NCT04527861 Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
| NCT ID | NCT04527861 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 710 participants |
| Start Date | 2021-04-08 |
| Primary Completion | 2024-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 710 participants in total. It began in 2021-04-08 with a primary completion date of 2024-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Ren Zhao, MD, PHD
PRINCIPAL INVESTIGATOR
Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine
Frequently Asked Questions
Who can join the NCT04527861 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04527861 currently recruiting?
Yes, NCT04527861 is actively recruiting participants. Contact the research team at zhaorensurgeon@aliyun.com for enrollment information.
Where is the NCT04527861 trial being conducted?
This trial is being conducted at Lanzhou, China, Shenyang, China, Shenyang, China, Jinan, China and 7 additional locations.
Who is sponsoring the NCT04527861 clinical trial?
NCT04527861 is sponsored by Ruijin Hospital. The principal investigator is Ren Zhao, MD, PHD at Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine. The trial plans to enroll 710 participants.
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