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Tubeless NOSES Versus Laparoscopic Radical Resection for Rectosigmoid Cancers

Tubeless NOSES Versus Laparoscopic Radical Resection for Rectosigmoid Cancers

Recruiting
18-75 years
All
Phase N/A

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Overview

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.

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

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 details
    Tubeless NOSES
    Traditional Laparoscopic Radical Resection
    Rectosigmoid Cancers

NCT04037956

Sixth Affiliated Hospital, Sun Yat-sen University

27 January 2024

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