Clinical trial NCT05576766: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 90
Sex: MALE
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Length of stay in hospital
timeFrame: Up to 30 days after surgery
Secondary outcomes:
measure: Perioperative anxiety score
timeFrame: On the day before surgery and at day 1 after surgery.
measure: Perioperative depression score
timeFrame: On the day before surgery and at day 1 after surgery.
measure: Pain score within 3 days after surgery
timeFrame: Up to 3 days after surgery
measure: Incidence of postoperative complications within 30 days after surgery
timeFrame: Up to 30 days after surgery
measure: Incidence of readmission within 30 days after surgery
timeFrame: Up to 30 days after surgery
measure: Overall survival within 90 days after surgery
timeFrame: Up to 90 days after surgery
measure: Total hospitalization cost within 30 days after surgery
timeFrame: Up to 30 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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