跳至主要内容
临床试验/NCT04900181
NCT04900181Unknown不适用

Analysis of the Cost-Effectiveness of Same-day Discharge Surgery for Primary Total Hip Arthroplasty: A Pragmatic Randomized Controlled Study

Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2020年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
84
试验地点
1
主要终点
the Oxford Hip Score

研究概览

简要总结

Total hip arthroplasty (THA) causes a great medical burden globally, and the same-day discharge (SDD) method has previously been considered to be cost saving. However, a standard cost-effectiveness analysis (CEA) in a randomized controlled trial (RCT) is needed to evaluated the benefits of SDD when performing THA from the perspective of both economic and clinical outcomes. So the objective is to evaluate the cost-effectiveness of SDD for hip replacement.

This was a single center, pragmatic RCT with a 6-month follow up. Eighty-four participants who met the inclusion criteria were randomized to either the SDD group or the inpatient group (42 per group). Outcomes were assessed by an independent orthopedist who was not in the surgical team, using the Oxford Hip Score (OHS), EuroQol 5D (EQ-5D) and 36-Item Short-From Health Survey (SF-36) scores at the baseline and the 6-month follow up. All interviews were conducted face to face. All the cost information was collected both from payment receipts and insurance reimbursement records.

详细描述

This was a prospective RCT. Patients qualified for inclusion in the study if they met the following criteria: undergoing unilateral primary THA; having the ability to understand the relevant treatment process; aged between 18 and 75 years; a body mass index (BMI) ≤ 40 kg/m2; hemoglobin ≥ 12g/dL; American Society of Anesthesiologists (ASA) physical status classification of I or II; and no ongoing infection or blood coagulation disorders. Those with a history of coronary artery disease, chronic obstructive pulmonary disease, arrhythmias, or untreated obstructive sleep apnea were excluded. Eligible individuals who gave informed consent were randomly assigned (1:1) to an inpatient THA group or an SDD THA group. SDD-THA was defined as admission, surgery, and discharge within 24 hours, whereas the inpatients stayed in hospital for more than one day. Randomization occurred at the individual level and was performed by an independent statistician, utilizing an automatic computer-generated table of random numbers. Preoperatively, patients undergoing SDD-THA and their families received information in the form of teaching booklets and a teaching class conducted by a bedside clinician, which included the protocol, matters needing attention, exercise training, and home-based rehabilitation. All operations were performed by the same surgical team through a posterolateral approach. Standardized general anesthesia was administered by low-dose bupivacaine, to allow early postoperative patient mobilization. Celebrex 400 mg PO was used as routine analgesia before surgery. Cefazolin (1.0 g) and Tranexamic Acid (0.4 g) were administered 30 min prior to skin incision. A uniform perioperative multimodal pain management protocol was established by cocktail periarticular injection before wound closure, which consisted of Flurbiprofen axetil (50 mg) and Ropivacaine (200 mg). Patients in both groups accepted the same postoperative protocols. To avoid venous thromboembolism (VTE), all participants were encouraged to perform ankle pumping and quadriceps-setting exercises immediately. Additionally, patients were encouraged to get out of bed and ambulate progressively with assistance under the guidance of the bedside clinician.

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
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •undergoing unilateral primary THA
  • •having the ability to understand the relevant treatment process
  • •aged between 18 and 75 years
  • •a body mass index (BMI) ≤ 40 kg/m2
  • •hemoglobin ≥ 12g/dL
  • •American Society of Anesthesiologists (ASA) physical status classification of I or II
  • •no ongoing infection or blood coagulation disorders

排除标准

  • •with a history of coronary artery disease
  • •chronic obstructive pulmonary disease
  • •arrhythmias
  • •untreated obstructive sleep apnea

研究组 & 干预措施

the same-day discharge surgery

Experimental

Patients in the the same-day discharge surgery group were admitted to hospital, operated and discharged within 24 hour

干预措施: the same-day discharge surgery (Procedure)

inpatient surgery

No Intervention

Patients in inpatient surgery follow routine procedures and do not need to be discharged on the same day.

结局指标

主要结局

the Oxford Hip Score

时间窗: six months

the Oxford Hip Score consists of 12 questions reflecting the different aspects of hip function. Each question was scored from 0 to 4, with 4 representing the best outcome or least symptoms

次要结局

  • the quality-adjusted life years(six months)

研究者

发起方
Wuhan Union Hospital, China
申办方类型
Other
责任方
Sponsor

研究点 (1)

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