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Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer

Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer

Recruiting
18-80 years
All
Phase 3

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Overview

The purpose of this study is to compare the safety and efficacy of laparoscopic resection with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid colon or rectal cancer.

Description

Further study details as provided by Chinese Academy of Medical Sciences.

Eligibility

Inclusion Criteria:

  • 18 years < age < 80 years
  • Tumor located in rectosigmoid (defined as 8- to 30-cm from the anal verge)
  • Pathological rectosigmoid adenocarcinoma
  • Preoperative T stage ranging from T1 to T4a according to the 7th Edition of American Joint Committee on Cancer (AJCC) Staging Manual
  • Tumor size of 6 cm or less;
  • Eastern Cooperative Oncology Group (ECOG) score is 0-1
  • American Society of Anesthesiology (ASA) score is Ⅰ-Ⅲ
  • Informed consent

Exclusion Criteria:

  • Body mass index (BMI) >30 kg/m2
  • Pregnant woman or lactating woman
  • Severe mental disease
  • Previous abdominal surgery
  • Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
  • Requirement of simultaneous surgery for other disease

Study details
    Colorectal Cancer

NCT02635503

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

27 January 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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