Enhanced Recovery After Surgery (ERAS) Pathway in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
Primary Purpose
Prostate Cancer, Prostatectomy, Enhanced Recovery After Surgery
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Routine care
ERAS management pathway
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring Prostate Cancer, Robot-Assisted Laparoscopic Radical Prostatectomy, Enhanced Recovery After Surgery, Prehabilitation, Length of hospital stay
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.
Sites / Locations
- Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Routine care group
ERAS group
Arm Description
Perioperative management according to routine care.
Perioperative management according to the Enhanced Recovery after Surgery (ERAS) pathway.
Outcomes
Primary Outcome Measures
Length of stay in hospital
Length of stay in hospital of the first hospitalization.
Secondary Outcome Measures
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.
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.
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.
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.
Incidence of readmission within 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
Overall survival within 90 days after surgery.
Total hospitalization cost within 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.
Full Information
NCT ID
NCT05576766
First Posted
September 12, 2022
Last Updated
October 11, 2022
Sponsor
Peking University First Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05576766
Brief Title
Enhanced Recovery After Surgery (ERAS) Pathway in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
Official Title
Impact of Enhanced Recovery After Surgery (ERAS) Pathway on Outcomes in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostatectomy, Enhanced Recovery After Surgery, Prehabilitation, Length of Hospital Stay
Keywords
Prostate Cancer, Robot-Assisted Laparoscopic Radical Prostatectomy, Enhanced Recovery After Surgery, Prehabilitation, Length of hospital stay
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Routine care group
Arm Type
Active Comparator
Arm Description
Perioperative management according to routine care.
Arm Title
ERAS group
Arm Type
Experimental
Arm Description
Perioperative management according to the Enhanced Recovery after Surgery (ERAS) pathway.
Intervention Type
Procedure
Intervention Name(s)
Routine care
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
ERAS management pathway
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of stay in hospital
Description
Length of stay in hospital of the first hospitalization.
Time Frame
Up to 30 days after surgery
Secondary Outcome Measure Information:
Title
Perioperative anxiety score
Description
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.
Title
Perioperative depression score
Description
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.
Title
Pain score within 3 days after surgery
Description
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
Title
Incidence of postoperative complications within 30 days after surgery
Description
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
Title
Incidence of readmission within 30 days after surgery
Description
Readmission is defined as hospitalization for the second time after discharge within 30 days after surgery.
Time Frame
Up to 30 days after surgery
Title
Overall survival within 90 days after surgery
Description
Overall survival within 90 days after surgery.
Time Frame
Up to 90 days after surgery
Title
Total hospitalization cost within 30 days after surgery
Description
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.
Time Frame
Up to 30 days after surgery
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Ting He, MD
Phone
+86 15210585081
Email
heshuting0809@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Xin Wang, MD, PhD
Phone
+86 13910731903
Email
wangdongxin@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Phone
+86 13910731903
Email
wangdongxin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Shu-Ting He, MD
Phone
+86 15210585081
Email
heshuting0809@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Learn more about this trial
Enhanced Recovery After Surgery (ERAS) Pathway in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
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