Comparison of the safety and efficacy of single-port robot-assisted laparoscopic radical prostatectomy with different approaches

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100042127

Enrollment

Unknown

Registered

2021-01-14

Start date

2021-01-01

Completion date

Unknown

Last updated

2021-04-12

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

Conditions

prostate cancer

Interventions

Extraperitoneal approach:Perform the single-port robot-assisted laparoscopic radical prostatectomy via extraperitoneal approach

Transperineal approach:Perform the single-port robot-assisted laparoscopic radical prostatectomy via transperineal approach

Transvesical approach:Perform the single-port robot-assisted laparoscopic radical prostatectomy via transvesical approach

Eligibility

Sex/Gender

Male

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-85 years; 2. BMI <= 35kg/m2; 3. Histopathological diagnosis of localized prostate cancer; 4. Clinical stage T1c or T2a or T2b; 5. The total preoperative Gleason score is 6 or 7; 6. Preoperative PSA <= 20ng/ml; 7. Prostate weight <= 50g; 8. Can tolerate minimally invasive surgery for prostate cancer; 9. Can tolerate Trendelenburg position; 10. ECOG criteria (Eastern Cooperative Oncology Group criteria) score 0 or 1; 11. There are no obvious abnormalities in blood routine, blood coagulation and liver and kidney functions; 12. Voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. The histopathological examination of the patient was neuroendocrine/small cell prostate cancer; 2. The patient has developed distant metastases; 3. Suffered from untreated active infection (including local kidney infection); 4. The patient is vulnerable, such as mentally ill persons, intellectually disabled persons, minors, and cognitively impaired persons; 5. Suffered from other diseases that greatly shorten life expectancy or increase the risk of therapeutic intervention, such as other cancers; 6. Suffered from high blood pressure and poor drug control; 7. Suffered from severe cardiopulmonary insufficiency; 8. Abnormal blood coagulation, with bleeding tendency; 9. Are receiving thrombolysis or anticoagulation therapy; 10. Obviously abnormal liver and kidney function, unable to tolerate targeted and chemotherapy treatments; 11. A history of infection with human immunodeficiency virus, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. 12. Severe hemodynamics or respiratory instability occurred during the operation; 13. Intraoperative operation space is limited (such as kyphosis).

Design outcomes

Primary

Measure	Time frame
the incidence of intraoperative changes to open surgery;he incidence of perioperative complications;postoperative urinary control;postoperative sexual function;postoperative PSA;	—

Secondary

Measure	Time frame
operation time;robot operation time;estimated blood loss;hospital stay;drainage catheter removal;catheter removal;histopathological resection margin;biochemical recurrence time;adjuvant chemotherapy time;	—

Countries

China

Contacts

Public ContactLi Gonghui

Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University

3193119@zju.edu.cn+86 13588708507

Outcome results

None listed

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