Laparoscopic Colorectal Surgery
Conditions
Keywords
SILS, colorectal cancer
Brief summary
Single incision laparoscopic surgery (SILS) is the further development of the concept of minimally invasive surgery for colorectal cancer,which rapidly developed in the field of colorectal surgery. Through the development of single hole laparoscopic colorectal cancer radical surgery and clinical study and follow up accordingly, evaluating the feasibility, surgical effectiveness and economy help to promote the popularization and application of single hole laparoscopic techniques in the field.
Detailed description
The patients with colorectal cancer will randomly divided into single incision laparoscopic surgery group and conditional laparoscopic surgery group. The operation time, blood loss, the incidence of lymph node , the number of postoperative complications, the gastrointestinal function recovery time, postoperative hospital stay，the number of local recurrence and distant metastasis, survival rate and the total cost of hospitalization will be evaluated to confirm the feasibility of single incision laparoscopic surgery is effective and economical. It is worthy of clinical application.
Interventions
PROCEDUREsingle incision laparoscopic surgery
Patients undergo single incision laparoscopic surgery
PROCEDUREconventional laparoscopic surgery
Patients undergo 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
No
Inclusion criteria
* 18 years \< age \< 80 years * 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 * Tumor size of 5 cm or less * ECOG score is 0-1 * ASA score is Ⅰ-Ⅲ * Informed consent
Exclusion criteria
* Body mass index (BMI) \>30 kg/m2 * The lower border of the tumor is located distal to the peritoneal reflection * Pregnant woman or lactating woman * Severe mental disease * Previous abdominal surgery（except appendectomy and cholecystotomy） * 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 | morbidity rate 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss | intraoperative | Estimated blood loss（milliliters，ml） |
| Incision length | intraoperative | Incision length（centimeters，cm） |
| Lymph node detection | 14 days after surgery | Lymph nodes harvested（numbers） |
| Incisal margin | 14 days after surgery | Length of proximal and distal margin （centimeters，cm） |
| Tumor size | 14 days after surgery | The diameter of tumors（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
Outcome results
None listed