The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy (CGMH-SPEAR-P)

Chang Gung Medical Foundation

Status: Unknown

Conditions: Prostate Cancer

Treatments: Device: da Vinci SP system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05403190

202101419A0C601

Details and patient eligibility

About

The objective of this study is to evaluate the performance and safety of da Vinci Single Port (SP) system on the surgery for extraperitoneal approach radical prostatectomy

Full description

Enrolled subjects would receive extraperitoneal approach radical prostatectomy using da Vinci SP system and be assessed at baseline (preoperatively), during hospitalization, and postoperatively (at 1 month +/-4 days, 3 month +/- 7 days, 6 months +/- 10 days, 12month +/-14 days). The preoperative assessment includes any diagnostic tests to confirm the subjects' cancer status and eligibility for the intervention under consideration such as transrectal or transperineal biopsy, image studies for staging including MRI/CT and bone scan, and cardiopulmonary tests to evaluate risks for anesthesia. The hospitalization assessment includes the collection of perioperative and postoperative details, conversions, and complications. The postoperative assessment includes regular follow up studies to evaluate cancer status and functional outcome (For sexual function, the International Index of Erectile Function (IIEF-5) would be recorded before and after the surgery. For continence, the number of pads per day and 24hr total weight of pads would be recorded. No pad used or one safe pad per day with net wet ≤ 50gm would be considered as continent. International Prostate Symptom Score (IPSS) wound be recorded before and after the surgery to access voiding function).

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with biopsy-proved prostate cancer
2. Stage clinical T1-T2N0M0
3. Prostate volume ≦ 70cm (by transrectal ultrasound or other image studies)
4. BMI ≦ 35 kg/m
5. Low priority of nerve sparing (pre-op sexual dysfunction or don't care about sexual function)
6. Age between 18 and 78 years old
7. Suitable for minimally invasive surgery
8. Patients willing and able to provide informed consent
9. Patients willing and able to comply with study protocol requirements and follow-up

Exclusion criteria

1. Previous abdominal or pelvic major operation history

2. Previous radiation treatment to the pelvic area

3. Patients received transurethral resection of prostate in three months

4. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions

   • Severe heart disease (NYHA functional class III-IV)
   • Severe lung disease (GOLD Group C-D)

5. Anatomy unsuitable for endoscopic visualization or minimally invasive surgery

6. Hemodynamic or respiratory instability after anesthesia

7. Working space restriction (e.g. kyphosis or severe scoliosis)

8. Emergency surgery

9. Untreated active infection

10. vulnerable populations

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Study arm

Experimental group

Description:

Patients with prostate cancer

Treatment:

Device: da Vinci SP system