跳至主要内容
临床试验/NCT05192044
NCT05192044Unknown不适用

Less Than 100 Hours Hospital Stay After Pancreatico-duodenectomy, RCT

National Cancer Institute, Egypt2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年12月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Feasibility of enhanced recovery after pancreatico-dudenectomy

研究概览

简要总结

Few decades back pancreatico-duodenectomy (PD) was associated with a very high morbidity and mortality. With recent advancements in surgical and anesthetic techniques and improvement in peri-operative care, PD has evolved into a procedure with acceptable morbidity and mortality. Today PD is associated with a mortality of less than 5%, in high volume tertiary care centers. The multimodal concept of fast-track surgery was first introduced in colonic surgery. Several studies have demonstrated the effectiveness of this program in colonic resection. Recently, fast-track surgery has been attempted in pancreatic surgery with encouraging results, but such data are sparse. The core aims of ERAS protocols are to safely hasten postoperative recovery and ease the stress response.

Specifically, in the context of pancreatico-duodenectomy, such interventions have been shown to be safe with no increase in mortality or unplanned readmissions, delayed gastric emptying (DGE), or pancreatic fistula . Purported benefits include reduced admission related costs, incidence of DGE, overall morbidity and length of stay.

The aim of this study was to evaluate the feasibility of implementing fast track rehabilitation protocol following pancreaticoduodenectomy and to see if it is associated with improved recovery, reduced morbidity and reduced length of hospital stay.

详细描述

Study population: This is a prospective study that will be conducted on all patients of both sexes and definite age groups attending the National Cancer Institute, Cairo University and candidate for pancreatico-duodenectomy Sampling: all cases fulfilling the inclusion criteria will be included in the study.

Patients will be classified into two groups:

  • Group A: Fast track Care pancreatico-duodenectomy.
  • Group B: Conventional Care pancreatico-duodenectomy. Baseline demographics, body mass index (BMI), perioperative parameters, postoperative course, postoperative complications and 30-days operative mortality will be analyzed.

Inclusion criteria:

  • Age ≤ 75 years
  • ASA 1 or 2
  • BMI < 35 The underlying pathology or use of neoadjuvant chemotherapy did not preclude inclusion into the study

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
None

入排标准

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

入选标准

  • Age ≤ 75 years
  • ASA 1 or 2
  • BMI < 35
  • The underlying pathology or use of neoadjuvant chemotherapy did not preclude inclusion into the study

排除标准

  • pancreatico-duodenectomy with vascular reconstruction.

结局指标

主要结局

Feasibility of enhanced recovery after pancreatico-dudenectomy

时间窗: 1 month after surgery

Feasibility will be measured by recording post operative complications according to Clavien- Dindo classification

次要结局

未报告次要终点

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Sponsor

研究点 (2)

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