Status:
RECRUITING
Tubeless NOSES Versus Laparoscopic Radical Resection for Rectosigmoid Cancers
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Tubeless NOSES
Traditional Laparoscopic Radical Resection
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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.
Detailed 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 radica...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT04037956
Start Date
June 1 2019
End Date
July 31 2027
Last Update
March 31 2022
Active Locations (1)
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1
The Sixth Affiliate Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China