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

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

NCT ID: NCT05576766

Condition: Prostate Cancer
Prostatectomy
Enhanced Recovery After Surgery
Prehabilitation
Length of Hospital Stay

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
Prostate Cancer
Robot-Assisted Laparoscopic Radical Prostatectomy
Enhanced Recovery After Surgery
Prehabilitation
Length of hospital stay

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: Routine care
Description: 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).
Arm group label: Routine care group

Intervention type: Procedure
Intervention name: ERAS management pathway
Description: 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.
Arm group label: ERAS group

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.

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.

Criteria for eligibility:
Criteria:
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.

Gender: Male

Minimum age: 60 Years

Maximum age: 90 Years

Healthy volunteers: No

Locations:

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

Address:
City: Beijing
Zip: 100034
Country: China

Contact:
Last name: Dong-Xin Wang, MD, PhD

Phone: +86 13910731903
Email: wangdongxin@hotmail.com

Contact backup:
Last name: Shu-Ting He, MD

Phone: +86 15210585081
Email: heshuting0809@163.com

Start date: October 2022

Completion date: July 2024

Lead sponsor:
Agency: Peking University First Hospital
Agency class: Other

Source: Peking University First Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05576766