Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-01-05 @ 6:07 PM
Study NCT ID:
NCT05576766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-21
First Post:
2022-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Recovery After Surgery (ERAS) Pathway in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2022-09-12', 'studyFirstSubmitQcDate': '2022-10-11', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time required for the PADS score to meet the standard.', 'timeFrame': 'Up to 30 days after surgery.', 'description': 'The time required to achieve a post-anesthesia discharge score (PADS) of 9 or above after surgery.'}], 'secondaryOutcomes': [{'measure': 'Perioperative anxiety score', 'timeFrame': 'On the day before surgery and at day 1 after surgery.', 'description': '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.'}, {'measure': 'Perioperative depression score', 'timeFrame': 'On the day before surgery and at day 1 after surgery.', 'description': '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.'}, {'measure': 'Pain score within 3 days after surgery', 'timeFrame': 'Up to 3 days after surgery', 'description': '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.'}, {'measure': 'Incidence of postoperative complications within 30 days after surgery', 'timeFrame': 'Up to 30 days after surgery', 'description': "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."}, {'measure': 'Incidence of readmission within 30 days after surgery', 'timeFrame': 'Up to 30 days after surgery', 'description': 'Readmission is defined as hospitalization for the second time after discharge within 30 days after surgery.'}, {'measure': 'Overall survival within 90 days after surgery', 'timeFrame': 'Up to 90 days after surgery', 'description': 'Overall survival within 90 days after surgery.'}, {'measure': 'Total hospitalization cost within 30 days after surgery', 'timeFrame': 'Up to 30 days after surgery', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Robot-Assisted Laparoscopic Radical Prostatectomy', 'RARP', 'Enhanced Recovery After Surgery', 'ERAS', 'Prehabilitation', 'Length of hospital stay'], 'conditions': ['Prostate Cancer', 'Robot-Assisted Laparoscopic Radical Prostatectomy', 'Enhanced Recovery After Surgery (ERAS) Protocol', 'Prehabilitation', 'Length of Hospital Stay']}, 'referencesModule': {'references': [{'pmid': '29894274', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35070886', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32485118', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28222423', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28437313', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10100792', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27568654', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30207593', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21740262', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32676388', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30198392', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32583048', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29937184', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32552894', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19064985', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '27531014', 'type': 'BACKGROUND', 'citation': 'Angenete E, Angeras U, Borjesson M, Ekelund J, Gellerstedt M, Thorsteinsdottir T, Steineck G, Haglind E. Physical activity before radical prostatectomy reduces sick leave after surgery - results from a prospective, non-randomized controlled clinical trial (LAPPRO). BMC Urol. 2016 Aug 16;16(1):50. doi: 10.1186/s12894-016-0168-0.'}, {'pmid': '31348053', 'type': 'BACKGROUND', 'citation': 'Liu Z, Qiu T, Pei L, Zhang Y, Xu L, Cui Y, Liang N, Li S, Chen W, Huang Y. Two-Week Multimodal Prehabilitation Program Improves Perioperative Functional Capability in Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer: A Randomized Controlled Trial. Anesth Analg. 2020 Sep;131(3):840-849. doi: 10.1213/ANE.0000000000004342.'}, {'pmid': '35399176', 'type': 'BACKGROUND', 'citation': 'Hori T, Makino T, Fujimura R, Takimoto A, Urata S, Miyagi T. Favorable Impact on Postoperative Abdominal Symptoms in Robot-assisted Radical Prostatectomy Using Enhanced Recovery After Surgery Protocol. Cancer Diagn Progn. 2022 Mar 3;2(2):247-252. doi: 10.21873/cdp.10101. eCollection 2022 Mar-Apr.'}, {'pmid': '34423666', 'type': 'BACKGROUND', 'citation': 'Cao J, Gu J, Wang Y, Guo X, Gao X, Lu X. Clinical efficacy of an enhanced recovery after surgery protocol in patients undergoing robotic-assisted laparoscopic prostatectomy. J Int Med Res. 2021 Aug;49(8):3000605211033173. doi: 10.1177/03000605211033173.