NCT04669314

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

19 days

First QC Date

December 2, 2020

Last Update Submit

December 13, 2020

Conditions

Keywords

hemangiomaliver resectionenucleation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Hospital stay

    Hospital stay starting with operation and ends with discharge will be compared within 15 days after completion of data collection

  • Transfusion

    Erythrocyte transfusion during surgery will be analyzed within 15 days after completion of data collection

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients underwent surgery for liver hemangioma

You may not qualify if:

  • Cases lacking of more than 20% of critical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Ibni Sina Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemangioma

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Neoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 16, 2020

Study Start

October 1, 2020

Primary Completion

October 20, 2020

Study Completion

October 30, 2020

Last Updated

December 16, 2020

Record last verified: 2020-12

Locations