N/A
N=50
Comparison of Coagulation Factors During Laparoscopic Cholecystectomy
Gall Stone Disease · Polyp
Bottom Line
View on ClinicalTrials.gov: NCT02568852 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Duration of Operation — 54; 65 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Combined anaesthesia (Procedure); General anaesthesia (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lütfiye Nuri Burat Government Hospital
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Operation |
54; 65 | — |
| SECONDARY Fibrinogen Level |
352; 421 | — |
| SECONDARY Fibrinogen Level |
352; 421 | — |
| SECONDARY Fibrinogen Level |
352; 421 | — |
| SECONDARY PT(Prothrombin Time) |
12.43; 13.63 | — |
| SECONDARY PT(Prothrombin Time) |
12.43; 13.63 | — |
| SECONDARY PT(Prothrombin Time) |
12.43; 13.63 | — |
| SECONDARY D-Dimer |
0.91; 1.61 | — |
| SECONDARY D-Dimer |
0.91; 1.61 | — |
| SECONDARY D-Dimer |
0.91; 1.61 | — |
| SECONDARY aPTT(Activated Partial Thromboplastin Time) |
24.54; 26.92 | — |
| SECONDARY aPTT(Activated Partial Thromboplastin Time) |
24.54; 26.92 | — |
| SECONDARY aPTT(Activated Partial Thromboplastin Time) |
24.54; 26.92 | — |
| SECONDARY Thrombin Time(TT) |
16.06; 16.01 | — |
| SECONDARY Thrombin Time(TT) |
16.06; 16.01 | — |
| SECONDARY Thrombin Time(TT) |
16.06; 16.01 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Gall bladder stone
- Gall bladder polyp
Exclusion Criteria
- Pregnancy
- Malignancy
- Children
- Acute cholecystitis
- Vertebral deformities
Data sourced from ClinicalTrials.gov (NCT02568852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.