Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Recruiting · NCT04527861 · Interventional (participants receive a specific treatment) · Lead sponsor: Ruijin Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Conventional Laparoscopic SurgerySingle-incision Laparoscopic Surgery
What this trial is about
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.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
11 locations listed.
- 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
- The 940th Hospital of Joint Logistic Support Force of Chinese of PLA - Lanzhou, Gansu, China
- Shengjing Hospital - Shenyang, Liaoning, China
- Liaoning Tumor Hospital & Institute - Shenyang, Liaoning, China
- Shandong Provincial Hospital - Jinan, Shandong, China
- The General Hospital of Western Theater Command - Chengdu, Sichuan, China
- Zhejiang Provincial People's Hospital - Hangzhou, Zhejiang, China