A Prospective, Randomized Comparison of Multidisciplinary Recovery After Surgery Program and Conventional Protocol for Perioperative Care in Orthopedics and Traumatology
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Early Postoperative Complications
研究概览
简要总结
The aim of the recovery protocol is to reduce surgical trauma, postoperative pain, and complications, shorten hospital treatment and improve postoperative recovery. Orthopedic and traumatology surgeries are often followed by a long-lasting recovery with difficulties of everyday functioning. Up to this time, only a few publications of multidisciplinary protocol in orthopedics and traumatology have been published, mostly to improve the care of patients after elective surgical procedures. The goal of multidisciplinary after surgery recovery program in orthopedics and traumatology is to improve the care of both urgent and elective patients using standardized, multi-professional care programs. It focuses on patient education, preoperative respiratory training, adequate nutritive and hemodynamic support, modified anesthesia protocol, prevention of postoperative pain, nausea and vomiting, and early postoperative delirium detection. The implementation of the program will reduce the rate of postoperative complications and the rate of rehospitalization, enhance the recovery after surgery and increase the satisfaction with the treatment.
详细描述
The protocol combines scientifically proven interventions to standardize medical care, improve treatment outcomes and reduce healthcare costs. The aim is to reduce surgical trauma and postoperative pain, reduce complications, shorten hospital treatment and improve postoperative recovery. Moreover, it has been shown that using standardized, patient oriented recovery protocol significantly improves the outcomes and quality of care, but also brings financial benefit for the hospital as well as for the health system in general. Studies about implementing multidisciplinary recovery protocol in orthopedic and traumatology are scarce. Orthopedic and traumatology surgeries are often followed by a long-lasting and demanding recovery characterized by the difficulties of everyday functioning. Recovery is therefore multidisciplinary: for example, it is necessary to monitor the nutritional status of a patient, decrease postoperative pain, monitor cognitive status, etc. Until now only a few publications of recovery protocols in orthopedics and traumatology have been published, mostly to improve the care of patients after elective surgical procedures. The goal of this protocol in orthopedics and traumatology is to improve the care of both urgent and elective patients using standardized, multi-professional care programs. It was created based on evidence-based practice and modified by multidisciplinary team of orthopedic and traumatology surgeons, anesthesiologists, physiatrist, physiotherapists, specialized medical nurses, nutritionists, and psychiatrists. It focuses on patient preoperative education, preoperative respiratory training, adequate nutritive and hemodynamic support, modified local and regional anesthesia protocol, prevention of postoperative pain, nausea and vomiting, and early postoperative delirium detection. The investigators postulate that the implementation of this program will reduce the rate of postoperative complications and the rate of rehospitalization, enhance the recovery after surgery and increase the satisfaction with the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fracture od proximal femur or knee fracture requiring surgery
- •Hip or knee arthrosis requiring joint replacement
- •American Society of Anesthesiologists (ASA) score II or III
- •Ability to provide informed consent
排除标准
- •Severe cognitive impairment
- •Pregnancy
- •End stage of malignant disease
- •Decompensated heart or liver disease
研究组 & 干预措施
Multidisciplinary Recovery Program
Two cohorts of patients will randomly be placed in either experimental od no intervention group.
Patients undergoing Multidisciplinary Recovery After Surgery Program will gain better preparation for early mobilization after surgery, nutritional support, individually modified analgesia and psychological support during inpatient treatment. Program includes preoperative, intraoperative and postoperative multidisciplinary comprehensive interventions.
干预措施: Multidisciplinary Recovery Program (Procedure)
Conventional Perioperative Care
Patients undergoing conventional care
结局指标
主要结局
Early Postoperative Complications
时间窗: 48 hours after surgery
Occurrence of early complications: * Dislocation or malpositioning of joint replacement * Neurological deficit * Need for blood transfusion * Postoperative delirium * Nausea or vomiting * Pneumonia * Headache * Wound dehiscence, secretion, inflammation, bleeding
Late Postoperative Complications
时间窗: 10 days after surgery
Occurrence of late complications: * Wound infection, healing by secundam * Decubitus * Fracture of joint replacement * Aseptic loosening of hip joint replacement * Infection of joint replacement * Thromboembolism * Need for a revision
次要结局
- Readmission rates(30 days after surgery)
- Patient-reported outcome after orthopedic surgery using The Western Ontario and McMaster Universities Arthritis Index (WOMAC)(2 days, 60 days after surgery, 90 days after surgery)
- Pain assessment using Visual Analog Scale (VAS)(1 day, 2 days, 60 days after surgery, 90 days after surgery)
- Assessment of health related quality of life using Euro Quality of Life Index (Euro QoL 5-D 5-L)(baseline, 2 days, 60 days after surgery, 90 days after surgery)
- Evaluation of patients' satisfaction with the care provided using The Short-form patient satisfaction questionnaire (PSQ-18)(3 days after surgery)
研究者
Nikica Darabos
Assistant Professor
Klinički Bolnički Centar Zagreb
