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Prostate CancerNCT05576766

Enhanced Recovery After Surgery (ERAS) Pathway in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy

A study testing Routine care and ERAS management pathway in people with Prostate Cancer and Robot-Assisted Laparoscopic Radical Prostatectomy, run by Peking University First Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Prostate cancer ranks second among all malignances in men and has become a significant threat to men's health. Robot-assisted laparoscopic radical prostatectomy (RARP) has become a standard treatment for prostate cancer. How to improve recovery following RARP surgery is worth investigating. Read more about this study

Who is it for?
Ages 60 to 90 years, men only
What is being tested?
Routine care and ERAS management pathway
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteChina
Study dates
Sep 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 60 years or over but below 90 years.
  • Scheduled to undergo robot-assisted laparoscopic radical prostatectomy (RARP) for prostate cancer.
  • Agree to participate in this study and give written informed consent.

Who cannot join

  • Scheduled to undergo combined surgery, including RARP combined with pelvic lymph node dissection or other procedures.
  • American Society of Anesthesiologists (ASA) physical classification ≥IV.
  • Inability to receive preoperative aerobic exercise because of severe cardiovascular disease, motor system diseases (arthritis, lumbar vertebrae disease), or central nervous system diseases (epilepsy, parkinsonism).
  • Inability to communicate in the preoperative period because of profound dementia, deafness, or language barriers.
  • History of schizophrenia, anxiety or depressive disorders, or other mental disorders.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shu-Ting He, MD contact

+86 15210585081

heshuting0809@163.com

Dong-Xin Wang, MD, PhD contact

+86 13910731903

wangdongxin@hotmail.com

China1 site

  • Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Dong-Xin Wang, MD, PhD, +86 13910731903, wangdongxin@hotmail.com

    Shu-Ting He, MD, +86 15210585081, heshuting0809@163.com

Other trials in China

About this study

Official title: Impact of Enhanced Recovery After Surgery (ERAS) Pathway on Outcomes in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy: A Randomized Controlled Trial

Prostate cancer ranks second among all malignances in men and has become a significant threat to men's health. Robot-assisted laparoscopic radical prostatectomy (RARP) has become a standard treatment for prostate cancer. How to improve recovery following RARP surgery is worth investigating. The enhanced recovery after surgery (ERAS) pathway involves a series of evidence-based procedures. It is aimed to reduce the systemic stress response to surgery and shorten the length of hospital stay. This randomized trial aims to investigate the impact of Enhanced Recovery After Surgery (ERAS) Pathway on early outcomes after RARP surgery.

Read the detailed description

Prostate cancer ranks second among all malignancies in men and has become a significant threat to men's health. Surgical resection is the main treatment for patients with early and locally advanced prostate cancer. With the progress of technology, robot-assisted laparoscopic radical prostatectomy (RARP) is gradually accepted by surgeons and become the first line treatment for prostate cancer. How to improve recovery after RARP surgery is worth investigating.

The concept of enhanced recovery after surgery (ERAS) was first reported by Dr. Kehlet. The ERAS pathway involves a series of evidence-based managements to accelerate patients' rehabilitation, including selective bowel preparation, nutritional therapy, fluid management, multimodal analgesia, early mobilization, etc. It has been applied to many patient populations including those undergoing gastrointestinal surgery, cardiothoracic surgery, and urological surgery. Previous studies showed that practicing ERAS in patients undergoing laparoscopic prostate surgery shortened the time to flatus and defecate and the length of hospital stay. Specifically, prehabilitation including aerobic exercise and pelvic floor training may be beneficial and improve physical wellbeing in patients undergoing prostatectomy. However, little is known regarding the effects of ERAS in patients undergoing RARP surgery.

The purpose of this randomized controlled trial is to investigate the impact of ERAS management, including prehabilitation, on early outcomes in patients undergoing RARP surgery.

Being tested
Routine care, ERAS management pathway
Keywords
Prostate Cancer, Robot-Assisted Laparoscopic Radical Prostatectomy, RARP, Enhanced Recovery After Surgery, ERAS, Prehabilitation, Length of hospital stay
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Routine careProcedure or surgery

    1. Routine information provided before surgery.
    2. No nutritional therapy.
    3. No aerobic exercise.
    4. No pelvic floor muscle training.
    5. No psychiatrist intervention.
    6. Bowel preparation with oral cathartic agent.
    7. Fasting for over 8 hours; no oral carbohydrate solution (OCS) loading before surgery.
    8. Hypothermia prevention not emphasized.
    9. General anesthesia; regional block not emphasized.
    10. Routine blood pressure management.
    11. Mobilization from postoperative day 1.
    12. Start oral feeding from postoperative day 1.
    13. Patient-controlled analgesia with opioids.
    14. Thromboembolism prophylaxis with low-molecular-weight heparin (LMWH).
    15. Routine pelvic drainage tube removal (usually at postoperative day 4).
    16. Routine urinary catheterization removal (usually at postoperative day 14).

