PaThERAS Study- Application of Enhanced Recovery After Surgery Protocols in Thyroid and Parathyroid Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- To compare the rate of hypocalcemia in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols
研究概览
简要总结
Enhanced recovery after surgery (ERASP) are evidence-based perioperative protocols devised to expedite postoperative recovery and discharge, decrease surgical stress and costs. However, there is limited data on their use and effectiveness in thyroid and parathyroid surgery. Aim of PaThERAS study is to investigate the clinical benefits and cost-effectiveness of enhanced recovery protocols for the perioperative management in patients undergoing total thyroidectomy for large goiters/ cancers and parathyroidectomy for symptomatic hyperparathyroidism in non-day-care setting.
详细描述
AIMS AND OBJECTIVES
AIM: To evaluate if Enhanced recovery after surgery protocols; improves peri-operative outcomes in patients undergoing thyroid and parathyroid surgery
OBJECTIVES:
Primary Objective: To compare the rate of hypocalcemia in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols Secondary Objective: To compare the following outcome measures in in patients undergoing thyroid and parathyroid surgery
- length of hospital stay- defined as length of hospital stay from the date of surgery to the date of discharge
- hospital costs
- readmission rate
- postoperative complication rates
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patients diagnosed to have ASA Grade 1 and Grade 2 patients with thyroid and/or parathyroid (1° and 2° hyperparathyroidism) disease undergoing the following procedures via open or endoscopic approach • Total thyroidectomy/Focused parathyroidectomy/BNE with excision of enlarged glands +/- any additional procedure (Eg: Central compartment neck dissection, Lateral neck dissection, Cervical thymectomy etc)
排除标准
- •Patients undergoing thyroid and/or parathyroid surgery who
- •Undergo hemithyroidectomy
- •Refuse to consent to participate in the study in the cohort group
- •ASA Grade 3 and Grade 4* *Comorbidities of severe nature which may independently impact perioperative hospital stay, complications and outcomes in the study and control group
研究组 & 干预措施
ERAS Group
Those patients who follow ERAS protocols preoperatively, intraoperatively and post operatively
干预措施: Enhanced recovery protocols (Other)
Conventional Group
Those patients who conventional protocols preoperatively, intraoperatively and post operatively
干预措施: Conventional Protocols (Other)
结局指标
主要结局
To compare the rate of hypocalcemia in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols
时间窗: Post operative day 1, 2 & 7
S. Calcium levels will be measured. Levels \>8mg/dl were considered normal
次要结局
- To compare length of hospital stay in patients undergoing thyroid and parathyroid surgery in days(from date of surgery till Post operative Day 7)
- To compare hospital costs in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols(from date of surgery till Post operative Day 7)
- To compare postoperative complication rates in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols(from date of surgery till 6 months post surgery)
- To compare readmission rate(from date of surgery till 6 months post surgery)
研究者
Gaurav Agarwal
Professor and Head of Department Endocrine and Breast Surgery
Sanjay Gandhi Postgraduate Institute of Medical Sciences