Surgical Approach in Liver Hemangiomas

• Sponsor: Ankara University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04669314
• Collaborator: (none)
• Enrollment: 69
• Location: 1
• Actual Duration (Days): 29
• Patients Per Site Per Month: 72.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hemangioma Liver	Procedure: Liver resection or enucleation for liver hemangioma

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 Design

• Study Type: Observational
• Actual Enrollment: 69 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Surgical Approach in Liver Hemangiomas With Special Emphasis on Lesion Diameter and Type of Surgery
• Actual Study Start Date: Oct 1, 2020
• Actual Primary Completion Date: Oct 20, 2020
• Actual Study Completion Date: Oct 30, 2020

Outcome Measures

Primary Outcome Measures

1. Complications [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.

Secondary Outcome Measures

1. Hospital stay [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

2. Transfusion [Erythrocyte transfusion during surgery will be analyzed within 15 days after completion of data collection]

   Rate of erythrocyte transfusion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Patients underwent surgery for liver hemangioma

Exclusion Criteria:

• Cases lacking of more than 20% of critical data

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara University Ibni Sina Hospital	Ankara		Turkey

Sponsors and Collaborators

• Ankara University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elvan Onur Kirimker, M.D., Ankara University
• ClinicalTrials.gov Identifier: NCT04669314
• Other Study ID Numbers: AUTF-Hemangioma
• First Posted: Dec 16, 2020
• Last Update Posted: Dec 16, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Elvan Onur Kirimker, M.D., Ankara University: hemangioma; liver resection; enucleation
• Additional relevant MeSH terms: Hemangioma

Study Results

No Results Posted as of Dec 16, 2020