  • ERAS management pathwayProcedure or surgery

    1. Patient consultation and education before surgery.
    2. Nutritional intervention for patients whose BMI<18.5 or BMI>24 kg/m2.
    3. Aerobic exercise for 2 weeks before surgery.
    4. Pelvic floor muscle training for 2 weeks before surgery.
    5. Psychiatrist intervention for patients with severe depression and anxiety.
    6. No bowel preparation before surgery.
    7. Provide oral carbohydrate solution 2 hours before surgery.
    8. Hypothermia prevention.
    9. General anesthesia combined with regional block.
    10. Goal-directed fluid infusion and targeted blood pressure management.
    11. Early mobilization.
    12. Early oral feeding.
    13. Multimodal analgesia, including opioids and non-steroid anti-inflammatory drugs.
    14. Thromboembolism prophylaxis with low-molecular-weight heparin; rivaroxaban for high-risk patients.
    15. Early pelvic drainage tube removal (at postoperative day 2) unless contraindicated.
    16. Early urinary catheterization removal (at postoperative day 7) unless contraindicated.
Study groups in NCT05576766
Study groupRoleWhat they receive
Routine care groupActive comparatorPerioperative management according to routine care.
Receives: Procedure: Routine care
ERAS groupExperimentalPerioperative management according to the Enhanced Recovery after Surgery (ERAS) pathway.
Receives: Procedure: ERAS management pathway

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The time required for the PADS score to meet the standard.

    The time required to achieve a post-anesthesia discharge score (PADS) of 9 or above after surgery.

    Measured: Up to 30 days after surgery.

Secondary outcomes (7)

  1. Perioperative anxiety score

    The score of anxiety is assessed by using the Self-Rating Anxiety Scale (SAS). This is a 20-item self-report questionnaire; each item is rated from 1 to 4 denoting the increasing severity or frequency of anxiety; the sum score times 1.25 as a standard score, ranging from 25 to 100, with higher score indicating more severe anxiety.

    Measured: On the day before surgery and at day 1 after surgery.

  2. Perioperative depression score

    The score of depression is assessed by using the Self-Rating Depression Scale (SDS). This is a 20-item self-report questionnaire; each item is rated from 1 to 4 denoting the increasing severity or frequency of depression; the sum score times 1.25 as a standard score, ranging from 25 to 100, with higher score indicating more severe depression.

    Measured: On the day before surgery and at day 1 after surgery.

  3. Pain score within 3 days after surgery

    Pain score is assessed twice daily (8:00-10:00 am, and 18:00-20:00 pm) with the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 to 10, with 0=no pain and 10=the worst pain.

    Measured: Up to 3 days after surgery

  4. Incidence of postoperative complications within 30 days after surgery

    Postoperative complications are defined as new-onset medical events that are harmful to patients' recovery and required therapeutic intervention, that is grade II or higher on the Clavien-Dindo classification.

    Measured: Up to 30 days after surgery

  5. Incidence of readmission within 30 days after surgery

    Readmission is defined as hospitalization for the second time after discharge within 30 days after surgery.

    Measured: Up to 30 days after surgery

  6. Overall survival within 90 days after surgery

    Overall survival within 90 days after surgery.

    Measured: Up to 90 days after surgery

  7. Total hospitalization cost within 30 days after surgery

    Total hospitalization cost is defined as the sum cost of hospitalization from admission up to 30 days after surgery, including re-hospitalization within 30 days.

    Measured: Up to 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study startSep 2025 (estimated)
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05576766
Sponsor's protocol ID
2021-235
Status last verified
Aug 2025
First submitted
12 Sep 2022
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Scott JM, Zabor EC, Schwitzer E, Koelwyn GJ, Adams SC, Nilsen TS, Moskowitz CS, Matsoukas K, Iyengar NM, Dang CT, Jones LW. Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. J Clin Oncol. 2018 Aug 1;36(22):2297-2305. doi: 10.1200/JCO.2017.77.5809. Epub 2018 Jun 12.

    PubMed 29894274

  • Xing J, Wang J, Liu G, Jia Y. Effects of enhanced recovery after surgery on robotic radical prostatectomy: a systematic review and meta-analysis. Gland Surg. 2021 Dec;10(12):3264-3271. doi: 10.21037/gs-21-699.

