Status:
RECRUITING
Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Dongfang Hospital Affiliated to Tongji University
Fudan University
Conditions:
Colorectal Cancer
Colon Cancer
Eligibility:
All Genders
18-85 years
Phase:
NA
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
710 Patients enrolled
Trial Details
Trial ID
NCT04527861
Start Date
April 8 2021
End Date
April 1 2029
Last Update
October 10 2022
Active Locations (11)
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1
The 940th Hospital of Joint Logistic Support Force of Chinese of PLA
Lanzhou, Gansu, China, 730050
2
Shengjing Hospital
Shenyang, Liaoning, China, 110004
3
Liaoning Tumor Hospital & Institute
Shenyang, Liaoning, China, 110801
4
Shandong Provincial Hospital
Jinan, Shandong, China, 250021