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.

NCT ID: NCT02867293

Last Updated: 2016-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Massive Ascites

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Preop-drainage

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

Group Type ACTIVE_COMPARATOR

ultrasound guided ascitic fluid drainage

Intervention Type PROCEDURE

ultrasound

Intervention Type DEVICE

Op-drainage

ascetic fluid drained through an abdominal incision after anesthesia

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Interventions

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ultrasound guided ascitic fluid drainage

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

ultrasound

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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AlRefaey Kandeel

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Mansoura university

Al Mansurah, Dkahleya, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Ascites

Identifier Type: -

Identifier Source: org_study_id

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