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

Sponsor
Hospital Universitario Virgen de la Arrixaca (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05688137
Collaborator
(none)
365
Enrollment
2
Arms
17.5
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Abdominal drainage
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
365 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Supportive Care
Official Title:
Abdominal Drainage in the Postoperative Period of Liver Transplantation (DRALIT): Multi-institutional Randomized Clinical Trial
Anticipated Study Start Date :
Jan 15, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Abdominal drainage complications [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)

Secondary Outcome Measures

  1. Assessment of quality of life (QoL) during the perioperative process using the SF-36 questionnaire. [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.

  2. Evaluation of in-hospital stay after surgery. [90 days]

    Evaluate the postoperative stay in both groups from the hospital admission to discharge measured in days of admission.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hospital Universitario Virgen de la Arrixaca

Investigators

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

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Alvaro Cerezuela Fernandez de Palencia, Principal Investigator, Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier:
NCT05688137
Other Study ID Numbers:
  • 2022-3-9-HCUVA
First Posted:
Jan 18, 2023
Last Update Posted:
Jan 18, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 18, 2023