Single-center Prospective Randomized Controlled Study of the Three-port Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Ruijin Hospital
- Enrollment
- 282
- Locations
- 1
- Primary Endpoint
- Early morbidity rate
Study Overview
Brief Summary
This study is designed to evaluate the short-term and long-term results after three-port laparoscopic surgery for colorectal cancer（TLSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）.
Detailed Description
At present，surgical treatments is the main means to cure colorectal cancer（CRC）.The use of four or more ports has been routine in most laparoscopic colorectal resections. However，the drawbacks are the need for added manpower, consisting of another assistant to provide counter-traction, as well as costs and the unaesthetic effects of additional ports. In order to minimize surgical trauma, improve cosmesis ,reduce manpower，single-incision laparoscopic surgery (SILS) is attracting increasing attention. But it is challenging and highly demanding techniques. Becoming proficient at three-port laparoscopic surgery can make the transition to SILS more nature.Few studies about three-port laparoscopic surgery for colorectal cancer（TLSC） have been reported currently.More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TLSC. This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 282 eligible patients will be randomly assigned to TLSC group and CLSC group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the the feasibility, safety, and potential benefits of TLSC compared with CLSC.
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
- Yes
Inclusion Criteria
- •Body mass index (BMI) <30 kg/m2
- •Tumor located in colon and high rectum (the lower border of the tumor is above the peritoneal reflection)
- •Pathological colorectal carcinoma
- •Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual with or without neoadjuvant therapeutic history
- •ECOG score is 0-1
- •ASA score is Ⅰ-Ⅲ
- •Informed consent
Exclusion Criteria
- •Previous gastrointestinal surgery
- •History of inflammatory bowel disease
- •History of familial adenomatous polyposis（FAP）
- •Pregnant woman or lactating woman
- •Severe mental disease
- •Intolerance of surgery for severe comorbidities
- •Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
- •Requirement of simultaneous surgery for other disease
Arms & Interventions
Three-port Laparoscopic Surgery
Patients with colorectal cancer undergo three-port laparoscopic surgery.
Intervention: Three-port Laparoscopic Surgery (Procedure)
Conventional Laparoscopic Surgery
Patients with colorectal cancer undergo conventional laparoscopic surgery（4 or more ports）.
Intervention: Conventional Laparoscopic Surgery (Procedure)
Outcomes
Primary Outcomes
Early morbidity rate
Time Frame: 30 days after surgery
morbidity rate 30 days after surgery
Secondary Outcomes
- Lymph node detection(14 days after surgery)
- Postoperative recovery course(1-14 days after surgery)
- Distal resection margin(14 days after surgery)
- Proximal resection margin(14 days after surgery)
- Length of stay(1-14 days after surgery)
- Pain score(1-3 days after surgery)
- 3-year disease free survival rate(36 months after surgery)
- 5-year overall survival rate(60 months after surgery)
- Operative time(intraoperative)
- Intraoperative blood loss(intraoperative)
Investigators
Zhao Ren
Chief Physicion
Ruijin Hospital