Comparison of Coagulation Factors During Laparoscopic Cholecystectomy

Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02568852
• Other study ID #: lutfiyeETD
• Status: Recruiting
• Phase: N/A
• First received: October 1, 2015
• Last updated: January 1, 2016
• Start date: October 2015
• Est. completion date: February 2016

Study information

• Verified date: January 2016
• Source: Lütfiye Nuri Burat Government Hospital
• Contact: Turgut Donmez, Surgeon
• Phone: 905347400967
• Email: surgeont73[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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 cholecytectomy under general anaesthesia (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Gall bladder stone

• Gall bladder polyp

Exclusion Criteria:

• Pregnancy

• Malignancy

• Children

• Acute cholecystitis

• Vertebral deformities

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gall Stone Disease
• Gallstones
• Polyp

Intervention

Procedure:
• Combined anaesthesia
10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia
• General anaesthesia
10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia

Locations

Country	Name	City	State
Turkey	Lutfiye NBGH	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Lütfiye Nuri Burat Government Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Operation	group1 and group 2	up to 2 hours	No
Secondary	Fibrinogen level	A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation	pre-operative , 1st hour and 24th hours after operation	No
Secondary	PT(Prothrombin time)	measures of the extrinsic pathway of coagulation	pre-operative ,1st hour and 24th hours after operation	No
Secondary	aPTT(activated partial thromboplastin time)	measures of the intrinsic pathway of coagulation	pre-operative, 1st hour and 24 hours after operation	No
Secondary	D-Dimer	A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis	pre-operative ,1st hour and 24th hours after operation	No