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Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial. (AscitesLDLT)

Primary Purpose

Massive Ascites

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guided ascitic fluid drainage
operative drainage of ascites through small skin incision after induction of anesthesia
ultrasound
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Massive Ascites

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • liver transplant candidates with tense acsites

Exclusion Criteria:

  • severe coagulpathy (INR more than 2 or platlet count less than 50) MELD more than 20

Sites / Locations

  • Mansoura university
  • Mansoura university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Preop-drainage

Op-drainage

Arm Description

ascites drained over the pre-operative week through multiple ultrasound guided paracentesis

ascetic fluid drained through an abdominal incision after anesthesia

Outcomes

Primary Outcome Measures

graft survival

Secondary Outcome Measures

patient survival

Full Information

First Posted
August 11, 2016
Last Updated
August 12, 2016
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT02867293
Brief Title
Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial.
Acronym
AscitesLDLT
Official Title
Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Massive ascites is usually controlled over several weeks pre-operatively in liver transplant recipients with the risk of encephalopathy and peritonitis. We hypothesized that intra-operative drainage of ascites will be safe and avoids the inherent risks of pre-operative drainage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Massive Ascites

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preop-drainage
Arm Type
Active Comparator
Arm Description
ascites drained over the pre-operative week through multiple ultrasound guided paracentesis
Arm Title
Op-drainage
Arm Type
Active Comparator
Arm Description
ascetic fluid drained through an abdominal incision after anesthesia
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided ascitic fluid drainage
Intervention Type
Procedure
Intervention Name(s)
operative drainage of ascites through small skin incision after induction of anesthesia
Intervention Type
Device
Intervention Name(s)
ultrasound
Primary Outcome Measure Information:
Title
graft survival
Time Frame
one year
Secondary Outcome Measure Information:
Title
patient survival
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: liver transplant candidates with tense acsites Exclusion Criteria: severe coagulpathy (INR more than 2 or platlet count less than 50) MELD more than 20
Facility Information:
Facility Name
Mansoura university
City
Mansoura
State/Province
Dakahleya
ZIP/Postal Code
62215
Country
Egypt
Facility Name
Mansoura university
City
Mansoura
State/Province
Dkahleya
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial.

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