An interventional study of Three-port Laparoscopic Surgery and Conventional Laparoscopic Surgery in Colorectal Cancer, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-13.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
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）.
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.
Exclusion Criteria:
Patients with colorectal cancer undergo three-port laparoscopic surgery.
Procedure: Three-port Laparoscopic Surgery
Patients with colorectal cancer undergo conventional laparoscopic surgery（4 or more ports）.
Procedure: Conventional Laparoscopic Surgery
Patients undergo three-port laparoscopic surgery. The surgery will be completed by a surgeon and a camera-person without another assistant. The surgeon will adjust surgical position to expose the operative field with the help of gravity. All the orther operative procedures are the same as conventional laparoscopic surgery.
Patients undergo conventional laparoscopic surgery（4 or more ports）.The surgery will be routinely completed by a surgeon，a camera-person and another assistant to provide counter-traction.
Early morbidity rate
morbidity rate 30 days after surgery
Time frame: 30 days after surgery
Operative time
Operative time（minutes）
Time frame: intraoperative
Intraoperative blood loss
Estimated blood loss（milliliters，ml）
Time frame: intraoperative
Lymph node detection
Lymph nodes harvested（numbers）
Time frame: 14 days after surgery
Proximal resection margin
Length of proximal margin （centimeters，cm）
Time frame: 14 days after surgery
Distal resection margin
Length of distal margin （centimeters，cm）
Time frame: 14 days after surgery
Length of stay
Duration of hospital stay（days after surgery）
Time frame: 1-14 days after surgery
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）
Time frame: 1-14 days after surgery
Pain score
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
Time frame: 1-3 days after surgery
3-year disease free survival rate
3-year disease free survival rate
Time frame: 36 months after surgery
5-year overall survival rate
5-year overall survival rate
Time frame: 60 months after surgery
Plan to share: No
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Ruijin Hospital