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CBD Repair Over T-tube or Primary Repair

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StatusNot yet recruiting
Sponsors
Assiut University

Keywords

Abstract

the aim is to assess the benefits and harms of T-tube drainage versus primary closure without biliary stent after exploration common bile duct stones

Description

Common Bile Duct Exploration is a surgery that involves opening the main bile duct that drains from liver and gallbladder into the first part of the small intestine (the duodenum). This is needed when a gallstone drops out of the gallbladder into the duct and partially or completely blocks up the duct. This can cause jaundice , fever and chills, severe abdominal pain due to infection / inflammation of the bile duct, gallbladder or pancreas. This most often involves admission to the hospital and urgent intervention. Most commonly, a procedure called an ERCP is used to clear out the stones from the bile duct. If gallbladder will have to be removed soon to prevent this potentially serious condition from occurring again.

During the operation the investigators remove gallbladder then a duct exploration is performed. This involves opening the duct directly and removing the stones.

Prior to Common Bile Duct Exploration surgery, patient will be asked not to eat anything after midnight prior to the surgery. patient will be given specific instructions from the surgeon or anesthesiologist about which medications he should or should not take prior to the surgery. patient should not take any blood thinning medications at least 5 days prior to your operation. This should be discussed with the surgeon at the preop visit.

Dates

Last Verified: 08/31/2019
First Submitted: 09/24/2019
Estimated Enrollment Submitted: 09/25/2019
First Posted: 09/29/2019
Last Update Submitted: 09/25/2019
Last Update Posted: 09/29/2019
Actual Study Start Date: 09/24/2019
Estimated Primary Completion Date: 03/29/2022
Estimated Study Completion Date: 07/29/2022

Condition or disease

CBD Exploration

Intervention/treatment

Device: T-tube

Phase

-

Arm Groups

ArmIntervention/treatment
CBD exploration with T-tube
repair of CBD after CBD exploration over T-tube
CBD exploration with primary repair
primary repair of CBD after CBD exploration

Eligibility Criteria

Sexes Eligible for StudyAll
Sampling methodNon-Probability Sample
Accepts Healthy VolunteersYes
Criteria

Inclusion Criteria:

- Patients who will undergo common bile duct exploration

Exclusion Criteria:

- patients who has failed ERCP for management of common bile duct exploration

- CBD diameter 2 cm or more

Outcome

Primary Outcome Measures

1. bile leak from common bile duct [baseline]

Assessment which type of repair (with T-tube or primary repair) bile leak will occurs more

Secondary Outcome Measures

1. hospital stay length [base line]

Assessment which type of repair (with T-tube or primary repair) patient will stay in the hospital more after CBD exploration

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