Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05688137
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-18
First Post:
2022-05-31
Brief Title:
Abdominal Drainage in the Postoperative Period of Liver Transplantation DRALIT
Sponsor:
Hospital Universitario Virgen de la Arrixaca
Organization:
Hospital Universitario Virgen de la Arrixaca
Study Overview
Official Title:
Abdominal Drainage in the Postoperative Period of Liver Transplantation DRALIT Multi-institutional Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRALIT
Brief Summary:
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
Detailed Description:
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 28609 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
In the current bibliography the methodology of the studies is varied with the majority being non-randomized retrospective studies which is why it is a subject that requires studies with a better methodological design and a higher number of patients to obtain conclusions of clinical relevance that can set the direction in this area that is in constant discussion
Given the absence of any randomized non-inferiority clinical trial that studies the routine use of abdominal drainage in the postoperative period of liver transplantation consider that it is necessary to carry it out to increase the evidence
The number of HT performed in each center is limited and variable annually which is why consider that the best design for this clinical trial is a European multicenter
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
In the current bibliography the methodology of the studies is varied with the majority being non-randomized retrospective studies which is why it is a subject that requires studies with a better methodological design and a higher number of patients to obtain conclusions of clinical relevance that can set the direction in this area that is in constant discussion
Given the absence of any randomized non-inferiority clinical trial that studies the routine use of abdominal drainage in the postoperative period of liver transplantation consider that it is necessary to carry it out to increase the evidence
The number of HT performed in each center is limited and variable annually which is why consider that the best design for this clinical trial is a European multicenter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None