Oncologic Outcomes of Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer: A Multi-center, Prospective, Open Label, Non-inferiority, Randomized Controlled Trial
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
The General Hospital of Western Theater Command
RECRUITING
Chengdu
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Shandong Provincial Hospital
RECRUITING
Jinan
The 940th Hospital of Joint Logistic Support Force of Chinese of PLA
RECRUITING
Lanzhou
Changhai Hospital
RECRUITING
Shanghai
Dongfang Hospital Affiliated to Tongji University
RECRUITING
Shanghai
RenJi Hospital
RECRUITING
Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Shanghai Cancer Center
RECRUITING
Shanghai
Liaoning Tumor Hospital & Institute
RECRUITING
Shenyang
Shengjing Hospital
RECRUITING
Shenyang
Contact Information
Primary
Ren Zhao, MD, PHD
zhaorensurgeon@aliyun.com
+8618917762018
Backup
Kun Liu, MD
lookiere@126.com
+8618121263082
Time Frame
Start Date: 2021-04-08
Estimated Completion Date: 2029-04
Participants
Target number of participants: 710
Treatments
Experimental: Single-incision Laparoscopic Surgery
Patients with colorectal cancer undergo single-incision laparoscopic surgery.
Active_comparator: Conventional Laparoscopic Surgery
Patients with colorectal cancer undergo conventional laparoscopic surgery（3\~5 ports）.
Related Therapeutic Areas
Sponsors
Collaborators: Liaoning Cancer Hospital & Institute, Shengjing Hospital, RenJi Hospital, Shanghai Jiao Tong University School of Medicine, Fudan University, Dongfang Hospital Affiliated to Tongji University, Changhai Hospital, The General Hospital of Western Theater Command, Shandong Provincial Hospital, Zhejiang Provincial People's Hospital
Leads: Ruijin Hospital