Back to resultsImpact 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
About this trial
This is an interventional prevention trial for Massive Ascites
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
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
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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