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Hypercoagulation effect evaluation and deep vein thrombosis preventions after laparoscopic surgery.

Hypercoagulation effect evaluation and deep vein thrombosis preventions after laparoscopic surgery: a prospective randomized double blinded trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN62203940
Enrollment
150
Registered
2014-12-29
Start date
2014-01-01
Completion date
Unknown
Last updated
2015-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with hiautus hernia diagnosis and condition after laparoscopic fundoplications. The study domain is to evaluate the hypocoagulation effect and rate of deep vein thrombosis complications of intermittent pneumatic compression (IPC) combination of low molecular weight heparin (LMWH) after laparoscopic fundoplication Circulatory System Deep vein thrombosis

Interventions

The participants were randomly allocated into one of two groups: Group 1 received subcutaneous 2500 TV 0,2 ml LMWH Bemiparin (Zibor) - one dose (1h before the operation) Group 2 received three doses o

Sponsors

The Lithuanian University of Health Sciences (LUHS) (Lithuania)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective laparoscopic fundoplications because of gastroesophagial reflux disease, caused by hiatus hernia. 2. The patients in the two groups are similar in terms of age (18 - 75 years), weight, height, gender, duration of surgery and ASA score.

Exclusion criteria

Exclusion criteria: 1. Patients with coagulopathies disorders 2. Usage of prescription drug modifying cardiovascular response 3. Participants with systemics nervous system disease 4. Pregnant women 5. Patients, who refused to participate in the study

Design outcomes

Primary

MeasureTime frame
1. F1+2 and TAT concentrations in plasma samples were measured by solid phase sandwich ELISA method (Enzygnost® F1+2 and Enzygnost® TAT microenzyme immunoassay, Dade Behring, Germany). 2. fTFPI was performed by an ELISA technique (Diagnostika Stago, France) according to the manufacturer?s instructions. 3. Thromboelastograma - TEG measures the physical properties of the clot in whole blood via a pin suspended in a cup (heated to 37C) from a torsion wire connected with a mechanical?electrical transducer; koalin is used as activator.

Secondary

MeasureTime frame
Ultrasound examination - Toshiba Aplio SSA ? 770A - compression ultrasound (B-mode imaging only), duplex ultrasound (B-mode imaging and Doppler waveform analysis), and color Doppler imaging alone. Different lower extremity veins are best evaluated with different techniques: compression ultrasound is typically performed on the proximal deep veins - the common femoral, femoral, and popliteal veins, whereas a combination of duplex ultrasound and color Doppler imaging is more often used to interrogate the calf and iliac veins. Spiral CT venography - GE Light Speed Pro (320 slice) - using 150 mL of IV contrast - 4 mL/sec, with a delay three minutes after the start of injection, 5-mm thick axial CT venograms are acquired from the ankles to the mid abdomen.

Countries

Lithuania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026