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

Peking University

Status: Not yet enrolling

Conditions: Length of Hospital Stay; Enhanced Recovery After Surgery (ERAS) Protocol; Prehabilitation; Prostate Cancer; Robot-Assisted Laparoscopic Radical Prostatectomy

Treatments: Procedure: ERAS management pathway; Procedure: Routine care

Study type: Interventional

Funder types: Other

Identifiers

NCT05576766

2021-235

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: Male

Ages: 60 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Routine care group

Active Comparator group

Description:

Perioperative management according to routine care.

Treatment:

Procedure: Routine care

ERAS group

Experimental group

Description:

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

Treatment:

Procedure: ERAS management pathway