Tubeless NOSES Versus Laparoscopic Radical Resection for Rectosigmoid Cancers (CORNER)

Sun Yat-sen University

Status: Enrolling

Conditions: Traditional Laparoscopic Radical Resection; Tubeless NOSES; Rectosigmoid Cancers

Treatments: Procedure: traditional laparoscopic radical resection; Procedure: Tubeless NOSES

Study type: Interventional

Funder types: Other

Identifiers

NCT04037956

SixthSunYetSen-Lyx

Details and patient eligibility

About

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.

Full 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.

Enrollment: 458 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically or cytologically confirmed Rectosigmoid Cancers
2. Clinical stage at T 1-3 N0-2 M0
3. Tumors on peritoneal reflection，Tumor size is no more than 3 cm
4. Eastern Cooperative Oncology Group (ECOG) scale is 0-2
5. American Society of Anesthesiologists (ASA) score is Ⅰ-Ⅲ
6. BMI ≤ 30 kg/m2
7. Subjects must be willing and able to comply with scheduled visits, treatment schedule,and laboratory testing.

Exclusion criteria

1. Heart, lung, liver or renal or any organ function that are intolerance for surgery
2. History of treated colorectal malignant disease
3. Subjects with medical condition, such as intestinal obstruction, intestinal perforation, bleeding, requires emergency surgery
4. Subjects with previous malignancies
5. History of inflammatory bowl disease(IBD) or familial adenomatous polyposis (FAP)
6. Treatment with any other clinical trial within 28 days prior to randomization
7. History of severe mentally disease
8. pregnant or lactating women
9. The researchers believe that the patients are unsuitable to participate in the researchers with other cases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

458 participants in 2 patient groups

Tubeless NOSES

Experimental group

Description:

Patients receive Tubeless NOSES.

Treatment:

Procedure: Tubeless NOSES

traditional laparoscopic

Active Comparator group

Description:

Patients receive traditional laparoscopic radical resection.

Treatment:

Procedure: traditional laparoscopic radical resection