To evaluate the effectiveness and safety of laparoscopic urological surgery assisted by abdominal endoscopic surgery system (SR2000Plus)

o evaluate the effectiveness and safety of laparoscopic urological surgery assisted by abdominal endoscopic surgery system (SR2000Plus)

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400085108

Enrollment

Unknown

Registered

2024-05-31

Start date

2024-05-31

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

1. Radical prostatectomy+pelvic lymphadenectomy is needed

Interventions

NA:Abdominal endoscopic surgery system

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients who need urological surgery (2)18= age =75 years old, regardless of gender (3) Be able to cooperate and complete the follow-up and related examinations (4) Voluntary participation in this experiment and signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) there are serious uncontrolled diseases or acute infections (2) those who have serious complications/diseases and cannot tolerate surgery or anesthesia (3) those who have immune system diseases that cannot be controlled and cannot meet the surgical standards (4) pregnant or lactating women (5) Those who have not completed the clinical trials of other research drugs or devices (6) The researcher thinks that it is not suitable to participate in this experiment.

Design outcomes

Primary

Measure	Time frame
Non-conversion rate of operation;Incidence of device-related complications of Clavien-Dindo Grade III or above.;	—

Secondary

Measure	Time frame
A radical prostatectomy plus pelvic lymphadenectomy: A. Recovery of urinary control after operation;A. radical prostatectomy+pelvic lymphadenectomy: b.PSA;A radical prostatectomy plus pelvic lymphadenectomy: imaging results 30 days after operation.;B. ileal ureterectomy: imaging results : - - /;The tumor recurrence and metastasis were evaluated by imaging examination 30 days after operation.;2) Postoperative micturition function: According to different urinary diversion methods.;Surgical margin;Number of lymphadenectomy;Intraoperative blood loss and blood transfusion;Drainage within 24 hours after operation;Laboratory examination;Subject pain score;Adverse events and incidence of serious adverse events.;Postoperative hospitalization time;Incidence rate of instrument defects;Readmission rate, reoperation rate and mortality rate;Overall complication rate;	—

Measure

Time frame

A radical prostatectomy plus pelvic lymphadenectomy: A. Recovery of urinary control after operation;A. radical prostatectomy+pelvic lymphadenectomy: b.PSA;A radical prostatectomy plus pelvic lymphadenectomy: imaging results 30 days after operation.;B. ileal ureterectomy: imaging results : - - /;The tumor recurrence and metastasis were evaluated by imaging examination 30 days after operation.;2) Postoperative micturition function: According to different urinary diversion methods.;Surgical margin;Number of lymphadenectomy;Intraoperative blood loss and blood transfusion;Drainage within 24 hours after operation;Laboratory examination;Subject pain score;Adverse events and incidence of serious adverse events.;Postoperative hospitalization time;Incidence rate of instrument defects;Readmission rate, reoperation rate and mortality rate;Overall complication rate;

—

Countries

China

Contacts

Public ContactXuesong Li

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