Surgical Approach in Liver Hemangiomas

Hemangioma Liver Clinical Trial

Official title:

Surgical Approach in Liver Hemangiomas With Special Emphasis on Lesion Diameter and Type of Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04669314
• Other study ID #: AUTF-Hemangioma
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: December 2020
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Operations performed for liver hemangioma between January 2017 and December 2018 will be retrospectively analyzed.

Description:

Operations performed for liver hemangioma at Ankara University Hospitals will be retrospectively analyzed. Patient and disease characteristics including demographics, laboratory tests, imaging studies, type of surgical approach and outcomes including postoperative laboratory tests, record of complications, duration of hospital stay will be reviewed. Complications were classified according to Clavien-Dindo classification. The patients were informed about the surgeries in advance and their informed consents about surgeries and data collection for scientific purposes were obtained. Datafile will be anonymized before analysis and original file will be destroyed. Outcomes such as complications, hospital stay, blood transfusion and mortality will be compared between groups created according to type of surgery, lesion size, preoperative laboratory values and demographic features. Variables for prediction of better outcomes are expected to be discovered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: October 30, 2020
• Est. primary completion date: October 20, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients underwent surgery for liver hemangioma

Exclusion Criteria:

• Cases lacking of more than 20% of critical data

Related Conditions & MeSH terms

• Hemangioma
• Hemangioma Liver

Intervention

Procedure:
• Liver resection or enucleation for liver hemangioma
Operations in which the hemangioma is selectively removed from the liver parenchyma border are named enucleation, and the operations in which the hemangioma is removed anatomically or non-anatomically with some liver parenchyma surrounding it are named liver resection

Locations

Country	Name	City	State
Turkey	Ankara University Ibni Sina Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	Complications after surgery for hemangioma will be collected from records and and will be classified according to 'The Clavien-Dindo Classification of Surgical Complications'. The classification grades are ranging between Grade 1(better) which indicates minor deviation from normal postoperative course and Grade 5 (worst) which means death as a complication.	Complications reported within 3 months after surgery will be evaluated within 15 days after completion of data collection
Secondary	Hospital stay	Length of hospital stay postoperatively	Hospital stay starting with operation and ends with discharge will be compared within 15 days after completion of data collection
Secondary	Transfusion	Rate of erythrocyte transfusion	Erythrocyte transfusion during surgery will be analyzed within 15 days after completion of data collection