Tubeless NOSES Versus Laparoscopic Radical Resection for Rectosigmoid Cancers
A Perspective Study to Compare the Tubeless NOSES and Traditional Laparoscopic Radical Resection in Rectosigmoid Cancers (CORNER)
Sixth Affiliated Hospital, Sun Yat-sen University
458 participants
Jun 1, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria9
- 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.
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Interventions
The whole procedures undergo by total laparoscopic surgery with no specimen extraction incision in the abdominal wall. The specimen then will be removed through natural orifice such (anal).
The traditional laparoscopic operation undergo and then a small incision(5-8cm) is made in the middle of the lower abdominal wall to remove the specimen.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04037956