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

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05403190
Collaborator
Intuitive Surgical (Industry)
30
1
1
18
1.7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: da Vinci SP system
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study arm

Patients with prostate cancer

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Perioperative parameters-incision length (cm) [immediately after the surgery]

    incision length

  2. Perioperative parameters-console time (minutes) [immediately after the surgery]

    console time

  3. Perioperative parameters-blood loss (ml) [immediately after the surgery]

    blood loss

  4. Perioperative parameters-blood transfusion type [immediately after the surgery]

    blood transfusion type

  5. Perioperative parameters-blood transfusion unit [immediately after the surgery]

    blood transfusion unit

  6. 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

  7. Perioperative parameters-oxidative stress [immediately after the surgery]

    oxidative stress measured by the arterial malondialdehyde (MDA) level (micromole/L)

  8. Postoperative parameters-length of hospital stay (days) [immediately after discharge (assessed up to 10 days)]

    length of hospital stay

  9. 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

  10. Postoperative parameters-analgesic type [Every day during admission after the surgery (up to 7 days)]

    analgesic type

  11. Postoperative parameters-analgesic dose [Every day during admission after the surgery (up to 7 days)]

    analgesic dose

  12. 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

  13. 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

  14. 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.

  15. Functional outcomes-continence (pad amount) [Post-operation 1/3/6/12 months]

    pads used per day (for patients with incontinence)

  16. Functional outcomes-continence (leak amount in gram) [Post-operation 1/3/6/12 months]

    24hr total weight of pads (for patients with incontinence)

  17. 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.

  18. Oncologic outcomes-margin status (positive or negative) [when the pathology report is available (up to day 10)]

    surgical margin status

  19. Oncologic outcomes-biochemical recurrence [Post-operation 1/3/6/12 months]

    biochemical recurrence (PSA level ng/ml)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 78 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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)

  1. Anatomy unsuitable for endoscopic visualization or minimally invasive surgery

  2. Hemodynamic or respiratory instability after anesthesia

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

  4. Emergency surgery

  5. Untreated active infection

  6. vulnerable populations

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chang Gung Memorial Hospital Taoyuan City Taiwan 333

Sponsors and Collaborators

  • Chang Gung Memorial Hospital
  • Intuitive Surgical

Investigators

  • Principal Investigator: Chun-Te Wu, Professor, MD, PhD, Chang Gung Memorial Hospital at Keelung

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT05403190
Other Study ID Numbers:
  • 202101419A0C601
First Posted:
Jun 3, 2022
Last Update Posted:
Jun 3, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Chang Gung Memorial Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2022