跳至主要内容
临床试验/NCT03822247
NCT03822247
Unknown
不适用

A Prospective, Randomized Comparison of Multidisciplinary Recovery After Surgery Program and Conventional Protocol for Perioperative Care in Orthopedics and Traumatology

Klinički Bolnički Centar Zagreb1 个研究点 分布在 1 个国家目标入组 100 人2018年12月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Hip Fractures
发起方
Klinički Bolnički Centar Zagreb
入组人数
100
试验地点
1
主要终点
Early Postoperative Complications
最后更新
7年前

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.

注册库
clinicaltrials.gov
开始日期
2018年12月1日
结束日期
2020年1月1日
最后更新
7年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Klinički Bolnički Centar Zagreb
责任方
Principal Investigator
主要研究者

Nikica Darabos

Assistant Professor

Klinički Bolnički Centar Zagreb

入排标准

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

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)

研究点 (1)

Loading locations...

相似试验