Tubeless NOSES Versus Laparoscopic Radical Resection for Rectosigmoid Cancers

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Perspective Study to Compare the Tubeless NOSES and Traditional Laparoscopic Radical Resection in Rectosigmoid Cancers (CORNER)

Conditions
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Tubeless NOSES, Traditional Laparoscopic Radical Resection, Rectosigmoid Cancers

Intervention / Treatment
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* Procedure: Tubeless NOSES
* Procedure: traditional laparoscopic radical resection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tubeless NOSES<br>Patients receive Tubeless NOSES. | Procedure: Tubeless NOSES<br>* 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).<br>|
| Active Comparator: traditional laparoscopic<br>Patients receive traditional laparoscopic radical resection. | Procedure: traditional laparoscopic radical resection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival rate |  | 36 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year overall survival rate |  | 60 months after surgery | 
| Incidence of postoperative complications | All postoperative complications in the perioperative period will be classified by the Clavien-Dindo classification. | 1 month after surgery | 
| the functional outcome of defecation | Anal incontinence was evaluated using the Wexner Continence Grading Scale , the score being calculated after the patients' completion of a daily defecatory questionnaire. Range is from 0 (normal continence) to 20 (maximum incontinence with maximum disturbance of lifestyle). | 60 months after surgery | 
| the operation time | The descriptive unit would be minute (min). | in the perioperative period | 
| the blood loss during the operation | The descriptive unit would be millilitre (ml) | in the perioperative period | 
| Postoperative recovery of intestinal peristalsis | The descriptive unit would be hour (h). | in the perioperative period | 
| Pain score | A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain ( from 0 to 10). | in the perioperative period | 
| number of cases converted to laparotomy | The procedure for cases who underwent traditional laparoscopic radical resection for those who cannot be done with traditional laparoscopic radical resection or Tubless NOSES and convert to laparotomy as a result，these should be recorded and compared within two experimental arms. | in the perioperative period | 
| the mean postoperative hospitalization day | The descriptive unit would be day (d). | in the perioperative period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tubeless NOSES, traditional laparoscopic radical resection, Rectosigmoid Cancers