Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Recruiting now · Not applicable
Conditions studied: Colorectal Cancer, Colon Cancer, Rectal Cancer
In brief
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.
Key facts
- Study ID
- NCT04527861
- Run by
- Ruijin Hospital
- People needed
- 710
- Starts
- 2021-04-08
- Expected to finish
- 2029-04-01
- Last updated by the study team
- 2022-10-10
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- The 940th Hospital of Joint Logistic Support Force of Chinese of PLA — Lanzhou, Gansu, China (enrolling)
- Shengjing Hospital — Shenyang, Liaoning, China (enrolling)
- Liaoning Tumor Hospital & Institute — Shenyang, Liaoning, China (enrolling)
- Shandong Provincial Hospital — Jinan, Shandong, China (enrolling)
- The General Hospital of Western Theater Command — Chengdu, Sichuan, China (enrolling)
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (enrolling)
- Shanghai Cancer Center — Shanghai, China (enrolling)
- Dongfang Hospital Affiliated to Tongji University — Shanghai, China (enrolling)
- RenJi Hospital — Shanghai, China (enrolling)
- Changhai Hospital — Shanghai, China (enrolling)
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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