Abdominal Drainage in the Postoperative Period of Liver Transplantation (DRALIT)

Study Overview
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Brief Summary
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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
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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. 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.

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

Conditions
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Liver Transplant; Complications, Drainage

Intervention / Treatment
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* Procedure: Abdominal drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Having been rejected for liver transplantation by said committee. Age less than 18 years or greater than 75. Any contraindication by the main surgeon that makes the placement of an intra-abdominal drain necessary. Not having signed the Informed Consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups of equal size, total n = 365 patients. Simple intraoperative randomization prior to closure of the abdominal wall after fulfilling all the inclusion criteria and none of the exclusion criteria.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DRAINAGE GROUP (D)<br>This patients will take the abdominal drainage. | Procedure: Abdominal drainage<br>* The patients with intervention will take an abdominal drainage.<br>|
| No Intervention: NON DRAINAGE GROUP (ND)<br>This patients will not take the abdominal drainage. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal drainage complications | 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) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of quality of life (QoL) during the perioperative process using the SF-36 questionnaire. | Assessment of the quality of life (QoL) of transplant recipients, whether or not they are drainage recipients, during the perioperative process using the SF-36 questionnaire. | 120 days | 
| Evaluation of in-hospital stay after surgery. | Evaluate the postoperative stay in both groups from the hospital admission to discharge measured in days of admission. | 90 days |