Infection Clinical Trial
Official title:
Randomised Controlled Trial of Fibrin Sealant to Prevent Bile Leakage After Cholangiotomy
Bile leak reduction from the common bile duct, as a result of glue appliance after cholangiotomy.
Laparoscopic common bile duct exploration is a way of dealing with common bile duct stones
that has gained increasing acceptance. Following a cholangiotomy there is, however, the risk
of bile leakage from the incision.
A way of avoiding leakage following cholangiotomy may be to apply fibrin sealant on the
cholangiotomy.
The present study is based on patients undergoing laparoscopic cholecystectomy at the
department of surgery, Enköping hospital, Sweden. The patients are informed about the study
prior to the procedure. Cholangiography is performed routinely. In case common bile duct
stones are encountered on the cholangiography, an incision is made in the common bile duct
and the stones are extracted. After the stone extraction, a t tube is introduced into the
cholangiotomy and the incision is closed with running Vicryl sutures.
When the cholangiotomy has been closed, the randomisation is performed with a sealed
envelope system. If the patient is randomised to fibrin sealant, this is applied on the
cholangiotomy. A passive drain is introduced before the abdomen is closed.
Postoperatively, the amount of bile in the passive drain is measured by an observer
randomised to the allocation.
If the amount of bile in the drain does not exceed 100 ml three days postoperatively, a
secondary cholangiography is performed through the t tube. If the contrast passes to the
duodenum and no contrast leakage is seen, the t tube is withdrawn.
All postoperative complications are registered according to the Clavien-Dindo system.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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