跳至主要内容
临床试验/NCT05688137
NCT05688137尚未招募不适用

Abdominal Drainage in the Postoperative Period of Liver Transplantation (DRALIT): Multi-institutional Randomized Clinical Trial

Hospital Universitario Virgen de la Arrixaca0 个研究点目标入组 365 人开始时间: 2023年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
365
主要终点
Abdominal drainage complications

研究概览

简要总结

Classically, in the postoperative period of liver transplantation (LT), abdominal drainage has been used as a way to make the early diagnosis of hemorrhages, bile leaks and other postsurgical complications, as well as an evacuation route for ascites. The use of it routinely is currently under discussion due to the morbidities associated with its use.

详细描述

LT has become in recent years a procedure with an increasing number of indications and with a greater number of donations given the social knowledge of the donation process and donation in controlled asystole. The Spanish Registry of Liver Transplantation (RETH) shows a total of 28,609 TH in the period 1986-2019, which represents an average of 867 TH per year in Spain. These data place Spain among the first countries in terms of HT.

In LT, abdominal drainage has historically been used prophylactically as a way to identify early intra-abdominal postoperative complications such as hemorrhage, bile leakage, and others.

In transplant patients, the use of post-surgical abdominal drains on a routine basis has shown an increase in total protein losses in patients with refractory ascites, an increase in ascending infections secondary to drainage, infection and pain at the insertion point of the drain, as well as as, an increase in hospital stay. Nor can a higher rate of postsurgical bleeding and bile leakage be ruled out in patients with abdominal drainage.

Currently, in the few studies that there are in reference to the systematic use of abdominal drains in lTH, the need for them prophylactically is being discussed as an early diagnosis of postoperative intra-abdominal complications is not observed, but complications are seen to increase secondary to drainage. Therefore, the need to use it systematically in all patients is currently under discussion.

Currently, is facing an increase in ERASⓇ (Enhanced Recovery After Surgey) programs, which began in 2008 with colorectal surgery and are currently expanding to other surgical procedures. These programs advocate reducing the number of drains and even not using them in patients with a low risk of post-surgical complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • Patients of both sexes aged between 18 and 75 years included in the waiting list for HT by the committee of the Virgen de la Arrixaca University Hospital.
  • Sign Informed Consent.

排除标准

  • Having been rejected for liver transplantation by said committee.
  • Age less than 18 years or greater than
  • Any contraindication by the main surgeon that makes the placement of an intra-abdominal drain necessary.
  • Not having signed the Informed Consent.

结局指标

主要结局

Abdominal drainage complications

时间窗: 90 days

To assess whether the prophylactic use of abdominal drains in the postoperative period of LT increases the number of abdominal complications in the 90 postoperative days (Clavien-Dindo)

次要结局

  • Assessment of quality of life (QoL) during the perioperative process using the SF-36 questionnaire.(120 days)
  • Evaluation of in-hospital stay after surgery.(90 days)

研究者

发起方
Hospital Universitario Virgen de la Arrixaca
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alvaro Cerezuela Fernandez de Palencia

Principal Investigator

Hospital Universitario Virgen de la Arrixaca

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