Surgical Approach in Liver Hemangiomas

December 13, 2020 updated by: Elvan Onur Kirimker, Ankara University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara University Ibni Sina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients underwent surgery for liver hemangioma between 2007 and 2018 at Ankara University Hospitals

Description

Inclusion Criteria:

  • Patients underwent surgery for liver hemangioma

Exclusion Criteria:

  • Cases lacking of more than 20% of critical data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: Complications reported within 3 months after surgery will be evaluated within 15 days after completion of data collection
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: Hospital stay starting with operation and ends with discharge will be compared within 15 days after completion of data collection
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
Transfusion
Time Frame: Erythrocyte transfusion during surgery will be analyzed within 15 days after completion of data collection
Rate of erythrocyte transfusion
Erythrocyte transfusion during surgery will be analyzed within 15 days after completion of data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

October 20, 2020

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

December 13, 2020

First Posted (Actual)

December 16, 2020

Study Record Updates

Last Update Posted (Actual)

December 16, 2020

Last Update Submitted That Met QC Criteria

December 13, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUTF-Hemangioma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Study protocol will be seen on clicaltrials.gov

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemangioma Liver

Clinical Trials on Liver resection or enucleation for liver hemangioma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe