Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
- Conditions
- Rectal CancerColorectal CancerColon Cancer
- Interventions
- Procedure: Single-incision Laparoscopic SurgeryProcedure: Conventional Laparoscopic Surgery
- Registration Number
- NCT04527861
- Lead Sponsor
- Ruijin Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 710
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single-incision Laparoscopic Surgery Single-incision Laparoscopic Surgery Patients with colorectal cancer undergo single-incision laparoscopic surgery. Conventional Laparoscopic Surgery Conventional Laparoscopic Surgery Patients with colorectal cancer undergo conventional laparoscopic surgery（3\~5 ports）.
- Primary Outcome Measures
Name Time Method 3-year disease free survival rate 36 months after surgery 3-year disease free survival rate
- Secondary Outcome Measures
Name Time Method Operative time intraoperative Operative time（minutes）
Incision length intraoperative Incision length（centimeters，cm）
Intraoperative blood loss intraoperative Estimated blood loss（milliliters，ml）
Total incision length intraoperative The sum of all incision lengths（centimeters，cm）
Conversion rate intraoperative The proportion of converted to laparotomy and added trocars（%）
Early morbidity rate 30 days after surgery morbidity rate 30 days after surgery
Lymph node detection 14 days after surgery Lymph nodes harvested（numbers）
Length of stay 1-14 days after surgery The postoperative day when patients complied with the predefined discharge criteria（days after surgery）
Tumor size 14 days after surgery The diameter of tumors（centimeters，cm）
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-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)
Postoperative recovery course 1-14 days after surgery Time to first ambulation, flatus, liquid diet and semi-liquid 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
Incisal margin 14 days after surgery Length of proximal and distal margin （centimeters，cm）
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)
5-year overall survival rate 60 months after surgery 5-year overall survival rate
Trial Locations
- Locations (11)
The 940th Hospital of Joint Logistic Support Force of Chinese of PLA
🇨🇳Lanzhou, Gansu, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Liaoning Tumor Hospital & Institute
🇨🇳Shenyang, Liaoning, China
Shanghai Cancer Center
🇨🇳Shanghai, China
Dongfang Hospital Affiliated to Tongji University
🇨🇳Shanghai, China
RenJi Hospital
🇨🇳Shanghai, China
Changhai Hospital
🇨🇳Shanghai, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
Shengjing Hospital
🇨🇳Shenyang, Liaoning, China
The General Hospital of Western Theater Command
🇨🇳Chendu, Sichuan, China