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nThe 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.\n\nThe purpose of this randomized controlled trial is to investigate the impact of ERAS management, including prehabilitation, on early outcomes in patients undergoing RARP surgery."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 60 years or over but below 90 years.\n* Scheduled to undergo robot-assisted laparoscopic radical prostatectomy (RARP) for prostate cancer.\n* Agree to participate in this study and give written informed consent.\n\nExclusion Criteria:\n\n* Scheduled to undergo combined surgery, including RARP combined with pelvic lymph node dissection or other procedures.\n* American Society of Anesthesiologists (ASA) physical classification ≥IV.\n* 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).\n* Inability to communicate in the preoperative period because of profound dementia, deafness, or language barriers.\n* History of schizophrenia, anxiety or depressive disorders, or other mental disorders.'}, 'identificationModule': {'nctId': 'NCT05576766', 'briefTitle': 'Enhanced Recovery After Surgery (ERAS) Pathway in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Impact of Enhanced Recovery After Surgery (ERAS) Pathway on Outcomes in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2021-235'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Routine care group', 'description': 'Perioperative management according to routine care.', 'interventionNames': ['Procedure: Routine care']}, {'type': 'EXPERIMENTAL', 'label': 'ERAS group', 'description': 'Perioperative management according to the Enhanced Recovery after Surgery (ERAS) pathway.', 'interventionNames': ['Procedure: ERAS management pathway']}], 'interventions': [{'name': 'Routine care', 'type': 'PROCEDURE', 'description': '1. Routine information provided before surgery.\n2. No nutritional therapy.\n3. No aerobic exercise.\n4. No pelvic floor muscle training.\n5. No psychiatrist intervention.\n6. Bowel preparation with oral cathartic agent.\n7. Fasting for over 8 hours; no oral carbohydrate solution (OCS) loading before surgery.\n8. Hypothermia prevention not emphasized.\n9. General anesthesia; regional block not emphasized.\n10. Routine blood pressure management.\n11. Mobilization from postoperative day 1.\n12. Start oral feeding from postoperative day 1.\n13. Patient-controlled analgesia with opioids.\n14. Thromboembolism prophylaxis with low-molecular-weight heparin (LMWH).\n15. Routine pelvic drainage tube removal (usually at postoperative day 4).\n16. Routine urinary catheterization removal (usually at postoperative day 14).', 'armGroupLabels': ['Routine care group']}, {'name': 'ERAS management pathway', 'type': 'PROCEDURE', 'description': '1. Patient consultation and education before surgery.\n2. Nutritional intervention for patients whose BMI\\<18.5 or BMI\\>24 kg/m2.\n3. Aerobic exercise for 2 weeks before surgery.\n4. Pelvic floor muscle training for 2 weeks before surgery.\n5. Psychiatrist intervention for patients with severe depression and anxiety.\n6. No bowel preparation before surgery.\n7. Provide oral carbohydrate solution 2 hours before surgery.\n8. Hypothermia prevention.\n9. General anesthesia combined with regional block.\n10. Goal-directed fluid infusion and targeted blood pressure management.\n11. Early mobilization.\n12. Early oral feeding.\n13. Multimodal analgesia, including opioids and non-steroid anti-inflammatory drugs.\n14. Thromboembolism prophylaxis with low-molecular-weight heparin; rivaroxaban for high-risk patients.\n15. Early pelvic drainage tube removal (at postoperative day 2) unless contraindicated.\n16. Early urinary catheterization removal (at postoperative day 7) unless contraindicated.', 'armGroupLabels': ['ERAS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Dong-Xin Wang, MD, PhD', 'role': 'CONTACT', 'email': 'wangdongxin@hotmail.com', 'phone': '+86 13910731903'}, {'name': 'Shu-Ting He, MD', 'role': 'CONTACT', 'email': 'heshuting0809@163.com', 'phone': '+86 15210585081'}], 'facility': 'Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shu-Ting He, MD', 'role': 'CONTACT', 'email': 'heshuting0809@163.com', 'phone': '+86 15210585081'}, {'name': 'Dong-Xin Wang, MD, PhD', 'role': 'CONTACT', 'email': 'wangdongxin@hotmail.com', 'phone': '+86 13910731903'}], 'overallOfficials': [{'name': 'Dong-Xin Wang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman, Department of Anaesthesiology and Critical Care Medicine', 'investigatorFullName': 'Dong-Xin Wang', 'investigatorAffiliation': 'Peking University First Hospital'}}}}