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临床试验/NCT07072897
NCT07072897已完成不适用

Restrictive Versus Liberal Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy: A Prospective Randomized Controlled Study

Tribhuvan University Teaching Hospital, Institute Of Medicine.2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
2
主要终点
postoperative complications CD≥ IIIb

研究概览

简要总结

ancreaticoduodenectomy (also known as PD or the Whipple procedure) is a major surgery often done for conditions like pancreatic cancer. Over the past few decades, doctors around the world have greatly improved surgical techniques, reducing the risk of death after PD from about 24% in the 1980s to less than 2% today in good volume hospitals.

However, even though fewer patients are dying from the surgery, many still face complications after surgery, such as infections, delayed healing, or other problems called as morbidities. These problems can affect 17% to 50% of patients.

One important factor that may affect recovery is fluid management - the amount of fluids patients receive around the time of surgery.

Traditionally, surgeons gave large amounts of fluid during and after surgery, thinking it helped keep blood pressure and urine output stable. This approach is called liberal fluid therapy. But giving too much fluid can cause swelling, weight gain, and slower recovery.

A newer method, called restrictive fluid therapy, gives smaller, more controlled amounts of fluid to avoid these problems. This approach is new and has shown good results in some studies however the exact role is yet unclear.

At our hospital, we usually use liberal fluid therapy and give fluids based on the treating physician, using these fluids or restricting them as per the treating physician's choice.

So, the study compares these two fluid strategies in patients having PD. Our goal is to find out whether using less fluid (restrictive therapy) could help reduce complications and improve patient outcomes when compared to using more liberal fluids.

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
Single (Participant)

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

入选标准

  • All patients who underwent PD at TUTH during the research duration.
  • All patients above 18 years.

排除标准

  • Those not willing to participate in the study.
  • All patients with age ≥ 75 years.
  • Patients with Chronic renal failure.
  • Patients with major Cardiac illness.
  • Patients who died within 24 hours of surgery.
  • Failure to comply with the regimen due to any reason.
  • Those who underwent palliative procedure instead of planned PD.

结局指标

主要结局

postoperative complications CD≥ IIIb

时间窗: 1 month

CD IIIb and more were chosen as major complications as major morbidity occurs when the patient is taken to operating room or ICU to manage these complications.

次要结局

  • other complications(1 month)

研究者

发起方
Tribhuvan University Teaching Hospital, Institute Of Medicine.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Romi Dahal

principal investigator

Tribhuvan University Teaching Hospital, Institute Of Medicine.

研究点 (2)

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