Clinical trial NCT05403190: The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
radical prostatectomy
da Vinci SP system
extraperitoneal approach
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Intuitive Surgical
First posted: 2022-06-03
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Success rate (%)
timeFrame: immediately after the surgery
Secondary outcomes:
measure: Perioperative parameters-incision length (cm)
timeFrame: immediately after the surgery
measure: Perioperative parameters-console time (minutes)
timeFrame: immediately after the surgery
measure: Perioperative parameters-blood loss (ml)
timeFrame: immediately after the surgery
measure: Perioperative parameters-blood transfusion type
timeFrame: immediately after the surgery
measure: Perioperative parameters-blood transfusion unit
timeFrame: immediately after the surgery
measure: Perioperative parameters-intra-operative complications (SATAVA system)
timeFrame: immediately after the surgery
measure: Perioperative parameters-oxidative stress
timeFrame: immediately after the surgery
measure: Postoperative parameters-length of hospital stay (days)
timeFrame: immediately after discharge (assessed up to 10 days)
measure: Postoperative parameters-pain scale (VAS score)
timeFrame: Every day during admission after the surgery (up to 7 days)
measure: Postoperative parameters-analgesic type
timeFrame: Every day during admission after the surgery (up to 7 days)
measure: Postoperative parameters-analgesic dose
timeFrame: Every day during admission after the surgery (up to 7 days)
measure: Postoperative parameters-postoperative complications (CLAVIEN-DINDO system)
timeFrame: During admission after the surgery (up to 10 days)
measure: Postoperative parameters-readmission and reoperation
timeFrame: If happens, on the day of re-admission or reoperations (up to 30 days)
measure: Functional outcomes-continence status
timeFrame: Post-operation 1/3/6/12 months
measure: Functional outcomes-continence (pad amount)
timeFrame: Post-operation 1/3/6/12 months
measure: Functional outcomes-continence (leak amount in gram)
timeFrame: Post-operation 1/3/6/12 months
measure: Functional outcomes-sexual function change (IIEF-5)
timeFrame: Baseline, Post-operation 1/3/6/12 months
measure: Oncologic outcomes-margin status (positive or negative)
timeFrame: when the pathology report is available (up to day 10)
measure: Oncologic outcomes-biochemical recurrence
timeFrame: Post-operation 1/3/6/12 months
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital at Keelung
name: Chun-Te Wu, Professor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: