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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tubeless NOSES; Traditional Laparoscopic Radical Resection; Rectosigmoid Cancers
• Intervention / Treatment: Procedure: Tubeless NOSES; Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 458
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanxin Luo, MD，PHD; Phone Number: 86-13826190263; Email: luoyx25@mail.sysu.edu.cn
• Study Contact Backup: Name: Jinxin Lin, MD，PHD; Phone Number: 86-18998815200; Email: linjx69@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • GuangZhou, Guangdong, China
      • Recruiting
      • The Sixth Affiliate Hospital of Sun Yat-Sen University
      • Contact: Jinxin Lin, PhD,MD; Phone Number: 86-18998815200; Email: linjx69@mail2.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tubeless NOSES; Patients receive Tubeless NOSES.	Procedure: Tubeless NOSES; 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).
ACTIVE_COMPARATOR: traditional laparoscopic; Patients receive traditional laparoscopic radical resection.	Procedure: traditional laparoscopic radical resection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Investigators: Study Chair: Yanxin Luo, phD, The Sixth Affiliate Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ANTICIPATED): July 31, 2025
• Study Completion (ANTICIPATED): July 31, 2027

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 28, 2019
• First Posted (ACTUAL): July 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Tubeless NOSES; traditional laparoscopic radical resection; Rectosigmoid Cancers
• Other Study ID Numbers: SixthSunYetSen-Lyx

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No