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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
710
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.
In this group,the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.
The 940th Hospital of Joint Logistic Support Force of Chinese of PLA
Lanzhou, Gansu, China
RECRUITINGShengjing Hospital
Shenyang, Liaoning, China
RECRUITING3-year disease free survival rate
3-year disease free survival rate
Time frame: 36 months after surgery
Operative time
Operative time(minutes)
Time frame: intraoperative
Intraoperative blood loss
Estimated blood loss(milliliters,ml)
Time frame: intraoperative
Incision length
Incision length(centimeters,cm)
Time frame: intraoperative
Total incision length
The sum of all incision lengths(centimeters,cm)
Time frame: intraoperative
Conversion rate
The proportion of converted to laparotomy and added trocars(%)
Time frame: intraoperative
Length of stay
The postoperative day when patients complied with the predefined discharge criteria(days after surgery)
Time frame: 1-14 days after surgery
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and semi-liquid diet (hours after surgery)
Time frame: 1-14 days after surgery
Early morbidity rate
morbidity rate 30 days after surgery
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Liaoning Tumor Hospital & Institute
Shenyang, Liaoning, China
RECRUITINGShandong Provincial Hospital
Jinan, Shandong, China
RECRUITINGThe General Hospital of Western Theater Command
Chengdu, Sichuan, China
RECRUITINGZhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGShanghai Cancer Center
Shanghai, China
RECRUITINGDongfang Hospital Affiliated to Tongji University
Shanghai, China
RECRUITINGRenJi Hospital
Shanghai, China
RECRUITINGChanghai Hospital
Shanghai, China
RECRUITING...and 1 more locations
Time frame: 30 days after surgery
Pain score
Postoperative pain is recorded using the visual analog scale (VAS) pain score (0-10 points)tool on postoperative day 1, 2, 3
Time frame: 1-3 days after surgery
Tumor size
The diameter of tumors(centimeters,cm)
Time frame: 14 days after surgery
Incisal margin
Length of proximal and distal margin (centimeters,cm)
Time frame: 14 days after surgery
Lymph node detection
Lymph nodes harvested(numbers)
Time frame: 14 days after surgery
Cosmetic effect
Assessed using a "Beauty Questionnaire" evaluating patient's satisfaction according to a 5-scale score, ranging from ''Not satisfied at all'' to ''Very satisfied''
Time frame: 1 month, 6 months and 1 year after surgery
The quality of life-Core
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time frame: 1 month, 6 months and 1 year after surgery
The quality of life-Colorectal
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29)
Time frame: 1 month, 6 months and 1 year after surgery
5-year overall survival rate
5-year overall survival rate
Time frame: 60 months after surgery