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Clinical Trials/NCT04108780
NCT04108780UnknownNot Applicable

Comparative Study : Repair of Common Bile Duct After CBD Exploration Over T-tube or Primary Repair Without Tube

Assiut University0 sites30 target enrollmentStarted: September 25, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Primary Endpoint
bile leak from common bile duct

Study Overview

Brief Summary

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

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

bile leak from common bile duct

Time Frame: baseline

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

Secondary Outcomes

  • hospital stay length(base line)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Aboelhassan Mohamed Hassanein

doctor

Assiut University

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