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Comparison of Coagulation Factors During Laparoscopic Cholecystectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02568852
Enrollment
50
Registered
2015-10-06
Start date
2015-10-31
Completion date
2016-02-29
Last updated
2016-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gall Stone Disease, Polyp

Keywords

D-dimer, Fibrinogen, Laparoscopic cholecystectomy

Brief summary

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

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.

Interventions

PROCEDURECombined anaesthesia

Laparoscopic cholecystectomy under 10 mmHg pressure

PROCEDUREGeneral anaesthesia

Laparoscopic cholecystectomy under 10 mmHg pressure

Sponsors

Lütfiye Nuri Burat Government Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Gall bladder stone * Gall bladder polyp

Exclusion criteria

* Pregnancy * Malignancy * Children * Acute cholecystitis * Vertebral deformities

Design outcomes

Primary

MeasureTime frameDescription
Duration of Operationup to 2 hoursgroup1 and group 2(Duration of Operation)

Secondary

MeasureTime frameDescription
Fibrinogen Levelpre-operativeA soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation
PT(Prothrombin Time)pre-operativemeasures of the extrinsic pathway of coagulation
D-Dimerpre-operativeA fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis
aPTT(Activated Partial Thromboplastin Time)pre-operativemeasures of the intrinsic pathway of coagulation
Thrombin Time(TT)pre-operativemeasures of the extrinsic and intrinsic pathway of coagulation

Countries

Turkey (Türkiye)

Participant flow

Participants by arm

ArmCount
Group 1
Laparoscopic cholecystectomy in under 10 mmHg pneumoperitoneum
25
Group 2
Laparoscopic cholecystectomy in under 14 mmHg pneumoperitoneum
25
Total50

Baseline characteristics

CharacteristicGroup 2TotalGroup 1
Age, Continuous52 years48 years46 years
ASA(American Society of Anesthesiologists ) scores2 Scores on a scale(min:1 and max:6)2 Scores on a scale(min:1 and max:6)1 Scores on a scale(min:1 and max:6)
BMI28.2 kg/m^2
STANDARD_DEVIATION 3.5
28.15 kg/m^2
STANDARD_DEVIATION 3.72
28.1 kg/m^2
STANDARD_DEVIATION 4
Region of Enrollment
Turkey
25 participants50 participants25 participants
Sex: Female, Male
Female
19 Participants39 Participants20 Participants
Sex: Female, Male
Male
6 Participants11 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
5 / 255 / 25
serious
Total, serious adverse events
0 / 250 / 25

Outcome results

Primary

Duration of Operation

group1 and group 2(Duration of Operation)

Time frame: up to 2 hours

Population: All patients have gall bladder disease who are between 18-80 years old.

ArmMeasureValue (MEAN)
Group 1Duration of Operation54 minutes
Group 2Duration of Operation65 minutes
Secondary

aPTT(Activated Partial Thromboplastin Time)

measures of the intrinsic pathway of coagulation

Time frame: Post-operative 24th hours

Population: All patients have gall bladder disease who are between 18-80 years old.

ArmMeasureValue (MEAN)Dispersion
Group 1aPTT(Activated Partial Thromboplastin Time)24.54 secondsStandard Deviation 2.16
Group 2aPTT(Activated Partial Thromboplastin Time)26.92 secondsStandard Deviation 2.92
Secondary

aPTT(Activated Partial Thromboplastin Time)

measures of the intrinsic pathway of coagulation

Time frame: pre-operative

Population: All patients have gall bladder disease who are between 18-80 years old.

ArmMeasureValue (MEAN)Dispersion
Group 1aPTT(Activated Partial Thromboplastin Time)22.80 secondsStandard Deviation 1.48
Group 2aPTT(Activated Partial Thromboplastin Time)25.0 secondsStandard Deviation 2.86
Secondary

aPTT(Activated Partial Thromboplastin Time)

measures of the intrinsic pathway of coagulation

Time frame: Post-operative 1st hour

Population: All patients have gall bladder disease who are between 18-80 years old.

ArmMeasureValue (MEAN)Dispersion
Group 1aPTT(Activated Partial Thromboplastin Time)23.42 secondsStandard Deviation 1.54
Group 2aPTT(Activated Partial Thromboplastin Time)25.25 secondsStandard Deviation 2.35
Secondary

D-Dimer

A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis

Time frame: pre-operative

Population: All patients have gall bladder disease who are between 18-80 years old.

