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

January 14, 2023 updated by: Alvaro Cerezuela Fernandez de Palencia, Hospital Universitario Virgen de la Arrixaca

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

365

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal drainage complications
Time Frame: 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)
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.
Time Frame: 120 days
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.
Time Frame: 90 days
Evaluate the postoperative stay in both groups from the hospital admission to discharge measured in days of admission.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Virgen de la Arrixaca

Investigators

  • Principal Investigator: Álvaro Cerezuela Fernández de Palencia, Hospital Clínico Universitario Virgen de la Arrixaca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2023

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

January 14, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 14, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2022-3-9-HCUVA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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