Comparison of Coagulation Factors During Laparoscopic Cholecystectomy

• Sponsor: Lütfiye Nuri Burat Government Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02568852
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 12.4

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Oct 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Duration of Operation [up to 2 hours]

   group1 and group 2(Duration of Operation)

Secondary Outcome Measures

1. Fibrinogen Level [pre-operative]

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

2. Fibrinogen Level [Post-operative 1 st hour]

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

3. Fibrinogen Level [Post-operative 24th hour]

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

4. PT(Prothrombin Time) [pre-operative]

   measures of the extrinsic pathway of coagulation

5. PT(Prothrombin Time) [Post-operative 1st hour]

   measures of the extrinsic pathway of coagulation

6. PT(Prothrombin Time) [Post-operative 24th hours]

   measures of the extrinsic pathway of coagulation

7. D-Dimer [pre-operative]

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

8. D-Dimer [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 [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) [pre-operative]

    measures of the intrinsic pathway of coagulation

11. aPTT(Activated Partial Thromboplastin Time) [Post-operative 1st hour]

    measures of the intrinsic pathway of coagulation

12. aPTT(Activated Partial Thromboplastin Time) [Post-operative 24th hours]

    measures of the intrinsic pathway of coagulation

13. Thrombin Time(TT) [pre-operative]

    measures of the extrinsic and intrinsic pathway of coagulation

14. Thrombin Time(TT) [Post-operative 1st hour]

    measures of the extrinsic and intrinsic pathway of coagulation

15. Thrombin Time(TT) [Post-operative 24th hours]

    measures of the extrinsic and intrinsic pathway of coagulation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Gall bladder stone

• Gall bladder polyp

Exclusion Criteria:

• Pregnancy

• Malignancy

• Children

• Acute cholecystitis

• Vertebral deformities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lutfiye NBGH	İstanbul		Turkey	34300

Sponsors and Collaborators

• Lütfiye Nuri Burat Government Hospital

Investigators

• Principal Investigator: Turgut Donmez, Surgeon, Lutfiye Nuri Burat Goverment Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: TURGUT DONMEZ, General Surgeon, MD, Lütfiye Nuri Burat Government Hospital
• ClinicalTrials.gov Identifier: NCT02568852
• Other Study ID Numbers: lutfiyeETD
• First Posted: Oct 6, 2015
• Last Update Posted: Jun 30, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by TURGUT DONMEZ, General Surgeon, MD, Lütfiye Nuri Burat Government Hospital: D-dimer; Fibrinogen; Laparoscopic cholecystectomy
• Additional relevant MeSH terms: Gallstones; Cholelithiasis; Cholecystolithiasis; Anesthetics

Study Results

Participant Flow

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy under general anaesthesia	Laparoscopic cholecystectomy under combined anaesthesia (Spino epidural).
Period Title: Overall Study
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Group 1	Group 2	Total
Arm/Group Description	Laparoscopic cholecystectomy in under 10 mmHg pneumoperitoneum	Laparoscopic cholecystectomy in under 14 mmHg pneumoperitoneum	Total of all reporting groups
Overall Participants	25	25	50
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	46	52	48
Sex: Female, Male (Count of Participants)
Female	20 80%	19 76%	39 78%
Male	5 20%	6 24%	11 22%
Region of Enrollment (participants) [Number]
Turkey	25 100%	25 100%	50 100%
ASA(American Society of Anesthesiologists ) scores (Scores on a scale(min:1 and max:6)) [Median (Full Range) ]
Median (Full Range) [Scores on a scale(min:1 and max:6)]	1	2	2
BMI (kg/m^2) [Median (Standard Deviation) ]
Median (Standard Deviation) [kg/m^2]	28.1 (4.0)	28.2 (3.5)	28.15 (3.72)

Outcome Measures

1. Primary Outcome

Title	Duration of Operation
Description	group1 and group 2(Duration of Operation)
Time Frame	up to 2 hours

Outcome Measure Data

Analysis Population Description

All patients have gall bladder disease who are between 18-80 years old.

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Measure Participants	25	25
Mean (Full Range) [minutes]	54	65

2. Secondary Outcome

Title	Fibrinogen Level
Description	A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation
Time Frame	pre-operative

Outcome Measure Data

Analysis Population Description

All patients have gall bladder disease who are between 18-80 years old.

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Measure Participants	25	25
Mean (Full Range) [mg/dL]	219	261

3. Secondary Outcome

Title	Fibrinogen Level
Description	A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation
Time Frame	Post-operative 1 st hour

Outcome Measure Data

Analysis Population Description

All patients have gall bladder disease who are between 18-80 years old.

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Measure Participants	25	25
Mean (Full Range) [mg/dL]	253	320

4. Secondary Outcome

Title	Fibrinogen Level
Description	A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation
Time Frame	Post-operative 24th hour

Outcome Measure Data

Analysis Population Description

All patients have gall bladder disease who are between 18-80 years old.

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Measure Participants	25	25
Median (Full Range) [mg/dL]	352	421

5. Secondary Outcome

Title	PT(Prothrombin Time)
Description	measures of the extrinsic pathway of coagulation
Time Frame	pre-operative

Outcome Measure Data

Analysis Population Description

All patients have gall bladder disease who are between 18-80 years old.

