NCT02635503RecruitingPhase 3
A Prospective Randomized Controlled Trial Comparing Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) Versus Conventional Laparoscopic Surgery for Sigmoid Colon or Rectal Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 site in 1 country366 target enrollmentStarted: November 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 366
- Locations
- 1
- Primary Endpoint
- Early morbidity rate
Study Overview
Brief Summary
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.
Detailed Description
Further study details as provided by Chinese Academy of Medical Sciences.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Early morbidity rate
Time Frame: 30 days
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery.
Secondary Outcomes
- Duration of the intervention(1 day)
- Peritoneal bacterial contamination(1 day)
- Pain score(14 days)
- 3-year disease free survival rate(3 years)
- 5-year overall survival rate(5 years)
- Plasma levels of several cytokines after colorectal cancer surgery(7 days)
Investigators
Zhixiang Zhou
director of Colorectal surgical Department
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Sites (1)
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