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

NCT05576766 | Not Yet Recruiting

• 1 other identifier: 2021-235
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Robot-Assisted Laparoscopic Radical Prostatectomy; Enhanced Recovery After Surgery (ERAS) Protocol; Prehabilitation; Length of Hospital Stay

Keywords

Prostate Cancer; Robot-Assisted Laparoscopic Radical Prostatectomy; RARP; Enhanced Recovery After Surgery; ERAS; Prehabilitation; Length of hospital stay

Outcome Measures

Primary Outcomes (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.

  Up to 30 days after surgery.

Secondary Outcomes (7)

• Perioperative anxiety score

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

• Perioperative depression score

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

• Pain score within 3 days after surgery

  Up to 3 days after surgery

• Incidence of postoperative complications within 30 days after surgery

  Up to 30 days after surgery

• Incidence of readmission within 30 days after surgery

  Up to 30 days after surgery

Study Arms (2)

Routine care group

ACTIVE COMPARATOR

Perioperative management according to routine care.

Procedure: Routine care

ERAS group

EXPERIMENTAL

Perioperative management according to the Enhanced Recovery after Surgery (ERAS) pathway.

Procedure: ERAS management pathway

Interventions

Routine care PROCEDURE

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).

Routine care group

ERAS management pathway PROCEDURE

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.

ERAS group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (19)

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MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Ting He, MD

CONTACT

+86 15210585081; heshuting0809@163.com

Dong-Xin Wang, MD, PhD

CONTACT

+86 13910731903; wangdongxin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Anaesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: October 13, 2022
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)