UMIN-CTR 臨床試験登録情報の閲覧

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000038549
受付番号 R000043929
科学的試験名 限局性前立腺癌におけるフレイルが術後疼痛に与える影響
一般公開日（本登録希望日） 2019/11/12
最終更新日 2022/12/06 (4版)

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。

基本情報/Basic information
一般向け試験名/Public title 限局性前立腺癌におけるフレイルが術後疼痛に与える影響 Effect of frailty on postoperative pain in patients with prostate cancer who underwent radical prostatectomy
一般向け試験名略称/Acronym 限局性前立腺癌におけるフレイルが術後疼痛に与える影響 Effect of frailty on postoperative pain in patients with prostate cancer who underwent radical prostatectomy
科学的試験名/Scientific Title 限局性前立腺癌におけるフレイルが術後疼痛に与える影響 Effect of frailty on postoperative pain in patients with prostate cancer who underwent radical prostatectomy
科学的試験名略称/Scientific Title:Acronym 限局性前立腺癌におけるフレイルが術後疼痛に与える影響 Effect of frailty on postoperative pain in patients with prostate cancer who underwent radical prostatectomy
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 限局性前立腺癌 Localized prostate cancer
疾患区分1/Classification by specialty
泌尿器科学/Urology
疾患区分2/Classification by malignancy 悪性腫瘍/Malignancy
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 限局性前立腺癌におけるフレイルが術後疼痛に与える影響を検討する To investigate the association between the frailty and postoperative pain in patients with prostate cancer.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others 術後痛みを予測する適切なフレイル評価法の検討 To investigate the association between the types of frailty measurement tools and postoperative pain in patients with prostate cancer.
試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes The primary purpose was the effect of frailty (G8<=14) on VAS in patients after RARP. The primary purpose was the effect of frailty (G8<=14) on VAS in patients after RARP.
副次アウトカム評価項目/Key secondary outcomes Secondary purpose included the effect of instrumental activities of daily living (IADL) and simplified frailty index (sFI) on VAS. Secondary purpose included the effect of instrumental activities of daily living (IADL) and simplified frailty index (sFI) on VAS.

基本事項/Base
試験の種類/Study type 観察/Observational

試験デザイン/Study design
基本デザイン/Basic design
ランダム化/Randomization
ランダム化の単位/Randomization unit
ブラインド化/Blinding
コントロール/Control
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms
介入の目的/Purpose of intervention
介入の種類/Type of intervention
介入1/Interventions/Control_1

介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢（下限）/Age-lower limit
20 歳/years-old 以上/<=
年齢（上限）/Age-upper limit
100 歳/years-old 以下/>=
性別/Gender 男/Male
選択基準/Key inclusion criteria Patients with prostate cancer who underwent radical prostatectomy.
Patients with frailty evaluation before surgery
Patients with pain evaluation after surgery (day 1, 2, 3 and discharge)		 Patients with prostate cancer who underwent radical prostatectomy.
Patients with frailty evaluation before surgery
Patients with pain evaluation after surgery (day 1, 2, 3 and discharge)
除外基準/Key exclusion criteria Patients with prostate cancer who were not eligible for radical prostatectomy Patients with prostate cancer who were not eligible for radical prostatectomy
目標参加者数/Target sample size 200

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
名 Hatakeyama
ミドルネーム
姓 Shingo
名 Shingo
ミドルネーム
姓 Hatakeyama
所属組織/Organization Hirosaki University School of Medicine Hirosaki University School of Medicine
所属部署/Division name Urology Urology
郵便番号/Zip code 036-8562
住所/Address 5 Zaifu-chou, Hirosaki 5 Zaifu-chou, Hirosaki
電話/TEL +81172395091
Email/Email shingoh@hirosaki-u.ac.jp

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person
名 Shingo
ミドルネーム
姓 Hatakeyama
名 Shingo
ミドルネーム Hatakeyama
姓 Hatakeyama
組織名/Organization Hirosaki University School of Medicine Hirosaki University School of Medicine
部署名/Division name Urology Urology
郵便番号/Zip code 036-8562
住所/Address 5 Zaifu-chou, Hirosaki 5 Zaifu-chou, Hirosaki
電話/TEL +81172395091
試験のホームページURL/Homepage URL
Email/Email shingoh@hirosaki-u.ac.jp

実施責任組織/Sponsor
機関名/Institute 弘前大学 Hirosaki University School of Medicine
機関名/Institute
（機関選択不可の場合）
部署名/Department Urology

研究費提供組織/Funding Source
機関名/Organization 弘前大学 Hirosaki University School of Medicine
機関名/Organization
（機関選択不可の場合）
組織名/Division
組織の区分/Category of Funding Organization 日本の官庁/Japanese Governmental office
研究費拠出国/Nationality of Funding Organization 日本

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先（公開）/IRB Contact (For public release)
組織名/Organization Hirosaki University Graduate School of Medicine Hirosaki University Graduate School of Medicine
住所/Address 5 Zaifu-chou Hirosaki
電話/Tel +81172395091
Email/Email rinri@hirosaki-u.ac.jp

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日（本登録希望日）/Date of disclosure of the study information
2019 年 11 月 12 日

関連情報/Related information
プロトコル掲載URL/URL releasing protocol https://pubmed.ncbi.nlm.nih.gov/35474865/
試験結果の公開状況/Publication of results 最終結果が公表されている/Published

結果/Result
結果掲載URL/URL related to results and publications https://pubmed.ncbi.nlm.nih.gov/35474865/
組み入れ参加者数/Number of participants that the trial has enrolled 154
主な結果/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. 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.
主な結果入力日/Results date posted
2022 年 12 月 06 日
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/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). To investigate the association of pain with frailty in patients with localized prostate cancer (PC) who underwent robot-assisted laparoscopic radical prostatectomy (RARP).
参加者の流れ/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. 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.
有害事象/Adverse events none none
評価項目/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. 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.
個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2017 年 01 月 06 日
倫理委員会による承認日/Date of IRB
2017 年 01 月 06 日
登録・組入れ開始（予定）日/Anticipated trial start date
2017 年 01 月 06 日
フォロー終了(予定)日/Last follow-up date
2022 年 12 月 05 日
入力終了(予定)日/Date of closure to data entry
データ固定（予定）日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information We evaluated the geriatric 8 score (G8) and visual analog scale (VAS) in localized prostate cancer (PC) patients who underwent robotic-radical prostatectomy (RARP). VAS was measured at preoperative day 0, postoperative day 1, 2, 3, and discharge. The primary purpose was the effect of frailty (G8<=14) on VAS in patients after RARP. Secondary purpose included the effect of instrumental activities of daily living (IADL) and simplified frailty index (sFI) on VAS. We evaluated the geriatric 8 score (G8) and visual analog scale (VAS) in localized prostate cancer (PC) patients who underwent robotic-radical prostatectomy (RARP). VAS was measured at preoperative day 0, postoperative day 1, 2, 3, and discharge. The primary purpose was the effect of frailty (G8<=14) on VAS in patients after RARP. Secondary purpose included the effect of instrumental activities of daily living (IADL) and simplified frailty index (sFI) on VAS.

管理情報/Management information
登録日時/Registered date
2019 年 11 月 11 日
最終更新日/Last modified on
2022 年 12 月 06 日


閲覧ページへのリンク/Link to view the page
URL(日本語) https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043929
URL(英語) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043929