Colorectal Cancer
Conditions
Keywords
Colorectal cancer, Laparoscopic surgery, Three-port
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.
Interventions
PROCEDUREConventional 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.
PROCEDUREThree-port 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.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early morbidity rate | 30 days after surgery | morbidity rate 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss | intraoperative | Estimated blood loss（milliliters，ml） |
| Lymph node detection | 14 days after surgery | Lymph nodes harvested（numbers） |
| Proximal resection margin | 14 days after surgery | Length of proximal margin （centimeters，cm） |
| Distal resection margin | 14 days after surgery | Length of distal margin （centimeters，cm） |
| Operative time | intraoperative | Operative time（minutes） |
| Postoperative recovery course | 1-14 days after surgery | Time to first ambulation, flatus, liquid diet and soft diet （hours 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 |
| 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 |
| Length of stay | 1-14 days after surgery | Duration of hospital stay（days after surgery） |
Countries
China
Contacts
Primary ContactRen Zhao, MD
Outcome results
None listed