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

Prostate Cancer Clinical Trial

— CGMH-SPEAR-P  

Official title:

The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy-a Single Arm Pivotal Trial Initiated by Chang Gung Memorial Hospital, Taiwan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05403190
• Other study ID #: 202101419A0C601
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2022
• Source: Chang Gung Memorial Hospital
• Contact: Po-Hung Lin, MD
• Phone: +886975366240
• Email: m7587[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• da Vinci SP system
using da Vinci SP system to perform extraperitoneal approach radical prostatectomy

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan City

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Intuitive Surgical

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate (%)	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.)	immediately after the surgery
Secondary	Perioperative parameters-incision length (cm)	incision length	immediately after the surgery
Secondary	Perioperative parameters-console time (minutes)	console time	immediately after the surgery
Secondary	Perioperative parameters-blood loss (ml)	blood loss	immediately after the surgery
Secondary	Perioperative parameters-blood transfusion type	blood transfusion type	immediately after the surgery
Secondary	Perioperative parameters-blood transfusion unit	blood transfusion unit	immediately after the surgery
Secondary	Perioperative parameters-intra-operative complications (SATAVA system)	intra-operative complications accessed with SATAVA system, Grade 1 to 3, higher grade indicates serious complications	immediately after the surgery
Secondary	Perioperative parameters-oxidative stress	oxidative stress measured by the arterial malondialdehyde (MDA) level (micromole/L)	immediately after the surgery
Secondary	Postoperative parameters-length of hospital stay (days)	length of hospital stay	immediately after discharge (assessed up to 10 days)
Secondary	Postoperative parameters-pain scale (VAS score)	pain scale accessed with visual analog scale (VAS) score, 1-10, higher score indicates more pain	Every day during admission after the surgery (up to 7 days)
Secondary	Postoperative parameters-analgesic type	analgesic type	Every day during admission after the surgery (up to 7 days)
Secondary	Postoperative parameters-analgesic dose	analgesic dose	Every day during admission after the surgery (up to 7 days)
Secondary	Postoperative parameters-postoperative complications (CLAVIEN-DINDO system)	postoperative complications accessed with CLAVIEN-DINDO system, Grade I to V, higher grade indicates severe complications	During admission after the surgery (up to 10 days)
Secondary	Postoperative parameters-readmission and reoperation	Thirty-day readmission and reoperations in relation to the index procedure	If happens, on the day of re-admission or reoperations (up to 30 days)
Secondary	Functional outcomes-continence status	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.	Post-operation 1/3/6/12 months
Secondary	Functional outcomes-continence (pad amount)	pads used per day (for patients with incontinence)	Post-operation 1/3/6/12 months
Secondary	Functional outcomes-continence (leak amount in gram)	24hr total weight of pads (for patients with incontinence)	Post-operation 1/3/6/12 months
Secondary	Functional outcomes-sexual function change (IIEF-5)	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.	Baseline, Post-operation 1/3/6/12 months
Secondary	Oncologic outcomes-margin status (positive or negative)	surgical margin status	when the pathology report is available (up to day 10)
Secondary	Oncologic outcomes-biochemical recurrence	biochemical recurrence (PSA level ng/ml)	Post-operation 1/3/6/12 months