UMIN-CTR Clinical Trial

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
Email	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
Email	shingoh@hirosaki-u.ac.jp

Sponsor
Institute	Dept. of Urology, Hirosaki University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044442