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Measure Participants	25	25
Mean (Standard Deviation) [seconds]	11.94 (0.64)	11.78 (0.75)

6. Secondary Outcome

Title	PT(Prothrombin Time)
Description	measures of the extrinsic pathway of coagulation
Time Frame	Post-operative 1st hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Measure Participants	25	25
Mean (Standard Deviation) [seconds]	12.1 (0.53)	12.69 (0.84)

7. Secondary Outcome

Title	PT(Prothrombin Time)
Description	measures of the extrinsic pathway of coagulation
Time Frame	Post-operative 24th hours

Outcome Measure Data

Analysis Population Description

All patients have gall bladder disease who are between 18-80 years old.

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Measure Participants	25	25
Mean (Standard Deviation) [seconds]	12.43 (0.86)	13.63 (1.07)

8. Secondary Outcome

Title	D-Dimer
Description	A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis
Time Frame	pre-operative

Outcome Measure Data

Analysis Population Description

All patients have gall bladder disease who are between 18-80 years old.

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Measure Participants	25	25
Mean (Standard Deviation) [mg/L]	0.31 (0.08)	0.34 (0.10)

9. Secondary Outcome

Title	D-Dimer
Description	A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis
Time Frame	Post-operative 1st hour

Outcome Measure Data

Analysis Population Description

All patients have gall bladder disease who are between 18-80 years old.

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Measure Participants	25	25
Mean (Standard Deviation) [mg/L]	0.56 (0.22)	1.06 (0.7)

10. Secondary Outcome

Title	D-Dimer
Description	A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis
Time Frame	Post-operative 24th hours

Outcome Measure Data

Analysis Population Description

All patients have gall bladder disease who are between 18-80 years old.

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Measure Participants	25	25
Mean (Standard Deviation) [mg/L]	0.91 (0.34)	1.61 (0.95)

11. Secondary Outcome

Title	aPTT(Activated Partial Thromboplastin Time)
Description	measures of the intrinsic pathway of coagulation
Time Frame	pre-operative

Outcome Measure Data

Analysis Population Description

All patients have gall bladder disease who are between 18-80 years old.

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Measure Participants	25	25
Mean (Standard Deviation) [seconds]	22.80 (1.48)	25.0 (2.86)

12. Secondary Outcome

Title	aPTT(Activated Partial Thromboplastin Time)
Description	measures of the intrinsic pathway of coagulation
Time Frame	Post-operative 1st hour

Outcome Measure Data

Analysis Population Description

All patients have gall bladder disease who are between 18-80 years old.

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Measure Participants	25	25
Mean (Standard Deviation) [seconds]	23.42 (1.54)	25.25 (2.35)

13. Secondary Outcome

Title	aPTT(Activated Partial Thromboplastin Time)
Description	measures of the intrinsic pathway of coagulation
Time Frame	Post-operative 24th hours

Outcome Measure Data

Analysis Population Description

All patients have gall bladder disease who are between 18-80 years old.

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Measure Participants	25	25
Mean (Standard Deviation) [seconds]	24.54 (2.16)	26.92 (2.92)

14. Secondary Outcome

Title	Thrombin Time(TT)
Description	measures of the extrinsic and intrinsic pathway of coagulation
Time Frame	pre-operative

Outcome Measure Data

Analysis Population Description

All patients have gall bladder disease who are between 18-80 years old.

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Measure Participants	25	25
Mean (Standard Deviation) [seconds]	19.88 (1.58)	20.57 (2.12)

15. Secondary Outcome

Title	Thrombin Time(TT)
Description	measures of the extrinsic and intrinsic pathway of coagulation
Time Frame	Post-operative 1st hour

Outcome Measure Data

Analysis Population Description

All patients have gall bladder disease who are between 18-80 years old.

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Measure Participants	25	25
Mean (Standard Deviation) [seconds]	17.78 (0.74)	17.61 (1.02)

16. Secondary Outcome

Title	Thrombin Time(TT)
Description	measures of the extrinsic and intrinsic pathway of coagulation
Time Frame	Post-operative 24th hours

Outcome Measure Data

Analysis Population Description

All patients have gall bladder disease who are between 18-80 years old.

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Measure Participants	25	25
Mean (Standard Deviation) [seconds]	16.06 (1.05)	16.01 (0.72)

Adverse Events

Time Frame	up to 24 weeks
Adverse Event Reporting Description	In this time period, hypotension,urinary retention,nausea and headache were observed.
Arm/Group Title	Group 1		Group 2
Arm/Group Description	Laparoscopic cholecystectomy in under general anaesthesia.(10 mmHg CO2 pneumoperitoneum)		Laparoscopic cholecystectomy in under spinal epidural anaesthesia.(10 mmHg CO2 pneumoperitoneum)
All Cause Mortality
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/25 (20%)		5/25 (20%)
Cardiac disorders
Hypotension	1/25 (4%)	1	2/25 (8%)	2
Gastrointestinal disorders
Nausea/vomiting	4/25 (16%)	4	1/25 (4%)	1
Nervous system disorders
headache	0/25 (0%)	0	1/25 (4%)	1
Renal and urinary disorders
urinary retension	0/25 (0%)	0	1/25 (4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.