Comparison of Coagulation Factors During Laparoscopic Cholecystectomy

May 23, 2016 updated by: TURGUT DONMEZ, Lütfiye Nuri Burat Government Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey, 34300
        • Lutfiye NBGH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gall bladder stone
  • Gall bladder polyp

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Operation
Time Frame: up to 2 hours
group1 and group 2(Duration of Operation)
up to 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibrinogen Level
Time Frame: pre-operative
A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation
pre-operative
Fibrinogen Level
Time Frame: Post-operative 1 st hour
A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation
Post-operative 1 st hour
Fibrinogen Level
Time Frame: Post-operative 24th hour
A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation
Post-operative 24th hour
PT(Prothrombin Time)
Time Frame: pre-operative
measures of the extrinsic pathway of coagulation
pre-operative
PT(Prothrombin Time)
Time Frame: Post-operative 1st hour
measures of the extrinsic pathway of coagulation
Post-operative 1st hour
PT(Prothrombin Time)
Time Frame: Post-operative 24th hours
measures of the extrinsic pathway of coagulation
Post-operative 24th hours
D-Dimer
Time Frame: pre-operative
A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis
pre-operative
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
Post-operative 1st hour
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
Post-operative 24th hours
aPTT(Activated Partial Thromboplastin Time)
Time Frame: pre-operative
measures of the intrinsic pathway of coagulation
pre-operative
aPTT(Activated Partial Thromboplastin Time)
Time Frame: Post-operative 1st hour
measures of the intrinsic pathway of coagulation
Post-operative 1st hour
aPTT(Activated Partial Thromboplastin Time)
Time Frame: Post-operative 24th hours
measures of the intrinsic pathway of coagulation
Post-operative 24th hours
Thrombin Time(TT)
Time Frame: pre-operative
measures of the extrinsic and intrinsic pathway of coagulation
pre-operative
Thrombin Time(TT)
Time Frame: Post-operative 1st hour
measures of the extrinsic and intrinsic pathway of coagulation
Post-operative 1st hour
Thrombin Time(TT)
Time Frame: Post-operative 24th hours
measures of the extrinsic and intrinsic pathway of coagulation
Post-operative 24th hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lütfiye Nuri Burat Government Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimate)

October 6, 2015

Study Record Updates

Last Update Posted (Estimate)

June 30, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lutfiyeETD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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