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NCT Number: NCT02568852

Comparison of Coagulation Factors During Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Gall Stone Disease Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyp Polyps

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lutfiye NBGH

Istanbul, 34300, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gall bladder stone
  • Gall bladder polyp

Exclusion criteria

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

Treatment and study plan

Combined anaesthesia

Procedure

Laparoscopic cholecystectomy under 10 mmHg pressure

General anaesthesia

Procedure

Laparoscopic cholecystectomy under 10 mmHg pressure

Primary outcomes

  1. Duration of Operation

    Time frame: up to 2 hours

    group1 and group 2(Duration of Operation)

Secondary outcomes

  1. Fibrinogen Level

    Time frame: pre-operative

    A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation

  2. Fibrinogen Level

    Time frame: Post-operative 1 st hour

    A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation

  3. Fibrinogen Level

    Time frame: Post-operative 24th hour

    A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation

  4. PT(Prothrombin Time)

    Time frame: pre-operative

    measures of the extrinsic pathway of coagulation

  5. PT(Prothrombin Time)

    Time frame: Post-operative 1st hour

    measures of the extrinsic pathway of coagulation

  6. PT(Prothrombin Time)

    Time frame: Post-operative 24th hours

    measures of the extrinsic pathway of coagulation

  7. D-Dimer

    Time frame: pre-operative

    A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis

  8. D-Dimer

    Time frame: Post-operative 1st hour

    A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis

  9. D-Dimer

    Time frame: Post-operative 24th hours

    A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis

  10. aPTT(Activated Partial Thromboplastin Time)

    Time frame: pre-operative

    measures of the intrinsic pathway of coagulation

  11. aPTT(Activated Partial Thromboplastin Time)

    Time frame: Post-operative 1st hour

    measures of the intrinsic pathway of coagulation

  12. aPTT(Activated Partial Thromboplastin Time)

    Time frame: Post-operative 24th hours

    measures of the intrinsic pathway of coagulation

  13. Thrombin Time(TT)

    Time frame: pre-operative

    measures of the extrinsic and intrinsic pathway of coagulation

  14. Thrombin Time(TT)

    Time frame: Post-operative 1st hour

    measures of the extrinsic and intrinsic pathway of coagulation

  15. Thrombin Time(TT)

    Time frame: Post-operative 24th hours

    measures of the extrinsic and intrinsic pathway of coagulation

Sponsors and collaborators

Lead sponsor

Lütfiye Nuri Burat Government Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Oct 6, 2015
Registry last updated
Jun 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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