    PubMed 35070886

  • Xu Y, Liu A, Chen L, Huang H, Gao Y, Zhang C, Xu Y, Huang D, Xu D, Zhang M. Enhanced recovery after surgery (ERAS) pathway optimizes outcomes and costs for minimally invasive radical prostatectomy. J Int Med Res. 2020 Jun;48(6):300060520920072. doi: 10.1177/0300060520920072.

    PubMed 32485118

  • Sugi M, Matsuda T, Yoshida T, Taniguchi H, Mishima T, Yanishi M, Komai Y, Yasuda K, Kinoshita H, Yoshida K, Watanabe M. Introduction of an Enhanced Recovery after Surgery Protocol for Robot-Assisted Laparoscopic Radical Prostatectomy. Urol Int. 2017;99(2):194-200. doi: 10.1159/000457805. Epub 2017 Feb 17.

    PubMed 28222423

  • Visioni A, Shah R, Gabriel E, Attwood K, Kukar M, Nurkin S. Enhanced Recovery After Surgery for Noncolorectal Surgery?: A Systematic Review and Meta-analysis of Major Abdominal Surgery. Ann Surg. 2018 Jan;267(1):57-65. doi: 10.1097/SLA.0000000000002267.

    PubMed 28437313

  • Kehlet H, Mogensen T. Hospital stay of 2 days after open sigmoidectomy with a multimodal rehabilitation programme. Br J Surg. 1999 Feb;86(2):227-30. doi: 10.1046/j.1365-2168.1999.01023.x.

    PubMed 10100792

  • Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25.

    PubMed 27568654

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Magheli A, Knoll N, Lein M, Hinz S, Kempkensteffen C, Gralla O. Impact of fast-track postoperative care on intestinal function, pain, and length of hospital stay after laparoscopic radical prostatectomy. J Endourol. 2011 Jul;25(7):1143-7. doi: 10.1089/end.2011.0020.

    PubMed 21740262

  • Lv Z, Cai Y, Jiang H, Yang C, Tang C, Xu H, Li Z, Fan B, Li Y. Impact of enhanced recovery after surgery or fast track surgery pathways in minimally invasive radical prostatectomy: a systematic review and meta-analysis. Transl Androl Urol. 2020 Jun;9(3):1037-1052. doi: 10.21037/tau-19-884.

    PubMed 32676388

  • Lin C, Wan F, Lu Y, Li G, Yu L, Wang M. Enhanced recovery after surgery protocol for prostate cancer patients undergoing laparoscopic radical prostatectomy. J Int Med Res. 2019 Jan;47(1):114-121. doi: 10.1177/0300060518796758. Epub 2018 Sep 9.

    PubMed 30198392

  • Milliken D, Lawrence H, Brown M, Cahill D, Newhall D, Barker D, Ayyash R, Kasivisvanathan R. Anaesthetic management for robotic-assisted laparoscopic prostatectomy: the first UK national survey of current practice. J Robot Surg. 2021 Jun;15(3):335-341. doi: 10.1007/s11701-020-01105-3. Epub 2020 Jun 24.

    PubMed 32583048

  • Santa Mina D, Hilton WJ, Matthew AG, Awasthi R, Bousquet-Dion G, Alibhai SMH, Au D, Fleshner NE, Finelli A, Clarke H, Aprikian A, Tanguay S, Carli F. Prehabilitation for radical prostatectomy: A multicentre randomized controlled trial. Surg Oncol. 2018 Jun;27(2):289-298. doi: 10.1016/j.suronc.2018.05.010. Epub 2018 May 7.

    PubMed 29937184

  • Zhao Y, Zhang S, Liu B, Li J, Hong H. Clinical efficacy of enhanced recovery after surgery (ERAS) program in patients undergoing radical prostatectomy: a systematic review and meta-analysis. World J Surg Oncol. 2020 Jun 17;18(1):131. doi: 10.1186/s12957-020-01897-6.

    PubMed 32552894

  • Segal RJ, Reid RD, Courneya KS, Sigal RJ, Kenny GP, Prud'Homme DG, Malone SC, Wells GA, Scott CG, Slovinec D'Angelo ME. Randomized controlled trial of resistance or aerobic exercise in men receiving radiation therapy for prostate cancer. J Clin Oncol. 2009 Jan 20;27(3):344-51. doi: 10.1200/JCO.2007.15.4963. Epub 2008 Dec 8.

    PubMed 19064985

Questions about this trial

What is this clinical trial studying?

A study testing Routine care and ERAS management pathway in people with Prostate Cancer and Robot-Assisted Laparoscopic Radical Prostatectomy, run by Peking University First Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shu-Ting He, MD (+86 15210585081, heshuting0809@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The time required for the PADS score to meet the standard. (time frame: Up to 30 days after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05576766, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.

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Clinical Trial NCT05576766 | AzTrials