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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)

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ClinicalTrials.gov Identifier: NCT02867293
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
AlRefaey Kandeel, Mansoura University

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.

Condition or disease Intervention/treatment Phase
Massive Ascites Procedure: ultrasound guided ascitic fluid drainage Procedure: operative drainage of ascites through small skin incision after induction of anesthesia Device: ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : January 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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Arm Intervention/treatment
Active Comparator: Preop-drainage
ascites drained over the pre-operative week through multiple ultrasound guided paracentesis
Procedure: ultrasound guided ascitic fluid drainage
Device: ultrasound
Active Comparator: Op-drainage
ascetic fluid drained through an abdominal incision after anesthesia
Procedure: operative drainage of ascites through small skin incision after induction of anesthesia



Primary Outcome Measures :
  1. graft survival [ Time Frame: one year ]

Secondary Outcome Measures :
  1. patient survival [ Time Frame: one year ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867293


Locations
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Egypt
Mansoura university
Mansoura, Dakahleya, Egypt, 62215
Mansoura university
Mansoura, Dkahleya, Egypt
Sponsors and Collaborators
Mansoura University

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Responsible Party: AlRefaey Kandeel, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02867293     History of Changes
Other Study ID Numbers: Ascites
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Ascites
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs