Overview
This study is designed to evaluate the short-term and long-term results after Tubeless NOSES for the resection of Rectosigmoid Cancers compared with traditional laparoscopic radical resection.
Description
This is a randomized, single-center, open-label, non- inferiority study designed to evaluate the safety, efficacy and potential benefits of Tubeless NOSES compared with traditional laparoscopic radical resection in approximately 458 subjects with Rectosigmoid Cancers.
Eligibility
Inclusion Criteria:
- Histologically or cytologically confirmed Rectosigmoid Cancers
- Clinical stage at T 1-3 N0-2 M0
- Tumors on peritoneal reflection,Tumor size is no more than 3 cm
- Eastern Cooperative Oncology Group (ECOG) scale is 0-2
- American Society of Anesthesiologists (ASA) score is Ⅰ-Ⅲ
- BMI ≤ 30 kg/m2
- Subjects must be willing and able to comply with scheduled visits, treatment schedule,and laboratory testing.
Exclusion Criteria:
- Heart, lung, liver or renal or any organ function that are intolerance for surgery
- History of treated colorectal malignant disease
- Subjects with medical condition, such as intestinal obstruction, intestinal perforation, bleeding, requires emergency surgery
- Subjects with previous malignancies
- History of inflammatory bowl disease(IBD) or familial adenomatous polyposis (FAP)
- Treatment with any other clinical trial within 28 days prior to randomization
- History of severe mentally disease
- pregnant or lactating women
- The researchers believe that the patients are unsuitable to participate in the researchers with other cases.