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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Active Comparator | Laparoscopic cholecystectomy in general anaesthesia |
|
| group 2 | Active Comparator | Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined anaesthesia | Procedure | Laparoscopic cholecystectomy under 10 mmHg pressure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Operation | group1 and group 2(Duration of Operation) | up to 2 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Turgut Donmez, Surgeon | Lutfiye Nuri Burat Goverment Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lutfiye NBGH | Istanbul | 34300 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21371576 | Background | Ntourakis D, Sergentanis TN, Georgiopoulos I, Papadopoulou E, Liasis L, Kritikos E, Tzardis P, Laopodis V. Subclinical activation of coagulation and fibrinolysis in laparoscopic cholecystectomy: do risk factors exist? Int J Surg. 2011;9(5):374-7. doi: 10.1016/j.ijsu.2011.02.011. Epub 2011 Mar 1. | |
| 22906327 | Background |
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yes
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Laparoscopic cholecystectomy under general anaesthesia |
| FG001 | Group 2 | Laparoscopic cholecystectomy under combined anaesthesia (Spino epidural). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Laparoscopic cholecystectomy in under 10 mmHg pneumoperitoneum |
| BG001 | Group 2 | Laparoscopic cholecystectomy in under 14 mmHg pneumoperitoneum |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Operation | group1 and group 2(Duration of Operation) | All patients have gall bladder disease who are between 18-80 years old. | Posted | Mean | Full Range | minutes | up to 2 hours |
|
up to 24 weeks
In this time period, hypotension,urinary retention,nausea and headache were observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Laparoscopic cholecystectomy in under general anaesthesia.(10 mmHg CO2 pneumoperitoneum) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Turgut Donmez | Haseki-156 | 00905347400967 | surgeont73@hotmail.com |
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| ID | Term |
|---|---|
| D011127 | Polyps |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| General anaesthesia |
| Procedure |
Laparoscopic cholecystectomy under 10 mmHg pressure |
|
| 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 |
| Frantzides CT, Welle SN, Ruff TM, Frantzides AT. Routine anticoagulation for venous thromboembolism prevention following laparoscopic gastric bypass. JSLS. 2012 Jan-Mar;16(1):33-7. doi: 10.4293/108680812X13291597716906. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ASA(American Society of Anesthesiologists ) scores | ASA scores:ASA 1(better) and ASA VI(worse) ASA I:A normal healthy patient ASA II:A patient with mild systemic disease ASA III:A patient with severe systemic disease ASA IV:A patient with severe systemic disease that is a constant threat to life ASA V:A moribund patient who is not expected to survive without the operation ASA VI:A declared brain-dead patient whose organs are being removed for donor purposes | Median | Full Range | Scores on a scale(min:1 and max:6) |
|
| BMI | BMI:Body Mass Index | Median | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Fibrinogen Level | A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation | All patients have gall bladder disease who are between 18-80 years old. | Posted | Mean | Full Range | mg/dL | pre-operative |
|
|
|
| Secondary | Fibrinogen Level | A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation | All patients have gall bladder disease who are between 18-80 years old. | Posted | Mean | Full Range | mg/dL | Post-operative 1 st hour |
|
|
|
| Secondary | Fibrinogen Level | A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation | All patients have gall bladder disease who are between 18-80 years old. | Posted | Median | Full Range | mg/dL | Post-operative 24th hour |
|
|
|
| Secondary | PT(Prothrombin Time) | measures of the extrinsic pathway of coagulation | All patients have gall bladder disease who are between 18-80 years old. | Posted | Mean | Standard Deviation | seconds | pre-operative |
|
|
|
| Secondary | PT(Prothrombin Time) | measures of the extrinsic pathway of coagulation | Posted | Mean | Standard Deviation | seconds | Post-operative 1st hour |
|
|
|
| Secondary | PT(Prothrombin Time) | measures of the extrinsic pathway of coagulation | All patients have gall bladder disease who are between 18-80 years old. | Posted | Mean | Standard Deviation | seconds | Post-operative 24th hours |
|
|
|
| Secondary | D-Dimer | A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis | All patients have gall bladder disease who are between 18-80 years old. | Posted | Mean | Standard Deviation | mg/L | pre-operative |
|
|
|
| Secondary | D-Dimer | A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis | All patients have gall bladder disease who are between 18-80 years old. | Posted | Mean | Standard Deviation | mg/L | Post-operative 1st hour |
|
|
|
| Secondary | D-Dimer | A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis | All patients have gall bladder disease who are between 18-80 years old. | Posted | Mean | Standard Deviation | mg/L | Post-operative 24th hours |
|
|
|
| Secondary | aPTT(Activated Partial Thromboplastin Time) | measures of the intrinsic pathway of coagulation | All patients have gall bladder disease who are between 18-80 years old. | Posted | Mean | Standard Deviation | seconds | pre-operative |
|
|
|
| Secondary | aPTT(Activated Partial Thromboplastin Time) | measures of the intrinsic pathway of coagulation | All patients have gall bladder disease who are between 18-80 years old. | Posted | Mean | Standard Deviation | seconds | Post-operative 1st hour |
|
|
|
| Secondary | aPTT(Activated Partial Thromboplastin Time) | measures of the intrinsic pathway of coagulation | All patients have gall bladder disease who are between 18-80 years old. | Posted | Mean | Standard Deviation | seconds | Post-operative 24th hours |
|
|
|
| Secondary | Thrombin Time(TT) | measures of the extrinsic and intrinsic pathway of coagulation | All patients have gall bladder disease who are between 18-80 years old. | Posted | Mean | Standard Deviation | seconds | pre-operative |
|
|
|
| Secondary | Thrombin Time(TT) | measures of the extrinsic and intrinsic pathway of coagulation | All patients have gall bladder disease who are between 18-80 years old. | Posted | Mean | Standard Deviation | seconds | Post-operative 1st hour |
|
|
|
| Secondary | Thrombin Time(TT) | measures of the extrinsic and intrinsic pathway of coagulation | All patients have gall bladder disease who are between 18-80 years old. | Posted | Mean | Standard Deviation | seconds | Post-operative 24th hours |
|
|
|
| 0 |
| 25 |
| 5 |
| 25 |
| EG001 | Group 2 | Laparoscopic cholecystectomy in under spinal epidural anaesthesia.(10 mmHg CO2 pneumoperitoneum) | 0 | 25 | 5 | 25 |
| urinary retension | Renal and urinary disorders | Non-systematic Assessment |
|
| Nausea/vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
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