ArmMeasureValue (MEAN)Dispersion
Group 1D-Dimer0.31 mg/LStandard Deviation 0.08
Group 2D-Dimer0.34 mg/LStandard Deviation 0.1
Secondary

D-Dimer

A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis

Time frame: Post-operative 24th hours

Population: All patients have gall bladder disease who are between 18-80 years old.

ArmMeasureValue (MEAN)Dispersion
Group 1D-Dimer0.91 mg/LStandard Deviation 0.34
Group 2D-Dimer1.61 mg/LStandard Deviation 0.95
Secondary

D-Dimer

A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis

Time frame: Post-operative 1st hour

Population: All patients have gall bladder disease who are between 18-80 years old.

ArmMeasureValue (MEAN)Dispersion
Group 1D-Dimer0.56 mg/LStandard Deviation 0.22
Group 2D-Dimer1.06 mg/LStandard Deviation 0.7
Secondary

Fibrinogen Level

A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation

Time frame: Post-operative 1 st hour

Population: All patients have gall bladder disease who are between 18-80 years old.

ArmMeasureValue (MEAN)
Group 1Fibrinogen Level253 mg/dL
Group 2Fibrinogen Level320 mg/dL
Secondary

Fibrinogen Level

A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation

Time frame: pre-operative

Population: All patients have gall bladder disease who are between 18-80 years old.

ArmMeasureValue (MEAN)
Group 1Fibrinogen Level219 mg/dL
Group 2Fibrinogen Level261 mg/dL
Secondary

Fibrinogen Level

A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation

Time frame: Post-operative 24th hour

Population: All patients have gall bladder disease who are between 18-80 years old.

ArmMeasureValue (MEDIAN)
Group 1Fibrinogen Level352 mg/dL
Group 2Fibrinogen Level421 mg/dL
Secondary

PT(Prothrombin Time)

measures of the extrinsic pathway of coagulation

Time frame: pre-operative

Population: All patients have gall bladder disease who are between 18-80 years old.

ArmMeasureValue (MEAN)Dispersion
Group 1PT(Prothrombin Time)11.94 secondsStandard Deviation 0.64
Group 2PT(Prothrombin Time)11.78 secondsStandard Deviation 0.75
Secondary

PT(Prothrombin Time)

measures of the extrinsic pathway of coagulation

Time frame: Post-operative 24th hours

Population: All patients have gall bladder disease who are between 18-80 years old.

ArmMeasureValue (MEAN)Dispersion
Group 1PT(Prothrombin Time)12.43 secondsStandard Deviation 0.86
Group 2PT(Prothrombin Time)13.63 secondsStandard Deviation 1.07
Secondary

PT(Prothrombin Time)

measures of the extrinsic pathway of coagulation

Time frame: Post-operative 1st hour

ArmMeasureValue (MEAN)Dispersion
Group 1PT(Prothrombin Time)12.1 secondsStandard Deviation 0.53
Group 2PT(Prothrombin Time)12.69 secondsStandard Deviation 0.84
Secondary

Thrombin Time(TT)

measures of the extrinsic and intrinsic pathway of coagulation

Time frame: Post-operative 1st hour

Population: All patients have gall bladder disease who are between 18-80 years old.

ArmMeasureValue (MEAN)Dispersion
Group 1Thrombin Time(TT)17.78 secondsStandard Deviation 0.74
Group 2Thrombin Time(TT)17.61 secondsStandard Deviation 1.02
Secondary

Thrombin Time(TT)

measures of the extrinsic and intrinsic pathway of coagulation

Time frame: pre-operative

Population: All patients have gall bladder disease who are between 18-80 years old.

ArmMeasureValue (MEAN)Dispersion
Group 1Thrombin Time(TT)19.88 secondsStandard Deviation 1.58
Group 2Thrombin Time(TT)20.57 secondsStandard Deviation 2.12
Secondary

Thrombin Time(TT)

measures of the extrinsic and intrinsic pathway of coagulation

Time frame: Post-operative 24th hours

Population: All patients have gall bladder disease who are between 18-80 years old.

ArmMeasureValue (MEAN)Dispersion
Group 1Thrombin Time(TT)16.06 secondsStandard Deviation 1.05
Group 2Thrombin Time(TT)16.01 secondsStandard Deviation 0.72

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026