A multi-center, randomized, single-blind, parallel controlled clinical study on the safety and effectiveness of Jingfeng Laparoscopic Surgical System (MP1000) versus Da Vinci Endoscopic Surgical Control System (IS 4000/IS3000)

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: test group:Surgical treatment with Jingfeng laparoscopic surgery system (MP1000) ;control group:Surgical treatment with da Vinci endoscopic surgical control system (IS 4000/IS3000); CONDITION: Urological diseases PRIMARY OUTCOME: Rate of conversion to open surgery, conversion rate to laparoscopy; SECONDARY OUTCOME: operation time; Intraoperative blood loss;complication rate;Positive margin rate;Drainage volume, drainage tube retention time;Proportion of urinary continence immediately after prostate cancer surgery;doctor satisfaction; INCLUSION CRITERIA: 1), 18‐80 years old, male or female; 2), BMI: 18‐30Kg/m2; 3), Prostate cancer patients with radical prostatectomy, clinical stage = T2bN0M0, low‐to‐medium risk prostate cancer patients, patients with renal tumors = 4cm who underwent partial nephrectomy; 4), physiological conditions acceptable for laparoscopic surgery; 5), willing to cooperate and complete the research follow‐up and related inspections; 6), those who voluntarily sign the informed consent.
Epistemonikos ID: bc8414fa4c7743f431017e8a5af46b0a8575fcf5
First added on: Feb 20, 2024