Tubeless NOSES Versus Laparoscopic Radical Resection for Rectosigmoid Cancers

NCT ID: NCT04037956

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 458 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2027-07-31

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.

Conditions

Tubeless NOSES; Traditional Laparoscopic Radical Resection; Rectosigmoid Cancers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tubeless NOSES

Patients receive Tubeless NOSES.

Group Type: EXPERIMENTAL

Tubeless NOSES

Intervention Type: PROCEDURE

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).

traditional laparoscopic

Patients receive traditional laparoscopic radical resection.

Group Type: ACTIVE_COMPARATOR

traditional laparoscopic radical resection

Intervention Type: PROCEDURE

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanxin Luo,MD

Deputy Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanxin Luo, phD

Role: STUDY_CHAIR

The Sixth Affiliate Hospital of Sun Yat-Sen University

Locations

The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanxin Luo, MD，PHD

Role: CONTACT

luoyx25@mail.sysu.edu.cn

86-13826190263

Jinxin Lin, MD，PHD

Role: CONTACT

linjx69@mail2.sysu.edu.cn

86-18998815200

Facility Contacts

Yanxin Luo, PhD,MD

Role: primary

luoyx25@mail.sysu.edu.cn

86-13826190263

Jinxin Lin, PhD,MD

Role: backup

linjx69@mail2.sysu.edu.cn

86-18998815200

Other Identifiers

SixthSunYetSen-Lyx

Identifier Type: -

Identifier Source: org_study_id