Safety and Tolerability of Seroguard Use

Study Overview
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Brief Summary
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The performed study of safety and tolerability of Seroguard, solution (JSC Pharmasyntez, Russia) in patients, undergoing planned laparoscopic cholecystectomy, demonstrated that patients from the both groups had the similar safety profile

Detailed Description
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The present study was conducted as multicenter, randomized, double-blind, parallel group clinical study. After successful completion of screening procedures, patient underwent a planned laparoscopy. Randomization of patients into groups was performed on the day of surgery using envelops. The test drug or the placebo were used at the completion stage of surgery. Monitoring of patient on inpatient basis was performed for 6 days after completion of surgery. Discharge of patient from the hospital with no contraindications was possible on Day 7 of the study. In this case the follow-up of patient was performed on outpatient basis. Follow-up was performed for 4 weeks before Day 28 of the study. Study procedures aimed at evaluation of safety and tolerability of using the test drug or the placebo were identical in main and control groups.

Official Title
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Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Study of Safety and Tolerability of Seroguard, Solution (JSC Pharmasyntez, Russia) in Patients Undergoing a Planned Laparoscopic Cholecystectomy

Conditions
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Adhesion

Intervention / Treatment
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* Drug: Seroguard
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients. Age from 18 to 75 years, inclusive. Signed informed consent form. One of the following diagnoses as per International classification of diseases -10: 4.1. K80.1 Calculus of gallbladder with other cholecystitis 4.2. K80.2 Calculus of gallbladder without cholecystitis Indications for planned laparoscopic cholecystectomy. Exclusion Criteria: Recall of informed consent by patient. Non-compliance with the rules of participating in the study by patient. Getting pregnant. Required conversion during surgery. Required repeated surgery. Development of diseases described in non-inclusion criteria, required use of drugs not provided by the protocol in patient. Another reasons appeared during the study and interfering conduction of the study as per the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: laparoscopic cholecystectomy
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>the group were having the administration of Placebo (saline 2.4 mL/kg IP) | Drug: Placebos<br> <br> |
| Experimental: Seroguard<br>the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP | Drug: Seroguard<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) | Evaluation of safety of the study drugs Seroguard and the Placebo will be performed for all the study subjects at Visits 1-11, based on account of parameter: Vital signs (body temperature, BP, HR, RR) Laboratory investigations: Blood chemistry - total protein, glucose, ALT, AST, total bilirubin, alkaline phosphatase, amylase, creatinine Complete blood count - RBC, WBC, platelet count, hemoglobin, hematocrit, WBC differential, ESR Coagulogram - coagulation time, international normalized ratio (INR), thrombin time, activated partial thromboplastin time (APTT) Urinalysis - color, transparency, pH, specific gravity, protein, glucose, WBC, RBC, bacteria, casts, salts 12-channel ECG data - heart rate [HR], PR, QRS, QT intervals and calculated QTc interval USG data Incidence of adverse reactions Incidence of serious adverse reactions | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adhesion, Safety