Clinical trial NCT02568852: Comparison of Coagulation Factors During Laparoscopic Cholecystectomy
Official title: Comparison of Coagulation Factors During Laparoscopic Cholecystectomy With General Anesthesia and Spinal-epidural Anesthesia:Prospective Randomized Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gall Stone Disease
Polyp
Keywords: D-dimer
Fibrinogen
Laparoscopic cholecystectomy
Lead sponsor: Lütfiye Nuri Burat Government Hospital
Sponsor class: OTHER_GOV
First posted: 2015-10-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: Inclusion Criteria:

* Gall bladder stone
* Gall bladder polyp

Exclusion Criteria:

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

Primary outcomes:
measure: Duration of Operation
timeFrame: up to 2 hours
Secondary outcomes:
measure: Fibrinogen Level
timeFrame: pre-operative
measure: Fibrinogen Level
timeFrame: Post-operative 1 st hour
measure: Fibrinogen Level
timeFrame: Post-operative 24th hour
measure: PT(Prothrombin Time)
timeFrame: pre-operative
measure: PT(Prothrombin Time)
timeFrame: Post-operative 1st hour
measure: PT(Prothrombin Time)
timeFrame: Post-operative 24th hours
measure: D-Dimer
timeFrame: pre-operative
measure: D-Dimer
timeFrame: Post-operative 1st hour
measure: D-Dimer
timeFrame: Post-operative 24th hours
measure: aPTT(Activated Partial Thromboplastin Time)
timeFrame: pre-operative
measure: aPTT(Activated Partial Thromboplastin Time)
timeFrame: Post-operative 1st hour
measure: aPTT(Activated Partial Thromboplastin Time)
timeFrame: Post-operative 24th hours
measure: Thrombin Time(TT)
timeFrame: pre-operative
measure: Thrombin Time(TT)
timeFrame: Post-operative 1st hour
measure: Thrombin Time(TT)
timeFrame: Post-operative 24th hours
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Lutfiye NBGH
Study officials:
affiliation: Lutfiye Nuri Burat Goverment Hospital
name: Turgut Donmez, Surgeon
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.