NCT06943690Not yet recruiting
Safety and Efficacy Study of Single-port Robotic Versus Multi-port Robotic Radical Rectal Cancer Surgery
Safety and Efficacy Study of Single-port Robotic Versus Multi-port Robotic Radical Rectal Cancer Surgery: A Multi-center, Prospective, Open Label, Non-inferiority, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 24 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is designed to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 212 (estimated)
- First submitted
- 17 Apr 2025
- Start date
- May 2025
- Primary completion date
- Jun 2026
- Lead sponsor
- Ruijin Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06943690
What you commit to
- Study type: Interventional
- Planned participants: 212
- From May 2025 to the primary completion date, Jun 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous gastrointestinal surgery (except appendectomy ）
Other illness
- Inflammatory bowel disease (IBD)
- Multiple malignant colorectal tumors
- Severe mental disease
- Combination of intestinal obstruction, bleeding, perforation requiring emergency surgery
- Requirement of simultaneous surgery for other disease
- Serious disorders of liver and kidney function, coagulation function, or severe underlying diseases that cannot tolerate the surgery.
Other
- Body mass index (BMI) \>35 kg/m2
- Familial adenomatous polyposis (FAP)
- Pregnant woman or lactating woman
- Patients or family members who cannot understand the study program.
Who the study is looking for
- 18 years \< age ≤80 years
- Tumor located in the mid to high rectum (lower edge of tumor ≥ 5 cm from anal verge)
- Pathological rectal carcinoma
- Clinically diagnosed c/ycT1-3N0-1M0 lesions according to the 8th Edition of AJCC Cancer Staging Manual
- Tumor size of 10 cm or less
- No history of other malignant tumors
- ECOG score is 0-1
- ASA score is Ⅰ-Ⅲ
- Informed consent
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong Provincial Hospital Affiliated to Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The First Affiliated Hospital of Henan University of Science &Technology Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.