UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038969 |
|---|---|
| Receipt number | R000044442 |
| Scientific Title | Effect of frailty on postoperative pain after robot-assisted laparoscopic prostatectomy: prospective observational study(FRAP trial) |
| Date of disclosure of the study information | 2019/12/25 |
| Last modified on | 2022/12/05 22:49:01 |
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Basic information
Public title
Effect of frailty on postoperative pain after robot-assisted laparoscopic prostatectomy: prospective observational study(FRAP trial)
Acronym
Effect of frailty on postoperative pain after robot-assisted laparoscopic prostatectomy: prospective observational study(FRAP trial)
Scientific Title
Effect of frailty on postoperative pain after robot-assisted laparoscopic prostatectomy: prospective observational study(FRAP trial)
Scientific Title:Acronym
Effect of frailty on postoperative pain after robot-assisted laparoscopic prostatectomy: prospective observational study(FRAP trial)
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between the frailty and postoperative pain in patients with prostate cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary purpose was the effect of G8 =<14, sFI, postoperative complications, and use of analgesics on moderate-to-severe pain (NRS >=5) after RARP.
Key secondary outcomes
The secondary purpose was the association of G8 =<14 with sFI, postoperative complications, and analgesics.
Exploratory purposes included 1) the association of frailty and time-dependent change of NRS, 2) the association of the maximum pain and sum of NRS, and 3) the optimal cutoff value evaluation of G8 score for NRS >=5 using receiver operating characteristic (ROC) curve.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male
Key inclusion criteria
Localized prostate cancer (PC) patients who underwent robotic-radical prostatectomy (RARP)
Key exclusion criteria
1) Localized prostate cancer patients who underwent open prostatectomy and 2) who did not answered NRS after RARP
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Dept. of Urology, Hirosaki University Graduate School of Medicine
Division name
Urology
Zip code
036-8562
Address
5 Zaifu-chou, Hirosaki
TEL
0172395091
shingoh@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | Hatakeyama |
| Last name | Hatakeyama |
Organization
Dept. of Urology, Hirosaki University Graduate School of Medicine
Division name
Urology
Zip code
036-8562
Address
5 Zaifu-chou, Hirosaki
TEL
0172395091
Homepage URL
shingoh@hirosaki-u.ac.jp
Sponsor or person
Institute
Dept. of Urology, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Dept. of Urology, Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University Graduate School of Medicine
Address
5 Zaifu-chou, Hirosaki, Japan
Tel
0172395091
rinri@hirosaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Hirosaki University Hospital
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8988788/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8988788/
Number of participants that the trial has enrolled
154
Results
Frailty was significantly associated with moderate to severe pain after RARP, and might be a potential predictor of postoperative pain. Frail patients require individual care to avoid painful experiences.
Results date posted
| 2022 | Year | 12 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
To investigate the association of pain with frailty in patients with localized prostate cancer (PC) who underwent robot-assisted laparoscopic radical prostatectomy (RARP).
Participant flow
Between January 2017 and June 2019, we prospectively evaluated the geriatric 8 (G8) score, simplified frailty index (sFI), and numerical rating scale (NRS) of 154 patients with localized PC who underwent RARP at our institution. NRS was measured on preoperative day 0, postoperative days 1, 2, 3, and at discharge. Moderate to severe pain was defined as NRS>=5, whereas frailty was defined as G8<=14.
Adverse events
none
Outcome measures
The primary objectives of this study were to investigate the effects of moderate to severe pain (NRS>=5) on frailty, postoperative complications, and the use of analgesics after RARP. Our secondary objectives were the effect of frailty on postoperative complications and the use of analgesics.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Accounting for 15% withdrawal rate, we planned to enroll 180 patients within 30 months based on the annual number of RARP in our hospital. No statistical sample size calculation was performed because of no previous evidences for the effect of frailty on postoperative pain.
Management information
Registered date
| 2019 | Year | 12 | Month | 24 | Day |
Last modified on
| 2022 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044442
