Gall Stone DiseaseNCT02568852
Comparison of Coagulation Factors During Laparoscopic Cholecystectomy
A study testing Combined anaesthesia and General anaesthesia in people with Gall Stone Disease and Polyp, run by Lütfiye Nuri Burat Government Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gall Stone Disease, Polyp
- What is being tested?
- Combined anaesthesia and General anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gall bladder stone
- Gall bladder polyp
Who cannot join
- Pregnancy
- Malignancy
- Children
- Acute cholecystitis
- Vertebral deformities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gall Stone Disease, Polyp
- Being tested
- Combined anaesthesia, General anaesthesia
- Keywords
- D-dimer, Fibrinogen, Laparoscopic cholecystectomy
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined anaesthesiaProcedure or surgery
Laparoscopic cholecystectomy under 10 mmHg pressure
General anaesthesiaProcedure or surgery
Laparoscopic cholecystectomy under 10 mmHg pressure
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | Laparoscopic cholecystectomy in general anaesthesia Receives: Procedure: Combined anaesthesia |
| group 2 | Active comparator | Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). Receives: Procedure: General anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Operation
group1 and group 2(Duration of Operation)
Measured: up to 2 hours
Secondary outcomes (15)
Fibrinogen Level
A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation
Measured: pre-operative
Fibrinogen Level
A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation
Measured: Post-operative 1 st hour
Fibrinogen Level
A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation
Measured: Post-operative 24th hour
PT(Prothrombin Time)
measures of the extrinsic pathway of coagulation
Measured: pre-operative
PT(Prothrombin Time)
measures of the extrinsic pathway of coagulation
Measured: Post-operative 1st hour
PT(Prothrombin Time)
measures of the extrinsic pathway of coagulation
Measured: Post-operative 24th hours
D-Dimer
A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis
Measured: pre-operative
D-Dimer
A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis
Measured: Post-operative 1st hour
D-Dimer
A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis
Measured: Post-operative 24th hours
aPTT(Activated Partial Thromboplastin Time)
measures of the intrinsic pathway of coagulation
Measured: pre-operative
aPTT(Activated Partial Thromboplastin Time)
measures of the intrinsic pathway of coagulation
Measured: Post-operative 1st hour
aPTT(Activated Partial Thromboplastin Time)
measures of the intrinsic pathway of coagulation
Measured: Post-operative 24th hours
Thrombin Time(TT)
measures of the extrinsic and intrinsic pathway of coagulation
Measured: pre-operative
Thrombin Time(TT)
measures of the extrinsic and intrinsic pathway of coagulation
Measured: Post-operative 1st hour
Thrombin Time(TT)
measures of the extrinsic and intrinsic pathway of coagulation
Measured: Post-operative 24th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gall Stone DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lütfiye Nuri Burat Government Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, TURGUT DONMEZ, Lütfiye Nuri Burat Government Hospital
- Investigators
- Turgut Donmez, Surgeon, Principal investigator, Lutfiye Nuri Burat Goverment Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568852
- Sponsor's protocol ID
- lutfiyeETD
- Status last verified
- May 2016
- First submitted
- 1 Oct 2015
- Last updated
- 30 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: yes
Publications
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.
PubMed 21371576Frantzides 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.
PubMed 22906327
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Coagulation Factors During Laparoscopic Cholecystectomy With General Anesthesia and Spinal-epidural Anesthesia:Prospective Randomized Trials
- ClinicalTrials.gov ID
- NCT02568852
- Acronym / sponsor ID
- lutfiyeETD
- Conditions
- Gall Stone Disease, Polyp
- Keywords
- D-dimer, Fibrinogen, Laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Lütfiye Nuri Burat Government HospitalOther government
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 6 Oct 2015 (estimated)
- Results
- Posted 30 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Procedure: Combined anaesthesiaLaparoscopic cholecystectomy in general anaesthesia |
| group 2 | Active comparator | Procedure: General anaesthesiaLaparoscopic cholecystectomy in combined anaesthesia (Spino epidural). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Gall bladder stone
- Gall bladder polyp
Key exclusion criteria (5 listed)
- Pregnancy
- Malignancy
- Children
- Acute cholecystitis
- Vertebral deformities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined anaesthesiaLaparoscopic cholecystectomy under 10 mmHg pressure | Procedure or surgery | group 1 |
| General anaesthesiaLaparoscopic cholecystectomy under 10 mmHg pressure | Procedure or surgery | group 2 |
Primary outcome
Duration of Operation
Time frame: up to 2 hours
group1 and group 2(Duration of Operation)
15 secondary outcomes
Fibrinogen Level
Time frame: pre-operative
Fibrinogen Level
Time frame: Post-operative 1 st hour
Fibrinogen Level
Time frame: Post-operative 24th hour
PT(Prothrombin Time)
Time frame: pre-operative
PT(Prothrombin Time)
Time frame: Post-operative 1st hour
PT(Prothrombin Time)
Time frame: Post-operative 24th hours
D-Dimer
Time frame: pre-operative
D-Dimer
Time frame: Post-operative 1st hour
D-Dimer
Time frame: Post-operative 24th hours
aPTT(Activated Partial Thromboplastin Time)
Time frame: pre-operative
aPTT(Activated Partial Thromboplastin Time)
Time frame: Post-operative 1st hour
aPTT(Activated Partial Thromboplastin Time)
Time frame: Post-operative 24th hours
Thrombin Time(TT)
Time frame: pre-operative
Thrombin Time(TT)
Time frame: Post-operative 1st hour
Thrombin Time(TT)
Time frame: Post-operative 24th hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21371576Ntourakis 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.
- Background: PubMed 22906327Frantzides 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.
- Individual participant dataSharing planned: Yes. yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Turgut Donmez, Surgeon principal investigator
Lutfiye Nuri Burat Goverment Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined anaesthesia and General anaesthesia in people with Gall Stone Disease and Polyp, run by Lütfiye Nuri Burat Government Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Operation (time frame: up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02568852, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.