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NCT02867293 Clinical 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.

Massive Ascites Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02867293
Other study ID # Ascites
Secondary ID
Status Completed
Phase N/A
First received August 11, 2016
Last updated August 12, 2016
Start date January 2013
Est. completion date January 2016

Study information
Verified date August 2016
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• ultrasound guided ascitic fluid drainage

• operative drainage of ascites through small skin incision after induction of anesthesia

Device:
• ultrasound

Locations
Country Name City State
Egypt Mansoura university Mansoura Dakahleya
Egypt Mansoura university Mansoura Dkahleya

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary graft survival one year Yes
Secondary patient survival one year Yes