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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The test group | Standard therapy + Remaxol |
| |
| The control group | Standard therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remaxol | Drug | The perioperative infusion of Remaxol® (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 weeks |
| Complication rate in the postoperative period |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with gallstone disease and obstructive jaundice, hospitalized for surgical treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krai Clinical Hospital | Barnaul | Russia | ||||
| Hospital for War Veterans |
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Acute pancreatitis, acute renal failure, acute heart failure, pneumonia, stress hyperglycemia, infectious complications |
| Up to 2 weeks |
| Total hospitalization duration in days (in case of two-staged surgical treatment). | Total hospitalization duration in days | 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 | Up to 2 weeks |
| Interval (in days) between surgical interventions | Interval (in days) between surgical interventions | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 2 weeks |
| 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 |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D041781 | Jaundice, Obstructive |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D007565 | Jaundice |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C555877 | Remaxol |
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