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IRCT2012092410918N1 IRCT 2012-12-10 Deputy Dean of Reseach,Tabriz University of Medical Siences new method in the treatment of choledochal stones comparison between primary closure and T-tube drainage after open choledochotomy 2012-03-20 anticipated 30 Complete https://irct.ir/trial/11319 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A choledochal stone treatment. Intervention 1: All patients undergo operation with right subcostal incision, then the vertical incision made in the CBD. The stones take out with stone forceps and saline flushing.complete clearace of CBD comfirm with intraoperative colangiograhy. Next, in control group; T-tube of appropriate size insert into the CBD incision and CBD incision will be closed using interrupted absorbable sutures. Intervention 2: In intervention group;after incision of CBD and extraction of stones and intraoperative colangiography; CBD will be closed primarily without T-tube insertion by interrupted absorbable sutures.
public Abdolhamid Chavoshi Khamneh,MD
Tabriz- Golgasht Ave.
Tabriz Iran (Islamic Republic of) +41 13341317 chavoshiab@tbzmed.ac.ir Tabriz University of Medical Siences scientific Alireza Barband, MD
Tabriz-Golgasht Ave.
Tabriz Iran (Islamic Republic of) +41 15429060 alibarband@yahoo.com Tariz University of Medical Siences Iran (Islamic Republic of) inclusion criteria: jaundice on physical examination or hyperbilirubinemia in the presence of gall stone disease; choledochal stones in ultrasonnography; ERCP or MRCP, intraoperative palpation of stones in CBD. exclusion critria: patients with acute pancreatitis or colangitis presentation; suspicious malignancy; lesser than 20 or older than 80 Y/O; patients with history of laparotomy; history of heart failure; renal failure; cerebrovascular accidents and myocardial infarction; obese patients with BMI>35. 20 years 70 years Both K80.5 Calculus of bile duct without cholangitis or cholecystitis Treatment - Surgery Treatment - Surgery All patients undergo operation with right subcostal incision, then the vertical incision made in the CBD. The stones take out with stone forceps and saline flushing.complete clearace of CBD comfirm with intraoperative colangiograhy. Next, in control group; T-tube of appropriate size insert into the CBD incision and CBD incision will be closed using interrupted absorbable sutures. In intervention group;after incision of CBD and extraction of stones and intraoperative colangiography; CBD will be closed primarily without T-tube insertion by interrupted absorbable sutures. Biliary leak. Timepoint: During hospital stay,2 weeks,1 month, 3 months after surgery. Method of measurement: milliliter. Intra-abdominal collections. Timepoint: 1 month, 3 months after surgery. Method of measurement: ultrasonography. Residual stones. Timepoint: 2 weeks,1 month, 3 months after surgery. Method of measurement: ultrasonography, T-tube colangiography. Wound infection. Timepoint: During hospital stay,2 weeks,1 month, 3 months after surgery. Method of measurement: suppurative secretions-Ratio. Hospital stay. Timepoint: During admission. Method of measurement: day-calendar. Operating time. Timepoint: during admission. Method of measurement: hour. Time to removal of drain. Timepoint: during admission. Method of measurement: day-calendar. Abdolhamid Chavoshi Khamneh, MD Deputy Dean of Reseach,Tabriz University of Medical Siences Abdolhamid Chavoshi Khamneh, MD Approved 2012-04-30 Ethics committee of Tabriz University of Medical Siences Gogasht Ave.-Tabriz University of Medical Siences Tabriz Iran (Islamic Republic of)