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Comparison of Coagulation Factors During Laparoscopic Cholecystectomy

NCT ID: NCT02568852

Last Updated: 2016-06-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-02-29

Brief Summary

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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

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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.

Conditions

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Gall Stone Disease Polyp

Keywords

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D-dimer Fibrinogen Laparoscopic cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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group 1

Laparoscopic cholecystectomy in general anaesthesia

Group Type ACTIVE_COMPARATOR

Combined anaesthesia

Intervention Type PROCEDURE

Laparoscopic cholecystectomy under 10 mmHg pressure

group 2

Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).

Group Type ACTIVE_COMPARATOR

General anaesthesia

Intervention Type PROCEDURE

Laparoscopic cholecystectomy under 10 mmHg pressure

Interventions

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Combined anaesthesia

Laparoscopic cholecystectomy under 10 mmHg pressure

Intervention Type PROCEDURE

General anaesthesia

Laparoscopic cholecystectomy under 10 mmHg pressure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Gall bladder stone
* Gall bladder polyp

Exclusion Criteria

* Pregnancy
* Malignancy
* Children
* Acute cholecystitis
* Vertebral deformities
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lütfiye Nuri Burat Government Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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TURGUT DONMEZ

General Surgeon, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Turgut Donmez, Surgeon

Role: PRINCIPAL_INVESTIGATOR

Lutfiye Nuri Burat Goverment Hospital

Locations

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Lutfiye NBGH

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 21371576 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22906327 (View on PubMed)

Other Identifiers

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lutfiyeETD

Identifier Type: -

Identifier Source: org_study_id