Comparison of Coagulation Factors During Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Gall Stone Disease; Polyp
• Interventions: Procedure: General anaesthesia; Procedure: Combined anaesthesia

• Registration Number: NCT02568852
• Lead Sponsor: Lütfiye Nuri Burat Government Hospital

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-06
• Primary Completion: 2015-12
• Study Completion: 2016-02
• Results First Submitted: 2016-02-18
• Status Verified: 2016-05
• Results First Submitted QC: 2016-05-23
• Last Update Submitted: 2016-05-23
• Results First Posted: 2016-06-30
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Gall bladder stone
• Gall bladder polyp

Exclusion Criteria

• Pregnancy
• Malignancy
• Children
• Acute cholecystitis
• Vertebral deformities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 2	General anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
group 1	Combined anaesthesia	Laparoscopic cholecystectomy in general anaesthesia

Primary Outcome Measures

Name	Time	Method
Duration of Operation	up to 2 hours	group1 and group 2(Duration of Operation)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lutfiye NBGH; 🇹🇷 İstanbul, Turkey