Comparison of Coagulation Factors During Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Pneumoperitoneum is formed with CO2 during laparoscopic abdominal operations. Effect of pneumoperitoneum on coagulation factors is not well known. In our study the investigators aimed to compare the general anesthesia(GA) and combined spinal-epidural anesthesia (CA) during laparoscopic cholecystectomy(LC) with effect on coagulation factors. Fifty patients will be randomly assigned to either the Laparoscopic cholecystectomy under Combined anaesthesia (25 patients) or Laparoscopic cholecystectomy under general anaesthesia (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder.

Detailed Description
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Objective of study : The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy(LC).Laparoscopic cholecystectomies are usually performed under general anesthesia. Studies involving cholecystectomies with regional anesthesia recently published. During regional anesthesia pneumoperitoneum is performed with lower pressure(10mmHg CO2). Patients can not tolerate higher intraabdominally pressure. Thera are very few studies involving the effect of pneumoperitoneum on coagulation factors. In our study the investigators separate the patients into 2 groups. Group1:10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia ; Group2 : 10 mmHg pressure, laparoscopic cholecystectomy under Combined Spinal-Epidural Anesthesia The investigators performed standard conventional laparoscopic cholecystectomy procedure with 10mmHg pressure in both groups. The investigators aimed to investigate Prothrombin Time(PT), activated partial thromboplastin time(aPTT), thrombin time(TT), D-dimer and fibrinogen levels preoperative, postoperative 1st hour and 24th hour respectively.

Official Title
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Comparison of Coagulation Factors During Laparoscopic Cholecystectomy With General Anesthesia and Spinal-epidural Anesthesia:Prospective Randomized Trials

Conditions
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Polyp, Gall Stone Disease

Intervention / Treatment
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* Procedure: Combined anaesthesia
* Procedure: General anaesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gall bladder stone Gall bladder polyp Exclusion Criteria: Pregnancy Malignancy Children Acute cholecystitis Vertebral deformities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1<br>Laparoscopic cholecystectomy in general anaesthesia | Procedure: Combined anaesthesia<br>* Laparoscopic cholecystectomy under 10 mmHg pressure<br>|
| Active Comparator: group 2<br>Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). | Procedure: General anaesthesia<br>* Laparoscopic cholecystectomy under 10 mmHg pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Operation | group1 and group 2(Duration of Operation) | up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibrinogen Level | A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation | pre-operative | 
| Fibrinogen Level | A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation | Post-operative 1 st hour | 
| Fibrinogen Level | A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation | Post-operative 24th hour | 
| PT(Prothrombin Time) | measures of the extrinsic pathway of coagulation | pre-operative | 
| PT(Prothrombin Time) | measures of the extrinsic pathway of coagulation | Post-operative 1st hour | 
| PT(Prothrombin Time) | measures of the extrinsic pathway of coagulation | Post-operative 24th hours | 
| D-Dimer | A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis | pre-operative | 
| D-Dimer | A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis | Post-operative 1st hour | 
| D-Dimer | A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis | Post-operative 24th hours | 
| aPTT(Activated Partial Thromboplastin Time) | measures of the intrinsic pathway of coagulation | pre-operative | 
| aPTT(Activated Partial Thromboplastin Time) | measures of the intrinsic pathway of coagulation | Post-operative 1st hour | 
| aPTT(Activated Partial Thromboplastin Time) | measures of the intrinsic pathway of coagulation | Post-operative 24th hours | 
| Thrombin Time(TT) | measures of the extrinsic and intrinsic pathway of coagulation | pre-operative | 
| Thrombin Time(TT) | measures of the extrinsic and intrinsic pathway of coagulation | Post-operative 1st hour | 
| Thrombin Time(TT) | measures of the extrinsic and intrinsic pathway of coagulation | Post-operative 24th hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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D-dimer, Fibrinogen, Laparoscopic cholecystectomy