Actively Recruiting
Application of the "Off-Clamp And Sutureless" Technique in Robot-Assisted Partial Nephrectomy: A Single-Center, Prospective Cohort Study
Led by Shao Pengfei · Updated on 2025-09-05
190
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new surgical method called the off-clamp sutureless technique for removing small kidney tumors less than 7 cm. This approach aims to preserve kidney function by avoiding clamping of the renal artery and using special techniques to control bleeding instead of traditional stitching. Current evidence mainly comes from smaller, retrospective studies focused on tumors smaller than 4 cm, so this study seeks to provide stronger data for larger or more complex tumors. The study involves patients undergoing robot-assisted partial nephrectomy using the off-clamp sutureless technique. During surgery, the renal artery is not clamped, and the tumor is removed with a small margin. Bleeding is controlled with electrocautery and hemostatic agents instead of sutures. This approach is designed to minimize damage to healthy kidney tissue and simplify the surgical process. Participants will be monitored for kidney function three months after surgery, measuring glomerular filtration rate (GFR) in both kidneys. Researchers will also track complications within one week after surgery and measure blood loss during the operation. The study includes detailed imaging and assessments before and after surgery to evaluate safety and effectiveness. The total participation period includes surgery and follow-up visits to assess recovery and kidney health.
CONDITIONS
Brief Title
Application of the "Off-Clamp And Sutureless" Technique in Robot-Assisted Partial Nephrectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old, regardless of gender
- Radiological findings showing a tumor size of 7 cm or smaller
- Imaging studies showing no invasion of the kidney's collecting system
- Scheduled for robot-assisted partial nephrectomy (RAPN) surgery
You will not qualify if you...
- Evidence of distant metastasis or lymph node involvement on imaging before surgery
- Multiple kidney lesions not suitable for removal at the same time
- Previous systemic therapy such as targeted therapy, immunotherapy, or chemotherapy
- Conversion to radical nephrectomy during surgery
- Conversion to open surgery during the procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and hospital stay
Participants undergo robot-assisted partial nephrectomy using the off-clamp and sutureless technique to remove the tumor while preserving kidney function.
1 surgical visit and immediate post-operative care
Duration - Up to 3 months after surgery
Participants are monitored for recovery and kidney function, including assessment of renal function and complications.
1 follow-up visit at 1 week and 1 visit at 3 months
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, China, 210036
Actively Recruiting
Research Team
P
Pengfei Shao, Professor
H
Haoqi Miao, Postgraduate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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