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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age60-90
SponsorPeking University First Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Routine care

    Procedure/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 pathway

    Procedure/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.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Routine care groupActive comparator 1 intervention
Group B: ERAS groupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Up to 30 days after surgery.

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Up to 30 days after surgery

Other outcomes

Sponsors and contacts

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