Colorectal Cancer, Colon Cancer, Rectal Cancer
Conditions
Keywords
single-incision laparoscopic surgery, conventional laparoscopic surgery, colorectal cancer
Brief summary
This study is designed to investigate long-term oncologic outcomes of single-incision laparoscopic surgery (SILS) compared to conventional laparoscopic surgery (CLS) for colorectal cancer.
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
In this group，the surgery is performed through a single incision. 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
In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.
Sponsors
Dongfang Hospital Affiliated to Tongji University
Fudan University
Changhai Hospital
Shengjing Hospital
RenJi Hospital
Liaoning Cancer Hospital & Institute
Zhejiang Provincial People's Hospital
Shandong Provincial Hospital
The General Hospital of Western Theater Command
Shanghai Jiao Tong University School of Medicine
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
* 18 years \< age ≤85 years * Tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection) * Pathological or highly suspected 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 * Familial adenomatous polyposis (FAP) * Inflammatory bowel disease (IBD) * Multiple malignant colorectal tumors * Pregnant woman or lactating woman * Severe mental disease * Previous gastrointestinal surgery (except appendectomy ） * Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer * Requirement of simultaneous surgery for other disease * Simultaneous or metachronous multiple cancers with disease-free survival ≤ 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease free survival rate | 36 months after surgery | 3-year disease free survival rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss | intraoperative | Estimated blood loss（milliliters，ml） |
| Incision length | intraoperative | Incision length（centimeters，cm） |
| Total incision length | intraoperative | The sum of all incision lengths（centimeters，cm） |
| Conversion rate | intraoperative | The proportion of converted to laparotomy and added trocars（%） |
| Length of stay | 1-14 days after surgery | The postoperative day when patients complied with the predefined discharge criteria（days after surgery） |
| Postoperative recovery course | 1-14 days after surgery | Time to first ambulation, flatus, liquid diet and semi-liquid diet （hours after surgery） |
| Early morbidity rate | 30 days after surgery | morbidity rate 30 days after surgery |
| Operative time | intraoperative | Operative time（minutes） |
| 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） |
| Lymph node detection | 14 days after surgery | Lymph nodes harvested（numbers） |
| Cosmetic effect | 1 month, 6 months and 1 year after surgery | Assessed using a Beauty Questionnaire evaluating patient's satisfaction according to a 5-scale score, ranging from ''Not satisfied at all'' to ''Very satisfied'' |
| The quality of life-Core | 1 month, 6 months and 1 year after surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) |
| The quality of life-Colorectal | 1 month, 6 months and 1 year after surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29) |
| 5-year overall survival rate | 60 months after surgery | 5-year overall survival rate |
| 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 |
Countries
China
Contacts
Primary ContactRen Zhao, MD, PHD
Backup ContactKun Liu, MD
Outcome results
None listed