The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Device: da Vinci SP system

• Registration Number: NCT05403190
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

Detailed 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).

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-30
• Study First Posted: 2022-06-03
• Study Start: 2022-08-01
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-22
• Primary Completion: 2023-07-31
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study arm	da Vinci SP system	Patients with prostate cancer

Primary Outcome Measures

Name	Time	Method
Success rate (%)	immediately after the surgery	Percentage of successful extraperitoneal approach radical prostatectomy with da Vinci SP system (no conversion to conventional laparoscopic, multiport da Vinci surgery or open surgery; addition of access port to complete the procedure would not be considered as conversion.)

Secondary Outcome Measures

Name	Time	Method
Perioperative parameters-blood transfusion unit	immediately after the surgery	blood transfusion unit
Perioperative parameters-console time (minutes)	immediately after the surgery	console time
Perioperative parameters-intra-operative complications (SATAVA system)	immediately after the surgery	intra-operative complications accessed with SATAVA system, Grade 1 to 3, higher grade indicates serious complications
Perioperative parameters-incision length (cm)	immediately after the surgery	incision length
Perioperative parameters-blood loss (ml)	immediately after the surgery	blood loss
Perioperative parameters-blood transfusion type	immediately after the surgery	blood transfusion type
Postoperative parameters-length of hospital stay (days)	immediately after discharge (assessed up to 10 days)	length of hospital stay
Postoperative parameters-analgesic type	Every day during admission after the surgery (up to 7 days)	analgesic type
Functional outcomes-continence (leak amount in gram)	Post-operation 1/3/6/12 months	24hr total weight of pads (for patients with incontinence)
Perioperative parameters-oxidative stress	immediately after the surgery	oxidative stress measured by the arterial malondialdehyde (MDA) level (micromole/L)
Postoperative parameters-analgesic dose	Every day during admission after the surgery (up to 7 days)	analgesic dose
Functional outcomes-continence status	Post-operation 1/3/6/12 months	Continence status after Foley catheter removed. Pad-free or one safe pad used are defined as continence intact. More than one pad used is defined as post-operative incontinence.
Functional outcomes-sexual function change (IIEF-5)	Baseline, Post-operation 1/3/6/12 months	sexual function at baseline and 1/3/6/12 months with International Index of Erectile Function (IIEF-5), 0-25, higher score indicates better sexual function.
Oncologic outcomes-biochemical recurrence	Post-operation 1/3/6/12 months	biochemical recurrence (PSA level ng/ml)
Postoperative parameters-pain scale (VAS score)	Every day during admission after the surgery (up to 7 days)	pain scale accessed with visual analog scale (VAS) score, 1-10, higher score indicates more pain
Postoperative parameters-postoperative complications (CLAVIEN-DINDO system)	During admission after the surgery (up to 10 days)	postoperative complications accessed with CLAVIEN-DINDO system, Grade I to V, higher grade indicates severe complications
Functional outcomes-continence (pad amount)	Post-operation 1/3/6/12 months	pads used per day (for patients with incontinence)
Oncologic outcomes-margin status (positive or negative)	when the pathology report is available (up to day 10)	surgical margin status
Postoperative parameters-readmission and reoperation	If happens, on the day of re-admission or reoperations (up to 30 days)	Thirty-day readmission and reoperations in relation to the index procedure

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan City, Taiwan