Obstructive jaundice is observed in 10-80 % of gallstone disease cases. The conventional tactics for the management of patients with obstructive jaundice is to remove biliary hypertension by using endoscopic or minimally invasive methods. The final surgical treatment is performed after jaundice reduction and normalization of hepatic functions. We suppose that the administration of the drug Remaxol (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid) during the perioperative period shortens jaundice duration and decreases the complications rate.
Study Type
OBSERVATIONAL
Enrollment
286
The perioperative infusion of Remaxol® (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid)
Krai Clinical Hospital
Barnaul, Russia
Hospital for War Veterans
Kazan', Russia
City Clinical Hospital No. 7
Nizhny Novgorod, Russia
Pavlov Ryazan State Medical University
Ryazan, Russia
Dzhanelidze St. Petersburg Research Institute of Emergency Medicine
Saint Petersburg, Russia
St. Elizabeth Hospital
Saint Petersburg, Russia
Samara State Medical University
Samara, Russia
Mirotvortsev University Clinical Hospital No. 1
Saratov, Russia
Kuvatov Republican Clinical Hospital
Ufa, Russia
Therapy response rate: decrease of total bilirubin level down to 20.5 µmol/l Visit 3 or decrease in total bilirubin by 70% compared to Visit 1.
Decrease of total bilirubin level down to 20.5 µmol/l Visit 3 or decrease in total bilirubin by 70% compared to Visit 1.
Time frame: Up to 2 weeks
Therapy response rate: decrease of total bilirubin level down to 61.5 µmol/l and lower by the time of cholecystectomy
Decrease of total bilirubin level down to 61.5 µmol/l and lower by the time of cholecystectomy, after successful common bile duct decompression.
Time frame: Up to 2 weeks
Complication rate in the postoperative period
Acute pancreatitis, acute renal failure, acute heart failure, pneumonia, stress hyperglycemia, infectious complications
Time frame: Up to 2 weeks
Total hospitalization duration in days (in case of two-staged surgical treatment).
Total hospitalization duration in days
Time frame: Up to 2 weeks
Total hyperbilirubinemia duration (in days) after the beginning of fluid administration.
Total hyperbilirubinemia duration (in days) after the beginning of fluid administration
Time frame: Up to 2 weeks
Interval (in days) between surgical interventions
Interval (in days) between surgical interventions
Time frame: Up to 2 weeks
Change of hepatic function tests (AST,)
Change of hepatic function tests (AST) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
Time frame: Baseline, on the day after surgery, up to 2 weeks
Change of hepatic function tests ( ALT)
Change of hepatic function tests (ALT) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
Time frame: Baseline, on the day after surgery, up to 2 weeks
Change of hepatic function test ( AP)
Change of hepatic function test ( AP) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
Time frame: Baseline, on the day after surgery, up to 2 weeks
Change of hepatic function test (GGTP)
Change of hepatic function test (GGTP) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
Time frame: Baseline, on the day after surgery, up to 2 weeks
Change of hepatic function tests (protein, albumin, fibrinogen)
Change of hepatic function tests (protein, albumin, fibrinogen) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
Time frame: Baseline, on the day after surgery, up to 2 weeks
Change of PTI
Change of PTI relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
Time frame: Baseline, on the day after surgery, up to 2 weeks
Change of renal function test (urea)
Change of renal function test (urea) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
Time frame: Baseline, on the day after surgery, up to 2 weeks
Change of renal function test (creatinine)
Change of renal function test (creatinine) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
Time frame: Baseline, on the day after surgery, up to 2 weeks
Number of patients whose cholecystectomy was delayed till next hospitalization because of the insufficient dynamics of decrease in bilirubinemia.
Number of patients whose cholecystectomy was delayed till next hospitalization because of the insufficient dynamics of decrease in bilirubinemia.
Time frame: Up to 2 weeks
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