Skip to content

Clinical trial to evaluate the effectiveness and safety of laparoscopic urology assisted by abdominal endoscopic surgery system

Clinical trial to evaluate the effectiveness and safety of laparoscopic urology assisted by abdominal endoscopic surgery system

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075886
Enrollment
Unknown
Registered
2023-09-19
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer, kidney cancer

Interventions

Radical prostatectomy group/Partial nephrectomy group:Abdominal endoscopic surgery system

Sponsors

The First Hospital of Peking University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Prostate cancer: tumor TNM stage =T2N0M0, and those who received neoadjuvant endocrine therapy before operation can be included; 2. Partial nephrectomy: TNM stage of tumor is T1a, and R.E.N.A.L score is = 9; 3. Age 18-75 years old, regardless of sex (prostate cancer is only a male subject); 4. Be able to cooperate and complete follow-up and related inspections; 5. Take part in this experiment voluntarily and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. There are serious uncontrolled diseases or acute infections; 2. Cardiovascular and cerebrovascular diseases, blood system diseases and diabetes can not be controlled and cannot meet the surgical standards; 3. Patients with immune system diseases that can't be controlled and can't meet the surgical standards; 4. Pregnant or lactating women. 5. Those who have not completed the clinical trials of other research drugs or devices.

Design outcomes

Primary

MeasureTime frame
Surgical success rate: The successful definition of radical prostatectomy is the ability to complete the surgery according to the established plan without switching to other surgical methods (including regular laparoscopic surgery and open surgery), and without undergoing a second surgery due to surgical complications within 24 hours after surgery.;Surgical success rate: Definition of successful partial nephrectomy: ? The diseased tissue can be removed according to the established surgical plan with negative margin. ? When the R.E.N.A.L. score is 4-6, the time of intraoperative warm ischemia is less than 30min;; When the R.E.N.A.L score is 7-9, the time of intraoperative warm ischemia is less than 40min. ? Open, radical and laparoscopic surgery were not performed during the operation.;

Secondary

MeasureTime frame
Prostate cancer: postoperative urinary control recovery: from the first week to the fourth week after the removal of urinary catheter, the number of urinary pads used once a week was recorded.;Partial nephrectomy: ? estimated glomerular filtration rate (EGFR); ? Imaging examination: Renal morphology was observed by B-ultrasound.;

Countries

China

Contacts

Public ContactLi Xue song

The First Hospital of Peking University

pineneedle@sina.com+86 158 0139 9116

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026