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

August 15, 2025 updated by: Dong-Xin Wang, Peking University First Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Routine care group
Perioperative management according to routine care.
Procedure: Routine care
  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).
Experimental: ERAS group
Perioperative management according to the Enhanced Recovery after Surgery (ERAS) pathway.
Procedure: ERAS management pathway
  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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time required for the PADS score to meet the standard.
Time Frame: Up to 30 days after surgery.
The time required to achieve a post-anesthesia discharge score (PADS) of 9 or above after surgery.
Up to 30 days after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative anxiety score
Time Frame: On the day before surgery and at day 1 after surgery.
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.
Perioperative depression score
Time Frame: On the day before surgery and at day 1 after surgery.
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.
Pain score within 3 days after surgery
Time Frame: Up to 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
Incidence of postoperative complications within 30 days after surgery
Time Frame: Up to 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
Incidence of readmission within 30 days after surgery
Time Frame: Up to 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
Overall survival within 90 days after surgery
Time Frame: Up to 90 days after surgery
Overall survival within 90 days after surgery.
Up to 90 days after surgery
Total hospitalization cost within 30 days after surgery
Time Frame: Up to 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

August 21, 2025

Last Update Submitted That Met QC Criteria

August 15, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-235

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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