Choledochotomy Techniques During LCBDE
- Conditions
- Choledocholithiasis
- Interventions
- Procedure: choledochotomy techniques during LCBDE
- Registration Number
- NCT04463381
- Lead Sponsor
- Sohag University
- Brief Summary
complications after laparoscopic common bile duct exploration (LCBDE) regarding the choledochotomy technique have not been adequately studied in the literature. Therefore, this study aimed to retrospectively analyze and compare the impact of choledochotomy techniques during LCBDE among patients with choledocholithiasis during the early and late postoperative periods.
- Detailed Description
Background: complications after laparoscopic common bile duct exploration (LCBDE) regarding the choledochotomy technique have not been adequately studied in the literature. Therefore, this study aimed to retrospectively analyze and compare the impact of choledochotomy techniques during LCBDE among patients with choledocholithiasis during the early and late postoperative periods.
Methods: from March 2014 to February 2018, 85 patients with choledocholithiasis (52 females and 33 males) were enrolled in this study. These patients were treated by LCBDE using various choledochotomy techniques, including scalpel or scissor (28 patients, 33%) in group I, using diathermy hook (35 patients, 41%) in group II, or using an ultrasonic device (22 patients, 26 %) in group III. Postoperative follow-up was done for assessment of all possible complications either early (within 3-6 months postoperatively), or late (2-6 years postoperatively) with meticulous observation and study of any relevant postoperative event.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- All adult patients with choledocholithiasis who underwent LCBDE combined with LC were enrolled in this study. No limitations as regards the stone sizes or numbers were considered. The CBD diameter should be at least ± 1 cm.
- Exclusion criteria were normal caliber or stenosed CBD, or the presence of overt cholangitis. Additionally, treated patients with the trans-cystic approach for stone extraction were excluded from this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 2 choledochotomy techniques during LCBDE choledochotomy by a diathermy hook Group 3 choledochotomy techniques during LCBDE choledochotomy by an ultrasonic device Group 1 choledochotomy techniques during LCBDE sharp choledochotomy by a scalpel or scissor
- Primary Outcome Measures
Name Time Method biliary leakage/fistula first postoperative 6 months up to 6 years postoperatively According to the international study group of liver surgery, bile leakage is defined as fluid with an elevated bilirubin level (3 times higher than the serum bilirubin measured at the same time) in the abdominal drain or the intra-abdominal fluid on or after POD 3, or as the need for radiologic intervention because of biliary collections or re-laparotomy resulting from biliary peritonitis
biliary stricture 2-6 years The biliary stricture is known as abnormal narrowing of the bile duct associated with the rising of cholestasis indexes. Additionally, it has required an invasive treatment such as ERCP, percutaneous transhepatic drainage, or re-surgery \[16\]. Biliary complications were diagnosed by trans-tubal cholangiography or through MRCP and could be managed conservatively, ERCP, if there is an accessible route, PTD or surgical intervention.
- Secondary Outcome Measures
Name Time Method Recurrent stones 2-6 years recurrence
jaundice 2-6 years missed stone
Peritoneal sepsis and abscess first postoperative 6 months peritonitis
cholangitis 2-6 years inflammation of the biliary system
wound dehiscence 2-6 years Gapped wound
operative time from incision to closure from incision to closure
intraoperative bleeding during surgery in mm
conversion rate during surgery from laparoscopy to open
wound sepsis 2-6 years infection of the wound
Trial Locations
- Locations (1)
Sohag University
🇪🇬Sohag, Egypt