Three-port Versus Conventional Laparoscopic Surgery for Colorectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Procedure: Three-port Laparoscopic SurgeryProcedure: Conventional Laparoscopic Surgery
- Registration Number
- NCT03426514
- Lead Sponsor
- Ruijin Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 282
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Three-port Laparoscopic Surgery Three-port Laparoscopic Surgery Patients with colorectal cancer undergo three-port laparoscopic surgery. Conventional Laparoscopic Surgery Conventional Laparoscopic Surgery Patients with colorectal cancer undergo conventional laparoscopic surgery（4 or more ports）.
- Primary Outcome Measures
Name Time Method Early morbidity rate 30 days after surgery morbidity rate 30 days after surgery
- Secondary Outcome Measures
Name Time Method Lymph node detection 14 days after surgery Lymph nodes harvested（numbers）
Postoperative recovery course 1-14 days after surgery Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）
Distal resection margin 14 days after surgery Length of distal margin （centimeters，cm）
3-year disease free survival rate 36 months after surgery 3-year disease free survival rate
5-year overall survival rate 60 months after surgery 5-year overall survival rate
Proximal resection margin 14 days after surgery Length of proximal margin （centimeters，cm）
Length of stay 1-14 days after surgery Duration of hospital stay（days after surgery）
Pain score 1-3 days after surgery Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3 and the day of discharge
Operative time intraoperative Operative time（minutes）
Intraoperative blood loss intraoperative Estimated blood loss（milliliters，ml）
Trial Locations
- Locations (1)
Ruijin Hospital
🇨🇳Shanghai, Shanghai, China