Clinical trial NCT04037956: Tubeless NOSES Versus Laparoscopic Radical Resection for Rectosigmoid Cancers
Official title: A Perspective Study to Compare the Tubeless NOSES and Traditional Laparoscopic Radical Resection in Rectosigmoid Cancers (CORNER)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tubeless NOSES
Traditional Laparoscopic Radical Resection
Rectosigmoid Cancers
Keywords: Tubeless NOSES
traditional laparoscopic radical resection
Rectosigmoid Cancers
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 radical resection in approximately 458 subjects with Rectosigmoid Cancers.

Eligibility criteria: 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.

Primary outcomes:
measure: 3-year disease free survival rate
timeFrame: 36 months after surgery
Secondary outcomes:
measure: 5-year overall survival rate
timeFrame: 60 months after surgery
measure: Incidence of postoperative complications
timeFrame: 1 month after surgery
measure: the functional outcome of defecation
timeFrame: 60 months after surgery
measure: the operation time
timeFrame: in the perioperative period
measure: the blood loss during the operation
timeFrame: in the perioperative period
measure: Postoperative recovery of intestinal peristalsis
timeFrame: in the perioperative period
measure: Pain score
timeFrame: in the perioperative period
measure: number of cases converted to laparotomy
timeFrame: in the perioperative period
measure: the mean postoperative hospitalization day
timeFrame: in the perioperative period
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: The Sixth Affiliate Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: The Sixth Affiliate Hospital of Sun Yat-Sen University
name: Yanxin Luo, phD
role: STUDY_CHAIR
References: