Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy (ROBOPREP)
2026年9月2日 更新者：Daniel Steffens、Surgical Outcomes Research Centre (SOuRCe)
Multimodal Perioperative Optimisation for Patients Undergoing Robot-Assisted Radical Prostatectomy: A Randomised Controlled Trial Targeting Postoperative Erectile Dysfunction (ROBOPREP Trial)
Prostate cancer is the most common cancer in Australian men. Robot-assisted radical prostatectomy (RARP) - surgical removal of the prostate - is a standard treatment, but it frequently causes erectile dysfunction (ED) and urinary incontinence that can persist for years and significantly affect quality of life.
This trial (ROBOPREP) will test whether a multimodal program of prehabilitation (before surgery) and rehabilitation (after surgery) improves erectile function and urinary continence in men undergoing RARP, compared to standard care alone.
The program includes four components, all delivered virtually and in a self-directed manner:
- Pharmacological - tadalafil 5 mg once daily (a low-dose, TGA-approved erectile medication) beginning 4 weeks before surgery, paused during hospital admission, and resumed for 3 months following catheter removal after surgery.
- Exercise - pelvic floor muscle training (3 sets per day) and aerobic exercise (40 minutes, 4 times per week) to strengthen the muscles and vascular supply involved in erectile and urinary function.
- Nutrition - dietary guidance to support surgical recovery and vascular health.
- Psychological/wellbeing - relaxation techniques, psychoeducation about expected recovery, and self-compassion strategies to address cancer-related anxiety.
A total of 64 men will be recruited across three major Sydney hospitals (Royal Prince Alfred Hospital, Concord Repatriation General Hospital, and Chris O'Brien Lifehouse) and randomly assigned 1:1 to the multimodal program plus standard care, or to standard care alone. Outcomes - including erectile function (primary), urinary continence, quality of life, and psychological wellbeing - are assessed at baseline and at 6 weeks, 3, 6, and 12 months following surgery. All participant-facing elements of the program are digital, low-cost, and designed for real-world scalability.
調査の概要
状態
状態
募集
条件
条件
介入・治療
介入・治療
詳細な説明
The ROBOPREP Trial is a hybrid type 1 multicentre, assessor-blinded, parallel-group randomised controlled trial with nested qualitative and cost-effectiveness appraisal. The trial evaluates a virtually delivered, self-directed multimodal (p)rehabilitation program for men undergoing robot-assisted radical prostatectomy (RARP) for prostate cancer.
Background: Erectile dysfunction (ED) occurs in 25-75% of men following RARP, with unassisted recovery of erectile function in only 20-25%. Urinary incontinence affects a further 27-40%. Current evidence supports early initiation of phosphodiesterase type 5 inhibitors (PDE5i), pelvic floor muscle training (PFMT), and psychological interventions, but no multimodal perioperative program combining all modalities has been evaluated in a rigorous RCT.
Intervention: Participants randomised to the intervention arm receive, in addition to standard care: (1) tadalafil 5 mg/day orally commencing 4 weeks preoperatively, ceasing during hospital admission, and resuming for 3 months following postoperative catheter removal; (2) pelvic floor muscle training (3 sets/day: 20 fast and 20 slow contractions); (3) aerobic exercise (40 min, 4×/week, moderate-to-vigorous intensity); (4) nutritional guidance; and (5) psychological strategies including relaxation, psychoeducation, and self-compassion. Non-pharmacological components are delivered via a co-designed digital booklet and avatar videos. All components are self-directed to ensure scalability.
Randomisation and Blinding: Randomisation (1:1, stratified by age ≤60 vs >60 years, permuted blocks of size 2 and 4) is managed via a central secure REDCap randomisation module uploaded by an independent research officer. Outcome assessors are blinded to allocation; blinding of participants and treating clinicians is not feasible given the nature of the intervention.
Statistical Analysis: Primary analysis is intention-to-treat. The primary outcome (IIEF-5 at 3 months postoperatively) will be compared between arms using Mann-Whitney U tests and multivariate regression adjusting for baseline characteristics. Secondary outcomes will be analysed using mixed models, Cox regression (time to continence), and chi-square or Fisher's exact tests as appropriate.
The trial medication is funded by Generic Health (Lupin), who provide a donation covering participant reimbursement for tadalafil 5 mg (4-month supply; approx. AUD $120-150 per participant) and the TGA CTN application fee. Tadalafil 5 mg is TGA-approved for erectile dysfunction (ARTG: 289541).
研究の種類
研究の種類
介入
入学 (推定)
入学
64
段階
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
研究連絡先
- 名前：Nicholas Hirst
- 電話番号：+61 2 9515 3200
- メール：Nicholas.Hirst1@health.nsw.gov.au
研究連絡先のバックアップ
- 名前：SOuRCe Admin
- メール：SLHD-SOuRCe@health.nsw.gov.au
研究場所
-
-
New South Wales
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Sydney、New South Wales、オーストラリア、2050
- 募集
- Royal Prince Alfred Hospital
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コンタクト：
- Nicholas Hirst
- 電話番号：+61 2 9515 3211
- メール：nicholas.hirst1@health.nsw.gov.au
-
Sydney、New South Wales、オーストラリア、2050
- まだ募集していません
- Chris O'Brien Lifehouse
-
コンタクト：
- Nicholas Hirst
- 電話番号：+61 2 9515 3211
- メール：nicholas.hirst1@health.nsw.gov.au
-
Sydney、New South Wales、オーストラリア、2139
- 募集
- Concord Repatriation General Hospital (CRGH)
-
コンタクト：
- Nicholas Hirst
- 電話番号：+61 2 9515 3211
- メール：nicholas.hirst1@health.nsw.gov.au
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Adults aged ≥18 years undergoing elective robot-assisted radical prostatectomy (RARP) with curative intent for confirmed prostate cancer.
- Consulting a urological surgeon with an appointment at participating sites at least 4 weeks prior to scheduled surgery.
- Willingness to engage in prescribed self-directed interventions.
- Expected to have 100% unilateral OR >50% bilateral nerve sparing at prostatectomy
Exclusion Criteria:
- Cognitive impairment such that they lack capacity to provide informed consent.
- Currently taking intracavernosal injection therapy.
- Severe or complete erectile dysfunction at baseline, defined as an IIEF-5 score ≤7 or self-reported absence of erectile function.
- Prescribed nitrates or guanylate cyclase stimulators (e.g., riociguat) - pharmacological contraindication to PDE5 inhibitor use.
- Impaired renal function (GFR <50 mL/min and/or creatinine clearance <30 mL/min).
- Severe hepatic impairment or concurrent prescription of medications that inhibit CYP3A4.
- Loss of vision in one eye due to non-arteritic anterior ischaemic optic neuropathy (NAION).
- Myocardial infarction within the last 90 days.
- Stroke within the last 6 months.
- Unstable angina or angina occurring during sexual intercourse.
- New York Heart Association (NYHA) Class II or greater heart failure in the last 6 months.
- Uncontrolled arrhythmias, hypotension (<90/50 mmHg), or uncontrolled hypertension.
- Contraindications to participating in the prescribed exercise program.
- No access to a device with internet connectivity.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
2
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：Multimodal Prehabilitation and Rehabilitation plus standard care
Participants receive standard care PLUS a multimodal program commencing ≥4 weeks preoperatively and continuing for 3 months postoperatively (following catheter removal).
The program comprises four components: (1) tadalafil 5 mg orally once daily (paused during hospital admission); (2) pelvic floor muscle training 3 sets/day; (3) aerobic exercise 40 min, 4×/week; (4) nutritional guidance; and (5) psychological/wellbeing strategies.
All non-pharmacological components are self-directed and digitally delivered.
|
Tadalafil 5 mg tablet, taken orally once daily.
Commenced 4 weeks prior to surgery, ceased during hospital admission (3 days prior to surgery), and recommenced following postoperative urinary catheter removal (typically 5-10 days post-surgery) for 3 months.
Total intended duration approximately 4 months.
Supplied via standard prescription dispensing at community pharmacies (Generic Health brand).
Reimbursement provided to participants via a cash card.
TGA ARTG number: 289541.
他の名前：
Self-directed PFMT performed 3 sets per day.
Each set comprises 20 fast contractions (1-second duration) and 20 slow contractions (10 seconds on, 10 seconds off).
Adapted from Milios et al. (2020) using Continence Australia guidelines.
Delivered via co-designed digital booklet and avatar instructional videos.
Commenced 4 weeks preoperatively, continuing through 3 months postoperatively.
Self-directed aerobic exercise at moderate-to-vigorous intensity (e.g., brisk walking while able to maintain conversation), 40 minutes per session, 4 sessions per week.
Dose established by Gerbild et al. (2018).
Delivered via digital booklet and avatar videos.
Commenced 4 weeks preoperatively, continuing through 3 months postoperatively.
Structured dietary guidance addressing protein intake, fruit and vegetable consumption, wholegrains, healthy fats, hydration, and blood sugar control.
Designed by a dietitian to support surgical healing, vascular health, and erectile and urinary function recovery.
Delivered via digital booklet and avatar videos.
Commenced 4 weeks preoperatively, continuing through 3 months postoperatively.
Self-directed psychological wellbeing program comprising: (1) relaxation techniques (progressive muscle relaxation, diaphragmatic/rectangle breathing, mindfulness/grounding); (2) psychoeducation on psychogenic erectile dysfunction, expected postoperative complications (ED, UI); (3) self-compassion and cognitive reframing strategies; (4) motivational interviewing-style elements to support adherence; (5) advice on social connection, smoking cessation, alcohol reduction, and sleep hygiene.
Designed by a clinical psychologist and delivered via digital booklet and videos.
Commenced 4 weeks preoperatively, continuing through 3 months postoperatively.
Usual high-standard pre- and postoperative care delivered by the treating urological team, including clinical advice on exercise, nutrition, smoking cessation, alcohol reduction, expected surgical sequelae, pelvic floor exercises, blood sugar optimisation, medication review, and anaemia screening.
Includes prostate cancer nurse specialist consultations and urology clinic follow-up.
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アクティブコンパレータ：Standard Care
Participants receive usual high-standard perioperative care from their treating team, including clinical advice on exercise, nutrition, smoking cessation, alcohol reduction, expected surgical sequelae, and pelvic floor exercises, as well as medical considerations (blood sugar optimisation, medication review, anaemia screening).
Prostate cancer nurse specialist consultations and urology clinic attendance are included as standard.
|
Usual high-standard pre- and postoperative care delivered by the treating urological team, including clinical advice on exercise, nutrition, smoking cessation, alcohol reduction, expected surgical sequelae, pelvic floor exercises, blood sugar optimisation, medication review, and anaemia screening.
Includes prostate cancer nurse specialist consultations and urology clinic follow-up.
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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Erectile Function - International Index of Erectile Function-5 (IIEF-5)
時間枠：Assessed at 3 months postoperatively (primary endpoint). Also assessed at baseline (4 weeks preoperatively), 6 weeks, 6 months, and 12 months postoperatively.
|
The IIEF-5 is a validated 5-item self-report questionnaire assessing erectile function over the preceding 4 weeks.
Scores range from 5 (severe erectile dysfunction) to 25 (no erectile dysfunction).
A between-group difference of ≥4 points constitutes the minimal clinically important difference (MCID) as established by Rosen et al. (2011).
The IIEF-5 is the abbreviated version of the 15-item IIEF, widely used in prostate cancer rehabilitation trials.
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Assessed at 3 months postoperatively (primary endpoint). Also assessed at baseline (4 weeks preoperatively), 6 weeks, 6 months, and 12 months postoperatively.
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Urinary Incontinence - ICIQ-UI SF
時間枠：Baseline (≥4 weeks preoperatively), 6 weeks, 3 months, 6 months, and 12 months postoperatively.
|
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a validated 4-item patient-reported measure of urinary incontinence severity and impact on quality of life.
Scores range from 0 (no incontinence) to 21 (severe incontinence).
Assesses urinary leakage frequency, volume, and overall impact.
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Baseline (≥4 weeks preoperatively), 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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Number of Urinary Pads Used in 24 Hours
時間枠：Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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Total number of urinary pads used by the participant over a 24-hour period, as self-reported.
A higher number of pads indicates greater urinary incontinence severity.
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Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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Weight of Urinary Pads Used in 24 Hours
時間枠：Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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Total weight (grams) of urinary pads used over a 24-hour period.
Pad weight is obtained by weighing pads before and after use and calculating the difference.
Higher weight indicates greater urine leakage volume.
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Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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Maximum Urinary Flow Rate (Uroflowmetry - Q-max)
時間枠：Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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Maximum urinary flow rate (mL/s) measured by uroflowmetry during voiding.
Higher values indicate better bladder outflow function.
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Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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Post-Void Residual Urine Volume
時間枠：Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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Volume of urine remaining in the bladder after voiding (mL), measured by bladder ultrasound or catheterisation.
Lower post-void residual volumes indicate more complete bladder emptying.
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Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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Maximum Detrusor Pressure (Urodynamics)
時間枠：Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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Maximum detrusor pressure (cmH₂O) measured during urodynamic testing, reflecting bladder contractility and outflow resistance during voiding.
