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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05576766
• Other study ID #: 2021-235
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: July 2024

Study information

• Verified date: October 2022
• Source: Peking University First Hospital
• Contact: Shu-Ting He, MD
• Phone: +86 15210585081
• Email: heshuting0809[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery
• Length of Hospital Stay
• Prehabilitation
• Prostate Cancer
• Prostatectomy
• Prostatic Neoplasms

Intervention

Procedure:
• Routine care
Routine information provided before surgery. No nutritional therapy. No aerobic exercise. No pelvic floor muscle training. No psychiatrist intervention. Bowel preparation with oral cathartic agent. Fasting for over 8 hours; no oral carbohydrate solution (OCS) loading before surgery. Hypothermia prevention not emphasized. General anesthesia; regional block not emphasized. Routine blood pressure management. Mobilization from postoperative day 1. Start oral feeding from postoperative day 1. Patient-controlled analgesia with opioids. Thromboembolism prophylaxis with low-molecular-weight heparin (LMWH). Routine pelvic drainage tube removal (usually at postoperative day 4). Routine urinary catheterization removal (usually at postoperative day 14).
• ERAS management pathway
Patient consultation and education before surgery. Nutritional intervention for patients whose BMI<18.5 or BMI>24 kg/m2. Aerobic exercise for 2 weeks before surgery. Pelvic floor muscle training for 2 weeks before surgery. Psychiatrist intervention for patients with severe depression and anxiety. No bowel preparation before surgery. Provide oral carbohydrate solution 2 hours before surgery. Hypothermia prevention. General anesthesia combined with regional block. Goal-directed fluid infusion and targeted blood pressure management. Early mobilization. Early oral feeding. Multimodal analgesia, including opioids and non-steroid anti-inflammatory drugs. Thromboembolism prophylaxis with low-molecular-weight heparin; rivaroxaban for high-risk patients. Early pelvic drainage tube removal (at postoperative day 2) unless contraindicated. Early urinary catheterization removal (at postoperative day 7) unless contraindicated.

Locations

Country	Name	City	State
China	Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (13)

Angenete E, Angerås U, Börjesson 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay in hospital	Length of stay in hospital of the first hospitalization.	Up to 30 days after surgery
Secondary	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.	On the day before surgery and at day 1 after surgery.
Secondary	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.	On the day before surgery and at day 1 after surgery.
Secondary	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.	Up to 3 days after surgery
Secondary	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.	Up to 30 days after surgery
Secondary	Incidence of readmission within 30 days after surgery	Readmission is defined as hospitalization for the second time after discharge within 30 days after surgery.	Up to 30 days after surgery
Secondary	Overall survival within 90 days after surgery	Overall survival within 90 days after surgery.	Up to 90 days after surgery
Secondary	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.	Up to 30 days after surgery