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

Sponsor

Peking University First Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05576766

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Prostatectomy Enhanced Recovery After Surgery Prehabilitation Length of Hospital Stay	Procedure: Routine care Procedure: ERAS management pathway	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Routine care group

Perioperative management according to routine care.

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).

Experimental: ERAS group

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

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Length of stay in hospital [Up to 30 days after surgery]
Length of stay in hospital of the first hospitalization.

Secondary Outcome Measures

Perioperative anxiety score [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.
Perioperative depression score [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.
Pain score within 3 days after surgery [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.
Incidence of postoperative complications within 30 days after surgery [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.
Incidence of readmission within 30 days after surgery [Up to 30 days after surgery]
Readmission is defined as hospitalization for the second time after discharge within 30 days after surgery.
Overall survival within 90 days after surgery [Up to 90 days after surgery]
Overall survival within 90 days after surgery.
Total hospitalization cost within 30 days after surgery [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 90 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.