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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Routine care
  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 fe
• Процедура ERAS management pathway
  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.

Первичные конечные точки

• The time required for the PADS score to meet the standard. [Срок оценки: Up to 30 days after surgery.]

Вторичные конечные точки (7)

• Perioperative anxiety score [Срок оценки: On the day before surgery and at day 1 after surgery.]
• Perioperative depression score [Срок оценки: On the day before surgery and at day 1 after surgery.]
• Pain score within 3 days after surgery [Срок оценки: Up to 3 days after surgery]
• Incidence of postoperative complications within 30 days after surgery [Срок оценки: Up to 30 days after surgery]
• Incidence of readmission within 30 days after surgery [Срок оценки: Up to 30 days after surgery]
• Overall survival within 90 days after surgery [Срок оценки: Up to 90 days after surgery]
• Total hospitalization cost within 30 days after surgery [Срок оценки: Up to 30 days after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital — Пекин

Публикации

• Scott JM, Zabor EC, Schwitzer E, Koelwyn GJ, Adams SC, Nilsen TS, Moskowitz CS, Matsoukas K, Iyengar NM, Dang CT, Jones LW. Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. J Clin Oncol. 2018 Aug 1;36(22):2297-2305. doi: 10.1200/JCO.2017.77.5809. Epub 2018 Jun 12. PMID 29894274
• Xing J, Wang J, Liu G, Jia Y. Effects of enhanced recovery after surgery on robotic radical prostatectomy: a systematic review and meta-analysis. Gland Surg. 2021 Dec;10(12):3264-3271. doi: 10.21037/gs-21-699. PMID 35070886
• Xu Y, Liu A, Chen L, Huang H, Gao Y, Zhang C, Xu Y, Huang D, Xu D, Zhang M. Enhanced recovery after surgery (ERAS) pathway optimizes outcomes and costs for minimally invasive radical prostatectomy. J Int Med Res. 2020 Jun;48(6):300060520920072. doi: 10.1177/0300060520920072. PMID 32485118
• Sugi M, Matsuda T, Yoshida T, Taniguchi H, Mishima T, Yanishi M, Komai Y, Yasuda K, Kinoshita H, Yoshida K, Watanabe M. Introduction of an Enhanced Recovery after Surgery Protocol for Robot-Assisted Laparoscopic Radical Prostatectomy. Urol Int. 2017;99(2):194-200. doi: 10.1159/000457805. Epub 2017 Feb 17. PMID 28222423
• Visioni A, Shah R, Gabriel E, Attwood K, Kukar M, Nurkin S. Enhanced Recovery After Surgery for Noncolorectal Surgery?: A Systematic Review and Meta-analysis of Major Abdominal Surgery. Ann Surg. 2018 Jan;267(1):57-65. doi: 10.1097/SLA.0000000000002267. PMID 28437313
• Kehlet H, Mogensen T. Hospital stay of 2 days after open sigmoidectomy with a multimodal rehabilitation programme. Br J Surg. 1999 Feb;86(2):227-30. doi: 10.1046/j.1365-2168.1999.01023.x. PMID 10100792
• Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2 PMID 27568654
• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593

Идентификаторы

NCT: NCT05576766 · 2021-235

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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