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Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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Health-Related Quality of Life - Short Form-36 Health Survey, Version 2 (SF-36v2)
時間枠：Baseline, 6 weeks, and 6 months postoperatively.
|
The Short Form-36 Health Survey, Version 2 (SF-36v2) is a validated 36-item multidimensional self-report questionnaire assessing health-related quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional health, bodily pain, general health perceptions, vitality, social functioning, and mental health.
Each domain score ranges from 0 to 100, with higher scores indicating better health-related quality of life in that domain.
Physical Component Summary (PCS) and Mental Component Summary (MCS) scores are derived (each ranging from 0 to 100; higher scores indicate better health).
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Baseline, 6 weeks, and 6 months postoperatively.
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Anxiety and Depression - Hospital Anxiety and Depression Scale (HADS)
時間枠：Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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The HADS is a validated 14-item self-report questionnaire with two 7-item subscales assessing anxiety (HADS-A) and depression (HADS-D) severity.
Each subscale is scored 0-21; scores ≥8 indicate probable caseness.
Designed for use in medical settings with somatic symptoms excluded to avoid confounding.
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Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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Fear of Cancer Recurrence - Single-Item Scale (FCR-1)
時間枠：Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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A single-item 0-10 numerical rating scale measuring fear of cancer recurrence.
Scores range from 0 (no fear) to 10 (maximum fear of recurrence), with higher scores indicating greater fear of cancer recurrence.
This single-item scale has been demonstrated as equivalently effective to the short-form FCR scale in oncological populations.
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Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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Pain Intensity - Numeric Pain Rating Scale (NPRS)
時間枠：Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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The NPRS is a single-item 0-10 scale measuring current pain intensity (0 = no pain, 10 = worst imaginable pain).
Widely used in surgical and oncological populations.
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Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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Postoperative Complication Rate - Clavien-Dindo Classification of Surgical Complications
時間枠：Within 30 days postoperatively. Complications also monitored at 6 weeks, 3 months, 6 months, and 12 months.
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Proportion of participants developing postoperative surgical complications within 30 days of surgery, categorised under the Clavien-Dindo Classification of Surgical Complications.
Grades range from I (minor complication requiring no specific treatment beyond standard medications) to V (death).
Higher grades indicate more severe complications and represent a worse outcome.
Assessed by the treating clinical team from medical records.
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Within 30 days postoperatively. Complications also monitored at 6 weeks, 3 months, 6 months, and 12 months.
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Length of Hospital Stay
時間枠：At hospital discharge (postoperative), assessed up to approximately 5 days.
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Total number of days from RARP surgery to hospital discharge, extracted from medical records.
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At hospital discharge (postoperative), assessed up to approximately 5 days.
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Positive Surgical Margin Rate
時間枠：Following surgical pathology report, assessed within approximately 4 weeks of surgery.
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Proportion of participants with histopathologically confirmed positive surgical margins on surgical pathology report.
A positive surgical margin indicates residual tumour at the resection edge and represents an adverse oncological outcome.
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Following surgical pathology report, assessed within approximately 4 weeks of surgery.
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Pathological Staging - Tumour, Node, Metastasis (TNM) Classification
時間枠：Following surgical pathology report, assessed within approximately 4 weeks of surgery.
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Pathological TNM stage assigned from the surgical pathology report according to the Union for International Cancer Control (UICC) TNM classification system.
Staging reflects the pathological extent of disease including primary tumour (T), regional lymph nodes (N), and distant metastases (M).
Higher pathological stage indicates more locally advanced disease.
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Following surgical pathology report, assessed within approximately 4 weeks of surgery.
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Tumour Grade - Gleason Score and International Society of Urological Pathology (ISUP) Grade Group
時間枠：Following surgical pathology report, assessed within approximately 4 weeks of surgery.
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Gleason score (range 6-10; higher scores indicate less differentiated, more aggressive tumour histology) and International Society of Urological Pathology (ISUP) Grade Group (range 1-5; higher grade groups indicate more aggressive disease and a worse prognosis).
Both are derived from the surgical pathology report and are reported together as they describe the same histopathological characteristic.
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Following surgical pathology report, assessed within approximately 4 weeks of surgery.
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Adverse Pathological Features: Seminal Vesicle Invasion, Perineural Invasion, and Extraprostatic Extension
時間枠：Following surgical pathology report, assessed within approximately 4 weeks of surgery.
