Colorectal Cancer, Colonic Neoplasms, Rectal Neoplasms, Colon Disease, Colon Cancer, Rectal Cancer, Rectal Diseases
Conditions
Keywords
SILS, colorectal cancer
Brief summary
This study is designed to evaluate the short-term and long-term results after single incision laparoscopic surgery for colorectal cancer（SILSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）.
Detailed description
In order to improve cosmetic effect and reduce postoperative pain, single-incision laparoscopic surgery (SILS) is attracting increasing attention. SILS is considered to be the next major advance in the progress of minimally invasive surgical approaches to colorectal disease that is more feasible in generalized use. In most previous studies, SILS for colorectal cancer was feasible and short-term safe compared to conventional laparoscopic surgery (CLS) . However, there is still controversy over its potential better cosmetic effect and less postoperative pain. Moreover, the long-term oncologic outcomes are still inconclusive as only a few studies showed long-term survival data. Up to now, most studies were limited to their retrospective nature and small samples. So more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for SILS for colorectal cancer.
Interventions
PROCEDURESingle-incision Laparoscopic Surgery
Patients undergo single-incision laparoscopic surgery. In this group，the surgery is performed through a transumbilical port. The surgeon will adjust surgical position to expose the operative field with the help of gravity. Besides，hand over hand cross and parallel techniques are needed to achieve the SILS. All the other operative procedures are the same as conventional laparoscopic surgery.
PROCEDUREConventional Laparoscopic Surgery
Patients undergo conventional laparoscopic surgery. In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.
Sponsors
Changhai Hospital
Fudan University
RenJi Hospital
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: * 18 years \< age ≤85 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 8th 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) \>35 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 |
|---|---|---|
| Postoperative complications | 30 days after surgery | Postoperative complications rate 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | 1-14 days after surgery | Duration of hospital stay（days after surgery） |
| Postoperative recovery course | 1-14 days after surgery | Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery） |
| Operative time | intraoperative | Operative time（minutes） |
| Intraoperative blood loss | intraoperative | Estimated blood loss（milliliters，ml） |
| Incision length | intraoperative | Incision length（centimeters，cm） |
| Tumor size | 14 days after surgery | The diameter of tumors（centimeters，cm） |
| Incisal margin | 14 days after surgery | Length of proximal and distal margin （centimeters，cm） |
| 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 |
| Lymph node detection | 14 days after surgery | Lymph nodes harvested（numbers） |
Countries
China
Outcome results
None listed