Status:
NOT_YET_RECRUITING
Safety and Efficacy Study of Single-port Robotic Versus Multi-port Robotic Radical Rectal Cancer Surgery
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Shandong Provincial Hospital
First Affiliated Hospital of Wenzhou Medical University
Conditions:
Rectal Cancer
Surgery
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study is designed to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.
Detailed Description
Surgical robots were born in the 1980s and have the advantages of being precise, flexible, less invasive and remotely operable than traditional surgical methods. The single-port robot is a further ext...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Body mass index (BMI) \>35 kg/m2
- 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 ）
- 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.
- Patients or family members who cannot understand the study program.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT06943690
Start Date
May 1 2025
End Date
June 1 2027
Last Update
April 24 2025
Active Locations (4)
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1
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China, 471003
2
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China, 250021
3
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 201801
4
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000