus, and then the anastomosis is completed. |
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival rate | After the postoperative review, the patient had no tumor recurrence and metastasis | 2-year |
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Inclusion Criteria:
Exclusion Criteria:
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Randomized, controlled, multicenter, noninferiority clinical study
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