Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Coagulation Factors During Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568852
Recruitment Status : Completed
First Posted : October 6, 2015
Results First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
TURGUT DONMEZ, 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.


Condition or disease Intervention/treatment Phase
Gall Stone Disease Polyp Procedure: Combined anaesthesia Procedure: General anaesthesia Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Comparison of Coagulation Factors During Laparoscopic Cholecystectomy With General Anesthesia and Spinal-epidural Anesthesia:Prospective Randomized Trials
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Arm Intervention/treatment
Active Comparator: group 1
Laparoscopic cholecystectomy in general anaesthesia
Procedure: Combined anaesthesia
Laparoscopic cholecystectomy under 10 mmHg pressure

Active Comparator: group 2
Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
Procedure: General anaesthesia
Laparoscopic cholecystectomy under 10 mmHg pressure




Primary Outcome Measures :
  1. Duration of Operation [ Time Frame: up to 2 hours ]
    group1 and group 2(Duration of Operation)


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gall bladder stone
  • Gall bladder polyp

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568852


Locations
Layout table for location information
Turkey
Lutfiye NBGH
İstanbul, Turkey, 34300
Sponsors and Collaborators
Lütfiye Nuri Burat Government Hospital
Investigators
Layout table for investigator information
Principal Investigator: Turgut Donmez, Surgeon Lutfiye Nuri Burat Goverment Hospital
Publications:
Layout table for additonal information
Responsible Party: TURGUT DONMEZ, General Surgeon, MD, Lütfiye Nuri Burat Government Hospital
ClinicalTrials.gov Identifier: NCT02568852    
Other Study ID Numbers: lutfiyeETD
First Posted: October 6, 2015    Key Record Dates
Results First Posted: June 30, 2016
Last Update Posted: June 30, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: yes
Keywords provided by TURGUT DONMEZ, Lütfiye Nuri Burat Government Hospital:
D-dimer
Fibrinogen
Laparoscopic cholecystectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs