Comparison of Coagulation Factors During Laparoscopic Cholecystectomy

Lütfiye Nuri Burat Government Hospital

Status: Completed

Conditions: Gall Stone Disease; Polyp

Treatments: Procedure: Combined anaesthesia; Procedure: General anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT02568852

lutfiyeETD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gall bladder stone
• Gall bladder polyp

Exclusion criteria

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

Trial design

50 participants in 2 patient groups

group 1

Active Comparator group

Description:

Laparoscopic cholecystectomy in general anaesthesia

Treatment:

Procedure: Combined anaesthesia

group 2

Active Comparator group

Description:

Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).

Treatment:

Procedure: General anaesthesia