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Proportion of participants with each of the following adverse pathological features identified on surgical pathology report: (1) seminal vesicle invasion (SVI - yes/no), (2) perineural invasion (PNI - yes/no), and (3) extraprostatic extension (EPE - yes/no).
Each is reported as a proportion (%).
Presence of these features indicates more locally advanced pathology and is associated with poorer oncological outcomes.
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Following surgical pathology report, assessed within approximately 4 weeks of surgery.
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Incremental Cost-Effectiveness - Cost per IIEF-5 Improvement
時間枠：At 6 months postoperatively.
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Economic analysis estimating the incremental cost per point improvement in IIEF-5 score for the multimodal program versus standard care.
Costing data will include inpatient hospitalisation costs (from SLHD Performance Unit), out-of-pocket participant costs (reimbursed medication), and research-related resource utilisation.
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At 6 months postoperatively.
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Implementation Evaluation - RE-AIM Framework
時間枠：At trial completion (approximately 6 months postoperative of final participant).
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The RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework will be applied by investigators to evaluate the implementation of the trial, including reach of the eligible population, fidelity of intervention delivery, and potential for future adoption in clinical settings.
Assessed via a structured investigator-completed survey.
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At trial completion (approximately 6 months postoperative of final participant).
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Acceptability of the Multimodal Program to Participants
時間枠：Following completion of the prehabilitation program, assessed at approximately 3 months postoperatively.
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Assessed via a structured qualitative survey (Likert-scale and open-ended questions) and semi-structured interviews with intervention arm participants.
Explores barriers and facilitators to engagement, satisfaction with the program, and experiences with pharmacological adherence including pharmacy logistics.
Qualitative free-text data will be analysed using reflexive thematic analysis.
This is a qualitative outcome and is not scored on a numerical scale.
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Following completion of the prehabilitation program, assessed at approximately 3 months postoperatively.
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その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physical Activity Level - International Physical Activity Questionnaire (IPAQ)
時間枠：Baseline and 3 months postoperatively
|
The International Physical Activity Questionnaire (IPAQ) is a validated self-report questionnaire measuring total physical activity across four domains (work, transport, domestic, and leisure) over the preceding 7 days.
Total physical activity is expressed as metabolic equivalent of task minutes per week (MET-minutes/week).
There is no defined upper limit to the score; higher values indicate greater levels of physical activity, which represents a better outcome.
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Baseline and 3 months postoperatively
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Intensive Care Unit (ICU) Admission Rate
時間枠：At hospital discharge (postoperative), assessed up to approximately 5 days.
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Proportion of participants admitted to the intensive care unit (ICU) during their postoperative hospital stay following RARP, extracted from medical records.
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At hospital discharge (postoperative), assessed up to approximately 5 days.
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Intensive Care Unit (ICU) Length of Stay
時間枠：At hospital discharge (postoperative), assessed up to approximately 5 days.
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Total duration of ICU admission (hours) for participants admitted to the ICU postoperatively, extracted from medical records.
Assessed only in the subset of participants admitted to the ICU.
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At hospital discharge (postoperative), assessed up to approximately 5 days.
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30-Day Hospital Readmission Rate
時間枠：6-week postoperative assessment (capturing 30-day window).
|
Proportion of participants admitted to hospital within 30 days of RARP surgery, for any cause.
Assessed via participant self-report and medical records.
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6-week postoperative assessment (capturing 30-day window).
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Prostate Specific Antigen (PSA)
時間枠：Baseline (preoperative), 6 weeks, 3 months, 6 months, and 12 months postoperatively.
|
Serum PSA (ng/mL) extracted from medical records or pathology results.
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Baseline (preoperative), 6 weeks, 3 months, 6 months, and 12 months postoperatively.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
協力者
捜査官
捜査官
- 主任研究者：Daniel Steffens、Surgical Outcomes Research Centre (SOuRCe)
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
研究開始
2026年8月31日
一次修了 (推定)
一次修了
2028年12月1日
研究の完了 (推定)
研究の完了
2029年11月1日
試験登録日
最初に提出
最初に提出
2026年4月22日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年5月4日
最初の投稿 (実際)
最初の投稿
2026年5月8日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年9月9日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年9月2日
最終確認日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- X26-0106
- CH62/6/2026-007 (その他の識別子：SLHD CRGH HREC)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
There is no plan to make individual participant data available to other researchers.
All data will be stored securely for 15 years following trial closure in accordance with ICH-GCP, TGA, and HREC requirements.
Aggregate de-identified results will be disseminated via peer-reviewed publications and conference presentations.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。