Colorectal Cancer
Conditions
Keywords
Single-incision, Laparoscopy, Colorectal Cancer
Brief summary
* Compared with traditional open colectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its short- and long-term oncologic outcomes have been demonstrated. * In experienced surgeons' hands, single incision laparoscopic surgery is increasingly performed for colorectal disease, and even for malignant lesion because of its reduced incision-associated morbidity and scarring. * However, the safety and efficacy of single incision laparoscopic surgery for colorectal cancer has not yet been evaluated. Thus, the prospective randomized trial comparing single incision versus conventional laparoscopic surgery for colorectal cancer is needed.
Interventions
PROCEDURESingle incision laparoscopic surgery
PROCEDUREConventional laparoscopic surgery
Sponsors
Guoxin Li
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 rectosigmoid (defined as 10- to 30-cm from the anal verge) * Pathological rectosigmoid carcinoma * Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual * Tumor size of 5 cm or less; 6) ECOG score is 0-1 * ASA socre is Ⅰ-Ⅲ * Informed consent
Exclusion criteria
* Body mass index (BMI) \>30 kg/m2 * Pregnant woman or lactating woman * Severe mental disease * Previous abdominal surgery * 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 | The early morbidity rate is defined as the event observed during operation and within 30 days after surgery, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological outecomes | 5 days | Tumor size, length of proximal and distal margin and lymph nodes harvested are used to assess oncological resection. |
| Postoperative recovery course | 14 days | Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recoverty course. |
| Pain score | 14 days | Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day 1, 2, 3 and the day of discharge. |
| Operative outcomes | intraoperative | Operative time, estimated blood loss and incision length are recorded. |
| 3-year disease free survival rate | 36 months | — |
| 5-year overall survival rate | 60 months | — |
| Inflammatory and immune response | 7 days | — |
| Cosmetic assessment | 14 days | Cosmetic assessment is perform using body image scale and cosmetic scale. |
Countries
China
Contacts
Primary ContactGuoxin Li, M.D., PH.D.
Backup ContactYanan Wang, M.D.
Outcome results
None listed