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临床试验/CTRI/2024/02/062646
CTRI/2024/02/062646招募中3 期

A study to assess the efficacy of Enhanced Recovery After Surgery (ERAS) protocol in Open Abdominal Aortic Surgery - A Prospective, Randomized Controlled Trial

Sri Jayadeva Institute of Cardiovascular sciences and Research1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年2月19日最近更新:

试验速览

阶段
3 期
状态
招募中
入组人数
40
试验地点
1
主要终点
Mean duration of Stay in Hospital (days)

研究概览

简要总结

Enhanced Recover After Surgery (ERAS) pathways have gained popularity in improving perioperative outcomes. [1] They are being implemented in various surgical specialities and have shown widespread success in colorectal surgeries. [2] They accelerate the postoperative recovery thereby bringing down the expenses and reducing the burden on the health care system by efficient use of medical resources.

 Abdominal aortic surgeries are one of the commonly performed surgeries by vascular surgeons. This could be due to aortoiliac occlusive diseases which might require bypass surgery or due to pathologies such as Aortic aneurysms which may require an intervention.

 Open Abdominal Aortic surgeries can pose a challenge to the surgeons based on the location,   degree of disease or calcified vessel, previous surgeries and abdominal compliance. Though the surgeon does not have a control over these factors, there are certain patient variables that are amenable for modifications that can improve the perioperative outcome.

 Based on the clinical and radiological findings, interventions for aortoiliac occlusive diseases or aortic aneurysm diseases include bypass surgeries involving Aortoiliacs or Open Abdominal Aortic aneurysm repair and minimally invasive procedures such as Endovascular Aortic Aneurysm Repair (EVAR) or Angioplasty and stenting depending on patient factor, disease factor, comorbidities, et al. Endovascular procedures like EVAR offers many advantages since it is minimal access surgery but it is a costly procedure especially due to the use of stent graft systems, hence they are not suitable for all patients. Moreover, not all the patients will be having favourable anatomy for EVAR. In patients who undergo open repair, the post-operative hospital stay is longer and recovery is prolonged when compared to EVAR

 Open Abdominal Aortic surgery provides complexities not only during surgery but also in perioperative management. These group of patients commonly present with multiple comorbid conditions with poor general state. Although multimodal pathways have been used in various surgical disciplines, there are only limited studies that directly apply ERAS protocols in Abdominal Aortic

surgery population. [3] Hence we decided to implement an ERAS pathway for patients undergoing Open Abdominal Aortic surgery as it requires longer duration of stay.

 In this study the effect of ERAS pathway following Open Abdominal Aortic surgery in terms of time to regular diet, time for bowel movement and average duration of hospital stay following surgery will be compared with a standard care protocol. Further we will also be comparing time to oral analgesics and readmission rates. We hypothesised that patients for whom ERAS is implemented will have a   faster recovery time with better post-operative outcome and shortened hospital stay.

 ERAS protocol will be implemented for eligible patients undergoing open Abdominal Aortic surgery. The purpose of in-hospital assessment, details of the procedure, and follow up assessment will be explained clearly to the patient or the family, as is appropriate.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with aortoiliac occlusive diseases or abdominal aortic aneurysms who are fit for surgery Patients above the age of 18 years.
  • ASA grade between 1 to 3.

排除标准

  • Patients who required postoperative ICU admission.
  • Patients undergoing surgeries other than open abdominal aortic surgeries in the same sitting.
  • Patients requiring emergency surgery Patients allergic to Bupivacaine.

结局指标

主要结局

Mean duration of Stay in Hospital (days)

时间窗: Mean duration of Stay in Hospital (end point will be calculated on the day of discharge - which will be variable )

次要结局

  • Rate of 45 days readmission (in percentage)
  • Post-operative pain (using VAS)(Numeric pain scoring at 6,12,24,36,48,72 hours)
  • Post-operative opioid consumption (in mg)
  • Mean time for conversion from IV analgesics to Oral analgesics (days)
  • Mean time to first bowel movement (days)
  • Mean time to return to liquid and regular diet (days)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Poornima P

Sri Jayadeva institute of cardiovascular sciences and research

研究点 (1)

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